1、本文档共60页，可阅读全部内容。2、本文档内容版权归属内容提供方，所产生的收益全部归内容提供方所有。如果您对本文有版权争议，可选择认领，认领后既往收益都归您。3、本文档由用户上传，本站不保证质量和数量令人满意，可能有诸多瑕疵，付费之前，请仔细先通过免费阅读内容等途径辨别内容交易风险。如存在严重挂羊头卖狗肉之情形，可联系本站下载客服投诉处理。文档侵权举报电话：400-050-0739(电话支持时间：9:00-19:00)。 * - * k * * * AN EFFECTIVE CLEANING METHOD SHOULD PROVIDE A PROCESS THAT IS CONSISTENT AND REPEATABLE AS POSSIBLE. CLEANING SHOULD BE SEEN AS A PRODUCTION PROCESS * * * Settle Plates, Air sampler Plates, Particle Monitoring System * * * * ST at the end means the packs are sterile. In grade C we are not required to use STERILE cleaning agents. So the volume of vesphene is taken from a bulk container * What is the dilution rate for Vesphene that we use in Biotech facility? Ans: 1:128 dilution * * What is the dilution rate LpH that we use in Biotech facility? Ans: 1:256 dilution * How often is the rotation of disinfectant? Weekly… What happen if there is a contamination within the clean room? Do campaign cleaning with sporklenz and performed environmental monitoring These actions will depend on the severity of the contamination… Not severe – 1 day of cleaning * When opened in the Grade A area the bottle can only be used for – ONE DAY. The bottle CAN be then moved to other areas and continue to be used for a period of one month. Deionized water which is also known as demineralized water is water that has had its mineral ions removed, such as cations from sodium, calcium, iron, copper and anions such as chloride and bromide. * FYI -This product is 0.2um filtered in a Cleanroom environment but is then terminally sterilised by Gamma Irradiation * Quarternary ammonium example is benzalkonium chloride (BKC) used as antiseptics, disinfectants * Their strength… * We dun use this here in SP… * Deep scratches in the plastic are difficult to clean and they can harbour micro-organisms * Why WFI volume is critical? Too less or too much will change the effectiveness of the cleaning agent Disinfectants sachet are used in grade A/B area while grade c are measured out from a container via measuring cylinder… - * k * * Not all of the surface is in contact the disinfectant – therefore it hasn’t been cleaned * The area should be kept as dry as possible to ensure a HOSTILE environment