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In the realm of complex drug molecules, the imperative for high-quality primary packaging emerges as a critical factor in ensuring product efficacy, safety and regulatory compliance. Traditional packaging solutions, designed for simpler compounds, often fall short when faced with the intricacies of complex molecules. Hence high-quality packaging can not only mitigate the risk of product recalls, contamination and quality issues but also enhance their competitive edge and successful delivery of breakthrough therapies to patients.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
NovaPure® - Highest quality components trusted by approved biologics Learn More
Mitigate risk as you protect lyo and liquid drugs from visible, subvisible particles and unwanted stopper interactions.
Protect your drug with components of superior quality that allow you to choose your preferred/differentiated delivery system.
Optimize syringe performance by reducing plunger variability and reducing the amount of free silicone oil while maximizing quality.
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