Every day counts: How we helped a CDMO stay on schedule and on quality

The challenge: Time pressure, regulatory requirements and critical process steps

The customer needed to build a stable and reproducible filtration process for a sensitive manufacturing operation. This required high levels of documentation, extensive testing and strict compliance with regulatory standards.

During the project, we encountered problems in the Performance Qualification (PQ) batches, a critical step before commercial production. Errors in the process parameters meant that we had to rerun the batches. This created an urgent need for new filters in the right configuration and with a much shorter delivery time than normal.

Timeframes were already tight, and any delay risked delaying the launch and increasing costs.

The solution: Ensure expert support from the start and flexible help when it matters most

At Colly Flowtech, we were there from day one to ensure the right decisions were made from the start. Together with Parker Hannifin, we provided technical support and rapid problem solving throughout the project. To create a stable and reproducible process, we worked methodically in several steps:

• Went through the URS (User Requirement Specification) to clarify all requirements and expectations.
• Selected the right filter solutions for a stable and safe process.
• Ensured that the necessary E&L (Extractables & Leachables) tests were performed according to the applicable standards.
• Provided support during Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) to verify the functioning of the equipment both in the factory and on site.
• Contributed to the validation process and was available for external inspections.

The early collaboration allowed a stable and efficient process to be built from the start, reducing the risk of retakes and saving valuable time.

When the project later encountered acute challenges, including when the PQ batches threatened the schedule and the filters did not dry as planned - we acted quickly and efficiently thanks to our close collaboration with Parker Hannifin.

• Rescheduled production at Parker's Newcastle plant to prioritize the development of new filters.
• Ensured timely deliveries while maintaining quality to avoid delays.
• Analyzed and adjusted the process when drying required new solutions.

For the client, our local presence meant they always had a contact for quick decisions and advice, which proved crucial during the most critical phases of the project.

The result: on time, reduced risks and more confident decisions

Working closely with Parker Hannifin, the CDMO stayed on schedule, mitigated risks and ensured a stable process despite tight deadlines.

It shows how technical expertise, local presence and the right partnership make a difference in complex pharmaceutical projects. Working closely together from requirements specification to validation, Colly Flowtech and Parker Hannifin created a safe, efficient and time-saving solution - a crucial factor when every day counts.

Would you like to know more about our long-standing partnership with Parker Hannifin and their filtration solutions? Read more here: Efficient filtration solutions with Parker Hannifin