Pharmapack Europe has announced the winners of the 2021 Pharmapack Awards, and, due to the exceptional quality of this year’s entries, seven winners have been chosen across both the ‘Exhibitor Innovation’ and ‘Health Product’ awards.

The Exhibitor Innovation awards recognised four winners, along with one highly-commended product. Eveon was given the ‘routes of administration’ innovation award for their Intuity Spray which offers an accurate airless mist delivery with small particles to enhance surface covering. Nemera received an award for the ‘connected devices and wearables’ category for their Symbioze on-body injector. This sustainable alternative to self-injecting medication uses both reusable and disposable parts that are suitable for various drug platforms and cartridges.

The ‘primary packaging’ innovation award was given to ARaymondlife for OR2Pack, with Heinlein receiving a commendation. Finally, Hoffman Neopac was the recipient of the ‘Excellence in Packaging Sustainability’ award for their Polyfoil Mono-Material Barrier Tube. This tube is fully recyclable and gives protection to a wide range of pharma formulas.

In the Health Product awards, innovation was recognised across three categories for the first time. UCB Pharma won the Eco-Design award in partnership with CIMZIA for its 2×200 mg Syringe Maintenance Kit that incorporates innovative packaging to focus on sustainability while also addressing the unique needs of those living with Rheumatoid Arthritis.

Abbott Healthcare received the ‘Patient-centric Design’ award for their AcuDose product. This innovative measuring cap conveniently doses an accurate amount for the patient. The convenient packaging also reduces exposure to the environment and is travel-friendly. In a newly created ‘animal health’ category, Boehringer Ingleheim Vetmedica was awarded for their Aservo EquiHaler. It allows ease in the treatment of severe equine asthma. It also represents the first worldwide registered drug delivery device product for the treatment of horses by inhalation. With its integrated Soft Mist Technology, the medication can go deep into the lungs.

“Innovation and exploring new ways to overcome challenges has been integral to everything the industry has achieved in the last two years. Pharma packaging and drug delivery devices are no exception to this and the quality of our entries and the new products coming to market will help improve sustainability, patient compliance and the efficacious delivery of medicines to patients. So, I congratulate all the winners for advances they have made,” commented Tara Dougal, Head, Content and Insights, Pharmapack Europe.”

Professor Phillipe Arnaud, Chair, Health Product Awards Jury, commented, “After much discussion, we decided to attribute a special prize for Animal Health to the Aservo EquiHalerfrom Boehringer Ingelheim Vetmedica; the Jury were impressed by the innovative nature of the device, and its sustainable development approach. Compliance in animal health is a challenge, particularly with large animals and for asthmatic treatments. We look forward to seeing user feedback and case studies for this product.”

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India has blazed a trail in developing home grown manufacturing centres and the bio-pharma sector is no exception. Prime Minister Narendra Modi flew the flag earlier his year at the Hannover Messe, the world’s largest industry and technology trade fair. The massive presence of Indian companies at the show heralded India as a country that established markets could do business with; insisting that he was committed to introducing a ‘predictable’ business environment in his country. It would seem that the promises made in his pre-election ‘Make in India’ campaign to promote the country as an investment destination and manufacturing centre is beginning to pay off — in a big way. His goal is to market India as an industrial hub for foreign players eager to take advantage of the country’s large workforce, raw materials and infrastructure. This is especially relevant for new technology industries led by pharmaceutical companies including some of the world’s biggest players — and importantly with Indian businesses is the vanguard of manufacturers positioned to develop not just home markets but also creating a global footprint.

Opportunities for pharma sector

The opportunities for win/ win in best practice and cost control for players in the pharma industry are substantial, especially in India. International businesses have been on the receiving end of a full on assault by the Indian government and an army of financial advisors and business strategists who had placed emerging markets — and India in particular — on the radar for serious investors, due to its impressive growth, strong democracy and developing standards as well as its high numbers of skilled staff. What’s more, India itself is fast tracking its presence on the global pharmaceutical manufacturing scene by deploying smart strategies.

According to figures cited by the Indian government, last year globally, the Indian pharma industry is ranked third largest in volume terms and tenth largest in value terms. The sector is highly knowledge-based and its steady growth is positively affecting the Indian economy. In addition to the relatively low cost-base, the organised nature of the Indian pharma industry is attracting several companies that are finding it viable to increase their operations in the country. In terms of value, exports of Indian pharma products increased at a CAGR of 26.1 per cent to touch $ 10.1 billion during FY06-13.

But, there are some issues that are putting the brakes on an otherwise impressive growth of the indigenous manufacturing base. Currently, the Indian pharma industry is highly fragmented with about 24,000 players (33 per cent in the organised sector). The top ten companies make up for more than a third of the market.

Already major manufacturers based in the sub-continent have flexed their muscles with a flurry of M&A activity, with clearance to enter North America. The US market alone accounted for nearly 30 per cent of India’s medicine exports of $15 billion in the fiscal year through March 2014.

Europe’s reputation for quality and precision finished products, and German engineering excellence in particular, is still the order of the day with emerging markets keen to learn from years of experience. In 2012, Europe’s pharma trade surplus was estimated at €80 billion.

The advantage that India has over other emerging markets is a plethora of highly skilled engineers and technology graduates providing a ready-made low cost labour market. They cover the most sophisticated of manufacturing processes from R&D to world-leading production regimes. This is in sharp contrast with Europe where the skills gap for engineers has placed a premium on such avenues as a precious resource.

Partnership key to BRIC economies

Times are changing, however, with emerging markets gaining a foothold. For many BRIC economies, the question is how they manage to compete on a world stage with the developed regions such as Europe. The answer is simple — through partnerships. Indian pharma manufacturers are leveraging the expertise and brand strength of European engineering organisations to build GMP and cleanroom facilities that provide the necessary environments for manufacturing of pharma that meet stringent FDA and WHO regulations across the globe.

The strength of the pharma market in India is gaining traction and growing with investments continuing to pour in, largely through mergers and acquisitions. With many Indian drug companies investing outside of India as well, confidence in the market is growing from both sides. The benefits for European engineering organisations to partner with Indian pharma manufacturers lies largely in the cost benefits. Due to availability of skilled labour, India has the ability to deliver cost efficient programmes. Pharma manufacturing projects can cost between 30 and 40 per cent of manufacturing projects in the US, a significant reduction in costs leaving cash left over for investment or future projects. One of the main reasons why India’s pharma market has catapulted to become a significant player is the amount of government support it has received. With the implementation of ‘PharmaVision 2020’ the Indian government is aiming at making India a global leader in end-to-end drug manufacture.

Leading clean room technology solutions provider M+W Products’ work with global clients is regarded by many industry insiders as the ‘go-to resource’ for innovation and leveraging competitive edge. One of the key challenges according to Bardhan is the lack of readily available advanced technology products for facilities, which are needed in order for India to deliver its pharma manufacturing at global standards. European engineering and products both have strong reputations of technology and engineering excellence, which pharma companies in India are cottoning on to in terms of the benefits of partnering with such organisations. There is an incredible amount of research and development already taking place in the Americas and across Europe. Rather than follow the same route yet remain 50 to 100 years behind many organisations, businesses are realising that a combined approach to building up the Indian pharma manufacturing industry is ideal. Furthermore, these partnerships help Indian pharma companies deliver global levels of safety and quality while adhering to the – FDA and GMP standards which are essential for their products to be acceptable globally.

