Our vision on quality

Especially in the pharmaceutical industry the quality requirements of the products supplied by UltraPure International are becoming more and more important. That is the reason quality plays a central role in our daily processes. This doesn’t stop in terms of the quality of the component and/or assembly itself or related documentation and certification (for example; raw materials specifications, manufacturing conditions or Certificate of Conformance).

Risk Assessment
According to cGMP regulations, our pharmaceutical customers are required to perform a risk analysis to determine which factors in their supply chain and manufacturing process are critical, to ensure the quality of their final product and continuity of the production process and supply.
Our single-use components and assemblies are very often used in the manufacturing process as a drug contact material and as a consequence, they are critical for our customers.

Controlling the supply chain
For our customers it is of great importance that the entire supply chain of these critical products is well known and controlled. UltraPure International supports her partners and customers in this process where possible.
To make this possible we have a very close relationship with the suppliers who manufacture the components used in our assemblies in terms of change notification control, quality agreements, technical support, site visits, supplier qualification, supporting customer audits, managing customer complaints, and etcetera.

In terms of continuity, we offer our customers the possibility to consign their stock in our warehouse to ensure availability of their components and assemblies.

In addition to this UltraPure Internationale:

  • Is working conform ISO9001:2015.
  • Has a good knowledge about (cGMP) quality needs in Life Sciences & (bio)pharm.
  • Performs batch registration on all of its components and assemblies.
  • Has procedures for complaints, change notifications, recalls and non-conformities
  • Assemblies its single-use systems in a certified cleanroom according to client specifications.
  • Makes sure its employees are properly trained.
  • Prefers to close quality agreements with our customers and support our customers regarding quality agreements between customer and supplier.
  • Determines together with the customer the required quality level of the assembly.

In summary: quality is a very important matter in everything we do at UltraPure International, because we value our customers.

If you have specific questions or wishes regarding quality, please do not hesitate to contact your local supplier.