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Standard Interpretation



Standard: 2016
Section: V1M5, Section 1.7.3.1.a


REQUEST:

The 2016 TNI Standard is clear in V1M5 section 1.7.3.1 a) that all materials and supplies... must be checked by the laboratory once per lot, or as appropriate (for media). It is understood that this means that the manufacturer's certificate is not adequate, and it is the laboratory's responsibility to verify and document sterility. The question then is, does this laboratory check have to be on-site or can lots be checked corporately? Example: 120mL IDEXX bottles are purchased by a laboratory, checked, stored and forwarded to a sister laboratory (located in a different State) as needed. Since the first laboratory checked them, and there is easy access to that lab's records, does the sister lab need to check the same lot again?

TNI FINAL RESPONSE:

The laboratory location using the materials is responsible for performing the sterility check. Using the example provided, each sister laboratory is required to perform their own sterility check. A sterility check does not need to be performed until the items are received in their final location of use.