Delivering solutions for Indian customers

The latest technological innovations related to cleanrooms show that development is still being pursued 50 years after the first cleanroom was developed, although much of the innovation deals with improved equipment for individuals working within a cleanroom environment. Michael Rodd, M+W Products Chief Sales Officer has together with Abhishek been a driving force in delivering solutions for Indian customers. He cites, for example, when considering clothes, everyone working in cleanrooms has to change frequently. This costs time and money. This has led to many asking the question: what if the clothing could remain clean throughout the entire process?

Photodynamic disinfection

A potential solution being worked on is called ‘photodynamic disinfection’. With no negative impacts on the human body, photodynamic disinfection is a way to develop a highly disinfectant affect that destroys microorganisms in minutes. In order to achieve this, a suitable lighting technology is required which assures that light can penetrate into difficult areas of clothing such as folds or seams. This innovation is especially of interest for the food industry and medical facilities as well as cleanrooms.

Hygienic furniture

Over the past year, the design and manufacturing of hygienic furniture has evolved to meet specific cleanroom requirements. There has also been a clear shift in the way laboratory users want their cleanrooms to be designed, not only to meet current needs, but to future proof them for years to come This has taken two distinct routes: the first is a generic module approach that is flexible; the second is tighter involving furniture being placed in precise locations. Whichever route is chosen, the finish is becoming just as important as the function. There is increasingly a focus on achieving a ‘showroom’ finish in cleanrooms. This could be down to demands for the best quality working environment. Also, the viewing windows enable laboratories and cleanrooms to clearly demonstrate to visitors that they are committed to quality and control.

Is biopharma the next big thing for manufacturers?

According to a report by consulting firm McKinsey & Company ‘Rapid growth in biopharma: Challenges and opportunities,’ as the number of products rises and new process technologies such as continuous manufacturing are introduced, the complexity of biopharma operations and the biopharma supply chain will increase. Evidence indicates that current production programmes are already stretching the industry, with several players failing to deliver to the market. This challenge will only increase as sites move from the current ‘one line, one product’ setup toward nimble and flexible multiple-product operations and are required to manage both current and future technologies under one roof.

The high premium on biopharma products and the relatively smaller share of revenues they have historically accounted for in big pharma companies have led to industry-wide challenges in the supply chain. Complexity, cost and service levels are far from small-molecule best practices, even considering the additional complexity of cold-chain requirements.

New classes of molecules, from drug conjugates to the cell and gene therapies arriving in the next five years, will each require its own novel manufacturing, supply and quality-assurance approaches. Today, many companies that are insourcing these products in the late clinical or early commercialisation phase are struggling to set up the novel technologies and processes required to produce them.

Cleanrooms are not your everyday purchase. They have a very specific purpose to control and remove contamination. In today’s technologically advanced world, the key now is in attempting to future proof the cleanroom. As we all know, technologies are advancing at such a fast pace that keeping up is becoming impossible. This is why innovators like M+W Products are looking to the future and how we can make the products used, as opposed to the infrastructure, as future proof as possible. For example, many vendors are making products and controls that will be key to enhancing flexibility and sustainability in cleanroom facilities, and many of these systems are getting so complex and subtle in terms of how they will react to the building and its technologies.

By concentrating efforts on the equipment and controls, we are able to continue innovating, and more importantly, improve efficiencies and saving costs. M+W Products’ experience in India is demonstrating that European/ Indian partnerships are proving beneficial to both sides.’

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The joint venture between Bosch Packaging Technology and Klenzaids Contamination Controls, where the former will acquire a 49 per cent share in the latter, will complete a year this December. Viveka Roychowdhury gets an update on the integration process and a sense of the rationale behind the JV from Dr Andreas Mattern, Project manager – post merger integration of Klenzaids and Hamish Shahani, Managing Director, Klenzaids

Bosch already has a presence in India, so what was the rationale for the JV?

Speed was an important criterion for the joint venture. The Indian pharmaceutical market is growing at a very fast pace. The portfolios of Bosch and Klenzaids complement each other ideally. This enables us to service customers’ needs for cost-effective filling lines from a single source. By combining Klenzaid’s strengths in cleanroom equipment, peripherals and sterilising tunnels with Bosch’s innovative filling technology – such as the FLC 3005 vial filler series, which was developed in India — we are able to cater to the requirements of this so-called emerging market.

On a larger scale, we see high potential for joint projects and opportunities in further emerging markets, which goes well with our focus on Africa as a further growth market. Both Klenzaids and Bosch already have good references here. By strengthening our offer for cleanroom equipment, turnkey solutions and containment options, the joint venture will bring us a number of interesting new opportunities.

While the Bosch plant in Verna, Goa will continue to mainly focus on the confectionery and food equipment, Klenzaids brings another important asset into the joint venture, they already have a manufacturing set-up and a supply chain, which is tailored to the requirements of the pharma industry.

One year after the JV was announced, what is the progress on the integration front? What were the learnings from integrating a family-driven Indian company into the Bosch group?

We are extremely happy with the progress. The teams are connecting well, as they are driven by similar company cultures that emphasise a ‘customer first’ and quality mindset.

Bosch associates value the depth of knowledge and experience of their new Indian counterparts and the quality of the equipment they produce. This has generated trust and a lot of interest for joint projects, which is essential for the fast integration. On the other side, the Klenzaids colleagues also see the benefits of building a more scalable organisation, which is on the fast track to turning from a regional champion with some international outreach to a truly global player.

First successes prove that this is the reality, and not just theoretical planning. The first filling lines with licensed Bosch technology have been sold, and customer feedback on the partnership has been very positive. They see that we are now able to provide them the ‘best of both worlds.’

What is essential for a good integration? From our point of view it’s fast decisions, an open and honest communication, as well as being open for change on both sides. Bosch and Klenzaids had already worked together on joint projects in the past, so we knew each other quite well. This meant that from day one, we started with a common idea, and a high amount of mutual trust.

Is Bosch looking at other JVs in India? If so, at what kind of companies, services, products would be added to the Bosch Group? Any timeline to these fresh JVs?

Our current set-up perfectly matches our business needs and we are not actively looking for other partners in India. Of course, Bosch is always open to interesting opportunities.

What would you list as the top cleanroom challenges facing the industry. What are the current trends in India (from a machine manufacturer’s perspective) and how is the JV best positioned to meet these challenges and fulfill customer expectations?

One of the main challenges is to improve pharma quality standards and the accessibility of medicines for the general public at the same time. This is not only a challenge for the pharma industry but for the politics and the entire society, with numerous initiatives under way. With the joint venture, we have decades of global experience and offer high quality and safety features to India, while keeping the equipment on an affordable level for an emerging health system.

As far as projects and their timelines are concerned, it is not only about time to market. It is also about ‘time to money.’ By combining our turnkey project experience, the local service team can significantly speed up overall projects from equipment delivery through to full installation and validation cycles.

