Method Suitability Test
This test must be carried out simultaneously with the sterility testing of the examined product. It is carried out when a sterility testing of a new product needs to be carried out, or when the experimental conditions of the test change.
Use exactly the same procedure selected in the Product Sterility Testing described below except for the following modifications.
A) MEMBRANE FILTRATION METHOD
After transferring the contents on the container(s) of the products to be examined to the filter membrane, inoculate a small amount of viable microorganisms (<100 CFU) to the final sterile diluent amount used to rinse the filter.
B) DIRECT INOCULATION METHOD
After transferring the contents on container(s) of the products to be examined to the culture medium, inoculate a small amount of viable microorganisms (< 100 CFU).
In both cases, use the same microorganisms described in the test for the growth promotion of aerobic, anaerobes and fungus. Carry out a growth promotion test as a positive control. Incubate containers for a period not exceeding 5 days.
Sterility testing of the product to be examined
A) MEMBRANE FILTRATION METHOD
Product to be analyzed:
• Aqueous solutions
• Soluble solids
• Oils and oily solutions
• Semi-solids (creams and ointments)
B) DIRECT INOCULATION METHOD
Product to be analyzed:
• Oily liquids
• Semi-solids (creams and ointments)
• Suture thread and related products for use in animals
Incubate inoculated media for 14 days.
Observe during the incubation time and, once period has elapsed, observe the macroscopic evidence of microbial growth. If the medium becomes too turbid to read the presence/absence of microbial growth, transfer 1 ml to a new medium, and incubate it for not less than 4 days.
If there is no evidence of microbial growth, the product complies with the sterility testing.
Our Condalab catalog provides a variety or products for different industries including:
- Water
- Food
- Cosmetics
- Pharmaceutical
- Clinical
*Condalab. (2023). MICROBIOLOGICAL ANALYSIS IN PHARMACEUTICAL INDUSTRY.