Aptar Pharma, a global leader in drug delivery systems, components, and services, is pleased to announce an educational webinar on Container Integrity Testing at different storage temperatures. The webinar will take place on October 3rd and registration is open to pharmaceutical industry professionals, researchers, quality control specialists, and anyone interested in the latest developments in container-closure integrity (CCI) testing technologies.
With the ever-increasing demand for parenteral medicines, there is a critical need in the pharmaceutical industry to perform leak detection testing on finished sterile containers. Container-closure defects pose a significant risk, leading to a loss of sterility, which can adversely affect patients if undiscovered. These defects are often hidden from view and not easily detected by visual inspection.
One of the key factors to consider when validating a CCI method is the storage temperature. It can dramatically impact the physical properties of the container and its components, especially when stored at deep cold or cryogenic temperatures. Laser-based Headspace Analysis (HSA) is one of several deterministic CCI testing technologies acknowledged in USP <1207>, suitable for detecting leaks in sterile containers. HSA is optimized for testing CCI of drug substances stored in glass and polymer vials at various storage conditions.
The webinar will provide a brief USP <1207> overview and discuss how a laser headspace method can be validated based on a product’s storage temperature. Experts from Gateway Analytical, an Aptar Pharma company, will also present an overview and examples of using a validated HSA CCI method to assess container shelf life, optimize and validate filling lines, and perform shipping studies.
Aptar Pharma and Gateway Analytical are committed to advancing the field of CCI testing and understanding how it interacts with storage temperatures. By hosting this webinar, Aptar Pharma aims to equip attendees with the knowledge and tools to design, develop, and validate an effective HSA CCI method.
The webinar promises to be an engaging and informative session, drawing on the collective knowledge and expertise of seasoned industry professionals. Don’t miss this unique opportunity to gain insights into the rapidly evolving field of container integrity testing.
Registration is now open, and attendance is free. To reserve your spot, please click on the links below.
About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions and services. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using insights, proprietary design, engineering and science to create dispensing, dosing and protective technologies for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has approximately 13,500 dedicated employees in 20 countries.
For more information, visit www.aptar.com/pharmaceutical
About Gateway Analytical
Gateway Analytical, an Aptar Pharma Company, is a specialized analytical testing laboratory that businesses around the world trust to provide solutions for their most challenging foreign particulate characterization and materials analysis needs. Gateway Analyticals expert scientists, specialized test methods and comprehensive suite of instrumentation deliver the fast, accurate and reliable results that customers in the pharmaceutical, materials and medical device industries demand. With a strong focus on quality, Gateway Analytical is cGMP-compliant, FDA registered and inspected, and DEA licensed.
For more information, visit www.gatewayanalytical.com