Rotation Of Disinfectants in Secondary Pharmaceutical Facilities

It is considered good practice, and is an expectation of many regulatory inspectors, that a routine rotation of disinfectants used in general cleaning and decontamination is in place. The basis of this rotation, is the potential for resistant micro organisms to develop if a single disinfectant is used. Whilst the evidence for this resistance is somewhat anecdotal, the use of two or three disinfectants, which are changed as a cyclic basis is recommended. The disinfectants should be from different generic groups, as described in section 4 above, and an SOP should define the disinfectants and frequency of rotation.

The procedure should permit the use of other disinfectants (e.g. sporicidal agent) to be used at the request of QA/Microbiology or to change the rotation frequency, for example when ‘black spots’ are found. The frequency of rotation of disinfectants, and number used is not defined specifically in any internal or external references. It is recommended that two approved and validated disinfectants from different generic types are used alternatively and rotated on a monthly basis in most general applications. There are some circumstances where rotation of disinfectants is not practical or appropriate. Alcohol sprays used within sterile manufacturing facilities and non-aqueous hand washing agents are two examples where alternatives are not appropriate and rotation unnecessary.