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TPE April 22, 2016 0 Comments

THE BOTTOM LINE: Best Practices for Introducing Single-Use Processing Equipment to Your Aseptic Manufacturing Line

About ‘The Bottom Line’:

Equipment that improves plant efficiency is playing an increasingly important role in profitability for processing operations. In this recurring series, Triangle Process Equipment presents advice to help manufacturers realize cost-effective equipment investments.

Single-use processing equipment is shown to drive efficiency, lower maintenance costs, reduce cross-contamination concerns and improve speed-to-market for pharmaceutical and biotech manufacturing applications. Manufacturers who are considering implementing disposable technologies to their operation should adopt the following best practices to ensure a smooth, cost-effective transition to single-use equipment.

  1. Align single-use investments with business objectives.

Because some SIP procedures can take days or even weeks to be in compliance with a company’s validation plan, improving the cleanability of equipment can greatly reduce downtime of almost any pharmaceutical processing line. However, making strategic single-use system (SUS) investments as part of a greater business goal can help optimize the investment. For example, implementing a (SUS) can be especially cost-effective when the expense is rolled into the capital investment of introducing a new application or product. That notwithstanding, many manufacturers are realizing cost savings by combining SUS with existing stainless steel equipment.

  1. Partner with an experienced equipment representative to vet potential challenges with SUS.

Although single-use technologies have expanded greatly over the past 10 years and numerous turnkey systems are available, the technology is not yet “old-hat.” Collaborate with a trusted equipment representative to assess how installing SUS will impact operating flow, modularity and scalability. Confirm materials compatibility, identify customization requirements and assess the availability of SUS inventory to a determine a realistic timetable for start-up.

  1. Develop an on-site SUS training program.

Manufacturers who fail to develop and implement a training program for new single-use systems put their capital investments and potential cost-savings at risk. Operators who incorrectly change out single-use equipment risk leaks, contamination and product losses, while technicians who cannot quickly deploy a replacement SUS nullify the cost-savings yielded by the equipment’s innate efficiencies. Develop hands-on training for single-use components that enable operators to practice using them and become familiar with their nuances in the application setting.

  1. Implement inspection, storage and handling procedures for disposable processing equipment.

Bags containing disposable equipment should not be opened until they are in the GMP-controlled environment. SUS should be evaluated for defects such as tears and particles during receiving and then again just prior to installation. Organizing disposable inventory by implementing a labeling system will help operators clearly identify the correct equipment for their application.

Most pharmaceutical manufacturers that install single-use equipment to reduce maintenance costs quickly realize cost savings compared to their previous equipment. For help incorporating cost-effective single-use technology into your processing line, please contact us.