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The type of sampling material used and its potential impact on the test data is important as the sampling material may interfere with the test. Note: This method allows sampling of a large surface, of areas that are inaccessible or that cannot be routinely disassembled and provides an overall picture.(For example, the adhesive used in swabs has been found to interfere with the analysis of samples.)9.2.2 The location from which the sample is taken should take into consideration the composition of the equipment (e.g. Rinse samples may give sufficient evidence of adequate cleaning where accessibility of equipment parts can preclude direct surface sampling, and may be useful for checking for residues of cleaning agents, e.g. Note: This method relies on the manufacture of a placebo batch which is then checked for carry-over of the previous product. It is difficult to provide assurance that the contaminants will be dislodged from the equipment surface uniformly.Know about the procedure for cleaning validation and cleaning validation protocol and reports as per WHO.Method of sampling, Analytical methods and limits of recovery of swabs.The manner in which limits are established should be carefully considered.
This will depend on the products being produced, whether the cleaning occurs between batches of the same product (as in a large campaign) or whether the cleaning occurs between batches of different products.6.4 The design of equipment may influence the effectiveness of the cleaning process.Detergents that have persistent residues such as cationic detergents which adhere very strongly to glass and are difficult to remove, should be avoided where possible.8.5 Control of the bioburden through adequate cleaning and appropriate storage of equipment is important to ensure that subsequent sterilization or sanitization procedures achieve the necessary assurance of sterility, and the control of pyrogens in sterile processing.Equipment sterilization processes may not be adequate to achieve significant inactivation or removal of pyrogens.9.1.1 Equipment should normally be cleaned as soon as possible after use.The results of the cleaning validation should be presented in cleaning validation reports stating the outcome and conclusion.6.1 Normally only procedures for the cleaning of surfaces of the equipment that come into contact with the product need to be validated.Consideration should be given to “non-contact” parts of the equipment into which product or any process material may migrate.
(Note that the sensitivity of the assay may be greatly reduced by dilution of the contaminant.)10.5 Suitable methods that are sensitive and specific should be used where possible and may include chromatographic methods (e.g.