Best Practices for Adhering to ASTM Packaging Standards

Part 8: Practical approach and Concluding Thoughts

We have worked with thousands of packagers across various industries such as food, medical, biotech, pharma, automotive, aerospace, etc. and we have learned that the most successful packagers use a highly iterative, open minded, and systems thinking approach. When mistakes are made, the organization does not look for a person to blame, it looks for a process or system to improve. This approach will encourage every member of your team to be accountable without blame enabling them to contribute as a member of a greater team.

When it comes to packaging quality, hacking, hustling, and short-term thinking should be absolutely avoided. Any pirate, sumo, ninja, or karate analogies should immediately raise red flags. Quotes such as: “Let’s fix it this time to get this batch out and then we will focus on quality and fix it on our next batch” should never be heard from any of your line supervisors if you ever want to succeed.

Long term thinking is the key and it should be instilled in your culture. Your packaging quality cannot be resolved via a zoom meeting one Tuesday afternoon, it is a long-term project where the improvements are slowly seen via your quality constantly improving over the upcoming months and years.

How to Best Incorporate Quality into all Packaging Standards Ensuring compliance with ASTM packaging standards requires a proactive and systematic approach. The following best practices can help organizations consistently meet or exceed the standards and thus enhance packaging reliability and regulatory compliance.

Identify Relevant Standards Early:
During the package design phase, determine which ASTM standards apply to your product and industry. In the previous articles, we have talked in great detail which testing standards should be used for which type of test and environment. Feel free to go back and review these and incorporate them into your applications and projects.

For example, if you are packaging a sterile medical device, plan for ASTM F88 (seal strength), F1929 (seal leaks), and D4169 (transport) from the outset. Early identification allows you to design packaging and processes that will meet those test requirements.

Integrate Testing into Development:
Don’t wait until final production to test. Perform ASTM standard tests on prototype packages to catch issues early. For instance, do trial drop tests (D5276) or vibration tests (D4728) on package prototypes to see if cushioning needs improvement. If a new seal design is being tried, conduct seal strength and leak tests (F88, F1929) during development. Early testing is the key because it will save time and cost by avoiding late-stage design changes.

Use Certified Laboratories and Calibrated Equipment:
Whether you test in-house or outsource, ensure the tests are done according to the ASTM procedures with the right equipment. Labs should be accredited (e.g., ISO 17025) for the ASTM methods in question. If in-house, calibrate test machines (e.g., torque testers per ASTM D3474 or tensile testers for F88) and train personnel on the exact ASTM protocols. Following the standard method precisely (sample preparation, test speed, acceptance criteria, etc.) is crucial for valid results.

Leverage the Wisdom of Experts:
In addition to the using certified labs and calibrated equipment, companies like Sanatron, who have worked and helped thousands of companies, are a gold mine of expertise and resources in taking your package quality to the next level.

Develop Clear Acceptance Criteria:
ASTM standards often describe the test method but not what constitutes a PASS. Define your own acceptance criteria based on product needs and regulatory guidance. For example, you might specify that no package should leak such as no dye penetration or bubbles, and all seals must have ≥2.0 lbf peel strength (per F88) after aging. Having these criteria helps judge test results and makes it clear when a design is compliant. It will also create a quality standard for you to aim for and if deviations happen, you will be able to catch them swiftly.

Perform Comprehensive Validation Testing:
When validating a packaging system, cover all bases by including visual, functional, and environmental tests. A typical validation might include Visual inspection (ASTM F1886), seal strength (F88), leak tests (F1929/F2096), distribution simulation (D4169), and accelerated aging (F1980), followed by repeat seal/leak tests. This comprehensive approach, as guided by standards, ensures the package can maintain integrity through all foreseeable conditions. Document all results thoroughly.

Address Industry-Specific Needs:
Tailor your quality testing to any special industry requirements. For food, include barrier tests for shelf life (ASTM F1307, F1249 for Oxygen and moisture). For pharma, incorporate high-sensitivity CCIT methods like F2338 (vacuum decay) to satisfy FDA/USP expectations. For aerospace, consider additional environmental tests (thermal, altitude) per ASTM methods to cover transit extremes. Using relevant standards as building blocks, you can customize a test plan that fully reflects real-world use.

Train and Build Awareness:
Ensure that packaging engineers and quality teams are well-versed in the ASTM standards relevant to their work. Provide training on how to perform or interpret tests like dye penetration or vibration. A clear understanding of the “why” behind each test (e.g., “ASTM D4169 vibration test simulates truck transport to prevent transit damage”) fosters a quality culture that values packaging integrity beyond just checking a box.

Continuous Monitoring and Revalidation:
As have been stated before, adherence is not a one-time effort. Over a product’s life, periodically re-test packaging to ensure continued compliance. Materials can change (supplier modifications) or processes can drift. Many companies, for example, do an annual leak test on retains or conduct seal strength tests on each new lot of packaging material. If any critical change is made (new sterilizer, new corrugated box vendor, etc.), perform a targeted revalidation using the pertinent ASTM standard to confirm nothing has been adversely affected.

Stay Updated on Standards:
ASTM standards are periodically revised. Keep track of updates or newer methods that might be more suitable. For instance, ASTM F1929 was updated in 2023 to refine dye test techniques; being aware of such changes ensures you remain in line with current best practices. Participating in industry forums or ASTM committees can provide insight into common compliance issues and emerging improvements in testing.

Leverage Standards for Regulatory Compliance:
Use ASTM standards to demonstrate compliance in regulatory submissions and audits. Reference the standards and present test data showing packages passed those standard tests. Regulators recognize these methods, which can instill confidence that your packaging is properly validated. Having test reports that cite ASTM standards, with results and acceptance criteria, makes your case much stronger if any packaging-related questions arise from customers or regulators.

By following these best practices, manufacturers and packagers can ensure that they not only meet ASTM packaging standards on paper but truly achieve the underlying goal of those standards: reliable, safe, and effective packaging. This reduces the risk of product loss, recalls, or harm to end-users, and ultimately supports smooth operations across the supply chain. Packaging that complies with ASTM standards is packaging that stakeholders, from regulators to consumers, can trust.

Conclusion

ASTM packaging standards serve as a fundamental framework for designing and validating packaging across diverse industries. From preventing leaks in sterile medical device pouches to verifying that an aircraft part’s crate can survive a tumultuous journey, these standards provide proven methods to test and ensure packaging integrity, strength, and performance.

In our long and detailed write-ups, we have explored how seal integrity tests, like dye penetration and vacuum decay, safeguard against contamination, and how shipping tests (drops, vibration, etc.) recreate the distribution environment to prevent damage in transit. We also saw the unique considerations of different industries, the need for extended shelf-life and barrier protection in food packaging, the stringent sterility and CCIT demands in pharma/biotech, the comprehensive sterile barrier validations in medical devices, and the robust, mission-critical packaging requirements in aerospace.

In all cases, adherence to relevant ASTM standards not only helps meet regulatory and customer expectations but also promotes best-in-class packaging practices. By integrating ASTM standards into the packaging design lifecycle, conducting thorough testing, and following best practices for compliance, companies can greatly mitigate the risks of packaging failures. The result are a huge win for all stakeholders because products arrive intact and safe, and organizations avoid costly incidents while building a reputation for quality.

In essence, ASTM packaging standards are both a shield and a compass, they protect products through the rigors of the real world and guide packaging professionals toward continuous improvement and excellence in their craft. With diligent application of these standards, industries can keep raising the bar for packaging reliability, ensuring that what’s inside is preserved and delivered exactly as intended.