Klenzaids already has a good legacy in India, and to global clients. What then is the rationale for the JV?

We wanted to create a true centre of competence in the region for a comprehensive one-stop-solution to remain ahead of competition. In my view, Klenzaids should be positioned as a strong player in the international regulatory compliant market place. And the joint venture with Bosch would fast-track this goal. We also add value to the current Bosch portfolio with existing Klenzaids products going hand in hand and create unparalleled bandwidth in the scope of possible supplies which is unique in the market to our mind.

What are the ‘cultural changes’ necessary over the past one year? Given these learnings, what would be your advice to other Indian promoters looking at such JVs?

Bosch is arguably one of the most professional and ethnically managed companies in the world. At the same time, Klenzaids has always been professionally managed as a family-owned company. This has made operations smooth and seamless. Nevertheless, it’s very interesting to see the coming together of German quality systems and Indian value engineering. Culturally, one has to move to the means and methods that will ensure higher quality assurance. My advice to Indian promoters would be to take time and chose their partners and positions well. They should focus on becoming completely professional about every single aspect of the business and its execution.

Would there be a rise in prices of the equipment post the JV? Given that India is a price sensitive market, what is the strategy to sell given these constraints?

We are not seeking price increases. Of course, depending on requirements, we offer various solutions at different prices. Additionally, Klenzaids is now moving into high-volume production in a conscious attempt to rationalise costs. The strategy has evolved based on existing and trending market realities and is fully cognizant of client needs and imperatives.

What would you list as the top three cleanroom challenges facing the industry. What are the current trends in India (from a machine manufacturer’s perspective) and how is the JV best positioned to meet these challenges and fulfill customer expectations?

I would rank the top three challenges like this: First, the increasing reliance on cRABS and isolator technology as the primary barrier, relegating the cleanroom into a true ‘background.’ Second, Manufacturing Execution System (MES), other initiatives such as industry 4.0, and the like, which promise to change many things as we currently know them – including intelligent buildings. Third, ‘overall safety’ not just regarding the prefab suites themselves but every aspect and attribute of the system. I believe we have a lot to do to ensure compliance with the global standards. The joint venture is sensitive to these industry initiatives and is truly placing their best engineering talents to pursue this course.

viveka.r@expressindia.com

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What are the different types of products you manufacture?

We design, manufacture, supply, install and maintain highly sophisticated industrial and commercial doors and loading bay equipment. The doors meet various objectives like temperature control, dust ingress, noise control, maintain hygienic conditions etc. At the same time it allows seamless traffic of forklifts, pallet trucks etc. All our products are manufactured by European and American technology that conform to very high standards of safety. Our dock levelers also adhere to the most advanced concept. The pre-fabricated solutions for quick construction of loading bays allows a cut by 60 per cent of the construction time of pits and dramatically reduces the need of man labour.

Our product range includes high speed industrial doors, high speed clean room doors, sectional overhead doors, dock leveler, dock shelters, rolling shutters, fire rated rolling shutters, fire sliding doors, swing doors, aircraft hangar doors and shipyard doors, swing gates, sliding gates, retractable gates and boom barriers.

Which are your pharma specific products? Besides pharma, which other industries do you cater to?

We manufacture clean room high speed doors especially for the pharma industry. In this industry, clean room doors play a crucial role in the manufacturing of pharma products which require the environment to be free from microbial and particulate contamination and protected from moisture– controlled environment. These industries make high demands with respect to hygiene, sealing, operating reliability, fitting and a trouble free after-sales service. Our clean room high speed doors satisfy all these requirements and work in strictly regulated operating conditions.

Apart from pharma, we cater to logistics, warehousing, cold chain, food, safety, commercial, residential, etc. Basically our products are high in demand in industries which require safety and quick open and close applications at the entry and exit points where controlled environment needs to be maintained. This helps in not only maintaining the hygiene but also the temperature within the area and lower energy consumption thus reducing the costs substantially.

Apart from doors, we also manufacture loading bay equipment for efficiently loading and unloading of goods and maintain quality of the goods during loading till they reach to the consumers. We also manufacture aircraft hangar doors for aviation industry, shipyard doors for ports, gates and boom barriers for residential and commercial establishments.

Briefly describe these products.

• High speed industrial doors: Gandhi Automations develops prime range of high speed automatic doors used for fast access for internal and external areas of buildings. Prime high speed doors are designed and manufactured with German collaboration using innovative and creative engineering technology for frequent use in high traffic areas with opening speeds up to 3 m/s. The high opening speed reduces time taken in movement of material thus accelerating the logistics process. A wide range of prime high speed doors are available for various operations, including areas with special requirements for temperature control, hygiene, pharma, storage and handling of frozen foods, ATEX explosion proof areas, deep freezer, warehouse, loading bays and on conveyor systems. Prime reset features a special innovative self-repairing system.
• Loading bay equipment: Gandhi Automations offers complete logistics solution by providing dock levelers, dock shelters, scissor lifts, sectional overhead doors, high speed doors and dock houses. The dock equipment conforms to the highest safety standards like EN 1398 for dock levelers and EN 1570 for scissor lifts in addition to the CE mark on the products.

1. Dock levelers: Dock levelers are the most essential part of the material handling system. It improves safety, security and fast loading and unloading of goods at the warehouses, loading dock by compensating the difference in heights between the loading bay and the vehicle. It’s the most convenient way of loading and unloading goods. Dock levelers offered by Gandhi Automations are manufactured conforming to EN 1398 standards and using the advanced robotic welding technology to create a precision engineered product. A single push button activates the dock leveler into operation.
2. Dock shelters: Dock shelters cut off the inside environment from the outside. It is not only useful to the human working conditions, but also for avoiding useless wastes, therefore resulting in energy saving, ecological safeguard, protection of perishable goods and greater working efficiency. Gandhi Automations offers a complete range of dock shelters available for every kind of use and environment from the outside cold conditions or the chilled ones from outside heat and also from rain, wind, snow and dust. Dock shelters seal the gap between the building and the vehicle in such a way that when the sectional overhead door opens, goods and personnel are protected against the harsh weather conditions outside.
3. Sectional overhead doors: Porto sectional overhead doors are ideal for all industrial and logistics needs. The design and different solutions offered ensure the door to be aesthetically pleasing and perfectly suited to any architectural environment — from modern and traditional industrial buildings to fine commercial buildings. Porto doors are built to ensure the highest ease and flexibility of use which, in turn ensures a quick, hassle free and accurate replacement of old shutters. Depending on the structure of the building and the requirement, a choice can be made from a standard lift, vertical lift, horizontal lift, low headroom or inclined lift. The range consists of a wide series of track systems, panel options and safety features. Special glazed doors provide excellent lighting and vision into the building where required.
4. Scissor lift tables: Gandhi Automations offers lift tables that enhance the loading and unloading operations and conforms to EN 1570.

