Study on the technology of sterilization water for injection in celine bottle

Manufacturers of penicillin bottled sterile injection water often encounter the problem of increased pH of the produced sterile injection water. The qualified range of pH for sterile injection water specified in the Chinese Pharmacopoeia is 5.0 to 7.0, while the actual results of stability testing for penicillin bottled sterile injection water in the near term are often close to the upper limit. This article mainly explores the production process of sterilized injection water in penicillin bottles. The penicillin bottles are pretreated under different conditions, and then sterilized injection water is filled. The effect of pretreatment of penicillin bottles on the pH value and conductivity of sterilized injection water is investigated. After sterilization with a 121 °C water bath for 45 minutes, the pH value and conductivity of the sterilized injection water can be reduced, and the stability is good. After processing the penicillin bottles, the injection water is packaged and sterilized. The production process is stable, the product quality meets the requirements, and the long-term and accelerated stability is good.