What you really need to consider before upgrading or expanding an existing clean room
Before starting the process of building a brand new clean room or expanding/upgrading an existing facility, here is a detailed list of important information to gather.
What courses, regulations or guidelines must you comply with?
Do you know the level of cleanliness you need? According to your process and the regulations governing the field of work, you will need to determine the ISO level of the room. Sometimes, ISO levels are enforced by guidelines (USP, GMP, FDA). Sometimes they are defined by your company’s internal quality policy to increase product and reduce product defect rates. Remember to stay basic. Higher air exchange rates help to remove more particulate matter, but it also increases initial project costs and daily operating expenses. The ISO level affects the design, so it is very important to define it at the beginning. For example, a clean room that meets GMP requirements requires a complete flushing design, corners, monitoring systems, air locks, etc. Regulations will affect your clean room facility design, and guide you to answer the questions in the checklist below.
• ISO 5, 6, 7, 8?
• GMP level A, B, C, D?
• 503 B (USP + GMP)?
• USP 797, USP 800, USP 825?
Layout/sketch of floor plan
A drawing is worth a thousand words! Access to critical clean spaces and access to personnel and materials will need to be considered as early as possible. It will help establish material flow, location of passages, dressing areas, emergency exits, mechanical rooms, etc.
Clean room frame
1. What will you do in the room?
• Industry? Application? A detailed description of the process.
2. Which ISO class, level, regulation or guideline must you comply with?
• Note that over-specifying ISO/GMP levels will greatly increase your initial capital cost and monthly electricity bills.
• ISO 5, 6, 7, 8? (Per room)
• GMP level A, B, C, D? (Per room)
• 503B (USP + GMP)?
• USP 797, USP 800, USP 825?
3. What is the size (length x width x height) of the classified room (clean space)?
• Rough sketches or more detailed layout drawings
4. Do you need a front hall/dressing room/airlock room?
• For any room cleaner than ISO 8, one or more airlocks will be required (it is recommended to have one airlock for every lower ISO level).
5. Is an interlocking system required?
• Interlock prevents accidental opening of both doors at the same time. When one door is opened, the other doors will be locked to maintain the integrity of the airlock.
6. Window details
• Number and location? For example: Open a window every X feet on the outer wall (the standard is every 8'-12' every 36 inches)
• Embedded installation (more expensive, cleaner appearance, easier to clean) or semi-embedded with gasket
• Window size?
• Window shape?
7. Door details
• Quantity?
• Position?
• Door type? Single door, double door, sliding door or high-speed rolling door
• The type and size of the window?
• Automatically turn on/touch-free opener (wave your hand on the sensor) or manually turn it on?
8. Flooring requirements
• Pharmaceutical grade vinyl flooring (Pharma/GMP, USP) with welded joints or epoxy paint flooring that meets industrial needs.
9. Through train and/or cart pass (material handling)
• The standard size is 24" x 24", can also double the height or any custom size.
10. Clean room sink
• If needed-quantity, eyewash, shower?
11. Do you need to bend over?
• The concave angle eliminates the 90° angle that is difficult to clean. It can be done between the corners and between the wall and the ceiling.
12. Specific chemical resistance
• What cleaning solution/solvent do you use? Are there any chemicals that require attention in your process?
HVAC specifications, operating conditions, ventilation systems
How many people will work in your factory to meet your production needs? This information should not only consider the number of entrances interlocks and interlocks, but also the heat dissipation and size of the HVAC system.
Does your room need to be pumped? Operations that generate dust may require you to extract air. If this is the case, you need to determine the equipment that draws the air, its size, quantity, location, and determine its flow rate to plan the impact on your overall balance.
What is an electrical device that generates heat?
You need to plan your process requirements to consider the location of equipment (mills, ovens, sterilizers, freezers, etc.) in order to power the location of electrical outlets.
13. Project location
• Local weather will affect HVAC design. This is especially true when a lot of fresh air is needed.
14. The average and maximum number of people working in the room at one time?
15. What are the temperature set points and tolerances?
• Temperature ___°F±___°F (standard temperature is 68°F±3°F)
16. What is the humidity set point and tolerance?
• Humidity ___%±___% (standard is 45%±15%)
Host building
What space will we use? Are you installing a clean room in a warehouse to allow easy maintenance of suspended piping systems and overhead equipment, or are you remodeling an old office space and using a low tile ceiling? Is your space near the freight terminal or above 5 steps?
17. Is there space for air ducts above the clean room? How many feet?
• Ideally, at least 4 feet or more is required.
18. Is there a space for the machine room/air handling unit near the clean room?
• For maintenance and accessibility, a small independent room is a better solution; the unit can also be placed on the roof of an outdoor facility, but may require additional structural support.
19. The total height of the ceiling of the building that the clean room will enter (from the floor to the bottom of the joist)?
• Help understand work headroom.
