The primary container, which is in direct contact with the drug product, plays a critical role in preserving the drug’s integrity from production through to packaging, distribution, short- or long-term storage and administration. Any failure associated with the primary container has the potential to result in serious adverse effects for the patient or the healthcare practitioner, which, aside from the human impact, can have significant financial implications for the drug manufacturer. The use of highly sensitive vaccines technologies and increasing use of biologics strains the supply chain for ETFE-coated closure components worldwide.
While one supplier currently provides the vast majority of coated components to the global pharmaceutical market, other options exist for facilitating new drug development projects and ensuring supply through secondary sourcing strategies. Discover how simulated leachable studies can be used to evaluate the effectiveness of the ETFE film coating in limiting the amount and diversity of compounds leached from the rubber. Through the assessment of various model solvents, combine with the use of chromatography and mass spectrometry techniques, we showcased the advantages of employing PremiumCoat® as a protective solution for sensitive formulations.
Key Learning Objectives
- Understand how extractables and leachables can affect patient safety
- Understand how ETFE film coating can reduce extractables and leachables
- Discover PremiumCoat® ETFE-film coated platform of vial stoppers and syringe plungers
