Bacteriostasis – Fungistasis Testing
 As a precursor to medical device sterility testing, Microtest offers bacteriostasis and fungistasis testing to satisfy regulatory requirements for drugs and medical devices. We usually recommend testing USP compliance as first choice of methodology, although we can also test to International Standards Organization (ISO), Japanese and European Pharmacopeia requirements if clients prefer.
Devices are transferred to growth media, which is then inoculated with microorganisms and monitored for growth. The testing establishes whether the device’s materials or design possesses any properties that inhibit the growth of fungus or bacteria. If microorganisms can’t be recovered from the device in the growth medium because of some device characteristics, subsequent tests may need to compensate for any inhibiting effects (as by antibacterial coatings) to obtain true sterilization assurance.
Microtest facilities include specialized equipment and extensive capacity for bacteriostasis-fungistasis testing. So we can offer quick turnaround. Additionally, our staff is the most highly credentialed in the business, with extensive microbiological expertise. This allows us to increase your speed to regulatory approval and reduce your time to revenue.
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