496. Industrial Pharmacy: A Comprehensive Approach
atmospheric pressure. The added advantage of this method is that during processing air-
handling equipment is not required. The air, steam and hydrogen peroxide are
Introduced through the same HEPA filters used for laminar-flow hoods.
Initially to the processing area hot air of about 75 °C ~ 80 °C is introduced through
HEPA filters. Then filtered steam is put to raise the temperature to about 100 °C, there
after mixture of steam and hydrogen peroxide for sterilization. When the sterilization is
‘aver, dry hot air is introduced in place of steam and hydrogen peroxide. This helps to
remove residual condensate of hydrogen peroxide and its break down. Once this step is,
completed, cool air is introduced to bring down the temperature for next operation. Of
course, the method needs to be validated using biological indicator and the residual
peroxide level must be evaluated. The level must not exceed the permissible limit.
When evaluated the method using Bacillus stearothermophilus, a commonly used
bioindicator for steam sterilization, steam and hydrogen peroxide is found to have
synergistic effect. The sterilization of equipment can require only 15 min exposure.
Chlorine Dioxide
This is a greenish-yellow color gas with chlorine-like odor, commonly known as
euchlorine. This is an oxidizing agent. Its disinfecting property has been identified since
20" century, but its use as sterilizing agent is not long. Chlorine dichloride has
bactericidal, virucidal and sporicidal properties like chlorine and it does not react with
ammonia to form chloramines or it does not form trihalomethanes. For these reasons it
is widely used for purification of drinking water,
Chlorine dichloride is low toxic to humans; it is nonmutagenic, noncarcinogenic and
does not deplete ozone also. It is effective at low concentration. Chlorine dichloride is
thus less hazardous and can replace ethylene oxide “* ”, Chlorine dichloride gas need
not to be stored, can be generated as and when required by reacting dilute chlorine gas
with solid sodium chlorite
2NaCIO, + Cl, > 2CIO2 + 2Nacl
Sterilization with chlorine dioxide gas is cost-effective and does not require any
‘expensive special construction. Initially air from the sterilization chamber loaded with
materials is to be removed through vacuum. The relative humidity to be maintained at
about 75% for 30-40 min, then chlorine dioxide gas is to be injected at a rate of
10-30 mg/L. Air or nitrogen is to be introduced to maintain a subatmospheric pressure
‘of about 80 kP,, Holding period is about 1 hour. The chamber is then aerated by filtered
air to remove residual sterilant. Medical devices can be satisfactorily sterilized by
chlorine dioxide. any polymeric materials made of polyethylene, polypropylene, nylon,
polystyrene, polymethylmethacrylate (PMIMA), Teflon, etc can be easily sterilized by
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