Page 53 - MNU-PM502- Pharmaeutical Microbiology Theoritical Book
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Pharm D- Clinical Pharmacy Program        Third Level          Pharmaceutical Microbiology& Antimicrobials (PM 502)


                      •  Regardless of whether manufacture takes place in industry or on a smaller
                         scale in the hospital pharmacy, the microbiological quality of the finished
                         product will be determined by the formulation components used, the
                         environment in which they are manufactured and the manufacturing
                         process itself.


                  Water:

                      •  Water for pharmaceutical manufacture requires treatment, usually by
                         distillation, reverse osmosis or deionization.


                      •  Water should be stored at a temperature above 80°C.

                  Environment

                      •  Free-living opportunist pathogens, such as P. aeruginosa can normally be
                         found in all wet sites, such as drains, sinks and taps.

                      •  Cleaning equipment, such as mops, buckets, cloths and
                         scrubbing machines, may be responsible for distributing

                         these organisms

                  Packaging:

                      •  Packaging in hospitals is frequently re-used for economic reasons.

                      •   Large numbers of containers may be returned to the pharmacy, bringing
                         with them microbial contaminants introduced during use in the wards

                  In use


                      Human

                   •  During normal usage, the patient may contaminate his
                       medicine with his own microbial flora; subsequent use
                       of the product may result in self-infection.

                   •  Topical products are considered to be most at risk.


                   •   Opportunities for contamination may be reduced by
                       using disposable applicators for topical products.





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