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of the recognized LAL test methods or BET for bacterial endotoxins testing. See Table 1 for the LAL test methods recognized as the harmonized bacterial endotoxins tests in the USP <85> BETs that become official as of January 1, 2001(28-30). The requirements associated with conducting the inhibition and enhancement test or interfering factors test for these LAL test methods are covered in the FDA Guideline on the Validation of the LAL Test and in the USP/European Pharmacopeia/ Japanese Pharmacopeia (14,28-30).

A medical device manufacturer may provide technical rationale or justification for dividing its medical device products into groups of products (families) according to common chemical formulation (material of device and device components), and may qualify only a representative product from each similar group or family of medical device products. The representative product chosen from each group must be the one that with the largest surface area contacting body or fluid administration to a patient end user.

At least three production batches or lots of each product type must be tested for inhibition/enhancement (14). If one product batch or lot is manufactured only once a year, validate and release each batch or lot concurrently until all three batches or lots are completely validated for the LAL test method used. Once again, it is important to know that LAL testing prior to sterilization is permitted for dry medical devices only. Dry medical devices are devices that are manufactured without exposure to water through the entire manufacturing process. Medical devices that are exposed to water during the manufacturing process or contain solutions are considered wet devices. These wet devices have a higher risk of providing moisture and potential nutrition that can support microbial growth and may not be appropriate for pre-sterilization sampling.

If undiluted rinsing or extracting solution cause test interference to the LAL test method used, repeat the inhibition/enhancement testing after neutralizing and removing the inhibiting substance, or after the solution has been diluted by a factor not to exceed the MVD.

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