Benefits of Ready-to-Use Parenteral Packaging Components and Kits

By Robert Popilock

Legacy Approach and Challenges

As the demand for personalized, injectable drug products grows, so does the need for sterile, efficient packaging solutions. Ready-to-use (RTU) packaging components provide an innovative answer to some of the industry’s most pressing challenges.

Regulatory agencies expect drug developers and packagers to assure compliance with global sterile manufacturing controls, helping ensure that drug products meet patient safety, drug efficacy, and shelf-life claims. Those who choose to process primary packaging components in-house face challenges associated with sterility assurance and incur significant upfront and operational costs. Ready-to-use (RTU) primary packaging options offer solutions to many of these challenges.

A Simplified Approach to Aseptic Filling

The recent growth of personalized, complex, and 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. These benefits drive interest in replacing in-house washing, depyrogenation, and sterilization with RTU container closure systems (CCS).1,2

RTU components reduce costs and effort associated with traditional in-house/inline cleaning and sterilization by eliminating complex facility design, capital equipment investment, process controls and validations, and specialized operators.3

Benefits of Ready-to-Use Parenteral Packaging Components and Kits

Productivity and Cost Savings

The costs associated with inline preparation of processed vials are significant compared to drug filling using RTU primary packaging options. In our model, we assume the processing of 250,000 vials per year. The comparative analysis includes operational costs associated with the use of unprocessed vials undergoing in-house/in-line processing versus RTU components (Table 1).

The savings on operations alone is an estimated 37 percent. When the elimination of capital equipment is added to this analysis, the use of RTU alternatives can save an estimated 80 percent of total costs.4

Benefits of Ready-to-Use Parenteral Packaging Components and Kits

Cascade Benefits

Beyond cost, many drug manufacturers seek to reduce risks associated with implementing in-line process controls and executing validations required by international regulatory bodies.5 RTU components are certified to USP injectable application standards and ship with lot traceable certifications, allowing direct entry into the aseptic core.

For developers, RTU products allow them to identify promising injectable proteins and targets using primary packaging components, accelerating and derisking the development cycle and technology transfer.

RTU components directly enter the filling environment to streamline your workflow and negate the need for time-consuming, in-house/in-line processing steps. This results in developers and packagers having more time for primary development and manufacturing.

Conclusion

In today’s fast-paced pharmaceutical industry, efficiency and safety are paramount. With RTU components, developers and packagers can meet the demand for personalized medicines while significantly reducing costs, contamination risks, and operational complexities. As the industry evolves, adopting RTU solutions will help ensure companies remain at the forefront of innovation.

At DWK Life Sciences, we recognize the dynamic nature of today’s drug development and packaging markets and their need to meet validated aseptic operational requirements. Our RTU portfolio, which includes the CompletePAK and EZ-fill brands, is designed to maximize the selection of certified choices, assuring workflow efficiencies and alignment to development, clinical, and commercial packaging processes.

Learn more about DWK’s RTU capabilities.

Content provided by: DWK Life Sciences

References
1. Jennifer Markarian, Filling Small Batches, Pharmaceutical Technology, Vol. 2021 eBook, Issue 2, Pg. 14-17
2. Kristin Brooks, Pharmaceutical Packaging Market Report Digital Edition Contract Pharma, June 2019
3. Cynthia A. Challener, Prepping Fill/Finish Systems to Ensure Quality Output, BioPharm International, Vol. 33, Issue 12, Pg. 13-20, Dec. 2020
4. Prince Sterilization Services, LLC, RTU Contract Processing Workflow 2021
5. Marga Vines, Parenteral Manufacturing Market Trends, Contract Pharma Digital Edition, March 2015

Benefits of Ready-to-Use Parenteral Packaging Components and Kits

Content provided by:

DWK Life Sciences

Visit fishersci.ca/dwk-life-sciences for more information.

Reference