Many firms have used dedicated facilities and/or equipment, or conducted cleaning verification in order to circumvent some of the inherent difficulties in processing high risk drugs.
The difficulties of reproducibly demonstrating successful cleaning may make it operationally easier to dedicate the equipment and/or facility to the production of a single product rather than attempt to clean to the necessary level of cleanliness.
The route of administration of a product may affect the level at which the product is found to be allergenic, toxic or potent.
Generally speaking, injectable products, intra-ocular
formulations, and some inhalants which provide direct access to the systemic circulation systems of patients are a much greater concern in terms of cross-contamination.
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