Labware cleaning validation protocol example

I am aware that we do not need to conduct cleaning validation for laboratory labware, but just showing that the manual cleaning process rids the labware of detergent utilized in cleaning.

Does anyone have a cleaning validation example of labware (even if it's for a dishwasher)? I'd like to see what they felt relevant to include in the protocol write up.



Quite Involved in Discussions

Validation of Cleaning for Research Glassware
1. Developing a rugged, controlled glassware washing
SOP: This includes selection of the equipment,
selection of cycle conditions (such as times,
temperatures, detergent, detergent concentration and
water quality for wash and rinse), determination of any
limitations on loading pattern and drying conditions.
2. Developing acceptance criteria for what is clean:
This has to be done on a case-by-case basis, and
should be based on possible interferences of soils and
cleaning agents with the subsequent use of the cleaned
3. Developing suitable handling and storage
procedures for cleaned glassware: The key is to have
procedures that do not allow recontamination of the
glassware before use.

The first step in validation of an automated washer is the
Installation Qualification (IQ) and the Operational Qualification
(OQ) of the washer itself. Manufacturers of such equipment
can assist in the IQ/OQ process. Parameters that then need
to be established to operate an automated washer consistently
might include:
• loading configuration
• water temperature(s)
• wash water quality
• rinse water quality
• detergent
• detergent concentration
• cycle times (prerinse, wash, rinse)
Basics Of Labwasher Cleaning Validation
There are four ways to qualify a labwasher:
1. Design qualification (DQ) defines the specifications of the equipment and
documents the vendor selection process to ensure the proper equipment is
purchased to meet the user requirements.
2. Installation qualification (IQ) is often considered the first of the qualifications. It provides documentary evidence that the equipment has been installed correctly
and that all supporting services are available and connected correctly.
3. Operational qualification (OQ) demonstrates that the equipment functions as expected and is capable of consistently operating within established limits and tolerances. This includes running of programs, testing of functions
including error messages and controls. Essentially, OQ ensures that the equipment really does do everything that the user wants it to do. Completion of the OQ will allow the finalization of key items such as SOPs, user training and preventive maintenance tasks.
4. Performance qualification (PQ) Performance Qualification (PQ) is intended to prove the equipment operates as designed, in normal operation, and when there is a failure in the operating process. To do this each internal device must be manipulated to produce an actual failure so the appropriate fault will occur when this circumstance occurs. Prior to PQ, all SOP's must be finalized and cleaning requirements addressed to assure the validation team considers all operating parameters used in the process