Learn About Step by Steps Standard Operating Procedures for Vials Labeling Machines along with their Objective, Scope, Precaution, and Procedure.
1.0 OBJECTIVE: To lay down the procedure for operating of vials labeling machine.
2.0 SCOPE: This SOP is applicable in the Department of Production for the Injection Section.
3.0 RESPONSIBILITIES:
Head – Production for overall compliance with this SOP
Officer- Production for implementation tp this SOP
4.0 DISTRIBUTION:
Master Copy: Quality Assurance Department
Control Copy: Production Department
Display Copy: Production Department
5.1 PRECAUTION :
5.1.1 Ensure the line clearance of the machine is ok.
5.1.2 Do not touch the machine parts while running.
5.2 PROCEDURE:
5.2.1 Check the “CLEANED” label and ensure the cleanliness of the machine and its area.
5.2.2 Affix the batch in process label duly filled and signed on the machine.
5.2.3 Remove the upper plate of the midi unwinder by pressing the knob. Place the label reel on the dancing roll and fix the upper plate by pressing the knob.
5.2.4 Pull forward 1m of label strip and detach the label from the carrier strip.
5.2.5 Turn the knob to open the counter-pressure roller, fold down the carrier strip over the dispensing edge, and close the counter pressure.
5.2.6 Synchronize the height of the midi unwinder by turning the splendor shaft clockwise and anticlockwise with the height of the containers/bottles.
5.2.7 Bring the vials trays lot-wise near the machine.
5.2.8 Switch on the electric supply.
5.2.9 Load the vials on the turntable. Set the width of the conveyor guide, according to the size of the vials, either in forwarding or backward position with the help of a knob.
5.2.10 Set the proper distance between two containers By increasing or decreasing the speed of the space creator with the help of the spend controller, which is near the pace creator.
5.2.11 Place the label in the sensor slot using a reference mark on the tip for alignment.
5.2.12 The speed of the wrap-around conveyor synchronizes with the product conveyor. Rotate a bottle at least 2.5 to 3 times between the wrap-around belt and the opposite stationary guide with the required pressure.
5.2.13 Set the label length to be 10 mm longer than the actual label length.
5.2.14 Adjust the pre-disposition of the label to be 10 to 15 mm.
5.2.15 Adjust the speed of the ‘labels’ online by turning the knob clockwise and anticlockwise to increase or decrease the speed.
5.2.16 Run the machine continuously to label vials.
5.2.17 switch off the machine after labeling.
5.2.18 Record all observations in the Equipment Log Book.
5.2.19 Affix to be cleaned label on the machine.
Related: cleaning and operation of vials washing machine
6.0 ABBRIVIATIONS/DEFINITIONS:
SOP: Standard Operating Procedure
QA: Quality Assurance
BMR: Batch manufacturing record
Carrier Strip: release paper for a sticker.
M: Meter
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