TOC应用于制药备的清洁验证— 应对《药生产质量管规范修订》.ppt

* Right now, I am going to introduce you how to use the on-line TOC monitoring for cleaning validation. The container on the right site is the process vessel which will be cleaned. On the left site, this is a CIP skid. It consists of a PW storage tank, a WFI storage tank, a cleaning agent mixing chamber and a rinse tank with some auto valves. The TOC analyzer will take sample water from the pipe between the vessel and the skid. Let’s start the process: Step 1 – Cleaning Validation Process Activation The automated cleaning process is activated from a remote control room. Step 2 – Purified water Pre-Rinse Purified water supplied from the PW tank enters the Recirculation/Rinse Tank, circulates through the CIP skid piping, enters the Process Vessel for a brief rinse, then exists through the waste line. Step 3 – Cleaning Cycle Purified water enters the Cleaning Agent Mix Tank where appropriate concentrations of alkaline and or acidic solutions are added. The solution then passes through the CIP skid piping and washes the Process Vessel. After a preset time, valves open and tank contents exit through the waste line. Step 4 – Purified Water Rinse The entire CIP skid piping and equipment are rinsed with purified water, removing most agents and contaminants. Step 5 – WFI Rinse Final rinse uses water for Injection to remove last traces of residuals. After water exits Process Vessel, the PLC/SCADA system activates the 500 RL from standby mode. Water passes by the 500 RL on the CIP return line and both a TOC and conductivity measurement are taken. The cycle can be repeated as needed. Cycle Completion If TOC and conductivity measurements are acceptable, the equipment is released for production. After taking measurements, the 500 RL goes on standby until reactivated by the PLC/SCADA system. * * * * * * * * * * * * * * * * * * * * * * * * * Pre-1993 Industry Acceptance Limits1992 Pharmaceutical Manufacturers Association Survey listed 44 approaches, e.g.