The manner in which pharmaceutical isolators, compounding aseptic isolators and bio-safety cabinets are used dictate the somewhat varied approach to cleaning and where applicable, disinfection practices.
Isolators and bio-safety cabinets3 are well accepted as cost-effective, convenient and compact controlled environments to provide product and personnel protection. These devices consist of protective enclosures that physically isolate products from the background environment (the room outside the isolator), either because the product of interest is unsafe and therefore needs containment, or the product cannot tolerate contamination and therefore needs isolation. Collectively, they are known as “separative enclosures”, or more properly “separative devices”.
The term “isolator” is usually reserved for pharmaceutical and pharmacy applications, whereas the term “bio-safety cabinet” (BSC) is used in the pharmacy, biotechnology and microbiology industries. For this discussion, we will consider that isolators and Class II bio-safety cabinets (and associated transfer devices) in biotechnology, microbiology, pharmaceutical and pharmacy applications are used as ISO Class 5 devices in terms of air particle cleanliness and are maintained as sterile environments to a sterility assurance level (SAL) ranging from 10-3 to 10-6 depending upon application.