Primary Packaging in the Wake of Annex1

The pharmaceutical industry continually strives to ensure the safety and effectiveness of injectable medications. Ensuring particulate impurities and sterility remain at the center of discussions is key as the majority of product recalls by the FDA in the past few years were link to these exact concerns, underscoring the vital necessity for rigorous supervision and regulation in production procedures. The development of sensitive biologics and biosimilars, which demand utmost safeguarding throughout all phases from production to distribution, intensifies these hurdles. These ever-changing and strict regulatory norms exert additional pressure on the pharmaceutical industry to ensure the purity and safety of their products.

Recently, the European Medicines Agency (EMA) updated Annex 1 of the Good Manufacturing Practices (GMP), emphasizing contamination control throughout production and the supply chain. Manufacturers are now expected to establish a comprehensive Contamination Control Strategy (CCS) and demonstrate product sterility, potentially requiring process and supply chain adjustments to meet these new standards.

Aptar Pharma, a leading manufacturer of vial stoppers and pre-filled syringe plungers, has developped an array of Advanced Parenteral Closure Solutions tailored to address contamination risks during pharmaceutical filling processes. Aptar Pharma’s PremiumFill^® solutions provide enhanced specifications related to critical contamination criteria, ensuring elevated quality standards in compliance with annex 1 guidelines for contamination control. Additionally, these solutions improve operational efficiency and have the potential to reduce costs associated with rejected products.

The Ready-to-Use (RTU) gamma sterilization process guarantees sterility at the point of use, enhancing safety and reliability. RTU products also simplify our customers’ operations by eliminating the need for sterilization validation, a task typically handled by Aptar Pharma.

Finally, the Annex 1 revision strongly recommends the use of isolators or Restricted Access Barrier Systems (RABS), which involves the use of Rapid Transfer Port (RTP) bags. Aptar Pharma proposes a variety of design, to meet the diverse requirements of your operations.

Operating within a complex and highly regulated environment, Aptar Pharma delivers innovative and dependable solutions that align with and anticipate the evolving requirements of the pharmaceutical industry. With a steadfast commitment to quality, safety, and operational efficiency, Aptar remains at the forefront of pharmaceutical manufacturing, ensuring readiness to address present challenges and future uncertainties.