A NOVEL REVIEW ON CLEANING VALIDATION

About author :
E. Anka Rao*, D.Kiran Kumar, M.Madan Mohan Reddy
K.V.S Prasad, SK. Juveeria, S.Suneetha, A. Phanendra Babu
Narayana Pharmacy College, Nellore,  AP, India
*E-mail : [email protected]

ABSTRACT:
Manufacturing and cleaning equipment must be designed for effective and consistent cleaning to avoid cross-contamination and the cleaning processes must be verified as effective. this article provided background on cleaning validation and objectives, types of cleaning, sampling techniques, change control,equipment cleaning procedure. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels.The removal of adherent visible soil from the surfaces, crevices, serrations, joints, and analytic process that prepare smechlumens of instruments, and from devices and equipment, by a manual or the items for safe handling and/or further decontamination.  It is documented evidence with a high degree of assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits. Cleaning validation is primarily applicable to the cleaning of process manufacturing equipment in the pharmaceutical industry. The focus of cleaning validation is those cleaned surfaces that, if inadequately cleaned, could potentially contaminate the product subsequently manufactured in that same equipment. This primarily covers product contact surfaces in the cleaned equipment.
Key Words: Cleaning validation, Objectives, Types of cleaning, Sampling techniques, Change control, Equipment