The cleanroom design experts at Mecart discuss what really needs to be considered before upgrading or expanding an existing cleanroom
Your cell and gene therapy research just made a breakthrough. The FDA has approved your new medical device for production. Your compounding activities are expanding to match your incredible growth. Your semiconductor start-up is taking off. Whatever the motive, cleanroom projects are present in a wide variety of markets across the manufacturing, research and development spectrums.
Before you embark on the journey of building a brand new cleanroom or expanding/upgrading your existing facility, here is a detailed checklist of important information to gather.
Do you know the cleanliness level you need? Depending on your process and the regulations governing your field of work, you will need to determine the ISO class for your rooms. Sometimes ISO classes are enforced by a guideline (USP, GMP, FDA). Other times, they are defined by your company’s internal quality policy to improve product yield and decrease product defect rate. Remember to keep it very basic. Higher air changes help remove more particles but also increase your initial project costs and daily operational fees. The ISO class impacts the design, so it is important to define it at the beginning. For example, GMP compliant cleanrooms require full flush design, coved corners, monitoring systems, airlocks, etc. Regulations will impact your cleanroom facility design and guide your answers to the questions in the below checklist.
A drawing is worth a thousand words! Consider access in and out of crucial clean space and in and out for personnel and material. This task input from architects, engineers, facilities personnel and operators will need to be considered early on. It will help establish flows of material, position of pass-throughs, gowning zones, emergency exits, mechanical rooms, etc.
1. What will you be doing in the room?
2. Which ISO class, grade, regulation or guideline must you comply with?
3. What are the dimensions (length x width x height) of the classified rooms (clean spaces)?
4. Do you need antechambers/gowning rooms/airlocks?
5. Interlock system needed?
7. Door details
8. Flooring needs
9. Pass-throughs and or cart-throughs (material handling)
10. Cleanroom sink
11. Do you need coving?
12. Specific chemical resistance
How many people will work in your facility to meet your production needs? This information will not only be considered for access, interlocks, and number of interlocks but also with heat dissipation and sizing of your HVAC.
Any need for extraction in your rooms? Your hazardous process or a dust-generating manipulation might require you to extract air. If so, you will need to determine the equipment pulling the air out, its size, quantity, location, routing it to the outside, sizing its flow to plan impact on your overall balancing.
What is the electrical equipment generating heat gain? You need to plan the requirements of your process to consider the position of your equipment (mills, ovens, sterilisation, freezers, etc.) to be powered for the position of electrical sockets.
13. Project location
14. Average and maximum number of people working in the room at once?
15. What is the temperature setpoint and tolerance?
16. What is the humidity setpoint and tolerance?
What space will we be working with? Are you installing your cleanroom in a warehouse, allowing suspended ducting and ease of service for your overhead equipment or are you converting an old office space with a low suspended tile ceiling? Is your space adjacent to a shipping dock or located above 5 flights of stairs?
17. Is there room above the cleanroom for the ductwork? How many feet?
18. Is there space near the cleanroom for the mechanical room/air handling unit?
19. Overall height of the ceiling (from floor to bottom of the joists) in the building that the cleanroom is going into?
20. Do you have a receiving dock in the building? How far is it from the receiving area to the cleanroom location? What floor is the project on? Any stairs or elevators needed?
21. Can we use non-union labour, or do we need to use union labour?
22. How much load can your current roof support?