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.
Beginner (early-stage project) which class, regulation or guideline must you comply with?
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.
- 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?
Do you have a layout/sketch of your floor plan?
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.
The cleanroom shell/envelope
1. What will you be doing in the room?
- Industry? Application? A high-level description of your process.
2. Which ISO class, grade, regulation or guideline must you comply with?
- Be cautious, over-specifying an ISO class/GMP grade will have substantial increases to your initial capital costs as well as your monthly energy bills.
- ISO 5? ISO 6? ISO 7? ISO 8? (per room)
- GMP Grade A, Grade B, Grade C, Grade D? (per room)
- 503B (USP + GMP)?
- USP 797, USP 800, USP 825?
3. What are the dimensions (length x width x height) of the classified rooms (clean spaces)?
- A rough sketch or more detailed layout drawing is very helpful!
4. Do you need antechambers/gowning rooms/airlocks?
- For any room cleaner than ISO 8, one or more airlocks will be needed (recommendation is one airlock per ISO level decrease).
5. Interlock system needed?
- An interlock prevents two doors from being accidentally opened at the same time. When a door is opened, the other doors are locked to maintain airlock integrity.
- Quantity and location? Ex: Windows every X feet on the outside walls (standard is a 36” window every 8’-12’)
- Flush mount (more expensive, cleaner appearance, easier to clean) or semi-flush with gasket
- Window Size?
- Window Shape?
7. Door details
- Quantity?
- Location?
- Door type? Single swing; double, swing; sliding door; high-speed roll-up door
- Window type and size?
- Automatic opening/touch-free opener (wave hand across sensor) or manual opening?
8. Flooring needs
- We generally provide a pharma-grade vinyl floor with welded seams (Pharma/GMP, USP) or an epoxy painted floor for industrial needs.
9. Pass-throughs and or cart-throughs (material handling)
- Our standard size is 24” x 24”; we can also do double-height or any custom size.
10. Cleanroom sink
- If needed – quantity, eyewash, shower?
11. Do you need coving?
- Coving eliminates 90° corners that are harder to clean. It can be done between wall corners and between the walls and the ceiling.
12. Specific chemical resistance
- What are you using for your cleaning solutions/solvents? Do you have any chemicals in your process that we need to be concerned with?
HVAC specifications, operating conditions, ventilation system
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
- The local weather influences the HVAC design. Even more so when a high percentage of fresh air is needed.
14. Average and maximum number of people working in the room at once?
15. What is the temperature setpoint and tolerance?
- Temp ___°F ± ___ °F (Standard is 68°F ± 3°F)
16. What is the humidity setpoint and tolerance?
- Humidity ___% ± ___% (Standard is 45% ± 15%)
The host building
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?
- Ideally, we need at least 4 feet or more.
18. Is there space near the cleanroom for the mechanical room/air handling unit?
- We think a small, separate room is a better solution for maintenance and accessibility; the unit can also be placed outside on the facility roof but may require additional structural support.
19. Overall height of the ceiling (from floor to bottom of the joists) in the building that the cleanroom is going into?
- Helps us understand working clearances.
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?
- We are fine with either but there is a price premium for union in most locations.
22. How much load can your current roof support?
- This is a rhetorical question – we don’t need an answer. Mecart cleanrooms use load-bearing walls that require zero load capacity from the host building’s roof! Beware, an average cleanroom needs approximately 12-20 pounds per square foot of support from the existing facility roof (to support the cleanroom ceiling, ductwork, lights, HEPA filters, etc.) which represents a potential expense of $50,000-$250,000 in structural analysis and roof enhancements.