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 pharma 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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The cleanroom technology is witnessing continuous growth across the world.

There are countless factors which are responsible for the growth of pharma products and cleanroom technology such as stricter healthcare regulations, rigid standards, demand for good and quality products, growing frequency and awareness of contagious and infectious diseases, need for medicines and vaccines, growing facilities in the healthcare sector etc.

As per the current statistics and reports, the Asia market is witnessing a positive growth due to an increase in demand for medicines, cleanroom built products, semiconductors and micro biotechnology industry, increasing government initiatives for health, renewed focus on safety and efficiency of products and increase in demand for quality products. A majority of the growth in this region is due to growth and development of the healthcare industry in India.

Nowadays, the Indian cleanroom technology market is highly industrialised but unfortunately uneven and fragmented. New companies are looking forward to invest in cleanroom technology owing to its high demand in the Indian market and the numbers in the times to come will go beyond the predicted figures.

Development in cleanroom technology is also an important factor for the growth of manufacturers and turnkey contractors like us.

Pharmintech has been able to keep up its pace with the latest trends and has developed skill sets to provide the best quality products and services instantaneously so that there are no gaps between the growing trends and technology.

The clean-room technology market is expected to gain huge benefits in India. It is expected to be in the list of the top growing countries in the clean room market.

Quality, technology and needs are driving the industry at a very high speed. Cleanroom turnkey projects executors and contractors should take the opportunity to provide the best technology and quality to clients.

Pharmintech uses the best team of designers, engineers, officials to ensure that everything is done systematically and efficiently. This generates trust among the clients and makes the company a leader in the industry. Therefore, we have become one of the preferred choices of our customers in a short period of time.

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Dedusting tunnel

Dedusting Tunnel is designed to reduce initial non-viable particles from the raw materials received in drums, cartons, bags etc before they are transferred to ware house or while transferring from warehouse to the workshop, protecting personnel and environment.

Available options

• Integration with on line weight check
• Integration with on line sampling and dispensing
• Adjustable brushing system to maximise removal of non viable particle.
• Customised design to suit specific requirement like motorised sliding shutter, anti static PVC strips etc.
• Sequentially controlled PLC operation and process specific instrumentation.
• Modular reconstruction for retrofitting to other system.

MIST SHOWER

Mist Shower is used to reduce the possible re-suspension of the particulate in the operator breathing zone. Mist booth works by gently wetting the surface of an operators protective gown with a fine water mist, causing the powder to stick to the surface instead of becoming airborne.

Effectiveness of the misting booth at wetting particulate is dependent upon misting cycle duration time, the physical and chemical properties of the particulates , operator technique while misting and one the material and design on the protective garments.
Position of mist shower is generally at exit of potent or highly potent facility between processing and de-gown area.

Available options

• Dedicated skid mounted water system as per specific requirement like water heating arrangement etc.
• Combo system (Air shower cum mist shower)
• Customised arrangement for disposal of PPE.
• Custom built to suit any layout.
• Sequentially controlled PLC operation and process specific instrumentation.
• Modular construction for retrofitting to other system.

Online sampling

Sampling Booth is designed to provide Class 100 working environment rest with built in scavenging system to ensure product operator as well as surrounding environment protection.

Contact Details:
Fabtech Technologies International
615, Janki Centre,
Off Veera Desai Road,
Andheri (W),
Mumbai 400053
Tel: 022  6159 2900
Mob: +91 7718872725

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The TUBE MILL control and the TUBE MILL 100 control represents a unique product innovation – the world’s first batch mill with single-use milling vessels. For the first time, this unit will enable serial testing to be carried out under reproucible, contamination – free conditions.

The single-use milling vessels reduce the cleaning, time and energy that is devoted to the application process. These vessels also prevent cross-contamination of the sample material – a major advantage for quality assurance.

The 40 ml and 100 ml capacity milling vessels and hood are made from transparent material, allowing sample milling to be observed during the process itself. With the Tube Mill 100 control larger grinding chambers with a maximum volume of 100 ml (MT 100) can now be used. For sterile applications you can use the sterile disposable grinding chamber MT 40-10 sterile with a stainless steel beater. It reduces soft, medium, hard and brittle materials with a Mohs hardness of up to 5 (manganese or apatite: 5 Mohs).

