In the life sciences industry, packaging is far more than a box or a seal. It is a validated system—a safeguard designed to maintain sterility, preserve product integrity, and meet the rigorous requirements of ISO 11607 and FDA regulations. Yet one of the most overlooked risks in this space comes from a seemingly routine event: changes to supplier equipment.
When a supplier installs new machinery or modifies an existing production line, even the smallest variation can compromise critical packaging requirements such as seal strength, barrier properties, and consistency of sterile barrier performance. These shifts, if left unchecked, can lead to compliance issues, product recalls, or worse—risks to patient safety.
Why Equipment Qualification Matters
More organizations are recognizing that equipment qualification is no longer optional. A structured approach using IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) ensures that packaging systems can consistently deliver validated outcomes.
For example, a qualification effort might uncover that machine settings are gradually drifting outside optimal ranges. Left unaddressed, this drift could result in variable seal integrity, putting sterility at risk. By catching such issues early, companies can prevent costly findings during audits and avoid downstream consequences like recalls.
Building Supply Chain Resilience
Equipment qualification is more than just “checking a box” for compliance. It is about:
- Protecting patients by ensuring packaging maintains sterility and safety.
- Safeguarding product performance so that quality is preserved across global markets.
- Strengthening the supply chain by embedding resilience into packaging validation systems.
Companies that view packaging validation as a living system, rather than a one-time requirement, are better equipped to adapt to supplier changes and regulatory pressures. This proactive mindset is what separates resilient organizations from those constantly playing catch-up.
Key Questions to Consider
To evaluate your readiness, ask yourself:
- Are all of your suppliers’ equipment qualifications documented and aligned with your packaging requirements?
- Do you have visibility into how supplier equipment changes might impact sterile barrier performance?
- How frequently do you revalidate packaging specifications after process or equipment changes?
Meet SQA Services at the Generis Medical Device Summit
Supplier equipment changes may seem routine, but their impact on packaging performance can be profound. Treating equipment qualification as a strategic, ongoing process helps ensure compliance, reduce risk, and ultimately protect patients.
SQA Services will be at the Generis Medical Device Summit in Chicago, Illinois October 27-28. Contact us today to schedule a meeting with our team!
