Microbiological contamination quality requirements

Sample Location Selection, Uniform contamination over a complete aseptic manufacturing facility is remotely improbable. It would require a total breakdown of systems and would be evident in many ways other than environmental monitoring. The selection of locations for environmental monitoring becomes therefore a matter of professional judgement that should take account of two major considerations locations where, if contaminated, product quality would be most seriously affected and locations that due to some vicissitude of design or control are susceptible to microbiological contamination or proliferation. 

Microbiological contamination of starting materials should be minimal, and the bioburden should be monitored before sterilization. Specifications should indude requirements for microbiological quality when the need for this has been indicated by monitoring. 

The manufacture of sterile products is subject to special requirements in order to minimise risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance bears a particularly great importance, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test. 

The fabrication and packaging/labelling of sterile products requires special care and attention to detail because of the increased hazard to health should a product be non-sterile or otherwise contaminated. As the various processes used in the production of sterile drugs are susceptible to particulate, pyrogenic and microbiological contamination, the skill, training and altitudes of personnel involved are critical. Quality Assurance bears a particularly great importance this production must strictly follow carefully established and validated methods of preparation and procedures. 

Because products that require sterilisation are often aqueous solutions, the initial microbiological contamination can easily be determined in the quality control laboratory by the membrane filtration method (see Sect. 19.6.3). 

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