Ready-to-Use Bioprocessing Bottles: Enhancing Manufacturing Workflows, Safety, and Cost of Ownership
By Robert Popilock
Specific market trends are increasing the adoption of Ready-to-Use (RTU) glass packaging. For bioprocessing and pharmaceutical fill and finish entities, this adoption may help address operational challenges.
RTU is a term that commonly references the condition of primary packaging components prepared to strict regulatory standards. This includes removing particulate matter, microorganisms, and endotoxins and sterilizing in secondary packaging for direct entry into the aseptic drug filling core.
RTU packaging is a well-established solution for pharmaceutical fill and finish applications. RTU preparation has experienced rapid adoption by compounders and clinical and commercial small-batch packagers of sterile injectable drug products. This is driven by the need to accelerate development, simplify workflows, reduce risk, and improve operational costs.
The strong adoption of RTU packaging for pharmaceutical fill and finish applications suggests RTU bottles for bioprocessing applications to be a fast follower.
RTU Glass Bottles for Bioprocessing: Rising Opportunities
Bottle-based CCS components are mostly used for the preparation and storage of highly complex biologics, including high-value APIs. Such containers typically consist of Type I borosilicate glass, exhibiting a low extractable profile, excellent chemical resistance and barrier properties, and transport durability. DWK Life Sciences DURAN Bottles are the market-leading packaging solutions. They have been specifically designed as a biotech and pharmaceutical Good Manufacturing Practice (GMP) in-process and packaging container system, meeting the regulatory compliance and quality control standards required for the safe storage and transport of HP/APIs.
DWK Life Sciences, as a leader in bioprocessing bottle solutions, has extensive experience in providing RTU services for bottles. Their flexible platform helps enhance and mitigate risks within biopharmaceutical workflows. DWK offers various processing services, each with regulatory certification:
- Washing or Particulate Cleaning: Subvisible particles are removed using purified water or Water for Injection (WFI), IPA wash, and HC wash to achieve specific Total Organic Carbon (TOC) levels. Washed bottles are certified according to USP <788> and EP 2.9.19 for microscopic particle counts.
- Depyrogenation: Endotoxins are removed to meet acceptable limits defined by regulatory bodies. This process involves dry heat treatment in an ISO 7 cleanroom using a GMP ISO 5 oven with HEPA-filtered air. Bottles are certified according to USP <85> and EP 2.6.14 for bacterial endotoxin reduction, with a maximum of 0.25 EU/mL.
- Sterilization: The final step in processing involves sterilization via steam, gas, or radiation, performed in the bottle’s secondary packaging configuration. This process ensures compliance with USP <71> and EP 2.6.1, which defines acceptable Sterility Assurance Levels (SAL) of 10-6 for direct entry into aseptic environments.
DURAN RTU bottles are complimented with RTU closures that help ensure system-level compliance to regulatory standards for the sterile manufacturing and safe delivery of drug products.
Partnering with an RTU Expert
To enhance operational flexibility and meet stringent regulatory guidelines, the Fisher Scientific channel has partnered with DWK Life Sciences to provide RTU bioprocessing bottles. This collaboration offers several key benefits:
- Reduced Complexity: DURAN RTU bottles are pre-prepared for direct entry into the aseptic fill area, eliminating the need for costly inline processing while improving operational efficiency.
- Reduced Risk: RTU components undergo validated processes and meet global regulatory standards, reducing the risk associated with handling and processing.
- Increased Efficiency: RTU components can be processed, packaged, labeled, and analyzed to meet specific operational needs, streamlining manufacturing workflows.
- Simplified Sourcing: RTU bottles and container closure systems simplify the supply chain, providing critical compatibility and reducing sourcing complexity.
Contact your Fisher Scientific sales representative to learn more about DWK Life Sciences DURAN RTU bottles and how they can help you improve workflows, reduce risk, and meet TOC objectives.
Trademarks include: DWK Life Sciences DURAN
