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The pharmaceutical industry is shifting toward pre-filled syringes (PFS) as the optimal delivery system for many drug products. The utility of a syringe system is dependent upon its ability to maintain good container closure integrity (CCI) through drug product shelf life.
CCI failure presents a risk to patient safety – thus the ability to measure CCI is critical. USP <1207> (Package Integrity Evaluation – Sterile Products) endorses several deterministic methods; one of which, high-voltage leak detection (HVLD), is very well suited to syringe systems. HVLD equipment operates by moving a high-voltage probe along the length of a syringe; a defect (as small as 2 microns) usually results in a visible discharge through the fluid in the syringe system, however the position of the defect is always recorded.
HVLD can be useful for detecting a defect between the syringe body and plunger. West has full capability to measure CCI by HVLD, including a state-of-the art system suitable for polymer-based syringe systems with non-conductive fluids. This capability includes development and validation of a unique method for each syringe/drug system.
The scientists at West are available to help customers determine how HVLD can best serve them – from study design through execution – to ensure that West syringe components and customer drug products combine to fully meet the goal of patient safety. For more information on West Analytical Lab Services, visit our website or contact us.
West’s three locations in Germany recently concluded an impressive fundraising campaign as part of West without Borders, West’s employee-led giving program. <br />
Pharmaceutical manufacturers are faced with numerous challenges to produce, package, and ship products successfully to the patient or care giver. Common concerns for all pharmaceutical manufactures include meeting targeted timelines, guarding against drug shortages, increasing speed to market, and generating revenue. Maximizing operating speeds and minimizing operating down time are critical factors for all stakeholders.
In view of patient safety and product quality, extractables and leachables assessments of pharmaceutical packaging and delivery systems have become an integral part of both development and regulatory submissions. Two crucial USP guidance chapters, USP <1663> “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and USP <1664> “Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems” have been published to guide pharmaceutical companies on the practical and technical considerations required for extractables and leachables assessment programs.
An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market.
In many instances, injectable pharmaceuticals need to be administered by patients or their caregivers rather than by healthcare professionals. While it is convenient to receive treatment at home without having to travel to a healthcare facility, the notion of administering drug injections, or even the sight of needles, can be intimidating to many individuals. The process can be greatly simplified with the use of auto-injectors. These devices typically contain a drug-filled syringe and make the injection procedure more straightforward by semi-automating the process.
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