In a recent article, we reviewed and discussed key concerns when selecting a test partner for package testing. Oftentimes, Life Science manufacturers struggle with packaging system development and validation test plans; developing a program that aligns with regulatory requirements and falls within budget and market goals can be a challenge. As a follow up to that article, we would like to take a minute to review the major test options available and what’s needed to ensure successful product development and launch
Laboratory based distribution simulation testing provides a uniform and repeatable way of evaluating packaging designs by utilizing standardized equipment and procedures to subject the packaging system design to anticipated hazards that may occur with routine distribution of product. Drug product packaging and sterile medical device package systems must be capable of withstanding the effects of manufacturing, storage, transportation and distribution from the point of manufacture/packaging to the end user. A robust design preserves the package integrity and protects the primary product – without such investments in design and testing, lifesaving therapies may not reach the patient in usable form.
Insofar as distribution testing, there are several distribution simulation test methods that can be used for package performance testing:
ASTM International (American Society of Testing Materials)
- D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems”
- D7386, “Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems”
ISTA (International Safe Transit Association)
- 2 Series, “Partial Simulation Performance Tests”
- 3 Series, “General Simulation Performance Tests”
Which body of standards should you utilize for compliance purposes?
The first consideration is whether the test method is recognized as a consensus standard by the FDA. Next, consider whether the test procedure accurately simulates the anticipated storage and distribution environment.
What makes a method an FDA consensus standard?
For ASTM procedures (recognized as FDA consensus standards), a group of packaging experts develop and democratically approve the standards for publication. Any issues, concerns, and comments must be addressed before final approval as an ASTM standard by the governing committee. ISTA uses a similar ANSI accredited procedure for developing and maintaining standards, but currently only ASTM procedures are recognized on the FDA’s list of consensus standards. ISTA standards, however, are acceptable for complying with ISO 11607:2006, Part 1 for medical device manufacturers.
What method will accurately reflect the anticipated distribution environment?
Certain methods, such as ASTM D7386 and ISTA 3A, are geared towards certain modes of transport – single parcel delivery in less-than-truckload delivery systems – think FedEx or UPS. If you’re looking to evaluate your package system performance from the distribution site to the end user, these are good, modern methods. When you are looking at other areas of the supply chain, other methods may be more appropriate.
In general, ISTA procedures are broken into categories referred to as Series. Each Series contains procedures, projects and/or guides that contain test levels for specific hazards. There is some latitude in the specific test procedures for shock/drop, vibration and compression test procedures – the result is that the execution of certain test methods may vary between laboratories. However, ISTA procedure/categories encompass a wide range of packaging systems – from bulk packing configurations to small parcel. An ISTA certified laboratory and staff can direct you to the test method most appropriate for your evaluation.
Conversely, ASTM D4169 is a single Standard, broken down into specific Distribution Cycles (DC). Each DC represents the anticipated hazards a certain package system may encounter during routine distribution – shipping a palletized load is vastly different from single parcel shipments. D4169 requires the user to have advanced knowledge of the packaging system and anticipated distribution environment, but the methods therein have a solid history of releasing high-performance packaging designs. A test lab well versed in the intricacies of D4169 can help you determine the appropriate test schedules and help you develop a robust test plan.
In the end, simulated distribution testing should ultimately be considered product/package conditioning prior to performance tests. It is these evaluations that are carried out after simulated distribution testing that determine whether the product passes or fails. Typical post-distribution tests can include:
- Evaluation of Product/Package Integrity
- Evaluation of Product Functionality
- Evaluation of Product Damage
When considering your distribution simulation testing needs, work with your test lab partner to understand the specific test procedure or procedures that you will use to evaluate your shipping configuration. Your test lab partner should be able to direct you to the procedure or procedures that will best simulate your distribution environment – and prior to full blown validation, consider performing feasibility testing if your packaging system is new or in development; your test lab partner should have the knowledge and expertise to point you in the right direction.