1. Rolling shutters:

Gandhi rolling shutters — Classic, are ideal for situations where side room is at a premium and security is required. Our rolling shutters require very little headroom above the structural opening. They combine strength with elegance along with durability and are designed for both external and internal applications. Gandhi rolling shutters are fabricated of interlocked galvalume, galvanised insulated and non-insulated, stainless steel, patented aluminum or polycarbonate profiles and patented bright steel bar rolling grills. Each of our rolling shutters is solidly constructed to promote trouble-free operation and long life. The rolling shutters can also be designed as per client’s specifications or conforming to IS 6248.

All our rolling shutters are automated using robust drive technology with manual override in case of power failure and is compact, noiseless and reliable with low decibel level.

Gandhi rolling shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement.

2. Aircraft hangar doors and shipyard doors:

Aircraft hangar doors — Hoist-up and sliding offer remarkable advantages for versatility to be suitable for aircrafts in different sizes. Optimum reliability and operational safety are important design principles. The hangar doors are designed for tough environments with extremely large openings. The sliding aircraft hangar doors are recommended where no headroom is available and side clearances permitted, whereas hoist up doors obviates the need for heavy foundation under the door for bottom tracks.

3. Industrial sliding doors:

Motorised heavy industrial sliding doors are excellent for large openings and are custom built to meet the requirements of our customers. They are ideal for industrial applications, both as external and internal doors where maximum door opening is required. The doors are designed for tough everyday operation, extremely sturdy, resistant to impact and effectively corrosion-protected.

4. Commercial doors:

• Sliding doors: Automatic sliding doors are solutions devised to meet the modern requirements of interior design. They smartly enhance the look of commercial areas and work environments. These are ideal for office buildings, shopping malls, apartments, hotels, restaurants, conferences and others. Gandhi offers a complete range of automatic systems for sliding pedestrian doors (single leaf, double leaf, telescopic) curved doors.
• Swing doors: Gandhi Automations offers automation for swing doors that have very distinctive features. While being elegant they also comply with European regulations and are sturdy to be used for heavy duty application.
• Garage doors: Garage doors open vertically, they slide upwards, then along the ceiling, through the guides provided, making them ideal when space is at a premium or when the garage door opens directly onto the pavement. Garage doors help in sound proofing and have a heat insulation coefficient, due to their insulated panels, which ensures insulation rating from heat/ cold and contribute to saving energy.

5. Fire rated shutters and doors:

• Fire rated rolling shutters: Fire rolling shutters are rated physical barriers that protect wall openings from spread of fire. They provide automatic closing in the event of fire detection. Fire rated rolling shutters provide up to four hours protection against fire. The operating system can be directly wired for activation by fire alarm systems or smoke detectors.
• Fire rated sliding doors: Fire sliding doors are ideal for wall openings where headroom is limited and frames can butt up to a ceiling or fix directly to overhead lintels. The counterweight on the door is linked to the fuse and closes the door only when the fuse breaks at a temperature of 74°c. The sliding door remains in a ‘normally open’ position and goes to a complete closing in case of fire. Available in single and double leaf options.

6. Gates:

Gandhi designed and fabricated gates are not only aesthetically pleasing, but sturdy and perfectly aligned. The pre-tensioning of the gate leaf construction reduces the risk of bending. The leaf design is available in standard form or custom made to suit the client’s requirements. Electromechanically driven steel gates are robust and suitable to be installed at any industrial, commercial or residential premises. The automated gates ensure long-term reliability and superbly blends in with the style of the buildings. We offer different types of gates like: conventional sliding gates, telescopic sliding gates, cantilever sliding gates, retractable gates and swing gates.

7. Boom barriers:

The soft edges, rounded corners and high performance boom barriers offered by Gandhi Automations are suitable for any type of installation environment. The wide range of lengths and accessories available ensures that all installation requirements are met. All models are equipped with a provision of manual operation in the event of power failure and battery back-up facility in selected models. Wide range of models suit various applications like car parking sites, condominiums, toll collection and industrial entrance. The models are available for boom length up to 8.4 m. They can be opened up to 16.8 m, which can be covered with two barriers operating as master/ slave. The boom barriers can be manually released in case of power failure. Battery backup facility is available in select models.

Tell us about your infrastructure?

Our company is headquartered in Mumbai. We have state-of-the-art manufacturing and warehouse facility of 300,000 sq ft in Bhiwandi. With offices in 23 major cities of India and a strong team of more than 500 people, we have a strong national presence and international footprint.

What is your total market share in India?

We are the leaders in entrance automation and loading bay segment with a market share of more 70 per cent in India i.e. three out of every four entrance automation or loading bay equipment have been sold and installed by us. Our products are innovative, high-quality, safe and energy efficient. Our passion and commitment to quality propels us to continuously thrive to do better for our customers by exceeding their requirements and expectations. Gandhi Automations is committed to provide excellent customer service by prompt response to customer queries. Our customer care team is available to our customers 24*7.

How will you describe Gandhi Automations growth prospects in India?

The market for our industry has been growing at a steady pace over the past couple of years in India. Entrance automation and loading bays have become a common sight in several types of industries nowadays. Rapid industrialisation and the steady growth of the commercial realty sector have been behind this growth. The thrust being given to the manufacturing sector is what has brought this product category into sharp focus. With several Special Economic Zones (SEZs), National Manufacturing Investment Zones (NMIZs) being announced, apart from the various industrial corridors that have been proposed, it is not surprising that entrance automation and loading bay industry is rapidly growing. The market that has been tapped till now is only the tip of the iceberg. With a ready made market available, this could be one product category which could witness double digit growth rates over the next decade.

Which marketing strategies have you adopted that have led to the success of your products in India?

Our strategy is not to appoint dealers for marketing and selling our products. All our contacts with the clients are done directly by our staff themselves. We believe that a dealer will never be able to service a client with the same passion as we do. In this industry, the model of appointing dealers to service a client is an absolutely unsuccessful one which ultimately results in the client being unhappy.

What are the key strategic moves that have engineered the success of the company?

We constantly strive to grow. Our strategy is to focus on some of our key areas of operation. It is all about offering technologically advanced products to our customers. We understand the needs of our clients and offer them the best products along with high levels of service. We are having 3,00,000 sq ft of manufacturing and warehouse facility at Bhiwandi where we carry out our manufacturing process. Apart from catering to the Indian market, we have also been exporting our products to the US, Far East, the Middle East, Europe and Africa.

sachin.jagdale@expressindia.com

The post ‘Our products are innovative, high quality, safe and energy efficient’ appeared first on Express Pharma.

Which equipment will be displayed at P-Mec India 2015? What are their features?

We have a wide range of products and in P-MEC India 2015, we are going to display walk in stability chamber.

The equipment has the following technical features:

• CE approved
• PLC based control system (make: Allen Bradley)
• 21 CFR Software
• HMI (LED Touch Screen Display)
• Stand by refrigeration system
• Stand by humidity system
• Imported Hygroflex sensor
• 8+8 Scanner
• Password protected door access system
• Heavy duty Rack & Trays
• SMS mobile alert system
• Hooter system
• Full view glass door
• GMP model

Will you be launching any new products at the exhibition?

