Follow
Protocol
First, you need to create a protocol. When preparing a protocol, water quality, detergent used, rinse duration and system size should be considered. The protocol should contain the purpose of the entire process, scope of the protocol, responsibilities of departments, cleaning procedures, acceptance criteria and validation report of cleaning procedures.
Personnel
The persons operating the process should be trained before starting the validation process of the cleaning method. They must have knowledge of cleaning procedures, standard operating procedures and validation protocols.
Determine the parts of the equipment to be cleaned
There are parts of the machinery that come into contact with the product during production. Contact parts in these areas should be labeled while those that do not come into contact with the product are labeled non-contact parts. When cleaning, the contact parts of the equipment should be properly cleaned. Great care should be taken to clean areas that are difficult to clean. However, for the uninitiated, be careful not to remove these residues during cleaning. The design of the appliance should still be considered as it affects how it will be cleaned and how long it takes to clean.
Determine the detergent used
A good detergent should wash off easily when cleaning. Detergents that have difficult-to-remove residues are generally discouraged. Before choosing any cleanser out there, a manufacturer must know its composition. The manufacturer should also set detergent residue limits that are acceptable.
Microbial resistance
It is a requirement that the validation process does not support the growth of microbes. To determine whether the verification process supported microbial growth, the storage of equipment before cleaning and after cleaning is often considered to determine whether they support microbial growth. Make sure the equipment is dry after cleaning. Store it in a dry place. This is important because any other sterilization method that may be applied to the equipment will likely achieve the required standard.
Sampling
Sampling is required to determine the level of residue present in the equipment. Two types of samples are used in the validation process. Wash sampling and direct sampling. Direct sampling is used to collect samples from areas that are difficult to clean. By rinsing the sample, you can sample an area that is inaccessible or a large surface area. It is highly recommended to use both methods.
Calculating acceptance criteria
A clean process is defined before the process begins. An appropriate method is determined by creating a matrix of product characteristics and the tools used. The method chosen should be sensitive enough to detect equipment residues. The method adopted should identify an acceptable limit of contaminants and residues.
