Non-sterility

Food Diary products (cheese, yoghurts, etc.) Non-sterile... 

Changes to the size or shape of a container for a non-sterile drug... 

Filtered air may be used to purge a complete room, or it m be confined to a specific area and incorporate the principle of laminar flow, which permits operations to be carried out in a gentle current of sterile air. The direction of the airflow may be horizontal or vertical, depending upon the type of equipment being nsed, the type of operation and the material being handled. It is important that there is no obstruction between the air supply and the exposed product, since this may resnlt in the deflection of microorganisms or particulate matter fiom a non-sterile surface and canse contamination. Airflow gauges are essential to monitor that the correct flow rate is obtained in laminar flow units and in complete suites to ensure that a positive pressure fiom clean to less clean areas is always maintained. 

Recognizing these problems, UK food regulatory authorities have generally abandoned the use of quantitative microbial counts as enforceable standards of food quality. Despite this, the European Pharmacopoeia has introduced both quantitative and qualitative mierobial standards for non-sterile medicines, which might become enforceable in some member states. It prescribes varying maximum total microbial levels and exclusions of particular species according the routes of administration. The British Pharmacopoeia has now ineluded these tests, but suggest they should be used... 

Contamination of non-sterile pharmaceuticals in hospital and community environments... 

Pharmaceutical products are used in a variety of ways in the prevention, treatment and diagnosis of disease, hi recent years, manufacturers of pharmaceuticals have improved the quality of non-sterile products such that today the majority contain only a minimal microbial population. Nevertheless, a few rogue products with an unacceptable level and type of contamination will occasionally escape the quality control net and when used may, ironically, contribute to the spread of disease in patients. 

Baird R.M. (1985) Microbial contamination of non-sterile pharmaceutical products made in hospitals in the North East Regional Health Authority. J Clin Hasp Pharm, 10, 95-100. 

Baird R.M. Bloomfield S.F. (eds) (1996) Microbial Quality Assurance in Cosmetics, Toiletries and Non-sterile Pharmaceuticals. London Taylor Francis. 

The sole objective of all hygiene and manufacturing controls is to ensure the quality of the pharmaceuhcal product for the safety and protection of the pahent. The manufacture of non-sterile pharmaceutical products requires that certain criteria of cleanliness, personal hygiene, produchon methods and storage must be met. Many such products are for oral and topical use and the question may fairly be posed as to the point of what are now quite stringent conditions. Nevertheless, some carefully controlled hospital studies have indeed shown that both types of medicine may be associated with nosocomial (hospital-acquired) infections and this risk can be minimized by the application of GMP principles. 

A sterility test attempts to infer the state (sterile or non-sterile) of a batch from the results of an examination of part of a batch, and is thus a stahstical operation. 

If no growth occurs with the third sample, the batch passes the sterihty test if, however, any microorganism is found, the batch is treated as non-sterile, unless or until the material has been resterilized and has passed the above tests. 

Berg, T., Humphreys, P., Phillips, B. and Scherz, B., Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation , PIC Publication PH 1/96. 

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