Standard Operating Procedure of Sop For Vial Washing Machine in Pharmaceuticals is describe in this post.
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1 PURPOSE
1.1 To describe procedures for the operation of Vial Washing Machine.
2 SCOPE
2.1 It is applicable for the operation of Vial Washing Machine.
3 RESPONSIBILITIES
3.1 It is responsibility of Operator to follow this SOP as written, review and update as necessary
3.2 It is responsibility of the Production Manager to make certain that this SOP is followed in its entirety
3.3 It is responsibility of the Production Pharmacist to make certain that this SOP is followed in its entirety
4 PRECAUTIONS
4.1 For security of operating personnel and machine parts the following should be observed very carefully.
4.2 Ground the frame of the machine
4.3 Turn off Main switch when any cleaning or other operations are required
4.4 The machine is to be totally isolated when any electrical cleaning is to be done
4.5 Never run the machine with machine covers or acrylic covers open.
4.6 Emergency switch -1 on the loading side to stop the machine.
4.7 Emergency switch-2 on the output side if any problem is observed on that side
5 PROCEDURE:
5.1 Open the valves for the fluids and air line, fixed in the line of panel
5.2 Switch on the Main
5.3 Operation Through Hmi-Detailed Dscreen & Its Operation Attached Separately (If Machine With Plc & Hmi).
5.4 Press the Pump 1, 2,3 and Globe Valve 1,2,3 & 4 in on condition. To wash the pipe lines and remove any deposits that may have formed while the machine was idle.
5.5 Load the vials on the in feed conveyor. Here from it will pass through the wedge breaker system and subsequently enter the respective drums.
5.6 VIAL FEEDING
5.6.1 On the in feed conveyor belt there is a Cam system for minimum load detection installed on the sides of the conveyor, which stops the machine when the level of the vials on the feed belt drops to below the level of interception of machine. This device is used to keep the in feed channels from emptying completely, which is not advisable for continuous operation.
5.7 RE-ALIGNMENT OF WASHING MACHINE
5.7.1 STEP 1
5.7.1.1 Bring the belt to stationary lock position by rotating index box, by hand driven extended shaft of gear box.
5.7.2 STEP 2
5.7.2.1 Loosen the grip of coupler of drive shaft and move the Vial holder. Conveyor by hand so that the spray nozzle comes to the centre of the holders. This assures the centering of nozzles in all the vials and after rechecking once again tighten the coupler drive shaft.
5.7.3 STEP 3
5.7.2.2 Settings of overturning drum loosen the coupler sprocket of drum shaft. Set the position of drum in such a way that vials slides easily on the guide so that it takes easy entry to the Vial holder. For this you might have to disturb the position of slide also, then on satisfaction tighten up the coupler of driven shaft
5.7.3 STEP 4
5.7.2.3 Vials rectify support : Set the lock nut position one the shaft in such a way that when it is at the top position the container must be in perfectly vertical and then set it on the horizontal position
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