无菌工艺图文培训课件.ppt

* 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… * 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 for micro-organisms