Sterility Testing – USP <71>
Product Sterility is necessary for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms.
MicroMed performs sterility testing of devices and solutions in compliance with USP<71>. MicroMed performs all tests in a state of the art ISO Class 5 Clean Room in the confines of a biological safety cabinet to reduce the risk of false positives. Our technicians use only sterile gowning supplies and monitor the CER routinely to ensure that it is operating within specifications.
MicroMed follows USP sterility testing guidelines to determine if a given sample lot is sterile or not sterile. Various other regulatory agencies — including the U.S. FDA, the ISO, and AAMI — recognize the USP method as, in effect, the highest standard.
All EtO sterilization related spore strips are processed as soon as possible priority items upon receipt because we know your timelines are important for lot release.
Sterility Validation – ISO 11137
Sterilization Validation method validates any sterilization method. The samples will be sent to a sterilization company to be sterilized and then sent to MicroMed. Upon reception the samples will be tested by sterility to assure the samples are sterile.
Bacteriostasis/Fungistasis – USP <71>
Bacteriostais/Fungiostasis is used to test samples to determine if there are antimicrobial properties of a given sample so they can be used for further sterility testing. MicroMed tests sterile samples by introducing them to bacteria/fungi infested growth media with a known concentration of contaminant. This inoculation is plated as well to ensure the appropriate amount of bacteria/fungi was introduced to the sample. If there is growth similar to the positive controls, then the sample can be tested for sterility without further modification.
Dose Audits – ISO 11137
MicroMed tests products to assess the sterility of a known sterilization protocol. A portion of the samples will be sterilized at an external site and shipped to MicroMed. The other non-sterile portion of sample will be sent straight to Micromed. Upon reception, the devices will be tested for microorganism activity via bioburden and sterility.
Cleaning and Disinfection Validation – reusable device – AAMI, TIR 12, AAMI, TIR 30
Reusable medical devices must undergo cleaning and/or disinfection between patients. MicroMed can perform validation studies to ensure that cleaning/disinfection methods are adequate. Such studies involve inoculation of the device and are used to simulate manufacturer recommended cleaning instructions. In addition to the microbiological testing, validation includes cytotoxicity testing to ensure that residuals from the cleaning and disinfection process have been removed.
Autoclave Cycle Validation – HTM 2010, EN 285, EN17765, PDA Monograph and ISO standards
Our specialty is IQ/OQ/PQ, Cycle development and PQ’s of Autoclaves. Performance qualification (validation) is an accurate method of assessing and maximizing the efficiency of your autoclave cycles and your individual load types. Spore strips will be placed inside of a given device and autoclaved using the protocol to be validated. The spore strips will be transferred to growth media and incubated to assist growth. If no growth is present the autoclave cycle is acceptable to sterilize the device.
Autoclave Cycle Qualifications – ANSI/AAMI/ISO 17665 -1 and 2
MicroMed can qualify a standard cycle for use on your product per ANSI/AAMI/ISO 17665 -1 and 2 this cycle can then be duplicated at the final use site. Spore strips will be autoclaved using the protocol to be validated. The spore strips will be transferred to growth media and incubated to assist growth. If no growth is present the autoclave cycle is acceptable.
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Turn Around Time (TAT)
Validation Testing
| Code | Test Description | TAT |
|---|---|---|
| ST-001 | Bacteriostasis/Fungistasis, USP Method-One Time Test – ETO (6 organisms) – 6 units required | 16 – 18 days |
| ST-001.1 | Bacteriostasis/Fungistasis, USP Method-One Time Test – Radiation (3 organisms) – 3 units required | 16 – 18 days |
Device Sterility Testing
| Code | Test Description | TAT |
|---|---|---|
| ST-002 | Direct Transfer Method-per device/unit/solution-2 units required (TSB/THIO) – Device ≤ 1L | 16 – 18 days |
| ST-002.1 | Direct Transfer Method-per device/unit/solution-2 units required (TSB/THIO) – Large Device >1L | 16 – 18 days |
| ST-007 | Cleanroom Usage Fee (one-time fee per submission form) | 16 – 18 days |
| ST-002A | Membrane Filtration Usage (per test) | 16 – 18 days |
MISC Sterility Testing
| Code | Test Description | TAT |
|---|---|---|
| ST-003 | Direct Transfer Method-Spore Strips | 10 – 12 days |
| ST-004 | Growth Promotion Test-of Cultured Media (per sample or organism) | 10 – 12 days |
| ST-005 | Autoclave Cycle (per cycle) | 10 – 12 days |
| ST-006 | Biological Product Sterility – Direct Transfer | 10 – 12 days |
| ST-008 | Self-Contained Biological Indicators | 10 – 12 days |
| BP-001 | BI Population Verification (USP), Pooled Results, 3 Bis | 10 – 12 days |