Using Ready-to-Use (RTU) Parenteral Packaging Components & Kits to Improve Operational Efficiency
Robert Popilock
Legacy Approach and Challenges
Parenteral drug products are manufactured to strict sterility guidelines using well-documented and validated aseptic processes and quality controls. These are executed by highly trained personnel using ready-to-use (RTU) primary packaging components (serum vials, stoppers, and aluminum seals) often prepared in-house or in-line. Regulatory agencies expect drug developers and packagers to assure components comply with global sterile manufacturing controls foundational to their ability to deliver injectable drug products meeting patient safety, drug efficacy, and shelf-life claims. Developers and packagers that choose to process primary packaging components in-house face challenges associated with sterility assurance and a significant burden of upfront and operational costs.
A Simplified Approach to Aseptic Filling
The recent growth of personalized, complex, high-value injectable biologics is driving the need for drug research and development labs to qualify and use RTU packaging to accelerate development timelines and eliminate downstream adoption risks. Also driving interest in replacing in-house washing, depyrogenation, and sterilization (figure 1) with RTU container closure systems (CCS)1,2 is the reduction in cost and effort associated with traditional in-house or in-line cleaning and sterilization by the elimination of complex facility design, capital equipment investment, process controls and validations, and specialized operators3.
Figure 1: Traditional In-House Cleaning Versus Ready-to-Use (RTU) Packaging
Productivity and Cost Savings
RTU components are prepared for direct entry into the aseptic core and are accompanied by lot-controlled documentation certifying processing. This results in an estimated 37 percent saving in operational costs and an 80 percent total cost reduction by elimination of processing equipment (figure 2)4.
Figure 2: Operational Costs for In-House Cleaning Versus Ready-to-Use (RTU) Packaging
Cascade Benefits
Beyond cost, many drug manufacturers seek to reduce the risks associated with implementation of in-line process controls and the execution of validations required by international regulatory bodies in order to demonstrate conformance to sterility standards5. RTU components are certified to USP injectable application standards and ship with lot traceable certifications allowing direct entry into the aseptic core. The elimination of processing equipment dedicated to particulate cleaning, endotoxin removal, and sterility conserves valuable operational space for higher value activities. The elimination of equipment further eliminates costs associated with chemicals, maintenance, operation, and repair.
Conclusion
The injectable drug industry is preparing for continued migration away from time-consuming, capitally and operationally intensive, risk-based in-house/in-line processing towards the streamlined and flexible benefits offered through RTU primary packaging. Developers, clinical packagers, and commercial packagers are overcoming challenges by using industry standard RTU vials, stoppers, seals, and snap caps for associated TCO and regulatory compliance benefits. The range of RTU configurations offered by DWK Life Sciences™ meets specific developmental and operational requirements, benefiting both hand-fill and automated-fill processes. Compatibility with RABS/isolation systems is also forecast to hasten RTU adoption.
References
- Markarian J. Filling Small Batches, Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook. 2021; 2: 14-17. www.pharmtech.com/view/filling-small-batches
- Brooks K. Pharmaceutical Packaging Market Report. Contract Pharma. June 2019. www.contractpharma.com/issues/2019-06-01/view_features/pharmaceutical-packaging-market-trends/
- Challener CA. Prepping Fill/Finish Systems to Ensure Quality Output. BioPharm International. 2020; 33(12): 13-20. www.biopharminternational.com/view/prepping-fill-finish-systems-to-ensure-quality-output
- Prince Sterilization Services LLC. RTU Contract Processing Workflow. 2021.
- Vines M. Parenteral Manufacturing Market Trends. Contract Pharma. March 2015. www.contractpharma.com/issues/2015-03-01/view_features/parenteral-manufacturing-market-trends/
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