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In 2015, the FDA shed light on a problematic practice within the healthcare industry involving improper, off-label use of syringes as closed container storage systems for compounded or repackaged drugs. The incidents cited revealed that interaction with rubber plungers in syringes that were not cleared for the purpose of closed container storage resulted in the loss of potency of several drugs when administration was delayed.1
So how are these compounded syringes any different from FDA-approved pre-filled syringes on the market today? The difference is in the lack of proper evaluation by compounding pharmacies of the syringe systems for intended use/storage that the FDA requires for approval of pre-filled syringes. With subpotent drugs and further adverse consequences an all-too-real risk to patient safety, compounding pharmacies need to consider the risks of their packaging choices. Given the changing regulations affecting compounding pharmacies, it is no longer safe to assume past practices and previous component selections will continue to meet FDA requirements.
To mitigate risk and ensure future compliance with the changing regulations, the following packaging considerations should be addressed:
West can help achieve compliance by offering:
West is committed to the safe and efficient delivery of drug products. An element of this commitment is staying abreast of regulations and offering customers the information and testing services they need through the Integrated Solutions platform. For more information, contact an Account Manager or Technical Customer Support (TCS) representative.
Many complex biologic drug products, such as gene and cell therapies, require storage at low temperatures (from -60oC to -180oC). This presents a challenge for containment systems when maintaining container closure integrity (CCI) – especially for glass-rubber vial systems.
Selecting the best vial container closure system (CCS) components and capping process for a drug product ensures optimal performance and patient safety. An optimized CCS requires compatible components (rubber stopper, aluminum seal, glass or polymer vial) and proper capping setup. This provides predictable sealing performance, which maintains the container closure integrity (CCI) needed for patient safety and visual acceptance.
As drug development continues to evolve, further advances in delivery technologies will help to refine the overall drug delivery system, from improvements to safety and performance of delivery devices, to primary containers with consistent and higher-quality components.<br />
The future is now for parenteral pharmaceutical and biopharmaceutical sterile production. Traditional high-volume automated aseptic filling suites are maintained by contract filling services. But what’s emerging? Parenteral pharmaceutical and biopharmaceutical industries have transitioned to fully enclosed, isolator/restricted access barrier (RAB) systems. These small, efficient systems offer cost savings and can reduce the potential for particulate and microbial ingress during aseptic fill/finish manufacturing by eliminating direct human contact in the filling environment.
The glass transition temperature (T<sub>g</sub>) is the temperature at which a material loses its viscoelastic properties. It is also indicative of the lowest temperature at which the polymer system will retain its functionality.
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