Identical cleaning procedures should then be used for these products.4.2.1 The relevant cleaning records (signed by the operator, checked by production and reviewed by quality assurance) and source data (original results) should be kept.
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.
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.
This may be especially important for operations with topical products, suspensions and bulk drug or where the drying of residues will directly affect the efficiency of a cleaning procedure.9.1.3 The practice of resampling should not be used before or during cleaning and operations and is acceptable only in rare cases.
(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.
Additionally, if the particles of the contaminant or residue are large enough, they may not be uniformly dispersed in the placebo batch.9.4.2 Samples should be taken throughout the process of manufacture.
for removal of viral or mycoplasmal contaminants in the biological manufacturing industry.2.2 Normally cleaning validation would be applicable for critical cleaning such as cleaning between manufacturing of one product and another, of surfaces that come into contact with products, drug products and API.• bracketing products for cleaning validation.
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.Consideration should be given to “non-contact” parts of the equipment into which product or any process material may migrate.Critical areas should be identified (independently from method of cleaning), particularly in large systems employing semi-automatic or fully automatic clean-in-place systems.6.2 Dedicated equipment should be used for products which are difficult to clean, equipment which is difficult to clean, or for products with a high safety risk where it is not possible to achieve the required cleaning acceptance limits using a validated cleaning procedure.6.3 Ideally, there should be one process for cleaning a piece of equipment or system.A validation study of the “worst case” may be considered acceptable.
There should be a justified validation programme for this approach referred to as “bracketing”, addressing critical issues relating to the selected product, equipment or process.4.1.6 Bracketing by product should be done only when the products concerned are similar in nature or property and will be processed using the same equipment.
anovulent steroids, potent steroids and cytotoxics) should be undetectable by the best available analytical methods.