Optima Pharma reduces aeration phase of isolators
The aeration phase is the most time-consuming process in the decontamination of isolators used for pharmaceutical filling
With the use of catalytic aeration, M+P, part of the Optima Group, is able to reduce the duration of the aeration phase in isolators by more than 50%. The aeration phase is the most time-consuming process in the decontamination of isolators used for pharmaceutical filling.
Decontamination of isolators with hydrogen peroxide vapour (HPV) takes place in three process steps, beginning with the conditioning of the temperature and humidity. This is followed by the sterilisation phase, in which an HPV fog kills any viable microbes. Even in low concentrations, HPV can be detrimental to pharmaceutical products, so the final phase involves aeration with fresh air.
Without the use of catalytic aeration, and depending on the allowable residual concentrations (usually <1ppm – 10ppb, but dependent on the product), the average time required for aeration is between three and 12 hours. Using catalytic aeration, the aeration phase can be shortened by more than 50%.
The construction and decontamination process of M+P isolators allows the use of catalytic aeration. The microbial kill-rate of the HPV during decontamination is not influenced by the catalytic converter. The time advantage of catalytic aeration is of particular benefit; the smaller the residual concentration to be achieved, the better the efficiency. A further advantage is that the catalytic converters are also effective during the production phase.
The company says that HPV diffuses into plastic parts during the HPV phase and adsorbs over time. Even after the aeration phase and during production, an increase in the residual H2O2 concentration can occur. This increase in concentration is only slowly flushed out with time.
The catalytic aeration employed by M+P is effective during the production phase and prevents increases in residual H2O2 concentration.
A pilot project at a pharmaceutical company is being used to demonstrate catalytic aeration in practice.
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