We are going to launch updated 21 CFR software in this exhibition and below are their additional advantages/ details:

• Browser-based technology
• Free of cost software with equipment without any extra costing
• Unlimited equipment connectivity in single software
• Unlimited user creation and as per their designation provision of resources
• Automatically calculate MKT
• Data generated on PDF format
• Open door with reason master
• Input / Output status of major components
• Automatic back up facility
• Secured audit train (user, equipment, alarm, SMS & events)

With many of your competitors displaying their products in the same event, how are you going to differentiate your products from your counterparts?

High quality of our products with latest technology and prompt after sales service differentiates us from the competitors and this is how, we are growing faster than our competitors.

How will you describe your experience with previous editions of P Mec? What are your expectations from this year’s event?

P-Mec exhibition is number one hub to get top to user level crowd in overall pharma industry, so every year, it is a main plan for promoting and interacting existing as well as new clients in the market. This year, we are expecting foreign clients as well as distributors to promote our products.

What is Mack Pharmatech’s market growth over the last two years in India? What percentage of your revenue comes from the international markets?

In FY 2013-14, we have achieved 20 per cent hike as compared to FY 2012-13, whereas, in 2014-15, we grew up to 35 per cent and up to the end of third quarter, we reached 40 per cent.

Right from the beginning, there was a double digit growth to our sales Y-O-Y. This indicates the confidence of the buyer in our products and no doubt the aggressive approach by our marketing team. We have an all India marketing network covered by our own team of marketing people as well as the agents, who represent us in various parts of the country.

We have already crossed the borders by supplying our machines to Europe, Ukraine, Africa and other parts of Asia and a total of 25 per cent revenue comes from the international market. We are targeting new upcoming markets in the Middle East and South Asia as well and is expecting 50 per cent revenue in the years to come.

What are your business plans for the next five years?

With a strong new business visibility and our ability to expand existing relationships, we remain confident that we will continue to drive growth, achieve our strategic corporate objectives, and emerge stronger in our journey towards global leadership.

sachin.jagdale@expressindia.com

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Contec Airflow is involved in offering large centralised air conditioning and cleanroom projects. Tell us more about the company’s ongoing business activities.

Our main focus have been on the HVAC (heating, ventilating, and air conditioning) projects especially cleanroom applications. In cleanroom also, the major focus segment is pharmaceuticals, however, there have been a large number of requirements from thermal/ hydro power plants, dairy plants, logistics warehousing, cold storage, textile (spinning, quench, take up areas), digital printing etc. As production machines are getting more sophisticated, HVAC requirements is becoming necessary.

Contec has been serving the Indian pharma industry since the last 17 years. What changes did you see?

Clients have become very knowledgeable which in turn makes them very demanding. Their main focus is on compliance to the WHP cGMP / US FDA guideline. Everyone wants the best of the facilities.

The pharma industry is a highly regulated one. Which regulatory requirements do you adhere to?

We follow ISO 14644-1, 2, 3, and 4 guidelines for all our HVAC system designs and its validation. As far as process layout it is the prerogative of the client.

Contec is specialised in turnkey air handling system. Tell us more about it

Our main focus is on the design and build jobs. We focus on the industrial applications which provide design challenges in the system. Not that we don’t do routine jobs like hotels, offices, shopping malls etc. but these applications does not provide the required challenges/ excitement at the time of commissioning. We are working on design for hydro power plants which are 300 ft below the ground in a tunnel. We are implementing projects requiring humidity as high as 90 per cent RH and as low as 10 per cent RH and temperature ranging from +40° C to -30° C. Class of cleanliness from pure ventilation system to class 100 applications, from oral solid dosages to class B/A sterile areas.

Why clean room needs to have air conditioning?

In a cleanroom application, HEPA filters are part of the air filtration sequence. These filters are non-washable and throw away type. If the area is not air conditioned then we will have to have 100 per cent fresh air system. If it is 100 per cent fresh air system, then HEPA filters will get choked in about three to six months of time. This will increase the operating cost.

As the temperature increases, the disturbed state of motion (entropy) of the air increases. If the area is not air conditioned, the movement of dust particles is higher as compared to the air conditioned area. This higher energy levels or disturbed state of motion makes it difficult to maintain the class of cleanliness.

Tell us about the regulatory requirements in maintaining the air conditioning temperature?

The temperature to be maintained in purely guided by the process requirements and dress codes of the operators.

How critical it becomes in the pharma industry if the humidity is not maintained and And how adverse will it be?

Maintaining humidity is very critical. If the humidity is not maintained, quality of products suffers. This can have serious impact on shelf life, fungal/bacterial growth and end performance of product. Humidity levels are purely guided by hygroscopic nature of the product and it is very important and critical to maintain humidity as per product requirements.

Which are your major products and how does it work?

Our company’s main thrust area is projects and to complete a project, major equipment used are

• Air handling unit
• Pre fabricated ducts
• Terminal HEPA filters
• Chillers
• Cleanroom partitions
• Paintings and floorings
• Building management system
• Cleanroom equipment (Pass boxes, laminar airflow, dispensing booth, air shower etc.)

Some of the products are manufactured by us and the other products are made in our associates factory as per our specifications.

How many projects have been commissioned in the pharma sector?

In the industry on the whole, I’m not sure about the number of projects getting executed. We normally execute between 15-20 pharma projects in a calendar year.

Where do you see the Indian pharma industry in next two years and how it will help to accelerate company’s growth?

With regulatory authorities getting stricter, latest guidelines getting very comprehensive, manufacturers have to upgrade their existing facility. Therefore, the growth of pharma industry is phenomenal and the opportunities are immense. It is not about taking projects, it is about completing and handling over the project as per the technical requirements and within the timeline.

Whom do you consider as a major client and why?

Intas pharmaceuticals, ITC and ONGC petrochemical additives [OPAL] are some of the major clients for whom we are executing projects. Right now they are major clients because they give us large size projects on a continuous basis i.e. one after the other.

Tell us about the company’s future plans.

The company wants to focus on energy efficient design i.e as per green building codes and guidelines. Major operating cost in any pharma plant is power cost. With our design and calculation, we mainly focus to reduce the energy consumption. We have various equipment and design to achieve this goal. We are planning to have in-house manufacturing for cleanroom partition, cleanroom equipments and upgrade/ update the existing facility for AHU and filters.

u.sharma@expressindia.com

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Acino, the Swiss pharmaceutical producer, has trusted in Romaco Innojet technologies to make its MUPS tablets ever since 2004. Five processing machines in the VENTILUS series are currently used to coat micropellets at Acino’s Liesberg facility. There is a steadily growing demand worldwide for innovative oral release forms.

The backdrop is breathtaking, about 20 miles south of Basel, surrounded by the mountains of the Swiss Jura, is the site of Acino Pharma’s Liesberg production facility. The Acino Group, headquartered in Aesch, is specialised in the development and production of complex galenic formulations. The manufacture of pharmaceutical solids with delayed API release is one of the Liesberg plant’s core competencies. Around 1.5 billion tablets and capsules currently leave the factory every year.

“In spite of this, our capacities here are not yet exhausted and our international target markets are growing at exponential rates. That’s why we’re planning to double our volumes in the medium term,” explains Christophe Dohr, Pharmaceutical Production Head Liesberg, Acino Pharma.

