Aseptic handling guidelines

Some European countries have developed national guidelines for the preparation of ready to administer products in hospital pharmacy (German Society of Hospital Pharmacists Guideline for the aseptic preparation of ready to use-/administer parenterals) or at the hospital ward (Dutch Society of Hospital Pharmacist Guideline for the preparation prior to use on the ward) [49, 50]. For further information on aseptic handling see Chap. 31. 

Aseptic handling National Elution in class A background at guideline least class D At each elution (extent depending on risk assessment) Microbiological monitoring of the eluate endotoxins Product dossitn with validation data on elution and QC supplier assessment... 

For aseptic handling in closed systems a cabinet with unidirectional airflow (LAF or safety cabinet) or an isolator can be used (see Sect. 28.3). The requirements for the background room depend on national guidelines and on the types of containment in the cabinets. Adjustments are allowed but must be based on a risk assessment. 

GMP-H(ospital pharmacy) from the Dutch Society of Hospital Pharmacists NVZA, The Netherlands (in Dutch), contains the interpretation of GMP guidelines and Addenda on Formulation and Preparation method design, Extemporaneous preparation. Aseptic handling and Occupational Health and Safety [11]. 

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