Custom washing and packing of ready-to-use (RTU) Annex 1 compliant components

How we supported a global pharma business with the rapid provision of Annex-1 compliant customized primary components at scale by installing an entire production line to the customer’s exact requirements and deadline.

The challenge

Annex 1 of the EU GMP guidelines sets more stringent requirements for the manufacture of sterile medicinal products, with contamination control prevention being one of them. This new set of requirements includes robust sterility control, precise validation, complex facility design and extensive automation. These challenges make the process and production line set up highly capital and knowledge extensive. Particularly for organizations transitioning from lower grade cleanroom operations.

This is where specialist and experienced pharma service providers like Ensera can provide valuable support, supplying pre-sterilized and packed components in a ready-to-use format.

The solution

We began by developing a deep understanding of the customer’s precise requirements. With this insight, we designed tailored technical and regulatory processes that aligned with their specifications and internal protocols.

Allocated dedicated manufacturing space within our state-of-the-art facility in Poland
Procured specialist equipment for water purification, washing and sterilization
Constructed supporting infrastructure from the ground up
Designed and built bespoke Grade B, C and D cleanrooms

To ensure critical deadlines were met, our procurement and operations teams managed the entire supply chain from the start and continue to do so. Including sourcing of the primary components from the supplier and undertaking visual inspection and quality control upon receipt.

The execution

Our well-defined digitized systems and streamlined approval processes were instrumental in keeping the project on schedule with the right expertise at each stage, ensuring that the production line was operational in time to meet critical customer deadlines.

Within just 18 months of project initiation, a fully customized production line was built and brought online, delivering up to 100 million sterilized components per month directly to the customer’s aseptic facility.

Now fully operational, the line is managed through our integrated Manufacturing Execution System (MES), enabling full digital control, process transparency, and seamless integration with the customer’s own systems.

Impact

For the customer, our supply of ready-to-use Annex 1 components supports them to:

Meet Annex 1 requirements – by securing an ongoing supply of fully compliant components, backed by robust validation data
Reduce contamination risk – by receiving pre-sterilized, ready-to-use components processed in GMP compliant cleanrooms
Accelerate production timelines – by eliminating the need for in-house washing or sterilization processing
Lower operational costs – by removing the need for management of additional infrastructure, processes and personnel in house.

The project team have greatly valued the collaboration with Ensera. We have found your team to be exceptionally capable, professional and reliable partners. The flexibility and adaptability that you have shown during the project has been vital to our joint success as we are entering the operational phase.

- Project Lead, Global Pharmaceutical Customer

Do you have a need for ready-to-use primary components in Europe, US or Asia?

Get in touch today, we're ready to help.

Submit enquiry