Does anyone know of any written FDA quantifications of AQLs or quality levels other than:

1. Surgeon's and general exam gloves, which are specified for purposes of destructive sample-testing for gross leaks to have AQLs of 2.5 and 4.0 respectively.

2. General sterile-device SAL, which is specified as 10E-3 for devices with no direct/indirect patient contact or only intact skin contact, and 10E-6 for all other devices.

Does anyone know of any written FDA quantifications of AQLs or quality levels other than:

1. Surgeon's and general exam gloves, which are specified for purposes of destructive sample-testing for gross leaks to have AQLs of 2.5 and 4.0 respectively.

2. General sterile-device SAL, which is specified as 10E-3 for devices with no direct/indirect patient contact or only intact skin contact, and 10E-6 for all other devices.

Did you have a look at Federal register - Proposed Changes (http://bulk.resource.org/gpo.gov/register/2003/2003_15405.pdf) - points 4 and 5 ?

You can also have a look at Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure (CPG 7124.31) (http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg335-700.html)

Thank you, the first item is interesting. I'm familiar with the second one.

We don't actually have any activity related to gloves. Those were mentioned by me only as examples for my general inquiry as to other instances of FDA guidance regarding AQLs.

The general sterile-device SAL standard, OTOH, is directly relevant to us, since we make barrier-packaged, terminally sterilized products in large quantities using procedures that have to be validated per these numbers.

We operated for many years without knowing that the minimum SAL for non-patient-contact devices was 10E-3 rather than 10E-6...and we do make a few products that are non-patient-contact. My question was aimed at eliciting more new numbers that we somehow hadn't previously known. :)

Actually, I believe that if you are manufacturing terminally sterilized products, then you do not have a choice in SAL; it MUST BE 10E-6.
FDA allows 10E-3 for products that are aseptically assembled and not for direct patient contact.

What is the sterilization mechanism for your products? you have to run your validations as per AAMI/ISO 11137-1 guidelines.

Your Use of the term AQL threw me off. This is a term used for statistical sampling techniques per ANSI standards. Typically, when you sample products for testing, you have to establish and justify a sampling plan per ANSI standards. This plan must be based on risk level etc. Then you determine the inspection level ; etc. etc. and come up with how many parts to inspect from the lot.

AQL may be relevant to what we're doing in that we have a number of validated production processes for which the only defensible and standards-guided testing method is destructive, therefore a sampling approach must be used to establish and show continued performance to validation conditions.

Most of our sterilization is EtO, done by a validated and registered contract provider with whom we have a long-term relationship.

We have a strong recognition of the applicability of 11135, 11607 and 10993-7 (plus others driven by the marketplace, such as Japanese contamination and residuals expectations), although we're always looking for gaps and new perspectives for compliance improvement.

Please provide info as to the basis for your "aseptically assembled devices only" comment regarding SAL = 10E-3. FDA guidance K90-1:2002, available at http://www.fda.gov/cdrh/ode/guidance/361.html, says "(...) SAL (e.g., 10-6 for all devices, except 10-3 for devices only contacting intact skin (...)". Is that information superceded, incomplete, incorrect or misleading?