Acino Pharma presently employs some 110 staff in Liesberg, with production in three shifts, five days a week. The majority of the output is destined for licensees both in Switzerland and worldwide. Acino’s portfolio at the Liesberg site comprises oral drugs for treating cardiovascular disorders and Parkinson’s disease as well as various narcotic substances. So-called MUPS tablets form the mainstay of its business.

MUPS and their many advantages

Multiple unit pellet systems, or MUPS for short, are a dosage form consisting of coated API pellets, which are mixed with microcrystalline cellulose and pressed into tablets. Their main characteristic is the controlled release of the active ingredient, which is achieved by applying a functional coating to the pellets. The medication is absorbed in the intestine once the tablets have dissolved in the stomach. Since the tiny pellets pass through the digestive cavity rapidly and unhindered, MUPS tablets do not necessarily have to be taken on an empty stomach. They can also be halved without losing their therapeutic efficacy. Cutting the tablets in two does not damage the sustained-release coating of the micropellets. All of these criteria help improve patient compliance.

The demand for MUPS formulations has risen steadily in the last few years for these diverse reasons. In particular, tablets are a dosage form to which most patients are already accustomed. Acino was among the first to recognise this trend and position itself accordingly. Today, more than 90 per cent of all pellet batches are pressed into MUPS tablets. “Acino specialised in the manufacture of MUPS tablets over a decade ago. The highly complex production process has been continuously improved ever since and we’re now in a comfortable situation where we can deliver premium quality at attractive unit costs,” Dohr emphasises.

Two-stage coating process

Before being pressed into tablets, the pellets undergo a two-stage coating process in which their weight is more than doubled. Neutral pellets made from glucose are used as starter particles. In the first step, the active pharma ingredients are applied one layer at a time, followed by the sustained-release coating. This process takes several days, during which the diameter of the pellets increases from approximately 300 µm to 1000 µm (micrometres). The micro format gives a good idea of the complexity involved.

Since 2004, Acino has trusted in the air flow bed technology originally developed and internationally patented by Dr h.c. Herbert Hüttlin to build up these pellets. Five Romaco Innojet production machines in the VENTILUS series are installed at Acino’s Liesberg facility together with a pilot system of the same type, which is used for research and development. The containers of the production scale machines have a capacity of 800 litres and are designed to handle batches weighing up to about 600 kg. Despite its sheer physical size the technology saves valuable space on the production floor. “The air flow bed unites all the processes which are necessary to build up API pellets and granulates in one system,” confirms Michael Tewelde, Team Expert Granulation, Acino Pharma. “Alternative technologies would need a much bigger footprint, not to mention the additional storage capacity.”

Air flow bed technology

The process air used for the air flow bed is controlled by the special booster – an ingenious container bottom consisting of overlapping circular plates. The homogeneous flow conditions which are created in this way result in a spiral, orbital product flow. The process air causes the pellets to hover, so that gentle intermixing is guaranteed and particle collisions or friction are avoided. The speed of the pellets and the distance travelled are clearly defined. The evaporation rate can therefore be calculated precisely and the dose rate adapted to match. The coating material is sprayed into the product from below by a central bottom spray nozzle. This nozzle is designed with a rotating spray head which prevents the annular spraying gap from becoming blocked. The gap has an adjustable width, enabling the droplet size to be varied. In addition, the spray angle can be set exactly by means of the spraying and support air and there is virtually no measurable spray loss.

The pellets pass through the liquid film regularly. Before the next coating is applied, they must be sufficiently dry for the product not to be over-wetted. The spray rate can be adjusted to rule out unwanted agglomeration due to the carrier dissolving. “The Ventilus technology lets us regulate moisture extraction absolutely accurately; that way, the pellets are built up homogeneously with only a very small standard deviation,” Tewelde continues. “They’re spot on in terms of quality and process efficiency.” Owing to the selective application of the suspension, Acino’s consumption of raw materials and coating is moreover down between ten and fifteen percent, saving further time and money.

Acino’s Liesberg lab

Acino has an in-house test laboratory in Liesberg with air flow bed systems for laboratory and pilot trials. Many customers take advantage of this opportunity to test their formulations during the development phase. Scale-ups from pilot to production are a regular event there on a VENTILUS V 200. Video cameras which show the product movement directly on a screen are installed in all Innojet systems to permit the coating processes to be monitored. The operator can thus keep a close watch on the batch process at all times and intervene immediately if necessary. And for interested customers, it’s a unique chance to see the MUPS coating technology live in action.

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Pharmaceutical manufacturers of both sterile and non-sterile products, and medical devices, are required to demonstrate that manufacturing processes and procedures minimise any potential contamination to the product from the manufacturing environment. Contamination can arise from a number of sources: water, air, surfaces and personnel, each of which poses a potential risk to product.

These risks of contamination are avoided by putting environmental controls in place (through correct grade of air-supply, satisfactory cleaning and disinfection practices and so on). Where controls cannot off-set every contamination risk, and also as a means to demonstrate the level of control, environmental monitoring programmes are devised and put into action(1).

The primary protection from contamination is through well-constructed and maintained cleanrooms. This is supported by trained personnel, following strict gowning protocols, and cleaning and disinfection(2). Once environmental control has been accomplished, verification is undertaken through environmental monitoring (for both particulates and viable microorganisms).

Cleanrooms

Cleanrooms and clean air devices are typically classified according to their use (the main activity within each room or zone) and confirmed by the cleanliness of the air by the measurement of particles. The primary objective of cleanrooms in pharmaceutical processing is to minimise and control microbial and particulate contamination. There are many sources of contamination. There are four principles applying to control of airborne microorganisms in cleanrooms. These are(3):

• Filtration (through the use of HEPA filters). The air entering a cleanroom from outside is filtered to exclude dust, and the air inside is constantly re-circulated through HEPA (High Efficiency Particulate Air) filters (alternative filter are ultra-low penetration air (ULPA) filters). This is controlled through a HVAC (Heating, Ventilation and Air Conditioning) system.
• Dilution (to ensure that particles generated in cleanrooms, in addition to those which pass the filters, are carried away by diluting the area with new “clean” air).
• Directional Air Flow (to ensure that air blows away from critical zones, as particles and microorganisms cannot “swim upstream” against a directional air flow). This is achieved through pressure differentials.
• Air Movement (rapid air movement is important for as long as particles and microorganisms stay suspended in the air they are not really a problem, for it is only when they settle out that they become an actual cause of contamination).

Innovations with cleanrooms

There have been several advancements or changes in approach relating to cleanrooms. These include the use of modular cleanrooms and studies in energy efficiency, designed to make cleanrooms cost effective whilst still maintaining contamination control principles.

Cleanroom design

Modern approaches to cleanroom design is aimed at ensuring that the cleanroom is designed at optimising contamination control. It is important to dedicate time in designing cleanrooms and the equipment located in cleanrooms for, if there is a design fault in one part, this will affect the items of equipment and if there is a fault in conception stage this will be expensive and time consuming to rectify.

