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Informationsbild zu Zytostatika in Reinräumen.

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Briefly explained: Product and personal protection in pharmacies

Product and personal protection in the cleanroom? The best example of this is pharmacies, especially the production of cytostatics.

The production of cytostatics for cancer therapy places the highest demands on hygiene and occupational safety. The drugs for cancer therapy inhibit the cell division of tumour cells and are administered to individual patients, usually in the form of an infusion. During the production of cytostatic solutions, in addition to absolute sterility for the protection of the product, i.e. for the protection of the patient, complete occupational safety must also be guaranteed! Employees must be protected from any contamination when handling the toxic substances and the carry-over of individual particles must be excluded. The process is subject to the manufacturing authorisation according to § 13 of the German Medicines Act and the requirements of the Pharmacy Operations Regulations. Among other things, this requires the use of GMP-compliant cleanroom laboratories. This is one of the top classes in cleanroom construction.

This ensures product protection:
Multi-stage personnel and material lock 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 have to change their clothes and carry out cleaning and disinfection procedures before they enter the production room of the cytostatic laboratory, clean room area B.

This is how we ensure personal protection:
In the GMP-B laboratory, cytostatics are manufactured under safety workbenches with extraction and internal filtration 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 can escape from the cleanroom to the outside. Further safety is provided by the continuous monitoring of the particle count (and of course also of temperature, humidity and air pressure, which are recorded) in order to trigger an alarm within seconds in the event of an accident.

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