8/23/2020 Basics of Cleaning Validation : Pharmaceutical Guidelines

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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.

Manufacturing 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?

Protocol
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.

Personnel
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.

Sampling
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

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8/23/2020 Basics of Cleaning Validation : Pharmaceutical Guidelines

actions for not performing it. Therefore every company where a pharmaceuticals or whatsoever industries it operates in must always observe this
process.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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