Written and approved SOPs detailing the cleaning processes used for various pieces of equipment should be in place. The SOPs should detail different procedures if different cleaning methods are used.
For example:
- For cleaning between different batches of the same product and for cleaning between product changes
- For cleaning of water-soluble residues and for non-water-soluble residues
The SOP should contain:
- Detailed definition of levels of cleaning to be performed
- Detailed description of cleaning methods
- Any disassembly of system or equipment required
- Pre-cleaning activities
- Cleaning agents used and concentrations
- Operational parameters (for example, volumes, times, temperatures, flow rates)
The period and conditions should be stated for:
- Storage of unclean equipment before cleaning
- Between cleaning and equipment reuse
The SOP should detail where verification of cycle parameters (if automated) and checklists (for complex manual procedures) are necessary.
Where microbial contamination may be an issue, consideration should be given to the integrity of the vessel prior to manufacture.
Written cleaning procedures may also include additional items not specified above (for example, the steps needed to protect the equipment from contamination after cleaning).