Pharmaceutical Industry Clean Engineering

Recently, modern biotechnology, represented by genetic and cell engineering, has developed rapidly and increasingly influenced and changed people's production and lifestyle. More than 60% of biotechnological achievements are concentrated in the pharmaceutical industry, which has led to significant changes and rapid development of it. Bio-pharmaceuticals are the process of applying bioengineering technology to the drug manufacture, including vaccines, toxins, serums and genetic engineering products (recombinant DNA products, in vitro diagnostic reagents),etc. The basic characteristic of a pharmaceutical clean room is that it must be controlled for both particles and microbe. The pharmaceutical clean rooms are divided into four zones: A, B, C and D. The A zone is a high-risk operating zone; the B zone is the background of A zone; the C and D zones are the less important clean operating zones for the production of sterile pharmaceuticals. The A and B zones are equivalent to ISO5 class, and the A zone requires a higher demand for its environment; the C zone reaches ISO7 class, and the D zone ISO8 class.