Microbiological validation, aseptic handling

Aseptic handling National Elution in class A background at At the start of every Microbiological No validation... 

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... 

In many respects the hazards of many antineoplastics and radiopharmaceuticals for staff are similar. Also the required skills for aseptic handling are similar. This may lead to the consideration of designing a standard layout for all premises for handling with extremely hazardous substances. However, for antineoplastics no formal requirement for pressure applies (see Sect. 26.8). Therefore, the viewpoint that overpressure warrants a better microbiological air quality usually will prevail. In addition the validity of negative pressure premises may be impaired as a result of almost unavoidable air leakages. 

Aseptic handling Aseptic processing GMP Annex 1 < Antineoplastics Microbiological controls Monitoring < Validation Qualification... 

Although aseptic handling differs significantly from aseptic processing, the principles for microbiological controls, like monitoring and process validation, are the same. As most aseptic work is done manually, the aseptic technique of the operators has to be checked with additional microbiological controls. 

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