B-610

Inline Labeler

Section B — Manufacturing Revision 5 5 pages

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1.0 Purpose

The purpose of this procedure is to define the process for the setup, operation and cleaning of

an inline labeler.

2.0 Scope

This procedure applies to all inline labelers in operation at Ion Labs, Inc.

3.0 Responsibility

3.1 It is the responsibility of Production (Packaging) Personnel to follow this procedure.

3.2 It is the responsibility of the Department Supervisor/Manager to implement this
procedure and to ensure that the procedure is being followed.

3.3. It is the responsibility of Production and/or Maintenance & Engineering to keep this
procedure aligned with current practices.

4.0 Definitions

None

5.0 References

oe | B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment

6.0 Procedure

6.1 Setup and Operation

[SOP

Standard Operating Procedure SOP No | Rev
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Inline Labeler

6.1.1 Ensure that the unit is plugged into a power source and a compressed air source.

6.1.2 Ensure the labeler is clean and cleared of all previously used materials.

6.1.3 Obtain the approved labels that have been issued to the Batch Record.

6.1.4 Determine if Label Applicator components need to be changed, based on the

bottle to be labeled.

6.1.5 Retrieve components from Tooling

6.1.6 Install Label Applicator components

6.1.7 Thread the approved label from the Infeed Reel Assembly, through the
Labelling Heads, ending at the Waste Rewind Assembly.

6.1.8 Determine the correct height for the bottle to be labeled. Place the bottle on the
conveyor next to the applicator and adjust the height to the correct level for

consistent application.

6.1.9 Determine the correct adjustment of the gap sensor to achieve proper gap length.

61-10 Determine the correct adjustment of the label sensor to achieve proper flag
length.

(o Palbea Determine the correct adjustment to the speed the labeler applies a label to the

bottle.

6.1.12 Send a bottle down the conveyor, through the labeler to be labeled

6.1.13 If the labels stop or become jammed, press or turn the unit off and reset all of
the controls.

6.1.14 Determine the correct adjustment of the product sensor in order to match the
current production rate.

[SOP

Standard Operating Procedure SOP No Rev
Inline Labeler B-610 Page 3 of 5

6.1.15 Continue to send bottles through the labeler and make adjustments as needed to
ensure setup is completely accurate. The following adjustments will apply after

theoretical setup is complete:

6.1.15.1 Cap width compliance

6.1.15.2 Bottle width compliance

6.1.15.3 Label height compliance

6.1.15.4 Application speed

6.1.15.5 Conveyor speed

6.1.15.6 Gap sensor

6.1.15.7 Label sensor

6.1.15.8 Product sensor

6.1.15.9 Label sensor

6.1.15.10 Product Spacing

6.1.16 The machine must be observed during the entire packaging run for the

following:

6.1.16.1 Backing is being rewound by the Waste Rewind Assembly.

6.1.16.2 Bottles are feeding consistently into the Labeler.

6.1.16.3 Labels are consistently being released from the backing without
snatching.

6.1.16.4 Height of the label on the bottle is consistent.

6.1.16.5 Proper and consistent application of label to bottle.

[SOP

Standard Operating Procedure SOP No | Rev
Inline Labeler B-610 5 Page 4 of 5

6.1.17 Complete the following steps once the labeler is running:

6.1.17.1 Adjust the conveyor rails to feed the bottles directly into labeler.

6.1.17.2 Adjust the product spacer to feed the bottles properly to labeler,
without bottle tips, over-pushing, or overloading the labeler.

6.2 Setup Applicable Accessories: Hot Stamp

6.2.1 Ensure that the unit is plugged into a power source and a compressed air source.

6.2.2 Obtain the approved labels that have been issued to the Batch Record.

6.2.3 Ensure that the “hot stamp” section of the automatic labeler is cool and has not
been “on”’.

6.2.4 Hand thread the roll of labels from the spindle through the hot stamp section to
apply the batch number and shelf life.

6.2.5 Load the hot stamp roller section with a fresh ink roll if needed.

6.2.6 Verify that the batch number and shelf life has been changed to match the Batch

Record.

6.2.7 Turn on the main power and ensure that the run status light is on.

6.2.8 Jog the label forward through the hot stamp station after the stamp unit has
heated. Adjust the stamp head left or right until the batch number and expiration

date is located in the correct place on the label.

6.2.9 Move the label web from the stamp unit into the applier section, removing a few

labels to allow the web to be empty as it is positioned and locked into the take-

up spool.

6.2.10 Adjust the rails on the conveyor to fit the bottles that will move to the labeler.

[SOP

Standard Operating Procedure SOP No Rev
Inline Labeler B-610 Page 5 of 5

6.3 Setup Applicable Accessories: QR code printer

6.3.1 Power on the Video-Jet QR code printer

6.3.2 Retrieve USB and upload the correct QR code

6.3.3 Eject the front cover and ensure the black ribbon is correctly fed and sits straight

across the rolls, install the front cover back on the equipment.

6.3.4 Put the Video-Jet into print mode and line up the QR code to print in space
provided. (see batch for details)

6.3.5 Once QR code prints correctly in the area provided, scan the code to ensure it is
correct.

6.4 Cleaning

6.4.1 This type of equipment does not require any disassembly prior to cleaning.

6.4.2 Refer to SOP B-111 Cleaning of Manufacturing/Production Areas and
Equipment to follow the cleaning procedure applicable to this type of

equipment.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/27/10 | New : - 05/13/13. Updated SOP format 13-275 B. Mosall | - | - |
| 2 | 01/27/16 | Biennial Review: Changed the SOP format. Scheduled review: Removed obsolete definitions. Added reference ; : Wioeed to SOP B-111. Revised section 6.3. Benoit Reet | 15-0939 | P. Zittere |
| 4 | 04/18/22 | Scheduled review: Updated logo. Revised cleaning section. CC- Updated to include all In-Line Labelers. Updated logo and format. > ioe Updated responsibilities. Changed title. cola lalina ee | 22-0192 | K. Burris |