Design for validation

Developing new technologies for medical applications requires extensive validation efforts. If not considered in the early design phase, validation becomes complex and not properly interlinked with practical operation. Chempilots applies “design for validation” on a daily routine. 

What we offer

• We resolve yield issues and validation deficiencies by redesigning existing process technologies.
• In order to obtain reliable solutions, we prioritise simplicity and safety in process design.
• New processes are challenged to identify robust operating windows and control objectives.

• We can contribute to planning, executing and reporting of process validations through all steps (acceptance tests, IQ, OQ, PQ, PV).

One example: Line automation
For Contura we studied and challenged a manual process technology for making injectable hydrogels. The immediate outcome was used to set production specifications and inline controls, and to support process validation.

Driven by new growth opportunities, the process technology now must be upgraded. Chempilots proposed a new automated line for production of the hydrogel, and prototype equipment was built. Processing studies were conducted in our lab demonstrating technical feasibility. A regulatory compliance pre-evaluation was also provided. Together with machine constructors, a full-size automated line is now being fabricated and will meet validation requirements, in particular those of FDA 21 CFR part 820 (G).

Another example: Catheter assembling
Following a FDA inspection, a world-class supplier of catheters decided to have their manual assembly operations rescheduled to better meet validation requirements. We prepared scenarios of line automation/robotic sub-assembling versus change in sub-assembly stacking facilitated by redesigned key equipment.  

As an outcome, we redesigned and prototyped new curing ovens for parts potting and bonding. In our lab we conducted oven pre-qualification and robustness bench tests. Our customer conducted production studies that showed better operating flexibility and better yields, and based on our bench tests the process was validated in a test site.

Many other examples
Many of our assigned projects are originated from process yield issues or validation deficiencies in our customer’s present GMP set-up. Most of our customers are within the medical device or pharmaceutical industry, so we are familiar with validation requirements. Combined with our extensive R&D expertise and experience it is very likely that we also can assist you in designing and pre-qualifying processes that can be appropriately and practically validated in your production site.

Contact us
For more information, please contact Richard Schmidt on
+45 44 39 61 15 (9-17 CET) or send us an e-mail.