The unit is easy to operate thanks to the user-friendly, multilingual OLED display and timer function. The Tube Mill’s versatility is particularly noteworthy. The IKA Tube Mill control can be used to process hard and soft, brittle and dry material. In combination with dry ice, it also allows damp, fatty, elastic and fibrous materials to be milled thoroughly.

The wide speed range of this unit equates to processing times that are less than one minute for most samples. Particular attention was paid to safety in the development of this mill, which only operates if the hood is closed and the milling vessel is connected to the motor and properly secured. If any of these safety features are omitted, an error message is displayed. The milling vessel cannot be opened during the milling process.

Contact Details:
Sonja Steiert
Project Manager – Sales & Marketing
IKA India
814/475, Survey No.129/1 Mysore Road
Kengeri – 560060
Bangalore, Karnataka
Tel: +91 (080) 26253 960
Fax: +91 (080) 26253 901
Email: sonja.steiert@ika.in

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The controlled suction unit extracts the dust during filling keeps the filling chamber dust free. While using this machine to fill free flowing powders, the hopper stirrer can be switched off to reduce electrical consumption.

Specifications:

• Machine: Weigh Filler – GMP design
• Model: SASF-5K-LC
• Input: 230 Volts AC 50 C/S
• Power: 0.75 H.P + 80 watts
• Product: Free & Non free flowing powders, Granules, Veterinary Powders etc.
• Range: 500.00 to 5000.00 grams
• Output: 10 – 15 fills per minute.
• Accuracy: ± 1 per cent

Contact Details:
Autofill Engineering,
218, Ramgopal Industrial Estate,
Dr RP Road, Mulund west,
Mumbai – 400 080.
Email: kannan_autofil@yahoo.com

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A clean room is an environment typically used in manufacturing and scientific research with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapours. A clean room has a less or no level of contamination.

Usage and benefits of clean room doors

In the pharmaceutical 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.

Clean room high speed doors have been designed and manufactured by Gandhi Automations. They are high in demand in industries such as pharma and chemical, which require quick open and close applications at the entry and exit points as controlled environment needs to be maintained.

These industries make high demands with respect to hygiene, sealing, operating reliability, fitting and a trouble free after-sales service. The Clean Room High Speed Doors satisfy all these requirements and work in strictly regulated operating conditions.

Gandhi Automations offers custom-made solutions for these sectors, while investing a lot of time and money in courses and training for the company’s own production staff and technicians.

The key features of Clean Room High Speed Doors offered by Gandhi Automations are mentioned below:

• Clean Room High Speed Doors are designed for inside applications and protects the environment against draughts, humidity, dust and dirt
• Operating speed and superior sealing properties improve traffic flows and provide environmental control and savings on energy costs
• Concept of low air permeability in pressurised rooms with positive and negative air pressure
• High door efficiency and low permeability values
• EN 12426 EN 12427 : < 12m3 / m2h ? 50 PA
• High leak tightness is due to curtain being tightly integrated in special SS 316 matt finish side guides
• Bottom safety edges and photocells combine to ensure operator safety at all times
• Heavy duty motor: 400V three phase, opening speed upto 1.5 m / s with inverter system
• Size upto: 4000 mm (W) X 4000 mm (H)

Contact Details:
Gandhi Automations
Chawda Commercial Centre,
Link Road, Malad (West)
Mumbai – 400064
Tel: +91 22 66720200 / 66720300 (200 lines)
Fax: +91 22 66720201
Email: sales@geapl.co.in
Website: www.geapl.co.in

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According to a market report published by Persistence Market Research, titled ‘Global Market Study on Cleanroom Technology: Consumables to Witness Highest Growth by 2020,’ the global cleanroom technology market was valued at $3,156.0 million in 2014 and is expected to grow at a CAGR of 5.2 per cent from 2014 to 2020 to reach an estimated value of $ 4,290.1 million by 2020.

