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Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass containment systems. This is especially true when the drug is administered via prefilled drug-delivery systems such as auto-injectors or pens where glass cracks and breakage can be a serious risk for patients.
Novel alternatives to glass syringes include next-generation polymer syringes from the COP (cyclic olefinic polymer) family, as used in the prefillable Daikyo Crystal Zenith® syringe system. Through break resistance, dosage precision and highly reduced extractables and leachables, plastic prefillable syringes present attractive benefits that are gaining increased attention from manufacturers seeking new answers to growing drug delivery and administration challenges.
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.
<span>Manufacturers of parental drug package/delivery systems must be up-to-date on the ever-changing regulatory landscape. At Pharmapack 2017, Fran DeGrazio, Vice-President of Scientific Affairs and Technical Services, spoke on the topic of metal impurities in a presentation entitled: <em><span>The Changing Regulatory Environment Concerning Elemental Impurities and Container Closure Systems</span></em></span>
The Global Technical Customer Support (TCS) team has as its main focus engagement with customers – facilitating access to West’s expertise in pharmaceutical packaging components and delivery solutions, and providing assistance and technical information on West and Daikyo products and services.
West and its partner Daikyo have introduced a superior quality elastomeric piston the Daikyo D Sigma<sup>®</sup> 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<sup>®</sup> film, RB2 Coating, RSV<sup>®</sup> and RUV<sup>®</sup> 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.
On December 1, 2013, the United States Pharmacopeia (USP) General Chapter <1> Injections<em>, </em>Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010) revised standard will become effective. The revised chapter affects all injectable drug products, human and veterinary, intended for sale in the United States.
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