For cleanroom design, modern approaches utilise Computer Aided Engineering software for the design process, such as Building Information Modelling (BIM) software. Such software covers geometry, spatial relationships, light analysis, geographic information, quantities and properties of building components (for example manufacturers’ details)(4). Systems, assemblies and sequences can be shown in a relative scale with the entire facility or group of facilities. When designing modern cleanrooms, the following approach should be adopted:

• The type and function of the cleanroom should be established. This should include the required cleanroom grades or classes and how cleanrooms of different grades will interact (including requirements for air-locks and pressure cascades).
• The most important aspect is drawing up the process flow. Here the cleanroom management, together with engineers and quality assurance personnel, should map the path that equipment, product and operators will take in the cleanroom.
• Established quality risk management tools like HACCP (hazard analysis and critical control points) or FMEA (failure modes and effects analysis) can be used for this purpose. Areas which pose a contamination control risk should be noted and attempts should be made to design these risk areas out (the principles of quality by design). Other considerations can also be included at this stage, including whether there is adequate clearance under door frames for equipment to pass through.
• In the design, there should be sufficient space for equipment and connections.
• The cleanroom should be constructed from a material which is compatible with different cleaning and disinfection solutions.
• Ideally, a mock-up of the cleanroom should be constructed. This is particularly important for testing the process, product and personnel workflow. In terms of understanding contamination control it is essential to understand what objects are passed from one class of cleanroom to another.

Modular cleanrooms and bespoke design

Modular cleanroom are cleanrooms that are assembled from prefabricated modules. This process of cleanroom construction differs from standard (or ‘common’) cleanrooms in that:

• Common cleanrooms are assembled at the construction site from many elements
• For modular cleanrooms a significant part of assembling works is done at the factory that produces modules. Only assembling of complete modules remains for the customer’s site.

Common cleanrooms are tailor made cleanrooms. Their design follows specific layouts that are drawn by the technologist from understanding specific processes. Whereas modular cleanrooms are often designed to fit into existing spaces. With modular cleanrooms other restrictions can appear. This is because the cleanroom construction process is separated into two parts, which are executed in two different places: the modules manufacturer and the customer’s site. This can present certain difficulties in terms of transport and later assembly (5).

Antimicrobial coatings

Some types of equipment and surfaces can be manufactured with antimicrobial coatings. One example is the incorporation of silver or copper which are effective against a range of micro-organisms. An advantage of silver ions, for example, is that although they have antimicrobial properties, silver is rarely toxic against human cells. Examples of the application of silver include implements like forceps. Also in relation to surfaces, the incorporation of wipeable surfaces onto equipment allows for the easier cleaning and disinfection. Some of these innovations include polythene covered computer keyboards.

Energy efficiency

Cleanroom technologies are not only directed towards contamination control. The energy efficiency of cleanrooms is currently of great importance for companies who wish to save costs and to reduce the amount of carbon generated. To address this International Standard ISO 14001, which describes environmental management and practices and EN 16001, a European energy standard, are becoming increasingly used (both standards are likely to be amalgamated into international energy standard ISO 5001). Despite the appeal of controlling energy consumption, care must be taken when adopting such standards in relation to contamination control for actions to alter the operation of HVAC (heating ventilation and air conditioning) parameters can have an impact upon the level of non-viable particles and viable counts. Therefore microbiologists should always be involved in any energy saving projects.

Barrier technology

The use of barrier technology protects critical cleanroom operations. Within many cleanrooms unidirectional airflow (UDAF) units are found. A UDAF is classified as a minienvironment; an alternative term is ‘separative devices’ (separative devices range from open to closed systems and include isolators and Rapid Access Barrier Systems (RABS)). These are localised environments created by an enclosure to isolate a product or process from the surrounding environment. The advantages in using a minienvironment include the following:

• Minienvironments may create better contamination control and process integration.
• Minienvironments may maintain better contamination control by better control of pressure difference or through the use of unidirectional airflows.
• Minienvironments may potentially reduce energy costs.

Of these types of micro-environments, the most widely used for contamination control in relation to aseptically filled products are isolators.

Isolators intended for aseptic processing are required to be operated under positive pressure and are subjected to decontamination process before start of the batch processing. Modern isolators more often use vapourised hydrogen peroxide, although alternatives are available including peracetic acid or chlorine dioxide(6). These methods can also be deployed for the decontamination of cleanrooms.

The key principles for isolator use are (7):

• The air exchange between the isolator and with the surrounding environment must occur only through a microbial retentive filter such as HEPA or /Ultra Low Penetration Air (ULPA).
• The positive pressure aseptic processing isolator must be decontaminated in a reproducible and quantifiable manner to ensure the sterility assurance level of 10-6. This is assessed through the use of biological indicators of a suitable population, species and resistance. For vapour phase hydrogen peroxide systems, geobacillus stearothermophilus is normally used.
• Entire activity / handling of materials inside an isolator shall be achieved remotely; any part of human body cannot enter the isolator.
• Asepsis shall be maintained for each unit operation and for material transfers. Any material entering the isolator must either be decontaminated inside the isolator or shall be sterilised and taken inside via a rapid transfer port.

Disposable sterile plastic technology

A major advance with cleanroom technology is with single-use sterile disposable technologies. Such technologies have reduced risks by allowing organisations to move away from equipment which needs to be sterilised (such as stainless steel vessels). It also negates the need to use consumables that are recycled or which present a risk with their transfer into cleanrooms, to disposable and single-use sterile items. The advantages of this technology is that it eliminates the need for cleaning, eliminates the need for the pharma company to perform in-house sterilisation, reduces the use of chemicals, reduces storage requirements, reduces process downtime and increases process flexibility, and avoids cross contamination. Single-use items are typically sterilised using gamma rays (electromagnetic irradiation), which kill microorganisms by destroying cellular nucleic acid(8).

Aseptic connectors

A variant on single use technology is the aseptic connector. Innovations in aseptic connection technology have led to the development of single use connector systems. These are based on the so-termed alpha-beta principle which allows the connection to be performed in an environment this does not require unidirectional airflow or other capital equipment to maintain sterility.

Disposable holding devices

Plastic technology has also led to an array of sterile plastic holding devices. An example is with disposable mixing systems. These can be connected to capsule membrane filters and a hold bag. These interconnected disposable systems have a considerable advantage in that they are gamma sterilised and ready to use.

Garments

Given that people are one of the primary sources of microbial contamination in cleanrooms (through shedding of skin flakes, many of which contain microorganisms), attention has been paid to gowning. While behaviours and techniques for gowning can be addressed through training and procedures, aspects of the gown design require attention.

Manufacturing gowns using continuous strong fibres of pure high-density materials, like polyethylene, fabrics can be constructed that are low linting and free of inherent contaminants that could represent a risk in critical environments. Cleanroom managers are more often requesting certification for gowns to show that they are low in particulates. For gowns that are re-laundered, stipulating the maximum number of times that a gown can be washed and irradiated is important.

Polymeric flooring

A risk to cleanrooms arises from personnel transferring contamination into the area via footwear or through equipment transfer (such as trolley wheels). One way to minimise contamination is to use special mats which are designed to remove dirt, particles and micro-organisms. Where such mats are used they have traditionally been sticky-mats. Although these are fairly effective, more efficient contamination control can be achieved from polymeric flooring.

