In this post Standard Operating Procedure of Cleaning and Operation of Checkweigher cum Metal Detector in Pharmaceuticals is describe.
1.0 OBJECTIVE:
1.1 To lay down a procedure for cleaning and operation of Checkweigher cum metal detector.
2.0 SCOPE:
2.1 This procedure is applicable for cleaning and operation of Checkweigher cum Metal Detector in production department.
3.0 RESPONSIBILITY:
3.1 TA and TTA : Cleaning and operation.
3.2 Officer, Executive-Production : Supervision.
3.2 IPQA : Verification and implementation of SOP.
3.4 Manager-Production : SOP compliance.
4.0 DEFINITION (S):
4.1 NA
5.0 PROCEDURE:
5.1 CLEANING:
5.1.1 Ensure that all the materials of previous batch are removed from the packing cubicle.
5.1.2 Remove “EQUIPMENT STATUS “ label and affix “TO BE CLEANED’’ label on
the machine with date and sign of the production officer.
5.1.3 Switch ‘‘OFF’’ the all-utility supply before cleaning.
5.1.4 Clean the control panel with clean and dry lint free cloth.
5.1.5 Clean the top and outer surface of machine with the dry lint free cloth.
5.1.6 Clean inside surface of metal detector and Checkweigher, conveyer belts and its assembly, by dry lint free cloth.
5.1.7 Clean the rejection tray with dry lint free cloth.
5.1.8 Replace “TO BE CLEANED” label and affix “CLEANED” label on the machine with date and sign of the production officer.
5.1.9 Record the cleaning activity in equipment usage log as per SOP “Making entries in equipment usage and cleaning log sheet.”
5.1.10 Clean the surrounding area as per SOP “Cleaning of production area”.
5.2 Metal Detector Setting Procedure:
5.2.1 Turn “ON” the ON/OFF knob of Checkweigher, metal detector will turn ‘‘ON’’ and opening screen will displayed on the screen.
5.2.2 Start conveyor belt by pressing conveyer start button.
5.2.3 Press ‘‘SET UP’’ on the control panel. Red color ‘‘LED’’ light will glow.
5.2.4 Enter the password by pressing ‘‘UP/DOWN’’ arrow key on the control panel. For confirmation press ‘‘ENTER’’.
5.2.5 Press ‘‘RHS’’ arrow and ‘‘DEFECT THR’’ option will be opened and press ‘‘ENTER’’ key then set minimum possible threshold of machine which is 50.
5.2.6 Pass the five containers contain product separately from metal detector.
5.2.7 Record the Smax value each times in respective BPR.
5.2.8 Press ‘‘RHS’’ arrow key. Product phase degree screen will open. Press ‘‘ENTER’’ key. urser will appear. Set the product phase degree by trial and error method such that the product signal value should be minimum and signal value with bids should be maximum. Press ‘‘DISPLAY’’ key.
5.2.9 Pass bottle contain product with Ferrous bids 1.0 mm disc, record Smax value
5.2.10 Pass product with Non Ferrous bids 1.5 mm disc, record Smax value.
5.2.11 Pass product with SS bids 2.0 mm disc,record Smax value.
5.2.12 Set the threshold value in between the maximum Smax value of product and minimum Smax value of bids.
5.2.13 Press ‘‘SET UP’’ on the control panel. Red color ‘‘LED’’ light will glow.
5.2.14 Enter the password by pressing ‘‘UP/DOWN’’ arrow key on the control panel. For confirmation press ‘‘ENTER’’.
5.2.15 Press ‘‘RHS’’ arrow. Edit product screen will open. Press ‘‘ENTER’’. Edit product name, edit the product name by pressing ‘‘UP/DOWN’’ arrow key.
5.2.16 Press ‘‘RHS’’ arrow. Edit batch number screen will open. Press ‘‘ENTER’’. Edit batch number, edit the batch number by pressing ‘‘UP/DOWN’’ arrow key.
5.2.17 Press ‘‘RHS’’ arrow key. Operator delay screen will open. Load the operator delay by pressing ‘‘UP/DOWN’’ arrow key.
5.2.18 Press ‘‘RHS’’ arrow key. Hold delay screen will open. Load the hold delay by pressing ‘‘UP/DOWN’’ arrow key.
5.2.19 Press ‘‘RHS’’ arrow key. Product limit screen will open. Load the product limit signal by pressing ‘‘UP/DOWN’’ arrow key.
