All areas, where contact with cytotoxic drugs may occur, need to be regularly cleaned according to documented and approved procedures. Cleaning activities should only be executed by dedicated personnel that is being regulary trained on the relevant GMP elements.
Detergents and disinfectants should be selected and used according to specific requirements, in order to prevent microbial contamination. For A and B areas, sterile and spore free cleaning and disinfecting agents are recommended. In order to reduce contamination from spore forming microorganisms, the periodic use of sporicidal cleaning agents should be considered.
In order to comply with regulatory requirements and industry standards, cleanroom detergents and disinfectants should feature the following characteristics:
- manufactured to GMP standards, with full batch traceability
- detergents to comply with REACH and EC regulation 648/2004
- disinfectants to be tested agains the relevant European norms for biocidal activity
- full technical documentation
- standardised formulations, so you can use the same product in any European site
- protected formulations, to guarantee you will not need to re-validate the product unless they are force- majeure cases.
All cleaning tools and materials should be non-shedding and dedicated to use in the cleanroom.
The control of the hygiene of air and surfaces is crucial to confirm and validate the effectiveness of the operations of sanitisation, to identify a possible contamination carried by people (hands and garments) and to train the staff in regards to the right cleaning procedure. It is recommended to continously monitor and document the compliance of stipulated limits resp.to implement a plan of action, if these limits are exceeded.
"The effectiveness of cleaning should be routinely demonstrated, by microbiological surface sampling, e.g. contact plates or swabs". (PIC/S, p.34/29)
Information on European regulations and standards of practice for cleaning and disinfection can be found in the PIC/S, Annex 1, p.33/26ff, in the EU GMP Guidelines, Annex 1, p.5, item 19 and in the ISOPP, Section 13: Cleaning procedures. Local regulations may apply and need to be considered in addition.