Knowing that you’re prepared to face unexpected hurdles and delays during your facility design is a huge advantage. And by leveraging current trends, like modular pods and equipment, you can meet changing business needs in an agile way.
When shifting to a flexible facility design, engaging with a commissioning, qualification, and validation expert as early as possible is crucial so you can head off any roadblocks.
Why? Because having a reliable and consistent CQV partner from the get-go gives you a safety net throughout your construction process, reducing rework and ensuring your flexible facility is sticking to its timeline with limited interference.
Benefits of Designing Flexible Facilities
Pharma Manufacturing shares that a “flexible facility is one that is agile enough to adapt to change — whether it be a shift in capacity needs, regulatory demands, manufacturing processes, technologies, products, or some combination thereof.”
Modular designs allow manufacturers to improve product quality, easily replicate processes, and maintain flexibility with the available infrastructure while minimizing manufacturing delays. This means that manufacturers are in a key position to showcase their ability to adapt to the growing cell and gene therapy market and deliver quality products more quickly by adopting these flexible facility designs.
The CQV Advantages of Flexible Facilities
While modular systems typically come factory acceptance tested to verify the equipment works as intended prior to installation at your facility, thorough on-site site acceptance testing, validation and documentation is needed to ensure the equipment is ready for production.
Incorporating a CQV process from the beginning gives you the foresight to reduce delays and spot gaps ahead of time, keeping you on your timeline. The benefits of working with an experienced CQV firm include:
How Will You Incorporate CQV into Your Future Facility’s Design?
Don’t let a commissioning, qualification, or validation issue disrupt your flexible facility’s progress. ICQ is here to serve as your cell and gene therapy manufacturing consultant throughout the lifecycle of your facility — from design to start-up and beyond.
