In a pharmaceutical manufacturing business cleaning validation is performed to exhibit efficiency of procedures for cleaning in order to remove residue of products used prior. An active pharmaceutical industry comprises of manufacturing procedures that involve a series of chemical and physical changes. Generally early steps include processing which is followed by purification for removal of residue. Cleaning validation of pharmaceutical equipments offers confirmation since it certifies procedures involved in cleaning of pharmaceutical equipments.
Need for Cleaning Validation
Every firm is authorized to produce a detailed and descriptive analysis of the cleaning process of equipments that are being utilized. In case the product contains more than one active substance, the substance which is least soluble in water or is extremely potent is tested. The scientific data obtained analyzes efficiency of the system to produce results that meet predestined expectations. Before the procedure begins, product specifications are mentioned that evaluates acceptance criteria for the products. In the event that the criterion goes beyond expected standards or maximum rinse volume is changed after addition of new components, concerned departments are notified.
Evaluation
The initial phase comprises of inspecting the process being used i.e. focusing on the purpose of procedure used in cleaning validation. The measure of sample used by companies is not specific for testing hence it is necessary to understand the point of change or saturation ability of the product. At what measure does the product become clean and if it requires additional forms of purification are steps outlined in cleaning validation of pharmaceutical equipments.
Design
Examining the design of the equipment is a necessity in large systems where operators must have firsthand knowledge of the working and principle of the systems. Training and level of experience required to operate the system is another asset to confirm. Checking the written protocols under cleaning validation ensures whether the system has clearly been identified or not. Say for tropical suspensions and immense drug operators, it is important to analyze critical elements of validation process, microbiological testing, and organizing time frame between end processing and otherwise in every phase of the cleaning.
Documentation
The specificity of every product will be distinct hence close examination of the cleaning procedure is essential to calculate required documentation. Some procedures according to their scientific calculations require log sheets as per the testing methodologies used. Depending upon the complexity of the system’s cleaning process level of citations recorded will be different and should be clearly defined. Complex procedures composed of fundamental elements should be recorded especially history of cleaning residue levels. Changing of the test results can dictate magnitude of documentation required.
Analytical Methods
Whether qualitative or quantitative, analytical methods utilized should be specified within the field lines of the documents. Such analysis detects contaminants like identification of residue from manufacturing and cleaning processes at low concentrations. Technology used should challenge and address analytical approach in sampling and testing for determination of contaminants at distinct levels. Two specific kinds of sampling procedures are followed – direct surface sampling which evaluates sections that are difficult to clean. Rinse samples analyzes residues that are insoluble and must be removed physically however the surface area covered is larger and precise.
