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In a Single-Use World, Validation Falls on Multiple Parties

When it comes to manufacturing biopharmaceuticals, stainless steel systems have long been king. But single-use systems (SUS) have become increasingly more popular. They can be quickly installed, are easier to use and cost less.  But SUS come with a drawback. With these systems containing everything from connectors to clamps to bag chambers, how do you validate their multiple components?

The answer? Share the responsibility for validation with everyone in your supply chain.

That means validation needs to begin at the component raw material level and continue successively through all manufacturing, operational, and supply steps to the final assembly.

The Challenges of Component Validation

Common components for a single-use assembly include connectors, filters, tubing, clamps, cable ties, ports, and bag chambers. This is where validation begins for the completed SUS. The drug manufacturer and system integrator need to ensure quality controls and robust systems are in place. Yet several challenges exist:

  • Lack of a standard approach
  • Variability amongst suppliers
  • Understanding end users’ need

Despite these challenges, the end users’ expectation is a robust, scientific approach that results in a stable and dimensionally centered process. So how do you achieve that?

Best Practices for Component Validation

To help integrators and Good Manufacturing Process (GMP) manufacturers meet their regulatory needs, component suppliers need to 1) validate the product supply and 2) design and validate the manufacturing process. This could include:

  • Material and supplier qualification
  • A robust manufacturing validation process
  • Assembly process validation (if required)
  • Product performance validation
  • Inspection
  • Creating quality systems that mirror a GMP operation

Best Practices for Systems Integrators Validation

Key requirements for achieving product quality at the systems integrator level include the following:

  • Evaluating and managing the supplier base
  • Understanding the challenges customization presents for supply chain management
  • Ensuring the focus on product quality continues through the validation of the manufacturing process, facility, equipment, and personnel who manufacture the assemblies

There are also some critical areas where drug manufacturers and suppliers can work together to make the adoption of single-use technology simpler, more efficient, and less daunting for the benefit of the industry as a whole. These areas include setting clear expectations for the suppliers and more focus on proper training for the users.

Overall, realizing the full benefits of single-use technologies requires an unprecedented level of communication and information exchange among the key players. But shared validation will help us to develop a greater understanding of the needs and constraints facing the industry and ensure safe and effective drug products are supplied to patients in need.

For more detailed information on this topic, read Derek Pendlebury’s white paper “How to Overcome Validation Challenges in a Single-Use World.” 

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