Cleaning validation for parenteral nutrition equipment

A Clean-In-Place system (CIP) is integrated in a newly installed production plant for parenteral nutrition solutions. The CIP system is used to clean plant components in the preparation and filling processing line.

EXCO is commissioned with the cleaning validation to ensure that product residues are removed thoroughly and to an acceptable level from the plant components according to a defined cleaning procedure.

EXCO plans the validation by:

• defining worst case products
• examining the design of equipment to identify significant concerns
• specifying the locations to be sampled and the sampling materials and methods
• determining acceptance criteria for residues from the manufacturing and cleaning processes
• creating a test plan

EXCO organizes the implementation by:

• coordinating the sample sizes as well as the analytical methods in close cooperation with the laboratory
• training staff
• organizing and survey the sample collection at the production plants

EXCO is responsible for evaluation and report generation by:

• making conclusions based on the sample results
• generating a final validation report

• Customer receives proof that the cleaning-in-place process is valid and consistently produces an acceptable result that minimizes the risks of contaminated products.
• EXCO unburdens its customers who are freed up to concentrate on day-to-day business activities and run different projects simultaneously.

Global provider of healthcare products, Melsungen