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West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma® 1mL long piston, substantially raising the standard for product acceptance. The D Sigma piston combines Daikyo best practices with a known formulation (D21-7H), Daikyo Flurotec® film, RB2 Coating, RSV® and RUV® processing with key innovation improvements of automated dimensional measurements, tight Acceptable Quality Levels (AQLs), particulate testing per ISO 8871-3, and enhanced vision inspection to achieve high levels of performance and consistency.
Automated measurements of critical to function dimensions and the application of tight AQLs for defects allows for lower variability, maximizing part-to-part consistency and reducing risk. The new Daikyo D Sigma 1mL long piston has been tested for performance with industry standard ISO glass syringes for container closure integrity (CCI) and breakloose and gliding forces to show this impact. These evaluations show that the piston can maintain CCI via pressure testing, stationary testing and vacuum decay testing in line with the USP <1207> guidance. Evaluation for breakloose and gliding forces also show performance suitable for use with industry standard ISO glass syringes for manual and auto-injector applications. Additional data for performance evaluations will be collected over time.
The D21-7H formulation is also supported with Theoretical Material Extractables and Material Characteristic testing. Daikyo’s industry experience and innovation excellence has produced pistons that are designed to exceed expectations by combining the best of Daikyo materials, properties and inspection.
Learn more about the D Sigma component offering here or contact your Account Manager or Technical Account Specialist.
D Sigma®, Daikyo Flurotec®, RSV® and RUV® are registered trademarks of Daikyo Seiko, Ltd.
<p>Amy Miller and Jennifer Riter</p><p>Extractables from elastomeric components become an issue even before a pharmaceutical drug makes contact with the elastomeric component. The suitability of the elastomer and the drug product needs to be taken into consideration at the development stage of the packaging and delivery system for the drug product. The potential for an extractable to leach into the drug product and the impact that leachable will have on the drug’s stability, efficacy and toxicity needs to be scientifically evaluated. </p>
China has now stepped into its “golden age” of biopharma; this year regulators approved the country’s first biosimilar product, HLX01. Developed by Shanghai Henlius Biotech, it will be used primarily for treatment of non-Hodgkin’s lymphoma<span>. Biologics are sensitive large molecules, so selecting the appropriate packaging and delivery system is critical. To this end, West Pharmaceutical Services, Inc. (“West”) recently held <em>China BioPharma Summit for Injectable Drug Packaging and Delivery Systems</em> in Suzhou. Over 200 persons attended.</span>
West’s Peg Frandolig and Lynn Lundy share how vision inspection systems can help drug product manufacturers and packaging suppliers work together to regulate foreign and particulate matter in finished drug products in the December/January issue of <em>Pharmaceutical Formulation & Quality</em>.
This spring, West team members in Jersey Shore, PA hosted an annual raffle featuring some outstanding prizes in support of Camp Victory, a camp designed especially for children with special needs. Children who live with chronic health problems, physical or mental disabilities, or the aftermath of catastrophic illness, know lifelong challenges. Camp Victory was built for these children. West’s Jersey Shore team has supported the important mission at Camp Victory through their West without Borders employee-led fundraising campaign for more than 40 years.<br />
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.
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