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.
Head – Production for overall compliance with this SOP
Officer- Production for implementation tp this SOP
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.
5.2.1 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 1 m of label strip and detach the label from 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 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 to read in the sensor slot using a reference mark on the tip for alignment.
5.2.12 Speed of the wrap-around conveyor is synchronized with product conveyor. A bottle should be rotated at least 2.5 to 3 times between the wrap-around belt and opposite stationary guide with required pressure.
5.2.13 Set the label length, and it shall be 10 mm more than the actual length of the label.
5.2.14 Set the predisposing of the label, and it should be 10 to 15 mm.
5.2.15 Set the labels’ speed online by moving the knob clockwise and anticlockwise to increase and decrease the speed.
5.2.16 Run the machine continuously for labeling 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.
SOP: Standard Operating Procedure
QA: Quality Assurance
BMR: Batch manufacturing record
Carrier Strip: release paper for a sticker.