Managing Compliance Risk

Complying with ISO 11607 can be tough. Especially given the varying degrees of interpretation. The following areas require intentional thought and thorough justification as well as a strong understanding of the risk associated. Next time you’re ready to go to market, consider these things to help mitigate your compliance risk.

Worst Case Rationale

Some of the attributes to consider when writing a worst-case rationale, whether it be for similar devices that use the same packaging system or a worst-case packaging configuration, are weight, geometry, distribution environment and device fragility. Have you considered these attributes in your worst case rationale?

Sample Size

Sampling plans are required per ISO 11607. The specific sampling plan is dependent on many factors including distribution test method assurance level, risk level from failure mode and effective analyses, and confidence and reliability requirements. What are your organization’s tolerance levels? What sample size plans have you used and justified for previous products?

Conditions for Accelerated and Real Time Aging

Ensure proper justification for temperature for accelerated aging and temperature and humidity requirements for real time aging/stability. What is your organization’s definition of “ambient”? Can you obtain real time aging data from your supplier?

Minimum Seal Strength Specification

Minimum specification requirements are dependent on many factors and are continually challenged within the industry. Does your company follow the ‘standard’ 1 lb. minimum? What seal strength does the weight of your product require from your packaging?

Label Legibility

ISO 11607 requires labels to be adhered and legible as part of acceptance criteria during design verification. Legibility can be subjective, so ensuring you follow a standardized test method or use an in-house test method that has been validated is crucial. Have you considered your label legibility after distribution testing?
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Looking to reduce your risk in healthcare packaging?

Due to the sterility issues that have risen in the past, companies have developed methods and materials that reduce risk and ensure proper packaging for your product.
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Whether in our lab or in your facility, our healthcare packaging engineers tailor solutions that reduce costs, improve material performance, increase productivity, and can help troubleshoot packaging failures.
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What should your seal strength be?

Seal strength in medical device packaging is critical, and must stand up to the real-world stress of sterilization, distribution and product load. For more than 40 years, industry professionals have been asking: What should my minimum value be, and how do I meet the 1.0 lb. seal strength standard?
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