1.Adopt air bag seal,safety interlock control;
2.Adopt PE bag or ab valve for loading and unloading;
3.Adopt BIBO system for air exhaust, with F9/H13 filters;
4.WIP cleaning/CIP cleaning/Manual disassembly cleaning.
APIs with cytotoxicity and high activity are a class of pharmaceutical ingredients with high pharmacological activity, with lower clinical dosage and fewer side effects, and have attracted much attention from the market in recent years. Although the market for highly active drugs is broad, they also face greater challenges. In addition to killing cancer cells, anti-tumor drugs may also kill normal cells. Their sensitization can cause allergic reactions in people, and they are very harmful to the health of healthy people. Therefore, the main risk considered in the production process of cytotoxic and highly active APIs is dust exposure. The best solution is to use airtight isolation technology to control the amount of dust leakage in the production process. In view of this characteristic, this project mainly studies the applicable OEL (Occupational Exposure Limit) values under different active material toxicity hazard levels, as well as the corresponding equipment OEB airtight level and airtight strategy. According to the characteristics of cytotoxic and highly active raw materials, based on the existing labyrinth sealing technology, negative pressure sealing technology and airtight isolation technology, a variety of sealing combinations suitable for such materials have been studied. Micro-leakage sealing technology can block or block with high cytotoxicity. Leakage channels of active APIs to control the leakage rate
1.OEB 1~2 it is required to set up local induced draft facilities, such as effective local ventilation at exposed points.
2.OEB 3 When occupational contact is involved, airtight equipment and facilities should be adopted as much as possible, and control measures such as ventilation, laminar flow hood, independent operation compartment with local ventilation device, fume hood, etc. should be used in the exposed parts of drug dust.
3. OEB 4-5 level Priority should be given to the use of full-process enclosed equipment and facilities, and the design of enclosed technological production paths. The product line should adopt the entire enclosed equipment and facilities. Involving occupational contact, control measures such as isolator, glove box closed operation, α-β valve, bag in and bag out, etc. should be used. The production equipment should use its own high airtightness, such as a three-in-one dryer.
customer first, quality first, continuous improvement and excellence.
Advanced processing equipment + precision testing instruments + strict process flow + finished product inspection + customer FAT
=Zero defect of factory products