Page 64 - MNU PM502 Ph. Micreo practical
P. 64

Pharm D- Clinical Pharmacy Program        Third Level          Pharmaceutical Microbiology& Antimicrobials (PM 502)


                                                           LAB 5



                                                        Sterility test


                  Definitions:



                  •  Sterile  product:  Product  which  is  free  from  all  forms  of  living  beings  as

                      viruses, fungi, bacteria and parasites. So, sterility test should be done to detect

                      its sterility (absence or presence of microorganisms).

                  •  Sterilized product: product that passes sterilization process but it is not sure

                      whether it is sterile or not.

                  •  Batch:  number  of  units  subjected  to  the  same  sterilization  conditions.  Ex:

                      penicillin powder batch.

                  •  Batch number indicates which method applied for sterilization of the product.


                  Significance of sterility test:


                  Sterility test is performed to test absence or presence of microorganism (sterility
                  of the object).


                  Principles of sterility test:


                  1- Specialized media inoculated with specific amount of material under test and
                  incubated at specific temperature.


                  2- Test carried on: bacteria (aerobic and anaerobic), fungi and yeasts.

                  3- Results of the test may show:

                                  a) No growth and so material pass the test.

                                  b) Growth and in such case the material fails the test.







                                                               51
   59   60   61   62   63   64   65   66   67   68   69