5 Tactics for Cleaning Validation Compliance | IVT

For many processes, and cleaning validation is no exception, regulatory agencies are playing catch-up with major life science manufacturers. However, many pharmaceutical, food, and medical device manufacturers fail to stay current with regulatory initiatives. A total quality approach is now expected as a norm. This includes assessment, control, and management of risk; implementation of quality-by-design and process analytical technology; adherence to USP 797; and an application of a lifecycle approach. Taken from a Bill Hall presentation, the following are five strategies to help you avoid a regulatory citation of your cleaning validation process.

1. Create a List

Converting the known cleaning validation regulatory expectations into a checklist can help manage and organize the process. Items on this checklist include:

  • Implementing risk assessments (i.e., gap analysis).
  • Finding the “worst-case” situation and determining if you have cleaning validation for this product and if you have recently monitored the effectiveness of your cleaning of this product.
  • Having cleaning data on all equipment in your facility.
  • Reviewing change controls since the cleaning validation occurred to determine if there could have been any impact on the cleaning process.
  • Examining changes to utilities; especially water, air, and filtration systems; for impact upon cleaning, environment, and operator safety.
  • Establishing if the annual product review has indicated any cleaning issues.
  • Assessing if any customer complaints have indicated any cleaning or contamination issues.

2. Test Yourself

Consistently and effectively challenging your company’s readiness for inspections and audits will help avoid any regulatory action. Performing an internal audit focused on cleaning and containment will help prepare personnel and identify deficiencies in the process. Analytical data should be screened to determine if it supports conclusions in the final reports. You ought to identify and analyze the differences between the “as-built” blueprints of equipment and facilities and their current set-ups.

Regarding standard operating procedures (SOPs), they should be reviewed for currency; critical SOPs (e.g, gowning, sterilization, list of approved cleaning agents) should be updated. You should also compare dates of operational SOPs with dates of training records to determine if personnel-training is documented for the current version of the SOP.

3. Avoid Documentation Issues

Too often, poorly written procedures will lead to poorly executed, and ultimately non-compliant, cleaning validations. Too many “weasel words” will lead to operator confusion. Cleaning validation procedures also offer the potential to utilize visual imagery; you should take advantage of this opportunity. Utilizing digital photographs in procedures (e.g., cleaning procedures, protocols, sampling locations) will lead to more user-friendly directions (e.g., how far to disassemble equipment, where to obtain samples, direct operator to difficult to clean locations). Additionally, it should be noted that cleaning validation is a critical manufacturing step. Double signatures should be required.

When using consultants to assist in ensuring compliance, their training and experience needs to be documented. Keep a file of their resumes, publications, and other evidence of their expertise. This also applies to third-party validation, equipment maintenance, and calibration services. You need ensure and document that they are properly trained when they calibrate or manage your equipment. Furthermore, you must document the actual calibration to your equipment. Ask yourself, how much do you actually know about what was done to your critical equipment?

4. Be Mindful of Holding Times and Campaign Length

The longest, or worst-case, dirty holding time should be validated. Clean holding time will depend on environmental conditions; it should be tested with non-specific methods such as total organic carbon.

For the cleaning campaign, the worst-case should also be validated. This will be either the longest time and/or largest number of batches. Potential stability issues will arise and need to be considered. A useful strategy is to develop separate cleaning procedures for cleaning between batches and complete changeover cleaning at the end of the campaign.

5. Heed Overlooked Areas

Cleaning validation can, and should, be executed for non-product contact surfaces (e.g., freeze dryers, medical device manufacturing equipment, glove boxes, isolators), laboratory glassware and instruments, and new dosage forms (e.g., dermal patches, peels, biorelease dosage patches forms).

Cleaning validation does not need to be difficult. With thoroughness, sound science, and proper management oversight applied to the above schemes, citations can be avoided and contamination controlled.

Typical Cleaning Process Development and Validation Process

Typical Cleaning Process Development and Validation Process.


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