الفهرس 
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Abstract
Pharmaceutical products and active phrmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or (APIs ) or by cleaning agents , by micro -organisms or by other materials ( e.g.air- borne particles ,dust,lubricants,raw materials .intermediates,auxiliaries ).ln many cases the same equipment may be used for processing different products. To avoid contamination of the following pharmaceutical, adequate cleaning procedures are essential.
Cleaning procedures must strictly follow carefully established and validated methods of execution . this applies equally to manufacture of pharmaceutical products and active pharmaceutical ingredients ( APIs ). In any case , manufacturing processes have to be designed and carried out in away that
contamination is reduced to an acceptable level. (10 ppm ) ^ is considered the maximum acceptable limit of residue of active pharmaceutical ingredient in the following or other pharmaceutical product after cleaning .Cleaning validation is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing of pharmaceutical products or active pharmaceutical ingredients (APIs ). Objective of the cleaning validation is the confirmation of reliable cleaning procedure so that the analytical monitoring may be omitted or reduced to a minimum in the routine phase. Normally only cleaning procedures for product contact surfaces of the equipment need to be validated . consideration should be given to non contact parts into which product may migrate , for example ,seals,flanges,mixing shaft,fans of ovens, heating elements etc.
Cleaning procedures for product changeover in the case of marketed products should be fully validated. A direct measurement of the product residue or contaminant in the relevant solvent should be made when rinse samples are used to validate the cleaning process. The analytical methods should be validated before the cleaning validation study is carried out .The analytical methods used to detect residuals or contaminants should be specifics for the substances to be assayed and provide a sensitivity that reflects the level of cleanliness determined to be in acceptable limit .The analytical methods should be challenged in combination with the sampling methods used , to show that the contaminants can be recovered from the equipment surface and to show the level of recovery as well as the consistency of recovery . This is necessary before any conclusions can be made based on the sample results.A negative result may also be the result of poor sampling techniques. Samples should be drawn according to the cleaning validation protocol . There are two methods of sampling that are considered to be acceptable , direct surface sampling (swab method )and indirect sampling ( use of rinse solutions ). A combination of the two methods is genrally the most desirable , particularly in circumstances where accessibility of equipment parts can mitigate against direct surface sampling .where the suitability of the material to be used for sampling and the sampling medium should be determined . The ability to