Choosing Packaging Components for Lyophilised Drug Products

When selecting primary packaging systems for drug products, pharmaceutical manufacturers must ensure that components do not interact with the drug product itself and are applicable for the intended use. For moisture-sensitive lyophilised drug products, packaging components must be designed for long-term drug protection, machinability and patient safety. Various requirements include:

• proper and reproducible lyophilisation position of a stopper on the vial

• good insertion forces and reliable closing performance

• clean high-quality rubber composition (low extractables/volatiles)

• lowest possible level of foreign contamination (particulate)

• optimal moisture protection of the drug product over time

    — moisture and gas barrier

    — optimal stopper drying

West’s lyophilisation stoppers have been developed with the patient in mind. By using a QbD approach for NovaPure components, West focuses on controlling and minimising variability during the manufacturing process. Such methodical and science-based methods help assure quality through well-understood product and process parameters. By following QbD principles, significant improvements in various manufacturing processes result in a variety of benefits, including:

• enhanced quality assurance

• increased risk mitigation through improved product understanding, development and manufacturing

• lower total cost of ownership

• improved transparency between the component manufacturer and the pharmaceutical company

West’s NovaPure ready-to-sterilise and ready-to-use packaging components can help to mitigate risk and may make a difference in the efficacy and safety of a lyophilised drug product.

West Pharmaceutical Services, Inc., +1 610 594 2900, west.pharmaceutical.services@westpharma.com, www.westpharma.com.