Services for your in-house pharmacy
AST Service GmbH supports hospital pharmacies in carrying out regular tests within the scope of the testing obligation for finished medicinal products according to the “Apothekenbetriebsordnung” (Ordinance on the Operation of Pharmacies). Furthermore, we advise you on the determination of the relevant tests and records in order to comply with the legal requirements for the production of medical gases.
GAS QUALITY ANALYSIS SERVICE
According to the “Apothekenbetriebsordnung” (Ordinance on the Operation of Pharmacies) quality measurements and identity checks are required. In the Pharmacopoea Europaea / European Pharmacopeia (Ph. Eur.) the measuring methods are clearly defined. Due to the exemption according to §13 of the “Arzneimittelgesetz” (Medicinal Products Act) the pharmacist is, however, obliged to ensure the release and continuous testing of the medical gases.
For this purpose we offer the pharmacist two coordinated services
- Gas Quality Analysis Service
- Gas Quality Inspection Service
SOP – Standard Operating Procedure
In order to support pharmacies in defining responsibilities and test procedures for the production of, for example, medical compressed air, we will create a tailored SOP for you. This SOP describes the planned procedure for testing medical/pharmaceutical gases, oxygen, compressed air and other pharmaceutical gases. The target of the test is to determine whether the produced gas meets the specifications of the Ph. Eur.
GAS QUALITY – BIOBURDEN
According to the recommendation of the Central Office of the Federal States for Health (ZLG), the regular inspection of the produced medical compressed air is recommended. Germs in compressed air are a risk of infection for patients.
For the benefit of your patients, we carry out a validated measurement of your medicines, compressed air or oxygen for germ contamination.