How to Make a Cleaning Validation Design

There are three (3) most relevant factors to consider in cleaning validation design.

1. Placebo Product

A placebo batch in the equipment under essentially the same operating parameters used for processing products can be used to evaluate and validate cleaning processes.

A sample of the placebo batch must be tested for residual contamination.

2. Product Contact Surface

Select the correct surface area in which the product or patient shall be in contact to perform the recovery tests and cleaning validation execution.

3. Detergent Agent

Determine and consider the difficulty that may arise when attempting to test for residues when a detergent or soap is used for cleaning.

A common problem associated with detergent use is its composition.

Many detergent suppliers will not provide a specific composition, which makes it difficult for the user to evaluate residues.

As with product residues, it is important and it is expected that the manufacturer evaluates the efficiency of the cleaning process for the removal of any residues, including detergent residues.

However, unlike product residues, it is expected that no (or for ultra-sensitive analytical test methods – very low) detergent levels remain after cleaning. Detergents are not part of the manufacturing process and are only added to facilitate cleaning during the cleaning process. Thus, they should be easily removable. Otherwise, different detergents should be selected.

ADDITIONAL CONSIDERATIONS IN RELATED TO THE CLEANING VALIDATION DESIGN

Recovery of Product and Detergent Residues

Prior to initiating the cleaning validation, you must perform the recovery studies to determine the % of product and detergent that can be collected in your sampling method based on a known amount of product and detergent residues.

Test Until Clean

Testing until clean is a concept utilized by some manufacturers to examine and evaluate the level of testing and the retest results on the early stages of the cleaning process development.

It means to repeat, continue, or prolong the washing or cleaning process with the corresponding testing, resample, and retest equipment or systems until an “acceptable” residue level is attained.

This approach is mostly used during the initial design of the cleaning process and its procedure(s), before initiate the cleaning validation efforts.

For the system or equipment with a validated cleaning process, this practice of resampling should not be utilized and is acceptable only in rare cases.

In this case, constant retesting and resampling demonstrate that the cleaning process is not designed and validated appropriately since these retests actually document the presence of unacceptable residue and contaminants from an ineffective cleaning process.

SUBSCRIBE AND FOLLOW US TO LEARN MORE ABOUT CLEANING VALIDATION DESIGN

HOW TO WRITE A CLEANING PROCEDURES IN 6 STEPS.

CONSIDERATIONS TO SELECT THE CORRECT TEST METHOD

TOP CLEANING VALIDATION FACTORS AND LEVELS 

ESTABLISHMENT OF ACCEPTABLE CRITERIA

STATUTORY AND REGULATORY REQUIREMENTS

For more details on specific FDA expectations and how to create in cleaning validation design, follow us

Three (3) options to design a cleaning validation protocol:

Option 1. You can create a great cleaning protocol, using a template.

You can download a free sample of a validation template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own cleaning validation design protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create a customized cleaning validation designs.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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References: Cleaning Validation Design

PIC/S Guideline to Validation – PI -006-3 (2007)

ICH Guideline Q7 “GMP for APIs

Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/validation-cleaning-processes-793

httpss://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment

httpss://www.gmp-compliance.org/gmp-news/what-does-the-fda-expect-from-cleaning-validation-today

httpss://gmpnews.net/2019/06/fda-requirements-for-cleaning-validation/

httpss://www.pda.org/docs/default-source/website-document-library/chapters/presentations/australia/contamination-control-cleaning-validation.pdf?sfvrsn=4