Clean rooms for Pharmaceuticals & Medical Device Manufacturing
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Introduction to Clean Rooms
A cleanroom is a controlled environment where Pharmaceuticals, APIs, Medical Devices, Food, Cosmetics, Ayurvedic products are manufactured. It is a room in which the concentration of airborne particles is controlled to specified limits by using HEPA and filters. These contaminants are generated by external environment, people, process, facilities and equipment.
Federal Standard 209E is the widely referred standard for air cleanliness for Cleanrooms and clean zones. Using strict protocol and methods in Installation and assembly this can be achieved for critical manufacturing environments.
It only takes a quick monitor of the air in a cleanroom compared to a typical office building to see the difference. Typical office building air contains from 500,000 to 1,000,000 particles (0.5 microns or larger) per cubic foot of air. A Class 100 cleanroom is designed to never allow more than 100 particles (0.5 microns or larger) per cubic foot of air. Class 1000 and Class 10,000 Cleanrooms are designed to limit particles to 1000 and 10,000 respectively.
Once a cleanroom is built it must be maintained and cleaned to the same high standards.
Sources of Contamination
The below mentioned are commonly known contaminants that can cause problems in some cleanroom environments. It has been found that many of these contaminants are generated from five basic sources. The facilities, people, tools, fluids and the product being manufactured can all contribute to contamination. Review this list to gain a better understanding of where contamination originates.
1. Facilities 2. Human Factor 3. Tool Generated 4. Fluids
Contamination Control methods
High efficiency particulate air filter (HEPA)
Clean rooms design
Humans in Cleanrooms
General Cleanroom Regulations
For the better performance of the clean room personnel entering the clean room should be aware and follow these regulations at all times.
1. All personal items such as keys, watches, rings, matches, lighters and cigarettes should be stored in the personal locker outside the gowning room.
2. Valuable personal Items such as wallets may be permitted in the cleanroom provided they are NEVER removed from beneath the cleanroom garments.
3. NO eating, smoking or gum chewing allowed inside the cleanroom.
4. Only garments approved for the cleanroom should be worn when entering.
5. NO cosmetics shall be worn in the clean rooms. This includes: rouge, lipstick, eye shadow, eyebrow pencil, mascara, eye liner, false eye lashes, fingernail polish, hair spray, mousse, or the heavy use of aerosols, after shaves and perfumes.
6. Only approved cleanroom paper shall be allowed in the cleanroom.
9. Gloves or finger cots should not be allowed to touch any item or surface that has not been thoroughly cleaned.
10. Only approved gloves, finger cots (powder-free), pliers, tweezers should be used to
handle product. Finger prints can be a major source of contamination on some products.
11. Solvent contact with the bare skin should be avoided. They can remove skin oils and increase skin flaking.
13. All tools, containers and fixtures used in the cleaning process should be cleaned to the same degree as the cleanroom surfaces. All of these items are a source of contamination.
14. NO tool should be allowed to rest on the surface of a bench or table. It should be place on a cleanroom wiper.
Personal Actions Typically Prohibited in Cleanrooms
1. Fast motions such as running, walking fast or horseplay.
2. Sitting or leaning on equipment or work surfaces.
3. Writing on equipment or garments.
4. Removal of items from beneath the cleanroom garments.
5. Wearing the cleanroom garment outside the cleanroom.
6. Wearing torn or soiled garments.
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A www.i3cglobal.com/drugs-cosmetics/drugs/new-manufacturing-facility/clean-rooms.html">clean room is an environment, typically used in manufacturing or scientific research that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. More accurately, a www.i3cglobal.com/drugs-cosmetics/drugs/new-manufacturing-facility/clean-rooms.html">clean room has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.
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