526 _ Industrial Pharmacy: A Comprehensive Approach ‘+ Final volume of the solution is then adjusted with water for injection and mixed thoroughly. The solution is then analyzed Step Il Sterilization. + The bulk solution prepared in step | is first filtered through prefilter then through a membrane of suitable porosity, 0.45 mp1 or 0.2 mu, ‘+ The filtrate is stored in a suitable steel tank or glass vessel and closed with lid. Step Ill: Sterile filling and sealing. * This step is done under sterile environment. Appropriate volume of the sterile bulk solution is filed in sterile containers. The filled containers are immediately sealed with sterile closures and clean aluminium caps. + Thefilled containers are sampled for visual inspection and complete analysis, Most preferred method of sterilization is thermal heat sterilization and for packed products, sterilization by radiation. But, there are some drugs which cannot be sterilized by heat or radiation due to their stability problem. Hence, a part of the formulation, thermally stable, is sterilized. Then to the sterile solution sterile drug is added. ‘Sometimes the air from the filled containers is replaced by an inert gas (e.g, nitrogen) for protecting the drug from oxidation. The flow diagram of manufacture of sterile parenteral solution is shown in Figure 14,6, Table 14.7 presents a list of few small volume parenteral solutions and their compositions. ‘Table 14.7 Composition of few small volume parenteral solutions Injection and composition | Use of ingredient | Injection and composition | Use of ingredient [cyanocabalamine injection Prochlorperazine Injection {cyanocobalamine JActive constituent | _Prochlorperazine (as edisylate) Active constituent Sodium chloride ITonicty adjustment | Sodium biphosphate utter Methylparaben Preservative Sodium tartrate Do Propylparaben De Sodium bsuphite antioxidant ater for injection _|Solvent Benzyl alcohol Preservative Phenytoin Injection ater for Injection. Solvent Phenytoin sodium Active constituent Propylene glycol [cosolvent Alcohot Do Sodium hydroxide PH adjustment Water for injection __|Solvent HT O <