Clean Room Requirements
Pharmaceutical and medical device companies are increasingly manufacturing their products in clean rooms equipped with two types of enhanced clean room devices. One device is the simple hood or flow cabinet, the second is a fully enclosed clean work environment known as the isolator or barrier isolator. The common feature of clean room devices is the increased separation of the manufacturing activity from the human clean room technician. A key function of clean room devices is to control microbial contamination near and within the manufacturing area. This is accomplished by air flow through HEPA filters and the construction of walls or barriers. The ultimate success of the clean room device depends upon the ability to transport materials into and out of the clean work environment without the introduction of microbial contamination. XENON Pulsed UV Light Systems are designed to work in these clean room devices and control microbial contamination.
Pharmaceutical and medical device companies are increasingly manufacturing their products in clean rooms equipped with two types of enhanced clean room devices. One device is the simple hood or flow cabinet, the second is a fully enclosed clean work environment known as the isolator or barrier isolator. The common feature of clean room devices is the increased separation of the manufacturing activity from the human clean room technician. A key function of clean room devices is to control microbial contamination near and within the manufacturing area. This is accomplished by air flow through HEPA filters and the construction of walls or barriers. The ultimate success of the clean room device depends upon the ability to transport materials into and out of the clean work environment without the introduction of microbial contamination. XENON Pulsed UV Light Systems are designed to work in these clean room devices and control microbial contamination.
Completely enclosed barrier isolator manufacturers have designed transfer ports to move material into the isolator while controlling the introduction of microbial contamination. The transfer ports are designed differently than conventional transfer hatches or airlocks. The transfer ports are increasingly equipped with a method to sterilize the surface of materials entering the isolator and to allow a rapid transfer of materials. Systems equipped with slow acting vapor phase hydrogen peroxide or conventional UV light are being displaced with the more rapid decontamination agent, pulsed UV light, that is capable of sterilizing the surface of materials in seconds without significantly increasing the temperature in the chamber. Pulsed UV light systems also sterilize the empty transfer port after each use. No vapor or gaseous decontamination chemical is used or introduced into the clean room.
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