Diluting and Rinsing fluids:
Fluid A
Dissolve 1 g
of peptic digest of animal tissue in water to make 1 liter, filter or
centrifuge to clarity, if necessary, and adjust to a pH of 7.1±
0.2. Dispense into containers and sterilise.
Preparation for Penicillin or Cephalosporins:
Aseptically
add to the above preparation, if necessary, a quantity of sterile b-lactamase
sufficient to inactivate any residual antibiotic activity on the membrane
after the solution of the test specimen has been filtered.
Fluid D (Fluid B in IP)
To each liter
of fluid A add 1 ml of polysorbate 80, adjust to a pH of 7.1± 0.2,
dispense into containers and sterilize. Use this fluid for articles
containing lecithin or oil,
or for devices labeled as “sterile pathway”.
Fluid K
Dissolve 5 g
of peptic digest of animal tissue, 3 g of beef extract and 10 g of
polysorbate 80 in water to make 1 liter. Adjust the pH to obtain after
sterilization a pH of 6.9±
0.2, dispense into containers and sterilize.
Sample requirements:
1. Number of articles to be tested:
Selected
from sampling plan
2.
Opening of articles:
Greater care
must be exercised when opening an article so that the sample to be tested
for sterility is not contaminated by microorganisms present on the
exterior of the container. The exterior surface of ampoules and closures
of vials and bottles must be cleansed with a suitable decontaminating
agent and the containers must be placed in an environment that prevents
recontamination.
3. Incubation conditions:
Details
are already discussed in culture media.
4. Testing facilities:
Clean room
facilities along with laminar flow unit, air locking systems and all other
equipments are required for carrying out the sterility testing.
5. Volume of medium:
Select
from the table given below
Quantity of article: Select from the table given below
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