All You Need to Know About Cleaning Validation

all about cleaning validation

 

What is Cleaning Validation?

Cleaning validation is used to establish that a predetermined cleaning process and procedure are capable to reduce the chemical and microbial residues below safe acceptance criteria.

The following diagram is the Cleaning Validation Triangle (CVT) that summarizes the most relevant 12 elements and 8 levels considered during any cleaning validation.  Read more information 

12 elements of the cleaning validation program

What is Cleaning?

Cleaning is the process of removing the residues from manufacturing equipment/facilities below a predetermined level. Read more information.

Why Cleaning Validation?

  • Cleaning validation is necessary to demonstrate that all residues are removed from the product contact surfaces to a predetermined level prior to providing the equipment or device by the final user. Read more information 

When is Required a Cleaning Validation?

It is required when a firm may decide to use certain equipment for manufacturing process steps that produce contamination, foreign matter, tarry, or gummy residues that are difficult to remove from the equipment. Equipment that is difficult to clean and is often dedicated to a specific product.

Any residues from the cleaning process itself (detergents, solvents, etc.) also have to be removed from the equipment.

What 7 Factors Make a Cleaning Validation Successful?

Successful cleaning validation must demonstrate that the process and equipment do as established in the design documents under normal manufacturing operations. Read more information 

How to Prepare a Cleaning Validation Protocol in 24 Steps?

The cleaning validation protocol may include, but, is not limited to the following 24 sections and information, (as applicable), Read more information 

12 Errors to Avoid During a Successful Cleaning Validation

Cleaning Equipment Design

The design of equipment is the most important element to consider in cleaning process efficacy, specifically in large systems that may employ semi-automatic or fully automatic clean-in-place (CIP) systems since they represent a significant concern. Read more information 

How to write a Cleaning Process Procedures in 6 steps.

The cleaning process procedure is the core center of any cleaning validation. It is the most important element to consider in cleaning process efficacy, specifically in large systems that may employ semi-automatic or fully automatic clean-in-place (CIP) systems since they represent a significant concern.  Read more information. 

The Top Analytical Methods Used in Cleaning Validation:

Specific and non-Specific Methods

The success of the cleaning validation shall depend on the correct design and selection of the analytical method and its parameter characteristics to detect contaminants.  Some of these testings are physical as visual cleanliness and others are analytical testing. Read more information.

Cleaning Validation Sampling

There are two (2) most common types of sampling that have been found acceptable during cleaning validation. Read more information.

Cleaning Validation Design – Factors and Levels 

Placebo Product

Product Contact Surface

Recovery of Product and Detergent Residues

Detergent

Test Until Clean

Worst cases

Read more information.

Statutory and Regulatory Requirements

GMP Regulations (Part 133.4) stated as follows “Equipment … shall be maintained in a clean and orderly manner .” A very similar section on equipment cleaning (211.67) was included in the 1978 CGMP regulations. Of course, the main rationale for requiring clean equipment is to prevent contamination or adulteration of drug products. Read more information.

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More details on specific FDA expectations can be found in the guidance document below.

httpss://www.iso.org/standard/53394.html

For a preview, refer to httpss://www.iso.org/obp/ui/#iso:std:iso:14644:-1:ed-2:v1:en

Three (3) options to create a qualification protocol:

Option 1. You can create a great 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 formal training on how to create your own validation 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 qualification.

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

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

Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!