We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
Prefilled Cartridges and Needle Based Injection Systems Testing Services (ISO 11608 Series)
Applicable Products
Tests Available
Ready to Fill and Prefilled Glass and Advanced Polymer Syringes Testing Services (ISO 11040 Series)
Applicable Products
Tests Available
Vial Adapters and other Transfer Devices Testing Services
Applicable Products
Tests Available
Small Scale Container Fill-Finish for Early Compatibility Assessment
Applicable Products
Services Available
West’s Analytical Services Laboratory supports customers with USP <382> testing needs. This new chapter, Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems, was released December 2020 and will have a 5-year grace period for adherence.
West supports all USP <382> chapter sections referenced below:
Packaging and Delivery System Integrity Tests per USP <1207>
Needle and Spike Access Functional Suitability Tests
Plunger Functional Suitability Tests
Tip Cap and Needle Shield Functional Suitability Tests
Select West components will be evaluated to demonstrate USP <382> compliance to assist with appropriate component selection depending on the application and intended use.
For more information about USP <382>
Regulatory and Custom Testing Collaboration
Full understanding of product performance relative to widely accepted standards which reduces complexities of product regulatory submissions is critical. Combining accepted standards with customized testing and using proper execution greatly reduces risk to customer timelines and ultimately to the patient.
Focus on Regulatory Testing Standards as a Baseline
Combination Product Problem Solving and Custom Methods Development
New technical challenges and risks are often discovered in all stages of combination product development. West’s Analytical Service Laboratory has expertise in troubleshooting and in developing custom advanced test methodologies for various combination products, including examples below:
* Requires Knowledge Center account to access.
By Your Side With Analytical Solutions From West - Performance and Functional Testing of Combination Products
Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
Several important changes have been made recently in the United States Pharmacopoeia (USP): Chapter <381> was amended and new chapters <382>, <1382>, and <1381> were created. West has been aware of these changes and is prepared to address them from both a knowledge and a technology perspective.
When it comes to choosing the right container closure system, a significant amount of focus is directed at addressing issues that may be a risk to safety and efficacy of the parenteral drug before it is introduced to a patient. Examples are testing of container closure integrity (CCI) and drug stability. Prior to drug administration by a health care professional, the rubber stopper is pierced with a needle, at least once. Stopper puncture testing also needs to be considered, especially if the closure system will be used in a multi-dose application.
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
English
Chinese
