- Humidity
- Dust
- Air pressure
- Microorganisms
- Temperature
- Current Good Manufacturing Practices (CGMP): A higher standard than Good Manufacturing Practices (GMP)
- ISO 14644: A standard that establishes cleanliness criteria
- U.S. Food and Drug Administration (FDA) requirements: The FDA enforces cleanroom requirements and publishes standards for manufacturers and medical devices.
- Easy-to-wipe surfaces: Prevent contaminants from accumulating
- Semi-flush doors and windows: Prevent dust from settling and are easy to clean
- Pharmaceutical-grade anti-microbial UPVC coating: Applied to walls to enhance efficacy
- High efficiency particulate air (HEPA) or ultra low particulate air (ULPA) filters: Trap particles and reduce product contamination
- Air conditioning systems: Designed to provide the optimal level of cleanliness in various rooms.
What is a Cleanroom?
A cleanroom (or clean room) is a room that has HEPA filtration to remove particles from the air. Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing. The FDA mandates the use of cleanrooms to create GMP manufacturing factories.
𝐂𝐥𝐚𝐬𝐬𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐚𝐫𝐞𝐚𝐬 𝐢𝐧 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲:
- The classification of area in pharmaceutical industry is a way of defining the level of cleanliness and control of contamination in different zones of a manufacturing facility.
The classification is based on:
- Type of product, the process, and the risk of contamination.
- The classification also determines the requirements for the design, operation, and monitoring of the cleanroom environment.
- According to EU GMP, there are 4 grades of cleanroom environment:
- Grade A, B, C, and D as following :
● 𝐆𝐫𝐚𝐝𝐞 𝐀 :
- This is the highest grade, where the most critical operations, such as filling and sealing, are performed.
- Grade A requires a laminar airflow cabinet or an isolator to provide a unidirectional airflow and a high level of protection.
- Grade A requires ISO 5 environment at rest and in operation.
● 𝐆𝐫𝐚𝐝𝐞 𝐁 :
- This is the background zone for Grade A, where aseptic preparation and filling are done.
- Grade B requires an ISO 5 environment at rest and an ISO 7 environment in operation.
● 𝐆𝐫𝐚𝐝𝐞 𝐂 :
- This is used for less critical operations, such as preparation of solutions to be filtered or filling of products for terminal sterilization.
- Grade C requires an IS0 7 environment at rest and an ISO 8 environment in operation.
● 𝐆𝐫𝐚𝐝𝐞 𝐃 :
- This is used for the least critical operations, such as storage of materials or equipment.
- Grade D known as dirtiest area of GMP guidelines.
- Grade D requires an ISO 8 environment at rest and not defined for in operation.
● The ISO 14644-1 classification is based on the number and size of airborne particles in the cleanroom.
𝐈𝐒0 5:
- Means that there are no more than 3,520 particles of 0.5 microns or larger per cubic meter of air.
𝐈𝐒0 6:
- Means that there are no more than 35,200 particles of 0.5 microns or larger per cubic meter of air.
𝐈𝐒0 7:
- Means that there are no more than 352,000 particles of 0.5 microns/or larger per cubic meter of air.
𝐈𝐒0 8:
- Means that there are no more than 3,520,000 particles of 0.5 microns or larger per cubic meter of air.
What is Clean Room in Pharma?
A: In pharma a clean room is a controlled environment using HEPA filtration to minimize particulate contamination. Pharmaceutical manufacturers are subject to FDA validation of their manufacturing which typically specify use of a clean room to ensure the quality of the manufactured pharmaceutical product. Sterility is highest priority. Pharma cleanrooms focus on both non viable (inanimate) and viable (live) contamination. They typically use laser particle counters to measure non viable contamination levels and settling plates with culture media to measure viable contamination levels. Pharmaceutical cleanrooms use aggressive chemical and UV light cleaning techniques to maintain sterility.
How Do Cleanrooms Work?
A: Cleanrooms rely on HEPA or ULPA filtration to remove particles from the air and create an ultra clean environment. With sufficient air changes per hour and laminar air flow it is possible to reduce particulate count from greater then 500k/ft3in typical office space to as low as 100/ft3(class 100 cleanroom). Airlocks are used to prevent contamination from entering the cleanroom. Workers inside cleanrooms typically wear cleanroom garments such as booties and bunny suits to prevent them from bringing contamination into the room. Eating and drinking are never allowed in cleanrooms.
What are the Do and Don’ts in a Cleanroom?
Do:
- Do wipe down all surfaces on a regular basis to remove contamination.
- Do make sure doors are always closed to maintain positive pressure.
- Do always have all staff were cleanroom suits over their street clothes to prevent bringing contamination into the cleanroom.
Don’t:
- Don’t eat or drink in your cleanroom.
- Don’t bring dirty equipment or material into cleanroom – always wipe it down before bringing it in.
- Don’t turn off the HEPA fan filter units – it will take several hours after you turn them back on before the cleanroom is clean again.
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