Cleaning validation and act of demonstrating that the cleaning procedure applied after manufacturing a product is capable of removing possible residues of active ingredients, detergents used for cleaning, organisms, endotoxins and pyrogens (sterile products), from the contact surfaces of equipment below established acceptance limits.
For this type of Validation, it is usual to establish a worst-case product, being established through a rationale of all products produced in the line/equipment, taking into account minimum items established by current guidelines, being:
Cleaning validation guarantees the reliability, uniformity, robustness and purity of products. In this way, we comply with regulations and guarantee patient safety and meet the requirements of our customers.
This study must always be carried out with the aim of verifying the effectiveness of cleaning procedures, being evaluated over several periods, always respecting the rationale adopted by the company:
The documentation cycle is made up of guidelines established in the Master Validation Plan/Cleaning Validation Plan that together with the cleaning validation protocols determine the rationale for conducting the study. This documentation will contain information such as sampling of surfaces in contact with the product, the sampling technique (contact plates, swabs or rinses), the most critical sampling points, and the analytical methods must be verified or validated. Acceptance limits calculated following the approach determined by the company.
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