Industrial Hygiene
Pharmaceutical Compounding, International Organization for Standardization
Sterile compounding is defined as combining, admixing, diluting, pooling, reconstituting, repacking, or otherwise altering a drug or bulk drug substance to create a sterile medication. The team designed a comprehensive sampling and analysis plan to assess potential microbial contamination (nonsterility), excessive bacterial endotoxins, variability from the intended strength of correct ingredients, physical and chemical incompatibilities, chemical and physical contaminants, and/or use of ingredients of inappropriate quality, for review and approval. Per specifications, aseptic techniques must be followed for preparing any sterile medication.
Procedures must be in place to minimize the potential for contact with nonsterile surfaces,
introduction of particulate matter or biological fluids, and mix-ups with other products. In the sampling and analysis plan, various surfaces and air sampling are performed to secure proper sterility during compounding processes. Upon results from the laboratory, a report was prepared showing the sampling locations, analytical results, and recommendations based on the data. If results indicated contamination, the compounding unit must be temporarily shut down until the unit is decontaminated and retested. The laboratory unit may return to operation once the analytical results indicate a sterile environment.