Andersen Scientific

Description

Andersen Scientific develops sterilization validation protocols according to applicable portions of ISO11135, the internationally recognized sterilization standard. Our validation protocols employ the half cycle method, which is used to demonstrate a sterility assurance level of 10-6 (the FDA internationally accepted overkill method). Our in-house analytical laboratory is qualified to perform all validation test procedures, ageing studies and packaging validations--thereby reducing the validation completion time. Under the right circumstances, validations can often be completed in only eight weeks. The diagram below provides an example of a typical validation timeline. Our validation personnel will generate a custom timeline specific to your validation. This way, you can converse with our experts using the same technical "buzz words" and stay on top of the projected completion date. A common question is: how many devices will I need to complete the validation? Since the gas diffusion process uses independent 1.24ft3 sterilization bags/chambers, the number required for validation depends on the number of devices that fit into the bag/chamber. Example: CathMed1 manufactures balloon-tipped catheters and is need of a full validation. The size and density of this product allows each sterilization bag or flexible chamber to hold fifty (50) catheters. Device Numbers Required: Four fully-loaded sterilization bags —can be returned.

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