The new seal of approval: Why USP's new rules are shaking up manufacturing

But now, things are changing. New updates to the rules are raising the bar, with more detailed requirements on how materials are made, tested, and tracked. At ERIKS, we’re helping customers navigate these updates with expert guidance and fully compliant sealing solutions – all backed by a deep understanding of clean environments.

So, what’s changing?

There’s now more focus on knowing exactly what products are made from, how they behave in different conditions, and how safe they are for human contact.

The updated standards (particularly changes to USP <381>, <382>, <383>, <87> and <88>) are part of a wider industry move toward:

• Greater transparency: Full disclosure of a material’s chemical formulation and characterisation
• Improved traceability: Knowing the detailed documentation, including COA’s and COC’s
• Safer use in real-world environments: Vitro Biological Reactivity Testing (USP <87>) and analysis for extractables and leachables, not just raw material safety
• Assembly-level evaluation: For example, not just testing a rubber stopper, but testing it as part of the whole device it belongs to

Even packaging materials are now expected to meet these higher standards. That includes everything that touches the product, not just what’s inside.

“This has major implications,” says Lee Myatt, Head of Materials at ERIKS. “You can no longer assume that if the seal is certified, the rest of the system is automatically compliant. Every layer matters – including packaging.”
 

A truly global standard

One of the biggest shifts in the updated USP VI compliance is its move towards becoming a more international standard, rather than one focused solely on the US market. By incorporating broader bio-compatibility requirements, such as those from ISO 10993, USP is aligning itself with global regulations.

This harmonisation means that manufacturers worldwide – whether supplying pharmaceuticals, food packaging, or life sciences products – will need to meet consistent, rigorous standards. The result is a smoother pathway for companies operating across borders – and, crucially, a stronger level of consumer confidence in the safety, quality, and integrity of the products they use every day.
 

A step forward for safety – and ethics

Another positive outcome of this tighter regulation is the move away from sole reliance on USP <88> in vivo testing. The new approach encourages a deeper understanding of material chemistry early on, which can help manufacturers meet safety benchmarks without the need for traditional in-vivo testing.

“By using better material data and smarter testing, manufacturers can reduce reliance on animal models while still protecting patient safety,” Lee adds.

This is not only more ethical – it’s faster, more cost-effective, and easier to repeat and verify.
 

Who’s affected?

These changes will have the biggest impact on:

• Pharmaceutical manufacturers – including packaging of vials, stoppers, and delivery devices
• Life sciences companies – particularly those using elastomeric seals and tubing in sterile applications
• High-purity food production – where materials must be both clean and compliant with food safety laws

In all these areas, manufacturers will need to work closely with suppliers who understand the technical detail, and who can supply materials with full documentation and traceability.
 

Key deadlines at a glance

How ERIKS can help

At ERIKS, we offer more than just compliant seals and gaskets – we offer peace of mind.

Our clean environment solutions include:

• Seals and gaskets made from USP Class VI, FDA, and ISO 10993-approved materials
• Full traceability of formulation, source, and production history
• Support for packaging compliance and material compatibility
• Guidance from in-house materials and quality experts
• Rapid prototyping, documentation support, and custom solutions for regulated industries

Getting ahead of compliance

As the industry continues to move towards safer, more transparent material standards, companies that act early will avoid disruption – and gain a competitive advantage.

With decades of experience and deep technical knowledge, ERIKS is ready to help customers in food, pharma, biotech, and medical manufacturing stay compliant, confident, and clean.

For more information on Sealing and Polymer and to get in touch with one of our ERIKS specislists, please contact your local ERIKS Service Centre, who will be happy to discuss your options.

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