Cleanrooms are specified as products and processes require specific conditions for them to be undertaken within. Therefore, understanding of your process requirements is critical before specifying a cleanroom.

TPC can assist in discussing your process requirements due to their extensive knowledge of the Health and Life Sciences industry to help you ascertain your requirements.

The room temperature and humidity may be important to your product during manufacture and testing and is also important to the comfort level of the operators within the facilities. The accuracy of the control requirements can also lead to significant costs in the HVAC design.

The classification of the cleanroom for your process is critically important as this leads to the overall HVAC strategy to meet the Total Particulate Count allowed in the facility. The requirements maybe defined under two conditions “At rest” and possibly the “In Operation” condition for sterile medicinal products. The number of particulates allowed is defined by the process requirements and correlating to the relevant standard (i.e. AS/ISO14644 or PE009 Annex 1).

In addition to these requirements the process may have specific requirements due to the nature of the materials being processed. This can lead to other design considerations to ensure that the materials, process, environment, and operators can work in the area under safe conditions. For example, a dangerous goods processing step of cytotoxic compounds may require single pass air conditioning, HEPA filtration, and negative room pressures to ensure materials do not escape the area. Handling of some materials may need fume cupboards and specialist extraction and wet scrubbers to limit materials escaping to the environment.