Ready-to-Use Bioprocessing Bottles: Improving Manufacturing Workflows, Safety, and Total Cost of Ownership

By Robert Popilock

Ready-to-Use (RTU) is a term that commonly references the condition of primary packaging components prepared to strict regulatory standards through the removal of particulate matter, microorganisms, and endotoxins, with sterilization in secondary packaging for direct entry into the aseptic drug filling core.

Specific Market Trends and Operational Challenges: The Growing Adoption of RTU Glass Packaging

RTU packaging is a well-established solution for pharmaceutical fill and finish applications. RTU preparation has also experienced rapid adoption by compounders, as well as clinical and commercial small-batch packagers of sterile injectable drug products, 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 that the use of RTU bottles for bioprocessing applications will be a fast follower for those entities looking to address operational challenges.

RTU Glass Bottles for Bioprocessing: Rising Opportunities

Bottle-based container closure system (CCS) components are most used for the preparation and storage of highly complex biologics, including high-value APIs. Such containers are typically made of Type I borosilicate glass, which exhibits a low extractables profile, excellent chemical resistance and barrier properties, and transport durability. DURAN™ bottles are the market leading packaging solution and have been specifically designed as a 'Biotech & Pharmaceutical GMP In-Process and Packaging Container System' which meets the regulatory compliance and quality controls required for the safe storage and transport of HP/APIs. Furthermore, the manufacturer, DWK Life Sciences, is the market leader for bioprocessing bottles and has significant experience in RTU bottle services, leveraging a flexible platform designed to enhance and derisk workflows for biopharmaceuticals.

RTU Processing Services

DWK Life Sciences can perform one or all of the following processing services, each of which includes regulatory certification:

• Washing or particulate cleaning: The removal of subvisible particles-this is achieved using purified water or water for injection (WFI), IPA wash, and HCl wash to achieve specific total organic carbon (TOC) levels. Washed bottles are certified according to USP 788 and EP 2.9.19 microscopic particle counts
• Depyrogenation: The removal of endotoxins to acceptable limits defined by regulatory bodies. Depyrogenation using dry heat is performed in an ISO 7 clean room using a GMP ISO 5 oven with HEPA filtered air. Depyrogenated bottles are certified according to USP 85 / EP 2.6.14 for reduction of pyrogenic substances, including a bacterial endotoxin level of 0.25 EU/mL
• Sterilization: The terminal processing of the bottle in its final secondary packaging configuration using steam, gas, or radiation. Bottles are typically pouch packed and conform to USP 71 / EP 2.6.1 standards defining an acceptable sterility assurance level (SAL) of 10^-6 for direct entry into aseptic operating areas

DWK Life Sciences DURAN™ RTU Bottles are complimented with RTU closures ensuring system level compliance to regulatory standards for the sterile manufacturing and safe delivery of drug products.

Partnering with an RTU Expert

The Fisher Scientific channel has partnered with DWK Life Sciences to offer RTU bioprocessing bottles specifically designed to increase operating flexibility and comply with the most stringent regulatory guidelines. This solution contributes to:

• Reduced complexity: DURAN™ bottles are prepared for direct entry into the aseptic fill area, as such costs of inline processing can be eliminated while operational efficiencies can be improved
• Reduced risk: RTU components are processed using validated processes and meet global regulatory standards, reducing risk levels
• Increased efficiency: RTU components can be processed, packaged, labeled, and analyzed to meet specific operational requirements
• Simplified sourcing: RTU bottles and their CCS components reduce supply chain effort and ensure critical compatibility

Contact your Fisher Scientific Sales Representative to learn more about DURAN™ RTU bottles and how they can help you improve workflows, reduce risk, and meet total cost of ownership (TCO) objectives.