1.0 OBJECTIVE
To lay down the procedure for operation of EPD Collator coupled with strip packing machine.2.0 SCOPE
This SOP shall be applicable for operation of EPD Collator coupled with strip packing machine in Packing department used for tablets/Capsule packing.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 PROCEDURE
5.1 Machine Start-Up Procedure
5.1.1 Turn on 3 phase power supply.5.1.2 Turn on compressed air and see that pressure is not less than 4kg/cm2.
5.1.3 Clean strip chutes with thinner.
5.1.4 Clean Scanning Head.
5.1.5 Turn on the power to the panel through the MCB.
5.1.6 Ensure that the cooling fan in the panel is on.
5.1.7 Ensure that the display NFD is not blinking, i.e. there is no fault. If there is a fault, check it and clear it.
5.1.8 Ensure that the empty pocket detection and rejection facility is ON. LED 11R should be ON. (This should be ensured daily / after every power failure and this check should be recorded as part of ref Annexure (II). If LED 11R is not ON then press key 15 and key 1 together, to turn it ON.
5.1.9 Ensure that all the facilities are not bypassed, LED 14R should be OFF. (This should be ensured daily / after every power failure and this check should be recorded as part of, ref Annexure II). If LED 14R is not OFF, press key15 and 4 together.
5.1.10 Mount chute and connect the transmitters and receivers of the scanning head.
5.1.11 Check all the parameters according to the product table and keep a record.
5.1.12 By inching the strip-packing machine confirm that Tablet Release and Strip Cut signals are coming properly.
5.1.13 Turn on the vibrator and allow the tablets/caps to fill the chute.
5.1.14 When the rejection flaps reset for the first time, see that no strip is getting caught.
5.1.15 Ensure that separation of strips and flow into the collation box is smooth.
5.1.16 Check the proper functioning of the scanner by removing one tablet/caps. in each track , this check should be recorded as part of ref. Annexure(II)
5.1.17 Check the rejection of the first tablet missing and last tablet missing in any strip. Both conditions should be checked to verify the correctness of the parameters. This check should be recorded as part of ref Annexure (II).
5.1.18 If for some reason a strip jams either in the strip chute or the dispenser, then remove the corresponding bunch from the conveyor since its count will be disturbed.
5.1.19 Before starting the operation production person get line clearance from Q.A. person and affix a status label with Product Name, Batch details to Equipment and Area.
5.2 Machine Stopping Procedure
5.2.1 Stop the strip packing machine after all the tablets/caps. In the chute have been packed. Disconnect the transmitters and receivers of the scanning head and remove the chute.5.2.2 After the strip-packing machine is stopped, press key 15, key 16 and key 8 together. The conveyor will index once.
5.2.3 Now inch the strip-packing machine till next Strip Cut signal comes from the clock disc.
5.2.4 All the strips in the collation boxes will fall on the conveyor and the conveyor will index once more, remove this entire bunch.
5.2.5 Press key 15 + key 13, and keep them pressed for 3 to 4 seconds till LED 16R starts glowing. The conveyor will index 10 times, i.e. all the collated bunches will be transferred to the packers.
5.2.6 When the conveyor stops indexing i.e. when LED 16R goes off, switch off the power to the panel.
5.2.7 Close air valve. Do not shut off the air before switching the power to the panel.
5.2.8 Turn of 3 phase power supply.
5.2.9 Clean strip chutes and tablet chute.
5.2.10 Clean the control panel by compressed air.
NOTE : In Case of Sudden Power Failure:
- All the checks to be performed as per annexure.
- Remove the entire bunch from first 3 indexes coming out of the collation module, since the count can vary.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 BPR: Batch Packing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
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