Ready-To-Use, Gamma Sterilized Closure Components

Vial Containment Solutions & Syringe Components

Pharma

Ensuring that the drug remains sterile throughout fill-finish operations is crucial for delivering safe doses to patients. The recent revision to EMA GMP Annex 1 mandates that all sterile manufacturers adopt comprehensive sterility assurance strategies.

Aptar Pharma’s range of injectable components, including vial stoppers and syringe plungers, can be delivered in a Ready-to-Use (RTU), gamma sterilized format. Our unique processing and packaging methods allow us to guarantee 100% sterility at the time of use. Integrating gamma sterilized RTU components into your operations can enhance efficiency by eliminating the need for in-house sterilization procedures.

Guaranteed Sterility, Optimized Operations

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.

Enhance Operational Efficiency and Reduce TCO

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.

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.

Guaranteed Sterility

Sterility Assurance for RTU Components

Ready-To-Use (RTU) components guarantee 100% sterility at the time of use through an optimized upstream manufacturing flow and regular validation according to ISO 11137 standards. Each component features gamma irradiation indicators and is accompanied by irradiation and sterility certificates, ensuring packaging integrity and maintenance of sterility throughout their lifecycle.

Contamination Risk Reduction

Polyethylene Packaging and Akylux boxes

Aptar Pharma’s Ready-to-Use (RTU) components are packaged in polyethylene bags, which do not generate fibers. Complemented by secondary packaging in Akylux boxes to further minimize contamination risks, our Ready-To-Use (RTU) components help preserve the cleanliness of your operations.

Operational Efficiency

Streamlined Manufacturing with Ready-to-Use (RTU) components

Adopting Ready-To-Use (RTU) gamma sterilized components for injectables simplifies the manufacturing process for pharmaceutical companies by eliminating the need to manage sterilization equipment and operations. This strategic choice not only optimizes operational efficiency but also reduces Total Cost of Ownership (TCO).

Ready-to-Use (RTU) Gamma-sterilized Vial Stoppers

Vial stoppers for liquid and lyophilization: Bromobutyl and Chlorobutyl rubber formulation

Ready-to-Use (RTU) Gamma-sterilized Pre-filled Syringe Plungers

Pre-filled syringe plungers: Bromobutyl and Chlorobutyl rubber formulation

Rapid Transfer Portbags (RTP)

RTP bags for PFS plungers and vial stoppers – Getinge/Sartorius

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.

Akylux Boxes for Packaging

Pre-filled syringe (PFS) plungers and vial stoppers

Contact Aptar Pharma’s Parenteral Expert Team Today

Learn more about how we can support your compliance with EMA GMP Annex 1 revision and optimize your operations with our advanced injectable packaging solutions.

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