A cleanroom is a sterile environment with controlled airflow, temperature, humidity, and level of contaminants. Cleanrooms are utilized to maintain cleanliness (low particulate level) to not contaminate medications which are being mixed or manufactured.
In the pharmaceutical world anyone who compounds under USP 797 or 800 standards requires a cleanroom. This provides a controlled environment for the placement of Primary Engineering Control (PEC) for compounding of sterile or hazardous medications. In other industries you may need a cleanroom to control the cleanliness of your individual processes.
It all depends on the type of compounding you plan on doing (i.e. Hazardous sterile, non-hazardous sterile, non-sterile hazardous, non-sterile non- hazardous) This is will determine whether you will need an ISO classified cleanroom with ante-room or just a single room.
There are different ISO rating requirements based on the type of compounding you plan to do. Most sterile compounding (hazardous or non- hazardous) must be compounded in an ISO7 cleanroom. The ante-room ISO rating will differ based on the type(s) of compounding you are doing. Non-sterile compounding does not require an ISO classification, however non-sterile hazardous products shall be compounded in a negative pressure room with a minimum of 12 air changes per hour but does not require an ISO classification.
ISO Ratings are a set of guidelines to ensure low particulates and air changes (number of times air is replaced within the room every hour) are met within your cleanroom. These guidelines are met through introduction of air into the cleanroom through HEPA filters placed throughout the cleanroom to reduce the level of contaminants being introduced into the room.
A modular cleanroom is a room manufactured out of interlocking panels that can be easily reconfigured for expansion or relocation depending on your specific business future.
TCA will provide you with all walls, ceilings, HEPA’s, lights, and conduit drops for all your electrical and telecommunication needs. Outside of the room TCA also provides consulting, design, delivery, installation, and coordination with all onsite trades for final connections to ensure your final product is functioning to your satisfaction, as well a meeting all USP 797/800 standards.
TCA Cleanrooms are modular units allowing them to qualify for IRS Tax Code 179. This deduction has the potential of saving your facility thousands of dollars. Please ask your accountant to verify for your unique situation.
Non-Sterile Hazardous clean rooms (NSH rooms) are required for the compounding of hazardous medications that are not sterile. These rooms are used to protect personnel from exposure to hazardous chemicals such as hormones by exhausting them through the PEC away from the person mixing and out of the facility.