Monitoring aseptic handling

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... 

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. 

Fig. 31.3 Monitoring results over 1 year during/after aseptic handling in a Dutch hospital pharmacy. Every bar is a positive, the continuous line is the mean values over the last 100 samples...

Each test method selected for routine monitoring should be validated. All handling should be performed in an aseptic way. 

Fig. 5 Facility monitoring and control room (A) and operator interface screen with aseptic area differential pressure readings (B). Features that can be monitored via touch screen from the control room include water status, utility status, outside conditions, air-handling units, and process areas in non-sterile and sterile locations.

The environment to which the excipient may be exposed should be similar to that used in the manufacture of the final dosage form. This is especially true in the case of excipients intended for parenterals. For example, controlled areas may need to be established along with appropriate air quality classifications. Such areas should be serviced by suitable air handling systems and there should be adequate environmental monitoring programs. Any manipulation of sterile excipient post-sterilization must be performed as an aseptic process, including the utilization of Class 100 air and other aseptic controls. 

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