5.3 Check Weigher Setting
5.3.1 Open the compressed air valve and ensure that the compressed air pressure should not be less than 5 Kg/cm².
5.3.2 Switch “ON” the control panel of checkweigher and wait till it shows product detail screen will appear.
5.3.3 Press “setup 1” to show the display menu.
5.3.4 Press ‘‘SETUP 1’’ Key on the operating panel, display will show. SELECT PRODUCT VIEW/EDIT PRODUCT DATA DYNAMIC COMPENSATION CALIBRATION
5.3.5 To set the new product bring the cursor to view/edit product data, with the help of arrow
key.Press ‘‘ENTER’’.Display will shows:
PRODUCT NAME #
BATCH NO. #
TARGET WEIGHT #
PRODUCT LENGTH #
UPPER LIMIT #
LOWER LIMIT #
SPEED #
OPERATE DELAY (MD) #
OPERATE DELAY (CW) #
5.3.6 Bring the cursor to “PRODUCT NAME” and press enter key,display will show “ENTER PASSWORD”. Feed the password and press, “ENTER”.Feed the required Product name by using the arrow keys.
5.3.7 Bring the cursor to “BATCH NO” and press enter key. Feed the required batch no. by using the numeric keys and arrow keys foe enter of alphabets.
5.3.8 Bring the cursor to “TARGET WEIGHT” and press enter key. Take the average gross weight of the 20 good filled Containers and feed the value by using numeric key and press “Enter”.
5.3.9 Bring the cursor to ‘‘PRODUCT LENGTH’’ and press enter key. Feed the diameter of Containers by using the numeric key.
5.3.10 Bring the cursor to “UPPER LIMIT’’ and press ‘‘ENTER’’ key then feed the required value by the numeric key.(Upper limit is the maximum allowable weight from ‘‘TARGET WEIGHT’’ and is TARGET WEIGHT +1 g.
5.3.11 Bring the cursor to “LOWER LIMIT’’ and press enter key. Feed the required value by using the numeric keys.(Lower limit is the minimum allowable weight from ‘‘TARGET WEIGHT’’ and is TARGET WEIGHT -1g.
5.3.12 Bring the cursor to “SPEED’’ and press enter key. Feed the required speed by using the numeric keys.
5.3.13 Bring the cursor to “MD DELAY” and press enter key. Feed the required value by using the numeric keys. ‘‘MD delay’’ is the delay for reject mechanism to be activated after the object leaves the weighing conveyer.Feed trhe MD delay in milliseconds by pressing numeric key and pressure key. Higher the speed Lower the ‘‘MD delay’’.
5.3.14 Bring the cursor to “CW DELAY’’ and press enter key. Feed the required value by using the numeric keys. It is delay for reject mechanism to remain in “ON’’ condition.
5.3.15 Press “ SET UP 1” key for display.
5.3.16 Bring the cursor to “DYNAMIC COMPENSATION” and press enter key. It becomes “ON” .Dynamic compensation is used to compensate the weight difference of the pack when it is in motion and in static condition.
5.3.17 Bring the cursor to “NEW DYNAMIC COMPENSATION” and press enter key. Pass the earlier Containers 20 times. The conveyor will stop automatically after 20ᵗʰ time and display will shows
the compensation checkweigher is ready with dynamic compensation.
5.3.18 Bring the cursor to “SET ZERO” and press enter key. After delay it will show 0000.0 g.
5.3.19 Now machine is ready for operation.
NOTE: Dynamic compensation depends on speed of the conveyor target weight and product length so if either of these are changed or in case of power failure dynamic compensation has to be done again.
5.4 OPERATION:
5.4.1 Remove the “CLEANED” status label and affix “EQUIPMENT STATUS’’ label on the machine.
5.4.2 Press “SETUP 1” key.
5.4.3 Bring the cursor to “SELECT PRODUCT’’ and press enter key. Bring the cursor to the product, which is to be weighed and press enter key.
5.4.4 Press “WEIGHT DISPLAY” key 0000.0 g appears on screen, then press “SET ZERO”.
5.4.5 Before starting the operation ensure that the Containers taken for the setting are removed from the line.
5.4.6 Press the “CONVEYOR START” key to start the conveyor.
5.4.7 Start passing the Containers on the checkweigher.
5.4.8 Ensure that the tower lamp indications and its rejection mechanism is functioning by passing the Containers with less weight and higher weight as per the frequency given in the BPR.
5.4.9 Tower lamp in case of correct fill value glows green lamp.
5.4.10 At the end of activity, press “CONVEYOR STOP” to stop the conveyor. Switch “OFF” the mains of the checkweigher and close the compressed air valve.
5.4.11 Wait till the white line on the screen disappears to restart the checkweigher.
9.1 Master Copy: Quality Assurance
9.2 Controlled copy (S) : Production department (01),QA department (01)
9.3 Reference copy (S) : Production department (01)
10.0 REVISION HISTORY:
ANNEXURE I
CHECKWEIGHER DAILY VERIFICATION