Question:
What is pharmaceutical cleaning validation? What information can Alconox, Inc provide to support pharmaceutical cleaning validation?
Answer:
Cleaning validation is the methodology used to assure that a cleaning process removes any residues of the active pharmaceutical ingredients (API) of the product manufactured, as well as any residual cleaning agent utilized in the cleaning process and any microbial contaminants on the surface of the manufacturing equipment or utensil. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product.
Alconox, Inc provides validation support to help meet pharmaceutical cGMP requirements. Alconox, Inc Technical Team has written Pharmaceutical Cleaning Validation References that includes a directory of cleaner residue detection methods for each Alconox brand. Also to help comply with cGMP regulations all cleaner brands have traceable lot specific certificate of analysis (COA), Technical Bulletins and MSDS.
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