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A key aspect of supporting our customers consists of the capability to measure essential performance requirements (EPRs) of combination products which requires having the right equipment. To enhance this capability, West has added a Zwick/Roell zwickiLine testing system to its laboratory portfolio.
A well-constructed test plan for combination products is based upon accepted standards. The zwickiLine system is ideally suited, as it is capable of testing according to: ISO 11040 Part 4: Glass Barrels for Injectables and Sterilized Subassembled Syringes Ready for Filling – and its Annex Sections:
C.1: Flange Breakage Resistance
C.2: Luer Cone Breakage Resistance
E: Glide Force Test Method to Evaluate Syringe Lubrication
F: Needle Penetration Test
G.1: Needle Pull-out Force
G.2: Closure System Liquid Leakage
G.3: Luer Lock Adapter Collar Pull-off Force
G.4: Luer Lock Adapter Collar Torque Resistance
G.6: Tip Cap or Needle Shield Pull-off Force
A benefit of employing such a system is that it enables commonality of testing among laboratories and manufacturers. Using the same equipment, the same fixtures and the same software, test-related differences are reduced, and like-for-like testing is enhanced. This testing system speeds time to market, as custom equipment/software development is eliminated. Moreover, software is compliant with 21 CFR Part 11 (FDA regulation on electronic records and electronic signatures); this promotes seamless data sharing and, most importantly, data integrity.
As part of the Integrated Solutions platform, West strives continually to enhance capabilities to support customers in the safe and efficient delivery of drug products. The addition of the zwickiLine system is just one example. For more about West or the zwickiline system, please contact an Account Manager or Technical Customer Support (TCS) representative.
Traditionally, drugs and biologics have been sold in vials. Utilizing a vial system requires the use of a syringe or other transfer device to withdraw the medication from the vial and facilitate delivery directly to the patient or to an IV bag for subsequent administration to the patient. These steps can result in errors, spills, contamination, or other mishaps. A simplified approach for administration has been to package the drug or biologic as a <a href="/zh-cn/blog/2022/january/importance-of-prefilled-syringe-packaging-in-market">pre-filled syringe</a> combination product. Drug administration is then made easier because the syringe is both the containment system and the delivery system such that the drug can be directly injected into a patient or into an IV bag port.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
United States Pharmacopeia (USP) requirements for elastomeric components of container closure systems used for parenteral products are changing. The original USP chapter for elastomeric components used in injectable drug packaging was <381> <em>Elastomeric Components in Injectable Pharmaceutical Production Packaging/Delivery Systems</em>, which addressed characterizing for biological reactivity, physicochemical testing and functionality testing. The new chapter, <em>USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems</em>, will become effective on December 1, 2025 and will update the functionality tests for elastomers, whereas the functionality testing portion of USP <381> will be omitted. While under USP <381> compliance was typically a supplier responsibility, under the new chapter it will be the drug manufacturer’s responsibility to meet the functionality requirements on the final system, including the container closure system and the drug.
The combination product market has seen a significant amount of growth,<sup>i</sup> driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements. The use of combination products simplifies the process of drug administration for the patient and/or the caregiver and, in some cases, allows the patient to receive treatment at home rather than having to travel to a medical facility. However, there are many challenges that need to be navigated as one considers the transition from a vial system to a needle-based combination product.
West’s Integrated Solutions program brings together all West’s products/services and industry knowledge into customer-focused solutions that Simplify the Journey™. One aspect of Integrated Solutions is wide-ranging analytical services, which includes state-of-the-art container closure integrity (CCI) capabilities. Understanding CCI as it relates to industry expectations, manufacturing, and regulations can be a challenge.
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