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What standard must I follow to validate my packaging?

By November 4, 2016November 6th, 2016General

Medical devices are grouped into specified areas, and the FDA has provided guidances for nearly all of them. Sterile packaging is no different, and it too has its own guidance – ISO 11607.  Want your medical device packaging to perform efficiently, safely, and adequately? Follow ISO 11607.

There are two parts to ISO 11607. ISO 11607-1 deals with the basic attributes of the packaging system. Think materials, medical device, packaging design, conditioning, and sterilization methods. ISO 11607-2 describes validation requirements, covering mainly IQ, OQ, and PQ of the packaging equipment and process.

ISO 11607-1 Testing Requirements:

  1. Material Characterization
    • Do the materials suit their use (i.e., temperature, pressure, sterilization, biocompatibility, etc.)?
  2. Performance Testing:
    • How does the packaging/product assembly respond to stresses imposed by the manufacturing and sterilization process and the handling, storage, and shipping environment?
      1. Package Integrity Testing: ASTM F2096:2002
      2. Package Strength Testing: ASTM F88:2000
      3. Distribution Testing: ASTM D4169:2001 or ISTA 2A
  1. Stability Testing:
    • Does the packaging maintain integrity over time?
      1. Accelerated Aging: ASTM 1980:2002
      2. Real Time Aging

Ensure that the packaging meets all requirements. It is so easy to overlook variables such as compatibility with sterilization, storage temperatures, and distribution. Keep in mind that these tests are expensive, so experience in the initial design is essential.

ISO 11607-2 Testing Requirements

  1. Installation Qualification (IQ)
    1. Evidence that equipment has been provided and installed to spec
  2. Operation Qualification (OQ)
    1. Proof that installed equipment operates within predetermined limits when used as intended.
  3. Process Qualification (PQ)
    1. Evidence that the equipment, as installed and operating as intended, consistently performs in accordance with predetermined criteria.

A seamless integration (IQ) of the equipment to your facility is crucial. A design of experiments protocol will nail down the optimal operating parameters of your equipment (OQ).  Challenging the equipment to meet typical processing conditions and exposing the equipment to the minimum and maximum processing parameters will ensure the efficiency of your process (PQ).

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