English
Chinese
Cart
This product is not clubbable with other items in cart. Please remove this or other items to proceed further.
Deleting
No Items In Cart
Analytical Services
West Services and Solutions has vast expertise and experience in extractables and leachables, particle analysis, container closure integrity, and performance and packaging/delivery systems among other methodologies. As a result of our understanding of materials and delivery systems and their compatibility with the drug product, we can assist our customers in designing studies and in navigating the challenging and evolving regulatory landscape.
Analytical Lab Certification
West Analytical Labs are GMP and FDA compliant. The Labs are also DEA licensed, certified to ISO 9001:2008 and ISO 15378:2011, and have two MHRA certificates.
Featured Blogs
June 07, 2021
Robust CCI Performance Evaluation Through a New Integrated Approach
Container closure integrity (CCI) has been a fundamental core requirement of containment and delivery solutions in the West product portfolio. Container closure systems (CCSs) must maintain both the sterility and stability of pharmaceutical products; very importantly they must be free of microbial contamination. Microbial ingress into a CCS will jeopardize product sterility.
May 03, 2021
Understanding Particles and Their Impact to Biologics and Biosimilars
Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the FDA Recalls, Market Withdrawals, & Safety Alerts database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination1.
April 27, 2021
Container Closure Integrity Testing (CCIT) - What Does It Mean?
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
June 07, 2021
Robust CCI Performance Evaluation Through a New Integrated Approach
Container closure integrity (CCI) has been a fundamental core requirement of containment and delivery solutions in the West product portfolio. Container closure systems (CCSs) must maintain both the sterility and stability of pharmaceutical products; very importantly they must be free of microbial contamination. Microbial ingress into a CCS will jeopardize product sterility.
May 03, 2021
Understanding Particles and Their Impact to Biologics and Biosimilars
Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the FDA Recalls, Market Withdrawals, & Safety Alerts database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination1.
April 27, 2021
Container Closure Integrity Testing (CCIT) - What Does It Mean?
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
West Services and Solutions LLC is a wholly-owned subsidiary of West Pharmaceutical Services Inc.