Globally, the cleanroom technology market is witnessing significant growth due to growing regulatory concerns regarding the packaging, manufacturing, and processing of better quality products, and safety of the working personnel. Additionally, increasing demand for sterilised pharmaceutical formulations, and development of new biologics and its wide applications in the medical devices industry is driving the growth of the cleanroom technology market.

However, factors such as lack of skilled professionals and high cost associated with the setting up and maintenance of cleanrooms are restraining the growth of the global market for cleanroom technology.

North America is the largest segment in the global cleanroom technology market. This is due to technological advancements and growing applications of cleanroom technology in the region. The North American market for cleanroom technology was valued at $ 1,209.3 million in 2014 and is expected to reach $ 1,580.8 million by 2020, growing at a CAGR of 4.6 per cent. In terms of type, cleanroom consumables are the fastest-growing segment. In terms of construction, standard/ drywall cleanroom is the largest segment in the global cleanroom technology market.

Kimberly-Clark Corporation, Illinois Tool Works, and E.l. Du Pont De Nemours And Company are some of the leading players in the global cleanroom technology market. Some of the other major players in the cleanroom technology market are Azbil Corporation, Taikisha, Royal Imtech, Ardmac, M+W Group, Clean Air Products and Alpiq Group.

Asia is expected to experience a high growth rate in the global cleanroom technology market in the future. This is due to improving healthcare infrastructure, rising popularity of certified products, and increasing adoption of cleanroom technology by the healthcare industry in Asian countries.

Various factors such as increasing demand for better quality products and safety of the working personnel are driving the global cleanroom technology market.

Additionally, increasing demand for sterilised pharmaceutical formulations, and development of new biologics and its wide applications in the medical devices industry are propelling the growth of the cleanroom technology market.

However, lack of skilled professionals and high cost associated with the set-up and maintenance of cleanrooms are restraining the growth of the global cleanroom technology market.

EP News Bureau – Mumbai

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According to a recent report by Allied Market Research entitled, “Global Cleanroom Disposable Gloves Market (Product Types and Geography) – Size, Share Trends, Regional Trends, Segmentation and Forecast, 2013-2020”, the global cleanroom disposable gloves market is expected to reach $1.4 billion by 2020, registering a CAGR of eight per cent during 2014-2020. Neoprene disposable gloves would emerge as the fastest growing segment, at a CAGR of 17.5 per cent during the forecast period.

In order to maintain aseptic and contaminant – free environment during production, controlled environmental conditions are the prerequisites for pharmaceutical, semiconductor and electronics manufacturing companies. The prerequisites can be achieved by setting up distinct and separate cleanrooms, which necessitates the need for clean room disposable gloves in the production environment. Factors such as a large base of consumers, stringent regulatory requirements and the popularity of ‘cleanroom-customised’ gloves are driving the growth of the market. Following the positive strides in the adoption of the clean room disposable gloves, the market is expected to reach 35.6 billion pairs by 2020. Natural rubber/ latex disposable gloves, despite its conventional nature, continues to dominate the market. It held about 2/5th of the market share in 2013 making it the leading market segment, and shall continue to lead the market during forecast period. Unchallenged physical attributes such as comfort and dexterity supplement the growth of natural rubber/ latex gloves.

The study finds that nitrile gloves hold second highest CAGR i.e., 9.2 per cent during 2014-2020 while natural rubber/ latex gloves would account for the largest market share, both in terms of volume as well as value through 2020, followed by vinyl gloves. Asia Pacific accounted for the 48 per cent of the global market in 2013, followed by North America, at 28 per cent of the global market share. China emerges as one of the most lucrative markets during 2014-2020.

Geographically, the market share of developed countries in the global cleanroom disposable gloves market is expected to decline due to the use of industrials robots; whereas, the developing nations would witness a steady rise in their market share due to surplus work force and outsourced pharma manufacturing operations. Thus, countries such as China, India, Vietnam, and Philippines exhibit a double digit growth rate during the analysis period. Presently, US is leading the market in terms of volume and value; however, China would surpass US in the coming years and would subsequently emerge as a market leader.

EP News Bureau – Mumbai

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Contamination Control Society of India (CCSI) has recently organised several activities and many more have been planned for the current year.

