To evaluate whether cleanrooms are the best method of protecting today’s products and operators in set environmental conditions, one must consider the cleanroom classifications. Cleanrooms are classified according to the number and size of particles permitted per volume of air (see Table 1). For a typical cleanroom, the relevant particle size is 0.5µm and this is directly related to the bacterial contamination levels. Along with the classifications come the requirements for hypergeometric distribution sampling, utilities consumption and cleaning that has to be both validated and repeatable.
Cleanroom technology sets out to minimise particulates and maintain set environmental conditions – but why not consider the alternative: containment technology?
Containment, barrier isolation and isolator (or glovebox) technologies are all based on the same basic method of enclosing an environment. The International Society for Pharmaceutical Engineering (ISPE) defines containment technology as a ‘leak-tight enclosure designed to protect operators from hazardous or potent processes or protect processes from people or detrimental external environments or both’.
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