Due to the highly regulated nature of pharmaceutical cleanrooms, careful consideration must be given from the very beginning of their construction and design. What issues should be taken into account when initiating a cleanroom project?

1. What classes, regulations or other standards must be complied with?

The regulations and standards to be met vary depending on the applications and industries involved. A cleanroom for sterile pharmaceutical preparation is completely different from one for microelectronics. Depending on the industry and application, compliance with ISO Class 5 to 8 (Grade A, B, C, D), FDA and ISO-14644 regulations is mandatory. In the pharmaceutical industry, GMP compliance is essential.

2. What operating conditions are required for the cleanroom?

The HVAC design is driven by the room’s cleanliness level, and also influenced by the required temperature, humidity and pressure differentials. These specified conditions are determined by the processes conducted in the cleanroom and the comfort of personnel working inside. The precision of temperature and relative humidity is also a key factor in HVAC design. Heat generated by both users and equipment must be compensated by the air conditioning system. Therefore, it is critical to know the number of personnel working in the cleanroom; the pharmaceutical industry requires detailed data for each individual room, including production equipment and its heat output.

3. Expected layout of the cleanroom

Conceptual Design – Quickly sketch the intended layout of the cleanroom. Based on this drawing, the flow of personnel and materials, doors and windows, access control systems, pest control equipment, workbench locations, the need for air locks, and fire protection systems must be designed. It is also important to define which processes will be performed inside the cleanroom and which can be carried out outside, as this directly impacts the project budget. The more work performed indoors, the larger the cleanroom must be, the more heat and particles will be generated, the more powerful the HVAC system must be, and consequently the more expensive the cleanroom project. If any step in the process does not need to be completed in the cleanroom, you should consider performing it outside the clean environment.

4. Will fume hoods or biosafety cabinets be used in the cleanroom?

Some biosafety cabinets exhaust air directly in the cleanroom through HEPA filters without affecting cleanroom pressure, while other fume hoods and biosafety cabinets (for hazardous drugs or other chemicals) must exhaust air to the outdoors, which can unbalance indoor pressure. To maintain correct pressure in the cleanroom, fresh air must be supplied to compensate for the air exhausted. The exhaust volume of fume hoods or biosafety cabinets must be considered in advance.

5. Where will the cleanroom be designed and installed?

After sketching the intended cleanroom layout, we need to determine its specific location:

· What is the floor-to-floor height?

· What is the cleanroom height?

· What are the dimensions of production equipment?

· Are there columns?

· What is the existing floor material? Is it concrete? Is it level?

· What is the accessibility of the available space (warehouse material transfer & personnel access)?

· What power supply is available?

6. What about scalability?

The market changes rapidly today; output may double within a few years, or facilities may be demolished, relocated or sold after rapid development. Future reconfiguration or expansion can and should be considered in the design of cleanroom facilities.