7 Basic factor for Cleaning Validation process

Cleaning validation Basic

Reference: 21 CFR part 211, subpart D, section 211.67

Cleaning validation process

Cleaning validation process:

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

              The cleaning validation process is an integral part of the pharmaceutical industry and has high importance. Before starting and after completion of batch manufacturing, cleaning validation plays an important role to assure that, the product has manufactured in acceptable condition of the regulatory and will give a quality to the product. Improper cleaning gives harmful impact on the organization and its product quality.

    Here some major factors need to set while cleaning manufacturing equipment and instruments.

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

1. Protocol:

    The protocol should contain scope, objective, responsibility, cleaning procedure, acceptance criteria, and any additional information. The protocol should be approved by the authentic personnel.

2. Personnel:

    The person who deals with the cleaning validation process should have adequate knowledge and must be qualified. A person should be trained on a particular activity and shall follow the standard operating procedures define for the cleaning validation process.

3. Identification of parts to be cleaned:

     There should be identification in the manufacturing process for parts to be cleaned. There are two types of parts 1. The parts directly come into contact and 2. The parts are not directly come in contact. The parts which are come in contact with are required more proper cleaning than that of the non-contact parts.

4. Microbial growth prevention:

       Microbial growth prevention is a very important process in the cleaning validation process. The water uses for the cleaning process should not support growing the microorganism. The cleaning equipment should be dry. Wet equipment can give a chance of microbial growth. The place where equipment is stored after cleaning should be dry and free from microbial growth and any type of contamination. There should be a time limit for stored the cleaned equipment up to the next use to avoid microbial growth.

5. Detergent to be used:

     The detergent used for cleaning of manufacturing equipment should be easily removable and should have an acceptable limit. The detergent used for cleaning should have high detectability in testing.

6. Sampling:

    Sampling plays a key role. For identification of the residue present in the cleaning process. Sampling is of two types 1. Rinse sampling and 2. Swab sampling.

Nowadays most effective sampling is swab sampling where can get maximum residue traceability. 

7. Acceptance criteria: 

     Every cleaning validation process should have acceptance criteria. The method for cleaning validation should be adequate and have highly sensitive and should have specific to detect the residue present into the cleaned swab or rinse sample. The acceptance criteria define on the basis of the severe effect of the drug and daily acceptable limit.
      The limit of Acceptance criteria is based on dose criteria,10 PPM criteria, and visual clean criteria.

Cleaning validation

Advantages of Cleaning Validation:

a.    Reduction of quality costs.
b.    Assurance of Quality & Safety.  
c.    Government regulations.
d.    Making good business sense.
e.   Less downtime, fewer batch failures, and may operate/clean more efficiently. 
      

Cleaning validation

Refer link: https://en.m.wikipedia.org/wiki/Cleaning_validation


Also Read:

DMF in Pharmaceutical

cGMP in Pharmaceutical

Data Integrity and ALCOA Plus