7 basic factors of cleaning validation in pharma

What are the Factors Of Cleaning Validation In Pharma?

Cleaning validation is an integral part of the pharmaceutical industry and has high importance. FDA expects that, the firms have written procedures on how to validate cleaning processes.

According to 21 CFR part 211, subpart D, section 211.67 “Equipment cleaning and maintenance” a written procedure shall be followed for cleaning and maintenance of equipment, utensils used in the manufacturing processes.

Here are mentioned 7 basic factors of cleaning validation to meet the FDA expectation and regulatory requirements.

Before that, we should understand what is cleaning in pharmaceuticals?

Definition of Cleaning:

Cleaning is the process of removing residues of previous products in order to prevent contamination of the product from manufacturing instruments or equipment.


The removal of the residue of previous products to avoid contamination of the product from manufacturing instruments or equipments is called cleaning.

Factors of cleaning validation:

  1. Protocol
  2. Personnel
  3. Identification of cleaning parts
  4. Detergent to be used
  5. Sampling
  6. Prevention of Microbial growth
  7. Acceptance criteria

These are the basic factors needed to be set for the cleaning validation process.


Before validating any process there should be a proper protocol. It should include the scope, the objective, the responsibility, the cleaning procedure, the acceptance criteria, and any other information that is needed. The protocol should be approved by authentic personnel.


It is imperative that the person managing the cleaning validation process has the necessary knowledge and expertise. Cleaning validation processes should be validated by a person with training in a particular activity. The cleaning validation process should follow standard operating procedures.

Identification of cleaning parts:

In the manufacturing process, it should be identified which parts need to be cleaned. Parts are divided into two categories. 1. Parts that are in contact with and 2. Parts that do not directly come into contact.

Cleaning of parts that come into contact with needs to be more thorough than cleaning of parts that do not come in contact.

Detergent to be used:

It is important that the detergent used for cleaning manufacturing equipment should be easy to remove and have a limit that is acceptable. The detergent used should also be highly detectable in tests.


The importance of sampling cannot be overstated. To identify the residue present in the cleaning process, two types of sampling are available: 1. Rinse Sampling and 2. Swab Sampling.

Nowadays, the best sampling method is by swabbing, since this allows for maximum traceability of residues.

Prevention of Microbial growth:

In the cleaning validation process, microbial growth prevention is a very important task. Water used for the cleaning process should not support the growth of microorganisms. Dry equipment should be used for cleaning. If the equipment is wet, microbial growth could occur.

Equipment that has been cleaned should be stored in a dry place free of contamination and microbial growth. In order to prevent microbial growth, the cleaned equipment should only be stored for a limited amount of time before it is used again.

Acceptance criteria:

There should be acceptance criteria for every cleaning validation process. Cleaning validation methods should be adequate and highly sensitive. There should be a specific method for detecting residue in the cleaned swab or rinse sample.

The acceptance criteria are based on the severity of a drug’s effects and the maximum daily dosage that can be tolerated.

 The limit of acceptance criteria is based on dose criteria,10 PPM criteria, and visual clean criteria.

These are the 7 basic or major factors of cleaning validation in pharma to avoid contamination and to meet the regulatory requirements.

factors of cleaning validation in pharma

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