New ISO 11040-4 – Syringes

ISO 11040-4, “Prefilled syringes – Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling,” has just been updated.  The new 3rd Edition is available from Document Center Inc. now.  This 60-page revision has been technically updated with a number of important changes.  If you use this standard you’ll want to purchase this update right away.

ISO 11040-4 provides manufacturers with the requirements for producing syringe assemblies for sale to pharmaceutical companies for use as pre-filled syringes.  These systems provide a methodology for delivering drugs with a significantly reduced chance of contamination.  ISO 11040-4 allows for standardization of these systems, so that pharmaceutical companies can purchase these syringe systems confident in their sterility and quality for the delivery of their preparations.

If you use this standard, you’ll want to know what changes are in the new ISO 11040-1 2015.  Here’s a list for your review:

  • Sterilized subassembled syringes and their test methods have been added.
  • There’s new general requirements for quality systems, testing and documentation.
  • Labeling requirements have been updated.
  • Packaging requirements have been added.
  • The requirements for syringe barrels have been changed.  There are new requirements and test methods for flange and Luer cone breakage resistance.  Additional guidance and requirements for Luer conical fittings and functional testing are included.  And the clause on designation has been deleted.

Now to get a copy.  Of course, you’re aware that the ISO 11040-4 is a copyright document and must be purchased from an authorized dealer.  Since Document Center has been selling ISO standards under contract since the 1980’s, you can buy from us with confidence.  Order the ISO 11040-4 online for delivery in either paper format or as a pdf download.  You’ll use the Document Center Inc. webstore at www.document-center.com.  Would you prefer multi-user access?  Ask our staff about our Standards Online subscription service.  You can reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re a woman-owned small business, selling standards since 1982 from our Silicon Valley headquarters.  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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