528 Industrial Pharmacy: A Comprehensive Approach it has been reported that certain drugs prepared as concentrated slurry in saturated sodium chloride can be sterilized by autoclaving without any problem. ‘+ The organic drugs substances generally have melting point lower than 250°C. If the powders are sterilized by dry heat method, heating at 250 °C and above, the drugs may melt and decompose. Hence, dry heat sterilization is not suitable for most of the drugs. ‘+ Exposure to ethylene oxide is another method for sterilization of powders. The a5 is toxic and reactive. The residual gas and/or its by-products may be a problem, Utmost care should be taken to ensure that the residual gas does not cross the limit. Secondly, the gas is very reactive, If it reacts with the drug, a new ‘compound will form and/or the drug may decompose. This is another problem. ‘+ Sterilization of powders by radiation has also a problem. It can break the chemical bonds within the drug molecule and thus, many organic substances cannot be exposed to the radiation”. Due to these problems sterile erystallization or precipitation is preferred for preparing sterile solid powders for suspension. The drug is dissolved in solvent system (usually organic, along with a cosolvent), the solution is filtered aseptically through a 0.22 mu membrane filter. The sterile filtrate is poured into another sterile nonsolvent (in which the drug is not soluble). When the drug solution comes in contact with the nonsolvent, the drug precipitates. The precipitate may either be of crystalline or of amorphous form. By controlling the crystallization parameters, the particle size of the precipitated drug can be controlled to desired size range. The wet precipitate after repeated washing with the nonsolvent can be used directly for making the suspension. Otherwise, the precipitate is dried, milled and then used. All these activities should be done in aseptic environment. ‘Table 14.8 List of ingredients present in a typical sterile Ball mill or glass bead mill has suspension intended for parenteral administration been widely used for reducing Ingredients Use Particle size of the solids for |orug(waterinsoluble) [Active ingredient suspension. The sterile slurry of (Benzyl alahol [Preservative the powders as such or with a |Sodimcarboxymethylcelluiose {suspending agent portion of the suspension vehicle Po¥sorste 80 saree active agent is taken ina sterile ball mill and (ysrtorlaccton okey rolled on, Milling is continued until desired particle size is obtained. Since there is a chance of particulate contamination with this milling method, now-a-day the filtzpatrick mill or Air attrition mill, eg., Jetomizer, Micronizer, Jet Pulverizer, etc, is being used. Air attrition mills use sterile air (filtered air) for milling with sterile milling equipment. The milling process should be conducted under laminar air flow in a clean room. After completion of milling of the Ul O <