Thursday, June 26, 2014

A Mini-Guidebook On Cleanrooms

By Themedica on August 25, 2008 5:09 AM |
A cleanroom is an enclosure used in manufacturing or in hospitals wherein a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors needs to be maintained. These low levels of environmental pollutants are monitored and maintained with the aid of special equipment meant for the purpose.

Further, the controlled level of contamination is specified by the number of particles per cubic meter at a specified particle size.
Cleanrooms can be of variable sizes based on the requirement. For instance very large cleanrooms are often used in manufacturing facilities, or even the whole of a manufacturing unit may be built into a cleanroom. For the most part, they have applications in semiconductor manufacturing, biotechnology, life sciences and other fields that are acutely sensitive to environmental pollution.

The working of a cleanroom entails an air filtration unit so that the air entering a cleanroom is filtered to exclude contaminants, while the air inside is recirculated by means of high efficiency particulate air (HEPA) and ultra low penetration air (ULPA) filters. These filters are meant to clean up the pollutants generated due to the processes taking place inside the cleanroom.

There are also airlocks, typically with air shower stages, at the entry and exit points of cleanrooms. Usage of protective clothing such as boots, gloves, face masks and cover-alls is the norm for staffers.

Furthermore, the equipment inside the enclosure is specially designed to produce the minimum levels of pollutants. Office stationary viz. paper, pencils for use are made from natural substances or at best aren't allowed inside. Additionally, many cleanrooms are kept at a positive air pressure, so as to prevent any contaminated outside air to get in, in case there's a leakage.

Some Common Types of Cleanroom Supplies

As already outlined, there are a host of equipment and supplies that are specially designed for use in clean rooms. Some classes of essential supplies for cleanrooms are described below.

Cleanroom Disposables
Cleanroom disposables refers to all the products, items and packaging used once or only a few times within the cleanroom before being discarded. Examples of cleanroom disposable include Medical and Cleanroom Apparel, that is clothing and masks used in healthcare and pharmaceutical cleanrooms, or gloves meant for handling cytoxic formulations, etc. or Specialty bags and Packaging such as Light Inhibiting Bags, Sterile & Isolator Waste Bags or Theater Products meant to control contamination operation theater environment which entail supplies like floor mats, camera bags, filters, etc.

Cleanroom Equipment

Cleanroom equipment refers to tools, devices or other items necessary used in carrying out critical processes within cleanrooms, while maintaining a pollution free environment. They could cleanroom-equipment.jpg include Cleanroom Furniture viz. Operator/Technician Workbenches, Seating, Laboratory Furniture, Mobile Trolleys etc. or Cleanroom Wall Systems such as Demountable Partitions, Cleanroom Doorsets, Pass Through Hatches, Wall Cladding Systems and the like, or items needed for Cleanroom Laminar Flow like Laminar Flow Hoods, HEPA Filtered Fan Modules, Fume Cupboards, Air Showers, etc. Pass Thru Air Locks, Wet Process Stations, Cleanroom Garment Racks, Step Ladders are some other necessary cleanroom equipment.

Cleanroom Garments

Cleanroom Garments refer to clothing that prevents the contaminants on the body to mingle with the clean cleanroom-garments.jpg environment within a cleanroom enclosure. Cleanroom garments are made of selected fabrics viz polyester, that are durable, lightweight and have other desirable properties. They are designed to meet the most stringent requirements of cleanliness that cleanrooms warrant. Examples of such garments include special Gloves, Masks, Shoecovers, Coveralls, Gowns and Smocks, Head Covers, Undergarments, etc.

Cleanroom Services

Once a cleanroom has become operational it requires a series of maintenance procedures carried out at set time intervals or as needed, to ensure the upkeep of its 'cleanroom' status. Controlling and maintaining contamination is the hallmark of cleanrooms and expertly trained technicians cleanroom-services.jpg and sophisticated gadgets are often needed to conduct effective cleanroom services. Some examples of cleanroom services include regular Floor Care and Testing /Certification, Cleanroom Cleaning, Clean Room Sterilization, Micro-cleaning, Contamination Control, Protocol Development, Particle Count Certification, Sterile and non-sterile garment services, Cleanroom Training & Consulting, Cleanroom Audit, etc.

Tips For Ordering Cleanroom Products and Services

For the most part it's the quality of cleanroom products based on the requirements that determines their effectiveness. Supply and distribution of substandard cleanroom products poses a major challenge for buyers and consumers of these products. Use of substandard products can result in major losses to the users of these products. Quality of cleanroom supplies can be ensured to quite an extent through the following meassures.

1.Establish the integrity of the source prior to need.
2.Establish a list of approved suppliers.
3.If you source from an alternative source ensure that at least the following information is provided:
    a. A pedigree back to the previous source
    b. Certification that it is not a diverted product
    c. Certification that any actions by the alternative source will not alter any original manufacture warranties or         guarantees
    d. Certification that the product has been stored and handled consistent with product labelling requirements

4.Be wary of cleanroom products that are offered at an unusually cheap price.

5.Make a list of key cleanroom equipment that will not be purchased from any other source but the manufacturer, or authorised distributor.

6.Look for changes in the product’s package and compare them with previously purchased products, tears in the sealing tape and seals and variations in the size of the container.

Industry Overview

North America and Europe are the major markets for cleanroom products and services. The demand for cleanroom consumables in the US has grown at an annual rate of about 6 percent through 2007. Aside from the medical industry, the semiconductors industry and expansion of clean room technologies are the drivers of this growth. Products with the maximum demand will be drugs, hard disk drives, foods and beverages, flat panel displays, chemicals, apparel, wipes and swabs. The US market for clean room consumables is estimated to be worth US$ 1.2 billion.

Europe makes up for about 28% of the world's market. France and Germany are the leading European buyers of pharmaceutical clean rooms. The demand for clean room technology to be used in the pharmaceutical and biotechnology industry is on the rise. Moreover, the bio/pharmaceutical industry is the Europe's second largest consumer of clean room space.

Much of the demand for cleanroom products and services attributed to pharmaceutical industry is centered around contamination, where presence of bacteria and viruses can have a devastating effect on medicines packaged as tablets, capsules, liquids, etc.

As for investments, the year 2000 saw the European pharmaceutical and biotechnology firms spend $128 million on new clean rooms. Whereas the expenditure was US $542 million for the entire European industry on new clean rooms, during the same year. From 2002 through 2006 the clean room consumables purchases by the European industry rose from US $121 million to US $151 million.

The world market for clean rooms on the other hand grew from US $6.5 Billion in 2000 to US $9.1 Billion by 2006.

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