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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:
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:
Contact our Technical Customer Support team for additional information regarding the above packages.
Analytical techniques typically performed during extraction studies include:
Additional Techniques
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:
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.
* Requires Knowledge Center account to access.
By Your Side with Analytical Solutions from West – Extractables and Leachables Testing
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.
The concept of Extractables and Leachables (E&L) is well known today, especially since the publication of United States Pharmacopeia (USP) monographs <1663>1 and <1664>2. USP <1663> defined extractables as “organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system and into an extraction solvent under laboratory conditions.” Leachables are defined in USP <1664> as “foreign organic and inorganic chemical entities that are present in a packaged drug product because they have migrated into the packaged drug product from a packaging/delivery system, packaging component or packaging material of construction under normal conditions of storage and use or during drug product stability studies.”
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
The FDA states: Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
The concept of Extractables and Leachables (E&L) is well known today, especially since the publication of United States Pharmacopeia (USP) monographs <1663>1 and <1664>2. USP <1663> defined extractables as “organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system and into an extraction solvent under laboratory conditions.” Leachables are defined in USP <1664> as “foreign organic and inorganic chemical entities that are present in a packaged drug product because they have migrated into the packaged drug product from a packaging/delivery system, packaging component or packaging material of construction under normal conditions of storage and use or during drug product stability studies.”
Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission. Defined as extractables and leachables, these assessments continue to evolve and expand due to consistently increasing regulatory agency expectations. Agency expectations require you to act sooner rather than later. Waiting until Phase III in drug development can lead to delays and additional costs due to poor assessments that are questioned by the reviewer, or incomplete submissions that require you to redo or execute additional work. You can start your Extractables and Leachables (E&L) assessment as soon as you have selected your packaging components.
The FDA states: Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.* While they make this statement, there is no prescription offered in actually how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of containers and closures.
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