Complex drug molecules require cutting-edge primary packaging technologies to meet stringent standards

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The need for packaging that aligns seamlessly with the unique characteristics of complex drugs is underscored by challenges in maintaining container closure integrity, inconsistencies in performance and auto-injector malfunctions.

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Moreover, the evolving landscape of quality expectations and stringent regulatory guidance such as EU MDR, including Annex I, necessitates a proactive approach to risk reduction and compliance.

Challenges With Traditional Components

Particle Analysis

Traditional Stoppers Were Designed for Less Exacting Standards

Traditional stoppers, effective for small molecules, may not meet stricter parameters or suit complex molecules, raising concerns about particulate complaints and quality investigations. To mitigate these issues, the underlying cause needs to be addressed rather than rather than modifications to existing stoppers and processes.

Prefilled Syringe Components Icon

Traditional Plungers Were Designed for Manual Injections

Using traditional plungers for complex molecules could cause various issues including auto-injector malfunctions, problems with container closure integrity and sterility which may result in product recalls, delayed launches, patient dissatisfaction, and revenue shortfalls due to failure to meet evolving quality standards.

Vial Selection Icon

Traditional Components Aren’t Appropriate for Complex Drugs

For sensitive and high-value biologics, a higher standard is required compared to mass-market cartridge plungers and seals. Neglecting issues like migrating silicone oil and particulate levels may compromise trials, and packaging integrity problems, affecting regulatory approval and launch viability, especially with increasing self-administration of drugs by patients at home.

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Five Key Considerations for Component Selection

1

Product: Component Specifications​

Establishing the required specifications such as particulate matter, bioburden, and endotoxins is imperative, serving as a foundational step to ensure the chosen packaging aligns meticulously with the stringent criteria necessary for safeguarding the integrity and quality of pharmaceutical products.

2

Process: Manufacturing Design

The critical aspect of the manufacturing process such as determining the sterilization methods & location, method of introducing components to the fill/finish line etc as this decision plays a pivotal role in maintaining product integrity and ensuring a seamless and sterile production pathway.

3

Protection: Container Closure Integrity

Maintaining container closure integrity is paramount in pharmaceutical packaging, serving as a crucial defense against potential contamination, ensuring product stability, and safeguarding the drug's efficacy throughout its shelf life. A robust container closure system protects the product from most external influences.

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Proof: Documentation & Service

Presence of a well-documented Contamination Control Strategy (CCS) from the supplier, coupled with a steadfast commitment to continuous improvement. The documentation associated with the CCS serves as a critical benchmark, providing transparency into the measures implemented to control contamination throughout the manufacturing process.

5

Technical Support

Robust technical support, leveraging their expertise in pharmaceutical packaging solutions to assist clients in optimizing component performance, supporting regulatory compliance, and addressing specific challenges associated with complex drug formulations. 

Partner with West’s cutting-edge primary packaging technologies for your complex drug molecules

NovaPure® - Highest quality components trusted by approved biologics

ImageReady Pack
health & Safety

Mitigate risk as you protect lyo and liquid drugs from visible, subvisible particles and unwanted stopper interactions.

Product recommandation

Protect your drug with components of superior quality that allow you to choose your preferred/differentiated delivery system.

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Optimize syringe performance by reducing plunger variability and reducing the amount of free silicone oil while maximizing quality.

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Crystal Zenith® and D SigmaTM are trademarks of Daikyo Seiko, Ltd. Crystal Zenith® technology is licensed from Daikyo Seiko.
adaptiQ® is a trademark of SCHOTT AG.
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West Pharmaceutical Services Inc. is the exclusive distributor of Corning® Valor® Glass.