Cleaning Agent Selection
Cleaning agents are selected based on their suitability to remove the product residues, interactions with the process equipment and their own easy removal.
At the time of validation, review the information about the cleaning agents. The established cleaning agents are reviewed against the vendor’s current specification.
When selecting a new cleaning agent or utilizing an established cleaning agent for a new process, verify all of the ingredients which are present in the cleaning agent, along with the percentage each constituent.
Use water of suitable quality to prepare cleaning agents and to rinse equipment. Water used for final rinse to be the same grade used for manufacturing product e.g., Purified water is used for oral, liquid, topical products and WFI is used for parenteral products.
Different Organic solvents like Methanol, IPA, Ethanol are often used in finished pharmaceutical manufacturing machines, spart parts and to facilitate drying surfaces. For Organic solvents it must be ensured the removal of organic solvent to the acceptance level as per ICH Guideline Q3C (R6) on “Impurities: Guideline for Residual Solvents”.
Equipment Cleaning Procedures
A detail written cleaning procedures (SOP/EOP) for each piece of equipment to be prepared. This should include:
- Cleaning agents/solvents to be used
- Pictures or details of cleaning tools
- Volumes, flow rate and or concentrations
- Reflux or rinse times, and temperatures
- The sequence of cleaning steps or pre-defined repeats
- Description of pumps used (if needed)
- Agitation (if needed)
- Duration for each activity
