Container/Closure Innovation Delivers New Complexity In Drug Quality

February 5th, 2019 by Adam C. Fox

By Adam C. Fox, Senior Vice President, Analytical Operations, Nitto Avecia Pharma Services

Biologics syringe

Why is this service needed?

Many new delivery systems and drug-device combinations make dosing less cumbersome for patients and healthcare providers. But they add more complexity for drug developers.

Traditionally viewed as isolated subassemblies, container/closure systems today are essential to achieving therapeutic value.

What is the Nitto Avecia Pharma Services solution?

Nitto Avecia Pharma Services develops and validates new methodologies to support the latest in container/closure systems as well as traditional designs. It specializes in testing injectable products.

How is Nitto Avecia Pharma Services different?

The new generation of container/closure systems has led to a variety of regulatory responses. The revised U.S. Pharmacopeia (USP) Chapters <660> for glass containers and <381> for elastomeric closures are difficult to understand and, oftentimes, cumbersome for the inexperienced analyst. Nitto Avecia Pharma Services has vast experience with these monographs and has achieved successful outcomes with methods that handle the tests using the right timing and cadence.

Clients benefit from Nitto Avecia Pharma Services’ experience with the USP standards. For those clients who want to market their products outside the U.S., Nitto Avecia Pharma Services also offers container/closure testing that meets both European and Japanese regulatory standards.

Some competitors test to the USP standards. Several offer container/closure services for European markets. But very few provide services that meet Japanese standards. And almost no competitors of similar size provide a complete portfolio of container/closure services that meets regulatory expectations in the U.S., Europe, and Japan.

Also setting Nitto Avecia Pharma Services apart from competitors is its responsiveness to client needs for advanced testing. Most competitors do comply with minimum requirements, but Nitto Avecia Pharma Services goes a step further when asked by clients. For instance, when testing for arsenic in rubber stoppers, the company can detect impurities down to the parts-per-billion level using inductively coupled plasma instrumentation. The resulting trace-level impurity analysis is far superior to competitors’ methods, most of which detect at the standard parts-per-million level.

To achieve superior performance with its equipment, Nitto Avecia Pharma Services dedicates a group of instruments to container/closure sample preparation and analysis. Reserving these systems exclusively for this work helps the company respond quickly to customer needs. By contrast, many competitors run numerous studies with the same autoclave. This is compliant, but it can cause a delay for clients while personnel clean and requalify equipment before starting new container/closure studies.

Why work with Nitto Avecia Pharma Services?

There is nothing simple or straightforward about the new generation of container/closure systems. To achieve the promise of today’s advanced therapeutics, it is important to have a partner that can deliver robust testing services that ensure you deliver across major healthcare markets.

Posted in: Pharmaceutical Online


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