Equipment

Cytotoxic drugs being toxic chemical substances that can seriously harm people, the preparation of those drugs should only happen in clearly marked, separated rooms.

Those rooms should be exclusively accessible for authorized and trained personnel wearing protective clothing.

Size and air flow of the rooms should be appropriate to the production process, to allow a safe operation of the workbench. Safety workbenches need to comply with current standard regulations and regular service and testing is obligatory. During operation of the workbench adapted working behaviour is required, e.g. there should be no disturbance of the airflow in order to guarantee ultimate personal and product protection and to avoid any cross contamination.

All large types of equipment, such as carts and tables, should have smooth and groove-free surfaces in order to facilitate thorough cleaning and disinfection. Preferably, the material is stainless steel. Stools and chairs should conform to cleanroom quality.

In order to control particles in any area of the production premises, floors need to be nonporous and washable to facilitate regular disinfection. The additional use of adhesive mats is recommended.

Information on European regulations and standards of practice for equipment can be found in the PIC/S, p.15, 3.7, in the EU GMP Guidelines, Annex 1, item 46-47, 56-60, QuapoS 5, item 3.3.1. and 3.3.2., and in the ISOPP, section 13 for cleaning procedures. Local regulations may apply and need to be considered in addition.