All You Need to Know About Cleaning Validation

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 

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

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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.