Process or Product Validations and Testing 2017-04-01T05:55:33+00:00

Package & process validation

Package Validation is coming under increasing regulatory scrutiny. ISO 11607 has been updated in 2014 and ISO 13485-20XX looks very likely to directly reference requirements for package validation of sterile products. Sabre Medical carries over 20 years of experience with blister and pouching solutions that can save you the time, cost and stress of finding that your first choices were not up to the required standards. We make validation straightforward.

Package validation must demonstrate that the seal prevents the ingress of microorganisms, under test conditions which consider:

  • sterilization process,
  • handling,
  • distribution
  • transport
  • and storage
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The validation plan must address all planned modes or configurations the package must go through before reaching the customer.

Sabre has proven experience in assessing your manufacturing needs, developing package validation plans, executing the plan in short timeframes, and providing a significant portion of your design dossier that simply requires your approval before inclusion.

High degrees of reliability

Proving a package involves documenting and characterising the materials and intended sealing methods. The reproducibility of the package and uniformity of physical characteristics are demonstrated to be consistent with a high degree of reliability. This is done through strength and integrity testing at test conditions representative of the whole product lifecycle.

Risk Management (per ISO 14971) must be integrated deeply into package validation protocols in assessing the configurations and testing required. Our engineers are well placed to advise on this.

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Packaging testing services

We have a range of package testing services ready to slot into your validation plans. Sabre’s testing letterhead is well known to Australian auditors who trust the thoroughness and integrity of our work. You might be reading this page because of their referral.

Proving the reliability of the package and packaging systems provides the foundation for your Sterilisation Validation and is a critical in providing
you Sterility Assurance.

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Our clients

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Testimonials

“Quality of pouches is critical…The engineers at Sabre Medical are able to provide us with excellent sealing validation testing and data to ensure our packaging validation programs are complete and robust.” More…

Ken Logan, Managing Director, Logikal Health Products Pty. Ltd.

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“Sabre Medical is a long term supplier to our medical products division. We have come to rely on them for the highest standards in validated packaging after an initial, exhaustive consultation.” More…

Amy Seager, Product Manager, MobiLIFE

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