Polymeric flooring is an especially designed ‘plastic’ which works through electromagnetic forces causing particles to be attracted from surfaces like footwear, and retained on the surface of the mat. This mechanism ensures that any contamination residing on the mat is not passed back onto the personnel who walk across it.

Monitoring technologies

The most significant advancement with microbiological monitoring methods has been the advent of Real Time Laser-Induced Fluorescence Systems. These instruments continuously monitor both inert particulates and viable microorganisms in real time. They are very sensitive, where the limit of detection can be down to 1 microbial cell. It provides both total particulate and viable counts.

The instruments are based on optical spectroscopy. This is an analytical tool that measures the interactions between light and the material being studied. These instruments work by elastic light scattering. This measures two things (9):

Particle counts: where the size of a scattering particle, as it passes through a light beam, is comparable to a certain wavelength of light. The intensity of the scattering is dependent upon the size of the particle. Such systems will detect and quantify particles within a 0.5 to 20 um range.

Microbial counts: a 405 nm laser that intersects the particle beam, so that as a particle passes through the inelastic scattering measures the intrinsic fluorescence of the particle, from the metabolites (such as NADH and riboflavin) inside microorganisms.

There is a growing trend within the pharma industry towards the use of Process Analytical Technology (PAT). The goal of process analytical technologies (PAT) are to improve consistency of product quality, provide “right first time” manufacturing (to reduce costs and reduce cycle time), reduce the regulatory delays associated with changes in manufacturing, and improve the safety of chemical processes. PAT could also be used to reduce the end-of-line laboratory testing. The ‘real time’ counters fit well with this paradigm.

With more classical environmental monitoring methods (the use of agar plates), it is now commonplace to be able to track the use of the media through barcoding. Scanning bar codes allows the information about the plate, such as the media batch number and expiry time, to be transferred to a Laboratory Information Management System (LIMS). To ensure that the sample is not at risk to adventitious contamination, several types of Petri dishes now come equipped with lockable lids.

Environmental control

Arguably the most important aspect of environmental control in a cleanroom is the control of airborne particulates as this is a direct indicator of cleanroom contamination. Particles in the air are measured through particle counters. The most efficient means of monitoring particles is by linking particle counters to a facility monitoring system (FMS). It is consist of discrete particle counters, each with individual pumps, and the data is sent using wireless ethernet to a central data capture system. Modern particle counters have the advantage that they meet the more rigorous demands of the new international standard for particle counter calibration (ISO 21501). In the event of a counter breakdown a spare counter can quickly replace the malfunctioning counter due to ‘plug-and-play’ features and the particle counting software will record the serial number for audit purposes. This feature is important for aseptic filling where continuous particle counting is a GMP requirement.

References:
1. Sandle, T. and Saghee, M.R. (2013). ‘Cleanroom certification and ongoing compliance’. In: Sandle, T. and Saghee, M.R. Cleanroom Management in Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK, pp169-184
2. Sandle, T. (2012a). ‘Application of Disinfectants and Detergents in the Pharmaceutical Sector’. In Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK, pp168-197
3. Halls, N. (2004): ‘Effects and causes of contamination in sterile manufacturing’ in Halls, N. (ed.): Microbiological Contamination Control in Pharmaceutical Cleanrooms, CRC Press, Boca Raton, pp1-22
4. Sandle, T. (2013). Application of Quality Risk Management to cleanroom design, Clean Air and Containment Review, 13, pp24-25
5. Sandle, T. (2014) Modern Approaches to Pharma Cleanroom Design, Controlled Environments, 17 (1): 8-10
6. Mau, T., Hartmann, V., Burmeister, J., Langguth, P. and Häusler, H. (2004) Development of a sterilizing in-place application for a production machine using Vaporized Hydrogen Peroxide, PDA J Pharm Sci Technol. 58(3):130-46
7. Midcalf, B, Neiger, J. and Sandle, T. (2013). ‘Fundamentals of pharmaceutical isolators’. In: Sandle, T. and Saghee, M.R. (Eds.) Cleanroom Management in Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK, pp185-226
8. Sandle, T. and Saghee, M.R. (2012). “Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector”, Pharmaceutical Technology, Supplement: Bioprocessing and Pharmaceutical Manufacturing, May 2012, S20-S27
9. Sandle, T. (2012b). Real-time counting of airborne particles and microorganisms: a new technological wave?, Clean Air and Containment Review, Issue 9, pp4-6

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Werum IT Solutions, a leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries and Sarla Technologies jointly announced a memorandum of understanding to partner for delivering MES projects in India.

Sarla Technologies will become an official partner for Werum’s PAS-X MES throughout India providing project control and Werum’s PAS-X MES enables pharmaceutical facilities to run manufacturing processes completely paperless at the highest level and to be compliant with international GMP guidelines and FDA regulations. The requirements of the pharma industry are directly addressed by Werum’s out-of-the-box solution without any need for expensive and time-consuming customisation. Based on standard functionality and best practice content, pharma manufacturers will be able to have the number one global MES solution up and running in a very short.

“We are pleased that Sarla Technologies will join us as a partner to expand our presence in India and to leverage their great experience and track record in the Indian pharma industry and also in automation and process control for projects requiring complete integration with machines and equipment,” says Lars Hornung, Senior Director Global Sales, Werum IT Solutions.

Anil Mehta, Chief Executive Officer, Sarla Technologies adds, “Our partnership with Werum enables multinationals and leading local pharma companies in India to gain full advantage of MES. PAS-X and Werum’s expertise along with Sarla’s Level 2 integration and automation know-how will tremendously help them to increase productivity and meet global regulatory requirements.”

EP News Bureau – Mumbai

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The United Engineering Company (UEC) with the brand name ‘UNITED’ is known for being the pioneer and commander in packaging machinery manufacturing in India.

UEC, which was started in 1963 by GD Roy, from the beginning, attained a high reputation in providing machines and services of highest standards with utmost care. With the founder’s innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work.

Initiating the business with solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and has also mastered in providing machines for automatic tablet coating. UEC also provides customised solutions for its customers.

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries, cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

The company has also expanded its footprints abroad in a large way. Today, ‘UNITED’ machines are exported to more than 21 countries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, United Arab Emirates, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea and others.

UEC puts in a lot of effort for their research and development and strives to provide the best and optimised solution to its customers. By virtue of dedication and continuous hard work of their R&D team, ‘UNITED’ machines provide technically advanced solution for its customers.

Presently, UEC is having its head office at Kolkata. It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft. UEC is having another office at Mumbai along with a service station.

The United Engineering Company has been honoured by the prestigious ‘Innovator’s Award’ from the Indian Pharmaceutical Congress for their innovation and development.

Today, at UEC, machines are equipped with the latest technology. For its customers, UNITED machines are cost effective but are guaranteed with the highest quality, optimum production and ensured unconditional service.

UEC is equally focused on being a corporate citizen. It has never shirked the responsibility of the society and has always been an active participant in numerous social events which help in uplifting the quality of living of the deprived.

With almost every pharma formulation manufacturer being an ‘UNITED’ machine user coupled with over 50 years experience, UEC commits in becoming better than the best in the near future.

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