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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.
Sterilizing injection components in-house is a time-consuming and costly process for pharmaceutical companies that requires specialized equipment, extensive validation efforts, and dedicated operational teams. This complexity diverts resources and attention away from core sterile production activities, potentially hindering operational efficiency and increasing overall costs.
By adopting Ready-to-Use (RTU) gamma sterilized injection components, companies can simplify their parenteral manufacturing processes.
The gamma sterilization processes used on our syringe plungers, vial stoppers and low-particulate PremiumCoat® formulations, have been thoroughly validated to maintain the chemical, functional, and physical properties of the components after sterilization. Internal studies confirm that gamma irradiation does not significantly impact the extractable and leachable profiles of our injectables components.
Transitioning to Aptar Pharma’s Ready-To-Use (RTU) injectables component solutions can help pharmaceutical manufacturers reduce their total cost of ownership (TCO) by eliminating the need for in-house sterilization infrastructure, maximizing facility usage, and redirecting resources towards core parenteral drug manufacturing and filling.
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.
Ready-to-Use (RTU) gamma-sterilized vial stoppers are validated and readily available in 13mm, 20mm and 32mm sizes.
Special designs are available upon request.
Syringe plungers are validated and available in 0.5 mL, 1 mlL, 1-3 mL, 5 mL and 10 mL formats.
Other plunger sizes are available upon request.
All gamma-sterilized products are supplied in polyethylene-only bags, without Tyvek.
Additionally, polyethylene-only Rapid Transfer Port (RTP) bags from Getinge (105 mm or 190 mm) and Sartorius (110 mm) are available for the packaging of all our injectables components. These are designed for use with isolators or Restricted Access Barrier Systems (RABS) within your aseptic filling operations.
Gamma-sterilized vial stoppers and pre-filled syringe plungers are first packaged in polyethylene bags and then placed in Akylux boxes to minimize the risk of contamination.
Learn more about how we can support your compliance with Annex-1 revision requirements and optimize your operations with our Advanced Parenteral Packaging Solutions.