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Pharmaceutical Cleaning Validation Via Worst Case Matrix


Pharmaceutical Cleaning Validation is complicated.  We’re here to help.  Not only does Alconox Inc. provide validation service support, we also provide technical support via Free Downloadable Whitepaper.  Here is an excerpt about one way to simplify validation.

Simplify Validation Using a Worst Case Matrix

To simplify validations, it is recommended that a matrix of worst case equipment to clean and worst case residues to remove be created. Start by first assembling an equipment matrix and residue matrix that defines all shared and dedicated equipment with what residues they are exposed to. By conducting testing, it is possible to identify and document a “worst case”, for the most difficult to clean equipment and residues.

Then perform a complete validation on these worst-case equipment and residues, which in turn will serve to validate the process for easier-to-clean equipment and easier-to-clean residues. Typically groups of worst case situations are established with one piece of equipment representing a group of similar or easier-to-clean equipment, just as residues are grouped by cleaning with one residue representing a group of similar or easier-to- clean residues.

It’s important to validate a “worst case” scenario and justify its choice. The rationale for why a piece of equipment or residue was determined to be worst case needs to be documented. The worst case is usually based on a variety of factors including: product solubility in cleaner; toxicity of the products or respective degraded products being cleaned; dose sizes and normal therapeutic dose size (smaller may be more critical to validate); hardest-to-clean equipment; and worst interactions with the upcoming batch to be cleaned. Whenever a new residue or piece of equipment is used, an evaluation needs to be made if it can be added to an existing group or if it represents a new worst case that will require a new validation.

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