Microbiological test methods

PDA Technical ReportNo. 33, The Evaluation, Validation and Implementation of New Microbiological Testing Methods, Bethesda, MD, June 2000. 

Calibration of instruments, analytical/microbiological test methods, and qualification runs... 

There are no standard methods for verifying microbiological integrity of container-closure systems. Documents such as that published by the Parenteral Society in 1992 ° and the PDA in 1998 may be helpful in relating microbiological integrity to secondary physical tests, but they do not specify detailed microbiological test methods. 

Its implementation is easy in small countries due to centralization of management and ease of surveillance of this new form of accreditation by a national accreditation body. Due to the long-standing establishment of validation of food microbiological methods in some countries, the beginning of validation of water microbiological methods, and establishment of European standards for the validation of food microbiological test methods (Microval project), the flexible-scope type of accreditation must be adapted to certain national requirements, but could prove less complex than the standard requirements. 

Evaluation, validation and implementation of new microbiological testing methods. Technical Report No. 33. PDA J. Pharm. Sci. Technol. 54(3, Suppl. TR33), 2000. 

Harper, G.J. (1984). Evaluation of sealed containers for use in centrifuges by a dynamic microbiological test method. Journal of Clinical Pathology, 37, 1134-1139. 

Pauli. A. and K. H. Kubeczka, 1996. Evaluation of inhibitory data of essential oil constituents obtained with different microbiological testing methods. In Essential Oils Basic and Applied Research. Proceedings of 27th International Symposium on Essential Oils. C. Franz. A. Mathe. and G. Buchbaner, eds, pp. 33 36. Carol Stream, IL Allnred Publishing Corporation. 

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