When preparing to build a cleanroom for your business you want to make sure to think through several key factors early in the process to help you make sure to build the best cleanroom.
One of the major factors you want to consider is the standards requirements your room needs to meet. For example, GMP compliant cleanrooms require full flush design, coved corners, monitoring systems, airlocks, etc.
- ISO 5? ISO 6? ISO 7? ISO 8?
- GMP Grade A, Grade B, Grade C, Grade D?
- 503 B (USP + GMP)?
- USP 797, USP 800, USP 825?
What kind of standards will your room need to support? Sometimes only certain parts of the cleanroom need to meet certain requirements. Making sure to understand the impact of requirements early on will save you in time and money.
Thinking through and even diagraming the workflow of people and materials will be key in making sure the cleanroom is designed around making sure this process can function properly. You want to make sure people have the ability to move around and accomplish their tasks without causing issues with other workers or slow the process down. Thinking through the entry and exit of the room, how people need to move through the room, and how they can move materials or products will impact the long term profitability of your business.
Some times materials may be best passed in to another part of the room through passthrough windows or through other means other than being actually carried in from outside to prevent contamination. Using devices like passthrough windows, transfer boxes, etc. can help keep your room up to the appropriate standards as well as minimizing contamination in your cleanroom.
How will the air flow through the room? Are there specific temperature, humidity or particulate standards that need to be met? It is common in Pharmaceutical manufacturing that parts of your process may need to be quarantined or cut off from outside influence. Making sure you can properly control your airflow is very important to the quality of the work done in the room.
Will you need extra protection at the entrances and exits of your cleanroom to prevent contaminants? Are there spots in the room where airflow may be impeded and thus cause issues? Will you have to have fans to encourage the airflow? What can be the “downstream” effects of air moving from one station through other stations?