Background Sodium Bicarbonate is an alkaline agent and is indicated for treating acute or chronic metabolic acidosis. The substance is unstable and when heated in solution it gradually changes into sodium carbonate. That’ s why we prepared Sodium Bicarbonate Intravenous Infusion aseptically, according to the Standard Operating Procedure.
Purpose To validate the performance of aseptic processes used to produce our sterile product and to meet Good Manufacture Practice Requirements, i.e. to comply with the ‘low’, twice per year we are performing media fill (process simulation studies).
Materials and Methods Media fills are simulating the whole process in order to evaluate the sterility confidence of the process. Process simulations includes formulation (compounding), filtration and filling. Important factors in the process are: personnel (number, shift changes, fatigue), sterility test for the sterilised components (bottles, stoppers), filled volume per container (sufficient to wet all surfaces of the containers), frequency, media fill sizes, acceptance criteria, environmental monitoring. We select the growth medium and prepared the bulk media as the same process as routine production including filtering process and number of units (the batches is smaller than 1000). Than all units were incubated at 20–25º C for 14 days.
Results After the incubation period of the media filled containers they were visually examined for microbial growth. The contamination rate is zero, so, the accepted contamination rate is less then 0, 1%. (Contamination rate = Upper confidence limit/Number of filled units × 100 )
Conclusions With media fill we evaluate the aseptic assembly and operation of the sterile equipment, qualified the operators, and assess our technique, and demonstrate that the environmental controls are adequate to meet the basic requirements necessary to produce Sodium Bicarbonate Intravenous Infusion by aseptic procesing.
No conflict of interest.
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