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.
- 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.
- 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.
- 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.
- 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.