Microbiology & Quality Associates (MQA) provides sterility testing for injectable biopharmaceuticals and medical devices that claim to be sterile and free from microorganisms. Testing is performed in an ISO 5 laminar flow hood located in an ISO 6 clean room. The sterility test is performed in accordance with USP/EP requirements for biopharmaceuticals or AAMI guidelines for medical devices. The test must be validated using a method suitability or bacteriostasis and fungistasis test to ensure the material does not have inhibitory properties that affect microbial growth.
Bacteriostasis and fungistasis testing is required by all major pharmacopeias as a means of validating the Sterility Test. This essential step should be conducted on all new products or materials initially submitted for testing and should be repeated periodically to assure continued compatibility with established testing procedures or if the product formulation changes.
Products are tested by two methods:
- Membrane Filtration
- Closed system Steritest system
- Traditional membrane filtration
- Direct Transfer
MQA can also provide biological indicators (BI) designed to meet the ANSI/AAMI/ISO/EN 11138 standards and USP guidelines. We purchase our BI’s from selected vendors. BI’s provided by MQA are tested for spore population and identity by MQA. D value verification can be arranged per customer request.
Biological Indicators are:
- Used to evaluate the effectiveness of sterilization processes.
- Essential in performing sterilization cycle validation.
- Used for ethylene oxide gas, dry heat, steam, and radiation sterilization processes.
- BI’s are available in a wide range of organisms, populations, and packaging.
- Steam: Geobacillus stearothermophilus ATCC® #7953
- Dry heat: Bacillus atrophaeus ATCC® #9372
- Radiation: Bacillus pumilus ATCC® #27142
- Ethylene Oxide: Bacillus atrophaeus ATCC® #9372
- BI’s are available as strips (standard size or mini), discs, suspensions, self-contained, ampoules, and custom configurations.