What are the considerations for validating single use systems?

Considerations for Using Single-Use Systems
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Considerations for Using Single-Use Systems
Introduction
The concept of cost reduction, increase in speed to the market as well as the drive to meet regulatory requirements calls for the pharmaceutical companies to consider single-use technology, pre-sterilized, and plastic equipment systems as some of the alternatives towards the stainless steel process lines. In this case, the application of a single-use system ensures that the bio-manufacturing process becomes efficient at a lesser cost. The single-use system can easily be of help since the equipment can be used and ultimately disposed of, thereby, eliminating any form of capital investment as well as the development time required towards validation of the cleaning and sterilization processes. There is also the aspect of reducing market time through the removal of process validation steps, thereby, making the elimination of downtime required for the undertaking of such processes possible. Such actions could be very significant in enabling an increase in productivity. Notably, there are a number of approaches applicable to validation that could be easily adopted. These may include but not limited to user requirement specification, installation qualification, operational qualification, design qualification as well as performance qualification (Pahl et al., 2019).
Cost-considerations
The aspect of lower pricing flexibility alongside the strength of the US dollar determines the nature of modest reduction in the expectations for the pharmaceutical industry. There is a requirement for pharmaceutical companies to consider the implementation of cost-saving measures when it comes to the use of single-use systems. The use of single-use technology could be one of the appropriate ways of ensuring cutting of costs particularly in the biopharmaceutical space. The single-use systems comprise of pre-sterilized as well as disposable components that are basically polymer-based and are used as a replacement of reusable stainless steel or rather glass equipment. In this case, the utilization of single-use technology also helps in the increase of operational flexibility as well as reducing the overall risk towards cross-contamination. At the same time, the technology could easily reduce various operational costs, therefore, resulting in a positive environmental impact (Langer, 2009).
The process that requires extensive cleaning and re-sterilization between products in a production system is a necessity for industries. However, such traditional processes seem cumbersome especially for biologics companies since proteins appear most challenging when it comes to cleaning. The process of cleaning and re-sterilizing requires that the system be flushed with cleaning agents, rinsed with purified water and ultimately treatment through pressurized steam. Such elaborate processes involve the use of water, intensive labor as well as electricity. All these processes require quite some consideration especially when it comes to costs of cleaning agents, water, electricity, chemical disposal and distilled water. The full cost burden comes clear in the process of factoring in the downtime required for the rigorous process involved. In such a case, the application of a single-use system helps in the elimination of the need for validation for cleaning, sterilization and validation of sterilization, therefore, reducing changeover time significantly (Langer, 2009).
Environmental considerations
The aspect of minimizing the impact on the environment is considered a complementary goal with a reduction in operational costs. In this case, the use of the single-use system ensures a net positive impact on the environment despite the existence of plastic waste. The process ensures a significant reduction in the carbon footprint. Further, the single-use system also requires less water as compared to stainless steel system with the bulk of water channeled towards cleaning. Such a reduction in the use of water provides a sustainability advantage, hence making factory location flexible (Ho et al., 2010).
Regulatory aspects
There are other critical issues that need consideration for the implementation of the single-use system. For instance, it is important the validation of the supplier manufacturing processes. In this case, the suppliers are required to have sufficient data for the purposes of demonstrating reliability as well as the safety of their products. At the same time, it is required of them to have an adequate quality system in place. Additionally, ...