Study On Cleaning Verification Of Stainless Steel Tube & Tank System In New Drug Substance Workshop

In recent years,the biopharmaceutical industry at home and abroad has made rapid progress,and more and more new factories have been erected.In the process of producing drugs,pharmaceutical enterprises may have some residues of intermediate products,solutions or microorganisms.If these residues are not cleaned or not cleaned thoroughly,they may cause contamination,cross contamination and other risks.If subsequent batches are produced,these residues will have unexpected toxic and side effects on subsequent products.Therefore,there are clear laws and regulations that pharmaceutical enterprises must use very sanitary pharmaceutical equipment for production,and when changing varieties or production items,they need to clean such pharmaceutical equipment,and they need to carry out cleaning verification.Cleaning validation is divided into three main phases,from the development of the cleaning process to the implementation of cleaning validation at the production scale,and continuous cleaning validation during the commercial production phase.This Includes identifying contaminant assessment strategies,preliminary design of cleaning methods and selection of detergent,determination of cleaning levels,evaluation of sampling points,implementation of cleaning validation plans,output reports,and generation of effective cleaning procedures.For the stainless steel system in this study,the sampling results after cleaning were able to meet the established acceptable standards,including the microbiological limits of the leaching water,by using the following established cleaning methods: <10 cfu/ml.Limit of bacterial endotoxin in leaching water: < 10.0 EU/ml.TOC limit of blank water sample,wipe water sample,wash water sample: <1 PPM.On line conductivity <1.3 μs /cm,the electrical conductivity can meet the standard of water for injection.This cleaning validation protocol study included the cleaning retention time(DHT),the cleaning effect(CIP)and the cleaning retention time(CHT)of the purification collection tank related to product production.After challenging the worst conditions,the pollution retention time DHT can effectively output 28 h,the cleaning retention time CHT can effectively output 124 h,leaching and wiping recovery rate ≥50%,can also meet the corresponding requirements.Input the above validated cleaning methods into the fixed standard operating procedures for daily management and control before and after production.At the same time,synchronized cleaning confirmation is carried out in the subsequent production process to accumulate data.The significance of cleaning verification is to standardize the standard cleaning procedure of the production equipment in the production process,and to ensure the progress of continuous production,and adopt the cleaning method to remove pollutants by introducing cleaning solution or water to the fixed equipment or pipeline.Documentation establishing cleaning procedures that effectively and repeatedly remove product or detergent residues from equipment at or below preset acceptable cleaning standards.