Basics of Cleaning Validation : Pharmaguideline

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Basics of Cleaning Validation

Cleaning method validation has its great importance in pharmaceutical manufacturing. An improper cleaning can produce harmful product. This article provides a brief introduction of whole process of cleaning validation.
Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufactured are not contaminated. The removal of the residues of the previous products from manufacturing equipment is known as cleaning. If the whole process of cleaning has been documented, it is referred to as cleaning method validation.

Cleaning validation is proof that the cleaning process is effective to removed all residues of the product that was manufactured, cleaning agents those were used during the cleaning process and prevents micro-organisms from developing. This process is done as a requirement of regulatory authorities.

Cleaning validation basicsManufacturing companies should not do it for the sole reason of satisfying the regulatory authorities but they should put it in mind that it is required to ensure that the patients are safe.

What is required for a cleaning validation process?


First, you must create a protocol. When preparing a protocol, some of the factors that should be considered are the quality of the water, the detergent to be used, the rinsing period and the system's size. The protocol should contain the objective of the whole process, the scope of the protocol, responsibilities of the departments, the procedure of cleaning, acceptance criteria and cleaning method validation report.


The people conducting the process should be trained before they start the process of cleaning method validation. They must have knowledge of cleaning procedure, standard operating procedure and validation protocol.

Determine the Parts of the Equipment’s to Clean

There are some parts of the equipment that come into contact with the product during manufacturing. This places should be labeled contact parts while those that do not come into contact with the product are labeled non-contact parts. When cleaning, contact parts of the equipment should be cleaned properly. A lot of care should be taken for cleaning the of the place those are difficult to clean. However, for non-contacts take care that these residues during cleaning do not move to these places. Consideration should still be given to the design of the equipment as this influences how it will be cleaned and the time it takes to clean.

Determine the Detergent Used

A good detergent should be easily removed during the cleaning process by rinsing. Detergents which have residues that are hard to remove usually are discouraged. There before choosing any cleanser, a manufacturer must know its composition. The manufacturer should also define the limits of the detergent residue that are acceptable.

Prevent Microorganisms

It’s also a requirement that the validation process does not support the growth of microbes. In determining if the validation process has supported microbial growth, the storage of the equipment before cleaning and after cleaning is often considered to decide whether they support microbial growth. Make sure that after cleaning the equipment is dry. Store it in a dry place. This is important as any other sterilization procedure that might be applied to the equipment will more likely achieve the required standard.


Samples are needed to determine the level of residues present in the equipment. There are two types of sampling used in the validation process. Rinse sampling and direct sampling. Direct sampling is used to collect samples for areas that are hard to clean. With rinse sampling, you can get a sample of a place that is inaccessible or for a large surface area. Using the two methods is highly recommended.

Calculating the Acceptance Criteria

A cleaning process is determined before the process begins. An appropriate method is determined by creating a matrix of the product's attributes, and the equipment is used. The method chosen should be sensitive enough to detect any residuals on the equipment. The accepted method should also detect an acceptable limit of the contaminants and residues.

A proper cleaning method validation will enhance the process of the company’s equipment cleaning and will free the company from facing legal actions for not performing it. Therefore every company where a pharmaceuticals or whatsoever industries it operates in must always observe this process.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

11 comments: Post Yours! Read Comment Policy ▼

  1. Hello Ankur!
    I want to cleaning validation for filter bags (fluid bed dryer)
    Can you help me: sampling and Calculating the Acceptance Criteria?

    1. This comment has been removed by the author.

  2. Thanks Ankurbhai for sharing this. Cleaning Validation is becoming major concern now a days. Industry should comply with the European guidance which emphases on health based exposure limit evaluation :
    Questions and answers on implementation of risk-based prevention of cross contamination
    in production and ‘Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in
    shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)

  3. This is useful article

  4. We are calculating swab limit by considering entire equipment train. Swab arwa is taking as 0.01m2. but some companies taking this Value as 0.02, 0.03m2 based on selected swab areas. How many areas need to be swabbed, based on that this value is changing. Which is correct.
    Disorbent volume calculation is not available in a pic. How industry is using this. Kindly explain.

  5. Thank-you sir,useful article. Can I know MACO calculation for cleaning

  6. Very Useful Article....Thanks Sir

  7. Which sample to be collected first, swab or rinse? Give the rational for that.

    1. Obviously swab first because there would be no traces after rinse sample.

  8. Very useful content

  9. Thanks to the Author. Quite enlightening.


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