Seal of Approval: New Technology Is Streamlining Sterilization

To streamline the fill/finish process, Datwyler has introduced ready-for-sterilization (RFS) combiseals for cartridges used in pens and autoinjectors. RFS combiseals for cartridges arrive ready for immediate sterilization, eliminating the need for drug manufacturers to prep packaging components for sterilization, install washing equipment, and validate washing processes on fill/finish lines. The RFS combiseals adapt to existing lines, save time, and cut costs while complying with FDA and European Union regulations (1).

Because combiseals contact the contents of the cartridge directly, cleanliness is imperative to comply with regulatory requirements and prevent any risk to patients. Before shipping to a sterile drug manufacturer, the RFS combiseals undergo Datwyler’s water-for-injection washing process and are packed in a controlled environment. The steam-sterilizable bags, which hold the RFS combiseals, ensure a controlled state of microbiological cleanliness that meets regulatory requirements (1).

Data about the washing process will be filed in Datwyler’s Drug Master File so customers can reference it for drug submissions to FDA. The RFS combiseals also undergo 100% camera inspection to identify and eliminate seals with visual defects and minimize rejects on fill/finish lines. A concurrent development, DuraCoat lamination technology, reportedly minimizes particle generation and shows less abrasion than standard aluminum seals (1).

The RFS combiseals join other RFS components on the market such as Westar RS stoppers, plungers, and seals from West Pharmaceutical Services (2,3) and 13-, 20-, and 30-mm vial stoppers from QCVIALZ. Cleanliness of the QCVIALZ RFS13, RFS20, and RFS30 series vial stoppers is assured by bioburden and endotoxin testing conducted in an FDA- and ISO 17025-certified facility. Lot traceability and documented testing results accompany each shipment to drug makers (4).

“… pharma companies want to focus mainly on their core activities—drug manufacturing. Washing and sterilization of rubber materials are more and more done by the rubber manufacturers,” said Carina Van Eester, global platform leader, Prefilled Syringes and Cartridges at Datwyler, in a press release (1). “Combiseals are the final product in our portfolio to supply in RFS format,” she added.

To further simplify the preparation of components for fill/finish lines and complement the expanding use of pre-sterilized, ready-to-use (RTU) vials, syringes, and cartridges, Datwyler is developing RTU combiseals. The pre-washed and pre-sterilized seals are expected to be available in 2024 (1) and join RTU components from suppliers such as West Pharmaceutical Services (3), Aptar (5), and makers of glass vials, syringes, and cartridges.

The usage of RTU components is expanding because it further streamlines the fill/finish process. A report from Research and Markets predicts the global pre-sterilized RTU pharmaceutical packaging market will grow at a compound annual growth rate of 6.62% through 2035 from an estimated value of $9 billion in 2023. The integration of RTU packaging containers meets the growing demand for aseptic fill/finish processes, minimizes human intervention and reduces chances of contamination, enhances product quality and safety, streamlines the fill/finish process, supports regulatory compliance, and enables faster product launches (6).

References

1. Datwyler. Datwyler Introduces Ready-for-Sterilization Combiseals to Enhance Efficiency in Drug Filling and Packaging. Press Release. Oct. 17, 2023.

2. West Pharmaceutical Services. Westar Stoppers. Westar® Stoppers for Pharmaceutical Packaging Solutions (westpharma.com). Accessed Nov. 7, 2023.

3. West Pharmaceutical Services, Cartridge Systems and Components. Cartridge Plunger, Systems & Components for multi-use pen or injectors (westpharma.com). Accessed Nov. 7, 2023.

4. QCVIALZ. Benefits of Using Ready to Sterilize Vial Stoppers. Benefits of Using Ready to Sterilize Vial Stoppers (qcvialz.com). Accessed Nov. 2, 2023.

5. Aptar. Advanced Parenteral Closure Solutions. Advanced Parenteral Closure Solutions | Aptar. Accessed Nov. 7, 2023.

6. Research and Markets. Pre-Sterilized/Ready to Use Pharmaceutical Packaging Market (3rd Edition): Distribution by Type of Container, Type of Closure, Material of Fabrication and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035. Market Report. August 2023.

About the author

Hallie Forcinio is packaging editor for Pharmaceutical Technology^®.