CCSI brings together on a single platform, manufacturers and users of cleanroom equipment, instrumentation, consumables, furniture, panels, floorings, HEPA filters and validation contractors. It is an independent not-for-profit body, catering to the pharma and biotech industries, food processing, atomic energy, electronics, defence, education and research, consultants etc.

CCSI faculty has over 150 years of combined experience in this field and have conducted various such workshops /seminars / courses in India and abroad. CCSI is now a member of the International Confederation of Contamination Control Societies, thus benefitting from international expertise. CCSI has also announced special in-house training programmes for the cleanroom production/ supervision staff of large pharmaceutical and biotech companies at their premises.

Some of the subjects that are covered in such in-house training courses are:

• Airborne particle counting theory and practice
• Airflow measurement, airflow pattern studies
• Certification and monitoring of cleanrooms
• Cleanroom protocol, gowning and housekeeping
• Complying with International Cleanroom Standards and GMPs
• Continuous particle monitoring systems
• HEPA filter testing and standards
• Microbial air monitoring
• Understanding the new revised ISO 14644-1&2 cleanroom standards

A recently held training workshop in Mumbai was attended by over 100 participants. CCSI hopes to shortly get accreditation of their Associate Level certification course from the International Confederation of Contamination Control Societies. CCSI also circulates a newsletter with useful technical information on cleanrooms.

EP News Bureau – Mumbai

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With India striving to remain an important part of the global pharma supply chain, it cannot afford to be hauled up for faulty GMP. Thus, it is a given that demand for cleanroom technologies is only set to rise in India. Express Pharma has therefore put together a selection of interviews and articles cataloging trends in lifesciences cleanroom technologies in this supplement.

The lead article, ‘Changing Dimensions’ (see story on pages 5-8), explores how the cleanroom industry has come of age in India, with pharma companies demanding and willing to pay more for better designed cleanroom facilities. Basic cleanroom panels have given way to more advanced construction materials, as well as modular and flexible designs. Cleanrooms are also better designed today, incorporating energy efficiency aspects and integrating into the overall manufacturing plant’s associated engineering requirements like the HVAC systems, etc.

These demands are being met by local manufacturers. Aasif Khan, Managing Director, Fabtech Technologies, out their strategy saying, “Our aim is to imbibe the best from the west so that our customers get future-tech at affordable prices.” (See interview on page 9). Competition is fierce in this industry, with Prashant Kavale, Director, GMP Technical Solutions vowing that, ‘We develop plans to correct any issues that are uncovered”. (See his interview on page 10)

To share with us global insights on innovations in cleanrooms and environmental monitoring, we have Dr Tim Sandle, Head, Microbiology at Bio Products Laboratory and visiting tutor at the Department of Microbiology, University of Manchester, UK. His article touches on some innovations relating to cleanroom and clean device operations, together with personnel control and environmental monitoring. The article emphasises the importance of ensuing that good cleanroom design factors necessary for ensuring contamination control are met. (See pages 12-16)

But the strong demand for cleanroom technologies could possibly be hampered by access to skilled cleanroom operators in the future, points out Guy Tiene, MA, Director of Strategic Content, That’s Nice LLC / Nice Insight. (See pages 16-18).

Pharma companies as well as cleanroom technology providers in India should take serious note of this warning and plan now to create a pool of specialist cleanroom operators. The most expensive and advanced technologies in the world would be a waste if we do not also educate and train staff to use them effectively as per global GMP standards.

Besides a lack of skilled manpower, the high cost of setting up and maintenance will also restrain growth of the global cleanroom market. In India, financial resources will also always be a constraint. Smaller companies will see cleanrooms as a cost, while larger companies would be in a better position to reap the return on investment.

Even given these constraints, the cleanroom technology market, projected to be globally worth $3,761.9 million by 2019, is set to grow at a higher CAGR in India and the APAC region (8 per cent compared to 5.5 per cent in the US, EU and other more matured markets). As global cleanroom tech players  look at India and APAC for growth, here’s hoping that competition will make cleanroom tech more affordable.

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