The production of cytostatic drugs for cancer therapy places the highest demands on hygiene and occupational safety. The drugs for cancer therapy inhibit the cell division of tumor cells and are usually administered to individual patients in the form of an infusion. In the production of cytostatic solutions, complete occupational safety must be guaranteed in addition to absolute sterility to protect the product, i.e. to protect the patient! Employees must be protected from any contamination when handling the toxic substances and the spread of individual particles must be prevented. The process is subject to the manufacturing authorization according to § 13 of the German Medicines Act and the requirements of the Pharmacy Operating Regulations. Among other things, this requires the use of GMP-compliant clean room laboratories. This is one of the top classes in cleanroom construction.
This ensures product protection:
- Multi-stage personnel and material airlock systems, which are operated with different pressure and air changes, guarantee the cleanliness of the laboratory facility up to GMP class B. The pharmacy employees must carry out precisely prescribed changes of clothing as well as cleaning and disinfection procedures before entering the cytostatic laboratory’s production room, cleanroom area B.
This is how we ensure personal protection:
- In the GMP-B laboratory, cytostatics are produced under safety cabinets with extraction and internal filtering in a GMP A environment. In addition, unlike conventional cleanroom systems, the GMP cleanroom laboratories are operated with a slight negative pressure so that no harmful substances from the Cleanroom can penetrate to the outside. Further safety is provided by the continuous monitoring of the particle count (and of course the temperature, humidity and air pressure, which are recorded) in order to trigger an alarm within seconds in the event of an accident.
