New ISO 18362 – Microbiological Q.A.

ISO 18362, “Manufacture of cell-based health care products – Control of microbial risks during processing,” has just been released.  This new standard provides manufacturers using cell-based material in their health care products with a way to reduce the risk of contamination during processing.  Since cell-based health care products can include a wide variety of materials, the way in which each reacts to various forms of sterilization, etc., can vary widely.  The document addresses the process needed for a risk-based approach for handling these new materials.

CBHP (Cell-Based Healthcare Products) can include materials from human, animal, microbial or plant origin.  Some are able to withstand sterilization, others must be delivered without a guarantee of sterility.  What kinds of materials are we talking about here?  CBHPs include biological heart valves, sutures, tissue patches, corneal tissue and viable skin grafts.  These materials reflect the expanding world of medical science, where the use of biological material is replacing the previous metallic or plastic parts in order to achieve better results and longer lasting solutions.

However, using contaminated materials during surgury can have tremendously negative consiquences.   So manufacturers will want to reduce the risks of this as much possible, increasing the safety and quality of their products according to best practices.  ISO 18362 provides you with a thorough review of all elements necessary to achieve this goal.

It starts with the usual scope, referenced documents and terms and definitions sections.  Clause 4 addresses the quality system elements necessary here, with Clause 5 covering process definition, particularly risk management.  Clause 6 discusses the manufacturing environment, including such areas as manufacturing environment design, the workflow for materials and personnel, and even your HVAC system.

Next come clauses specifically on equipment, personnel, and the manufacture of your product.  Clause 10 is on process simulation and process confirmation, necessary to assure that your system is going to function correctly.  Clause 11 covers the final product release and your test for sterility, if applicable.  Clause 12 covers the final product released for those materials where biological contamination can’t be detected by sterility, for whatever reason.

There are an additional six Annexes in this standard.  Only one is a required section — Annex B on decision trees for the application of risk assessment for cell-based starting materials.  The balance of the Annexes are informational only:

  • Annex A on examples of microbial risks for CBHP,
  • Annex C on containment facilities,
  • Annex D on CBHP starting material itself,
  • Annex E on containment requirements for procured non-sterile starting material prior to entering the manufacturing area, and
  • Annex F on typical elements of a process definition.

A 24-item Bibliography completes the standard.

If you use CBHP’s in your business, you’ll surely want to get a copy of this new standard.  You can order with confidence at the Document Center Inc. webstore, www.document-center.com.  Here’s a direct link to the order page for ISO 18362.

Perhaps you’d like to have multi-user access to this document (and others as well!)  Contact our staff for more information about our Standards Online subscription service.  You can reach them by phone (650-591-7600) or email (info@document-center.com).  And, of course, you’ll find them to be a knowledgeable resource when you have any of the questions that compliance documentation sometimes generate.  After all, we’ve been selling standards since 1982.  Make us your Standards Experts!

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Claudia Bach

Claudia Bach is the President of Document Center Inc. and a world-wide recognized expert on Standards and Standards Distribution. You can connect with her on Google+

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