Leading with Science

Regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), are focusing on the presence of leachable elements and compounds in pharmaceuticals, drug delivery systems, and medical devices. In today’s regulatory environment extractable and leachable (E&L) information is expected. E&L studies are not created equal. West Analytical Services partners with our customers to help navigate the challenging regulatory landscape to design and execute E&L studies.

West Analytical Services has been performing E&L studies for over 20 years, providing a holistic approach for your container closure system, device or combination product. We partner with our customers delivering tailored E&L studies based on the stage of development of the product. Activities may include:

  • Extractable, simulation and migration studies
  • Extractable risk assessment using our E2L™ assessment
  • Leachables method development and validation
  • Leachables stability testing and storage
  • Toxicology support
Capabilities and Expertise

Knowledge

West’s highly trained and experienced E&L team can help at every stage for a successful regulatory submission. We perform customized, CGMP studies that follow the current regulatory requirements and guidances. West uses regulations such as USP <1663> “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and <1664> “Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems” when planning and performing extractables and leachable studies. West uses ISO 10993-18 when planning and performing studies for medical devices such as West’s SelfDose™ and SmartDose® injectors.

Expertise

West has unique insights as a manufacturer of components and devices - nearly 100 years of elastomer experience.

Our extensive expertise includes:

  • Injectable components such as container closure systems (stoppers and vials), syringes, devices (including West’s SelfDose™ and SmartDose® Injectors)
  • Other container closure materials including labels, foils, adhesives and films
  • Container/closure components for a range of product types, including drug and biological products

Service

In addition to services for customized E&L studies, West Analytical Services offers the VeriSure™ Technical Package for 4432/50 Gray and 4023/50 Gray elastomer formulations. The VeriSure™ Technical Package includes documents to support the pharmaceutical and biotech industry in the effective and proactive management of the complexity surrounding extractables (potential leachables) in these leading elastomer formulations.

The cornerstone of a leachable(s) investigation is a comprehensive chemical characterization of elastomer components in which critical materials are evaluated by conducting controlled extraction studies. The VeriSure™ Technical Package provides an extensive list of extractables which is carefully reviewed and updated.

Additional information for other elastomer formulations can be provided including:

  • Materials Characterization
  • Theoretical Material Extractables

Contact our Technical Customer Support team for additional information regarding the above packages.

Analytical Techniques

Analytical techniques typically performed during extraction studies include:

  • Volatile Organic Compounds — Headspace Gas Chromatography-Mass Spectrometry (GC-MS)
  • Semi-volatile Organic Compounds — Direct injection GC-MS
  • Non-volatile Organic Compounds — High Resolution Accurate Mass (HRAM) Liquid Chromatography-Mass Spectrometry (LC-MS)
  • Elemental Impurities (metals) — Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
  • Ionic Species — Ion Chromatography

Additional Techniques

  • ICP-Tandem MS
    • ICP tandem MS offers unparalleled performance for the removal of polyatomic interferences, allowing for ultra-trace analysis in the most demanding matrices.
  • Ion Mobility HRAM LC-MS
    • Complex matrices are not a problem with the added ion mobility capability
    • Accurate mass for detected compounds
    • The instrumentation allows for better separation which can lead to more information for unknown compounds
Verisure® and E2L Services Support your Extractables and Leachables Studies

Pharma and biotech companies needs to combine the containment system or combination product with analytical expertise to meet agency expectations and quickly progress through the extractables and leachables process. In order to help our customers, West Analytical Services has developed two unique tools, VeriSure® Technical Packages, specifically for our 4023/50 Gray and 4432/50 Gray formulations and E2L testing services to support their extractables risk assessment.

The VeriSure technical packages provide comprehensive technical packages for extractables which customers access online. They were created as a service to our customers to allow them the use of this data to support their regulatory filings in showing that their products meet extractables testing guidances. The package is a semi-qualitative compilation of results excerpted from years of data and studies for these formulations. Extractables data is acquired using multiple solvents, extraction conditions and analytical techniques. Study variables include:

  • cure conditions
  • multiple manufacturing sites, both domestic and international
  • multiple component configurations
  • post-processing considerations

The E2L testing is a service that provides a risk assessment for extractables to determine what leachables a manufacturer may want to focus on for their leachables studies. A risk assessment report is provided to assist in determining analytes for leachables method development. The assessment, based on measurable criteria, evaluates each extractable identified in the extractables assessment and ranks the risk based on 3 categories: low, medium and high risk. The report includes explanations of the criteria used to assess the risk, a color-coded visual reference table that ranks the extractables, and a total risk ranking for each extractable. West’s E2L testing assists our customers with their risk assessment, but it does not remove the need to perform a risk assessment for leachables specific to their drug products. It should also be noted that Analytical Services can provide the E2L risk assessment for any extractables services and not just those related to the VeriSure technical packages.

The VeriSure technical packages and the E2L risk assessment can help customers move efficiently through the first stage of the extractables and leachables process for their packaging components.

BY YOUR SIDE

By Your Side with Analytical Solutions from West – Extractables and Leachables Testing

Selecting a device partner for combination product development should be based on several key considerations. Listen to our webinar, "Factor to Consider when Selecting a Combination Product Device Partner"!

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SelfDose™, VeriSure™ and E2L logo are trademarks and registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. 
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.