Ready-to-use components make difference in primary packaging systems for parenteral drugs

The selection of primary packaging components as well as proper preparation before use by the pharmaceutical manufacturer is increasingly important. Primary packaging systems are considered an integral part of the drug product since the drug is in direct contact with packaging components throughout its shelflife.

High-quality elastomeric components deliver:

• high performance on drug filling lines for operational efficiency

• clean leachable profiles for drug protection

• low particle contamination level for patient protection

• excellent insertion penetrability and low fragmentation for safe drug application.

Modern elastomer formulations from West meet these requirements. To maintain cleanliness and physical functionality, component preparation steps such as sterilisation and drying require well-controlled processes.

To support science-based decision making in the effective pre-treatment of elastomeric components, West conducted a study to determine the effects of steam and high-gamma sterilisation methods on the physical and chemical properties of elastomeric closures. The study found that key features of elastomers can be affected by the method of sterilisation.

After gamma irradiation, elastomer material became significantly harder, which can lead to lower performance on filling lines, higher penetrability forces and increased fragmentation risk, plus more potential extractables were found during testing, which may result in increased risk of drug product interactions.

After steam sterilisation and optimised drying, no significant changes were observed in physical elastomer properties that could affect stopper performance, plus lower number of potential extractables was observed compared with pre-sterilisation levels

West strongly recommends the use of steam sterilisation for elastomeric components. Westar ready-to-use (RU) steam sterilised components undergo a fully validated washing, sterilisation and drying process to ensure superior functionality from filling line to final drug application.

Westar RU steam-sterilised components may help to:

• eliminate capital investments and maintenance costs for stopper washing, sterilisation and drying equipment

• minimise preparation time and effort

• increase operational efficiency

• improve total cost of ownership.

West Pharmaceutical Services, Inc., www.westpharma.com.