Site Environmental Monitoring Program Document

The policy document should be very stable. If found otherwise in practice, it merits serious review. Conversely, the site program document is intended to reflect actual practice, and may be subject to more frequent revision.

• First of all the program document should contain a floor plan of the aseptic facility with the areas within the area clearly identified by their grades.

• On this floor plan the locations for environmental monitoring should be marked. The locations should be identified versus the monitoring technique to be used at each particular location (say, T01-n for total particle counts, V01-n for active microbial air samples, etc.).

• It is then quite easy to tabulate the locations against frequency of testing (e.g., batch- or time-related), and against the alert and action limits to be applied.

• The program document should identify how media and equipment should be taken into aseptic areas, how samples should be labelled, and how they should be accounted for and reconciled for incubation, read out and review.

• The program document should ideally contain a flow diagram of responsibilities and interfaces.

• The program document should contain copies of all formal report forms.

• The program should contain directions about what to do when limits are exceeded.

• The program should state which of the microorganisms recovered in the program should be identified. The extent of identification may be quite different from one area grade to another.

The environmental monitoring program document should describe everything the personnel involved in undertaking environmental monitoring need to know. There are also important things that it should not contain, best referenced to other formal documents that can be self-contained. These other documents should, in common with the site environmental policy document, be quite stable. In "process" order these document should separately address the following "enabling" processes:

• Media preparation

• Growth support tests

• Total particle counters and how to use, maintain and calibrate them

• Microbiological sampling methods (e.g., active air sampling, swabbing, settle plates, etc.). These can be addressed in one document or split out into one document for each technique

• Identification of microorganisms

• Handling of out-of-specification and atypical results

• Conduct and reporting of trend analyses

This list is not definitive.

The author favors the principle of a documentation system that allows environmental monitoring to be addressed in a practical way, with procedures compartmentalized and focused for the likely tasks done by different personnel.

Thus documents will be facilitated as training aids and as day-to-day guidance, in the ongoing quest for safe pharmaceutical manufacturing environments and patient benefit.

REFERENCES

Agalloco J. Qualification and validation of environmental control systems. PDA

Journal of Pharmaceutical Science and Technology, 50: 280-289, 1996. Akers JE. Environmental monitoring and control: proposed standards, current practices, and future directions. PDA Journal of Pharmaceutical Science and Technology, 51: 36-47, 1997. Benbough JE. The Sampling Efficiency of the Biotest RCS PLUS Air Sampler.

Biosafety Test Section, Division of Biologies, PHLS Centre for Applied Microbiology, Wiltshire, U.K., 1992.

Food and Drug Administration of the United States Department of Health and Human Services (FDA). Guideline on Sterile Drug Products Produced by Aseptic Processing. Rockville, MD: Center for Drugs and Biologies, 1987.

Kaye S. Efficiency of "Biotest RCS" as a sampler of airborne bacteria. Journal of Parenteral Science and Technology, 42: 147-152, 1988.

Ljungqvist B. and Reinmuller B. Some aspects on the use of the Biotest RCS air sampler in unidirectional air flow testing. Journal of Parenteral Science and Technology, 45: 177-180, 1991.

Medicines Control Agency. Rules and Guidance for Pharmaceutical Manufacturers and Distributors. London: The Stationery Office, 2002.

Parenteral Drug Association (PDA). Validation of Aseptic Filling for Solution Drug Products, Technical Monograph No 2. Bethesda, MD: Parenteral Drug Association Inc., 1981.

Parenteral Society. Technical Monograph No. 2 — Environmental Contamination Control Practice. Swindon, U.K.: Parenteral Society, 1990.

PDA. Technical Report No 24. Current practices in the validation of aseptic processing. PDA Journal of Pharmaceutical Science and Technology 51 Supplement S2, 1997.

Parks SR, Bennett AM, Speight SE, Benbough JE. An assessment of the Sartorius MD-8 microbiological air sampler. Journal of Applied Bacteriology, 80: 529-534, 1996.

Pendlebury DE, Pickard D. Examining ways to capture airborne microorganisms.

Cleanrooms International, 1: 15-30, 1997.

Sykes G. The control of airborne contamination in sterile areas. In Aerobiology — Proceedings of the 3rd International Symposium, ed. Silver I.H. London: Academic Press, 1970.

Whyte W. Sterility assurance and models for assessing airborne bacterial contamination. Journal of Parenteral Science and Technology, 40: 188-197, 1986.

Whyte W, Niven L. Airborne bacteria sampling: the effect of dehydration and sampling time. Journal of Parenteral Science and Technology, 40: 182-188, 1987.

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