Sterility Assurance and Contamination Control in Pharmaceutical Manufacturing

Sterility assurance is fundamental to product safety in the pharmaceutical industry. During fill-finish operations, every component must remain sterile to prevent possible contamination of the final product and to protect patients’ health. The EMA GMP Annex 1 revision emphasizes the necessity for sterile drug manufacturers to demonstrate a comprehensive strategy for contamination control and sterility assurance.

Aptar Pharma’s Ready-to-Use (RTU) vial stopper and syringe plunger components offer a robust solution to these challenges. Delivered gamma sterilized, our Ready-to-Use component solutions guarantee 100% sterility at the time of use, through the use of irradiation indicators, validated sterilization processes, and packaging integrity checks as required by Section 8 of the EMA GMP Annex-1 revision.

To further support your contamination control strategies, all Aptar Pharma Ready-To-Use (RTU) injectable components are packaged in polyethylene bags, eliminating the use of Tyvek bags, a well-known source of fiber contamination. Additionally, our Ready-To-Use (RTU) gamma sterilized components are also packaged in Akylux^® boxes, thereby reducing the risk of accidental particulate introduction on the filling line.

Switching to Gamma Sterilization Only Requires a Regulatory Variation

Pharmaceutical companies often face the challenge of navigating complex and time-consuming regulatory submissions when making changes to their processes or products. These hurdles can lead to delays in product commercialization and increased overall costs.

Our Ready-To-Sterilize (RTS, for steam sterilization), and Ready-To-Use (RTU gamma sterilized) injectables components utilize the same rubber formulation, design, and washing process. Transitioning from Ready-To-Sterilize to Ready-To-Use components requires only a regulatory variation filing, reducing the administrative burdens and accelerating the implementation process.