Whether you run a food plant, a pharmaceutical facility, or both combined for cannabis edibles, you must know about cleaning validation. It can be one of the most time-consuming of processes in manufacturing, but it can also be the most important components of your quality control system.
What Is Cleaning Validation?
Cleaning validation is a requirement for compliance in the pharmaceutical industry and is part of Good Manufacturing Practices, or GMP. It also allows the plant to adhere to QSR—Quality Systems Regulations. It gets as intricate as the cleaning methods used to clean the plant and even the type of cleansers used. It’s done to document that the cleaning has been effectively completed in the facility, and that it’s done on a regular basis to a predetermined state of cleanliness.
The testing validation is done at least three times to determine that the cleaning process has removed residue to acceptable levels. Residue may be from materials, from microorganisms, and even from the cleansers themselves.
What’s Involved in Testing for Residues?
Residue from surfaces is tested for identification. There may be different methods selected based on types of surfaces. There is certain criteria that may need to be passed, such as residue levels below a certain number. There may need to be validation of specific methods used, and specific studies referenced, to show that this is a reliable method for testing. There may also be written procedures done, and training awareness of operators of the equipment.
Once a testing process can be repeated three times to determine that there is a good level of cleanliness, procedures will be put in place. After this point, cleaning validation may be done with periodical testing.
Common Detection Methods
The validation committee will first need to identify possible contaminants that could be on a manufacturing facility surface. These may include cleansers used on the equipment, materials, preservatives, and microorganisms.
There are various detection methods that can be used, including enzymatic detection, ion selective electrodes, high-performance liquid chromatography (HPLC), titration, derivative UV spectroscopy, and flame photometry.
While all these methods may seem overwhelming, many facilities choose to use ATP meters as a possible solution. These meters use adenosine triphosphate bioluminescent light units. They require minimal training by staff and can quickly help to determine the level of cleanliness on surfaces.
Create a Team to Manage Cleaning Validation
Most plants and facilities will set up an internal validation committee to ensure that cleanliness is maintained at higher than expected levels. Usually this team will consist of five different team members. One person will be the Validation Specialist who writes and sets up the procedures. A person in Manufacturing will write the SOPs—Standard Operation Procedures and provide the training.
The Engineering expert will provide equipment data and any changes to be made. The R&D will perform the studies, validate any new methods required, do the transfer methods, and select new cleansers for cleaning the equipment.
Cleaning validation is an important part of GMP compliance by GMP production facilities so you should never neglect this process.