Sterility assurance level (SAL) refers to the probability of a microorganism surviving the sterilization process, making the item non-sterile. Currently, a SAL of 10–6 is considered acceptable. Read more about the sterility assurance level HERE.
To achieve sterility a device must go through the sterilization process, have sterilized components, sterile filtration, and be contained in a sterilized container, and go through chemical or physical sterilization and aseptic processing. Many sterilization methods exist including autoclave steam sterilization, chemical methods such as ethylene oxide sterilization, and radiation methods like gamma ray sterilization.
Autoclave Steam Sterilization
The autoclave combines heat and moisture under elevated pressure. Objects are placed in the autoclave which is then sealed. Hot steam under high pressure is then forced into the autoclave. Microorganisms are destroyed in the moist heat by denaturing the enzymes and protein structures. Time and temperature vary from 15-60 minutes depending on the microorganisms being targeted.
Ethylene Oxide (ETO) Sterilization
Chemical methods of sterilization are often combined with physical methods to increase the sterility assurance level. Ethylene oxide sterilization is one such chemical method and has 5 stages: evacuation with humidification, gas introduction, exposure, evacuation, and air washes. The process takes about 2 1/2 hours. Ethylene oxide reacts with proteins, amino acids, and DNA to keep them from replicating.
Gamma Ray Sterilization
Gamma ray sterilization is performed by placing objects in the radiation field where they can receive the necessary radiation dosage. The radiation causes excitation, ionization, and free radicals, all three which damage molecules necessary for life in cells like DNA and enzymes. Gamma ray sterilization is faster than other physical or chemical methods.
If you are in need of sterility assurance level testing, submit your test request on our website or by call toll-free 1-855-377-6821.
The following are our most recent sterility assurance level and other sterility tests, click here to view more:
- Canada microbiology laboratory needed for pharmaceutical sterilization validation and Sterility assurance testing
- FDA GLP GMP Contract Pharmaceutical laboratory needed for GMP Testing: analytical chemistry testing, microbiology testing, sterility assurance testing, and biocompatibility testing stability testing microbiology testing
- Analytical Chemistry laboratory needed for medical devices – 501k Submission testing: Cytotoxicity Sensitization Irritation Ames Mutagencity Product Sterility for final package (3 year expiry) Gamma Irradiation Testing – radiation dose, sterility validation method, sterility assurance level
- FDA GMP, GLP Laboratory needed for ASTM and ISO Biocompatibilty Testing, Sterility Assurance Testing and Packaging Integrity Testing for disposable medical device
- LONG-TERM TESTING Medical Device Microbiology laboratory of Bioburden and sterility testing for implantable medical device. WE will send product for testing after sterilization using gamma radiation as the method of sterilization. 20 samples/ product family (4 families) every quarter.
- Pharmaceutical laboratory needed for USP <71> sterility tests and gram stain validation.
- Biopharmaceutical Contract Research Organization needed for initial method development and qualification of sterility, mycoplasmas, and bioburden tests for biologic materials.
- Medical device microbiology laboratory needed for sterility testing of various medical device sets.
- LONG-TERM TESTING Medical Device Laboratory needed for sterility test method validation and then routine sterility testing of medical device components per ISO requirements.
- Biopharmaceutical company needs microbiology laboratory for USP sterility testing of cellular therapy finished drug product API to USP monograph 71
- FDA cGMP microbiology laboratory needed for microbiological and sterility testing of generic drug products (tablets, capsules, and injections) including EP European Pharmacopoeia microorganisms parameter assays, microbial enumeration tests, total aerobic microbial count (TAMC) CFU/g or GFU/ml, total combined yeasts/molds count (TYMC) CFU/g or GFU/ml, microbiological identification, Escherichia coli, Salmonella, Pseudomonas aeruginosa, and Staphylococcus aureus.