B-636

Side Seal Shrink Wrapper

Section B — Manufacturing Revision 2 5 pages

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1.0 Purpose

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

intermittent motion side seal shrink wrapper (Conflex; Fusion) equipment.

2.0 Scope

This procedure applies to the intermittent motion side seal shrink wrapper (Conflex; Fusion)

equipment 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 followed.

3.3 It is the responsibility of Maintenance and Production Management to keep this
procedure current.

4.0 Definitions

4.1 IPA — 70% Isopropyl Alcohol

5.0 References

5.1 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 aes
Side Seal Shrink Wrapper B-636 2 ager oho

6.1.1 Ensure that air setup parameters are all within approximate operating range
(these values are nominal, minor adjustment may be necessary).

6.1.2 Set air pressure to 70-80psi. The main air regulator is located behind the
machine next to the film unwind strand.

The cross end should be set for 30-40psi.

Turn the power to the “ON” position.

Note: When the main power is turned on or when a safety cover is opened, the

‘Safety Mode” screen is displayed.

6.1.5 Press the “Fault Reset” button to exit safety mode.

6.1.6 When first powering up the machine after the safety mode reset is executed, the
“Welcome” screen will appear. Press the “Home” icon to exit.

Verify and enter the recipe by first observing the recipe number displayed.

6.1.8 Push the “I” icon then push the arrow icon next to “Load Recipe”.

6.1.9 Observe the number next to the desired recipe.

6.1.9.1 Ifthe desired recipe is loaded, press the “Home” icon to exit and return

to the main screen.

6.1.9.2 Ifa different recipe is desired, enter the name of the recipe, verify that

the number is displayed in the box to the left of the display screen, and

press the “Folder” icon.

6.1.10 After the recipe has loaded, a “Load Complete” message is displayed. Press the

screen indicating “Press Here to Continue”.

6.1.11 Press the “Home” icon and return to the main screen.

6.1.12 The top of the display screen will report which component temperature setting is
out of range until all components have reached their set points.

[SOP

Standard Operating Procedure SOP No | Rev
B-636 2 Page 3 of 5
Side Seal Shrink Wrapper

6.1.13 When all component temperatures have met their set points, the top of the
display screen will report that the machine is ready. The machine will not

operate until this message appears.

6.1.14 Before starting the job, confirm that the side rails are adequately adjusted by

first ensuring that the tray is all the way back against the frame rail.

6.1.15 Ensure that the gap between the tray and the guide rail is approximately 3 inches
or three fingers in width.

Note: If adjustment is needed, turn the “Infeed Conveyor Adjust” wheel
clockwise to increase the gap and counterclockwise to decrease the

gap.

6.1.16 There are three red dots visible on the display screen. Touch the one over the

infeed conveyor belt to put the machine into “Auto Mode”. The red dot will turn

green.

Note: Remove the empty bag that is in the wrapping area as soon as the first

tray enters to be wrapped. This is extremely important. If not removed,
the bag will enter the heat tunnel and melt onto the conveyor.

6.1.17 The first tray will now be staged in the wrapping area and the machine is ready
for production.

Note: There will always be one tray left in the wrapping area when feeding
stops.

6.1.18 When tray feeding stops and the last staged tray needs to be removed, press the
red dot over the exit conveyor to manually activate the conveyor.

6.1.19 To shut down the machine, turn off the main power.

6.2 Film Installation and Adjustments

[SOP

Standard Operating Procedure SOP No | _ Rev
Side Seal Shrink Wrapper B-636 2 Page 4 of 5

6.2.1 Follow the diagram on the side of the machine when threading a new roll of
shrink wrap.

6.2.2 The film inverters can be swiveled for the ease of the film threading.

6.2.2.1 Loosen the lockdown knob, then pull the adjustment hand wheel out

and swivel the inverters. This is also an easy way to clean the lower

inverter.

6.2.3. Load the roll of shrink wrap. Ensure that the end stop bars are centered on the

cardboard spool and not touching the film.

Note: Each time a film roll is changed, wipe off the drive roller with a lint-free

towel dampened with IPA and a clean scrubbing pad.

6.2.4 Pull out approximately 3-4 feet of film. This will help if the film is under the top

film inverter.

6.2.5 Wrap the bottom layer only around the corner of the conveyor.

6.2.6 Pull the edges of the bottom layer back and forth to thread the bottom inverter.

6.2.7 Place the top layer of film over the corner of the top converter.

6.2.8 Ensure that the film is threaded between the top inverter and the guide bar, not
under the guide bar.

6.2.9 Grab both to top and bottom layer of film and pull towards the exit end of the

machine.

6.3 Cleaning

6.3.1 Refer to SOP B-111 Cleaning of Manufacturing/Production Areas and

Equipment to follow the cleaning procedure applicable to this type of

equipment.

[SOP

Standard Operating Procedure SOP No | Rev picesiats
Sie de Seal Shrie nk Wrapper B—3 6 0

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 09/17/15 | New ' 01/08/19 Scheduled review: removed obsolete references and definitions. 19-0025 K. Burris Revised section 6.3. | 15-0564 | P. Zittere |
| 7 | 04/06/22 | Schedule review: changed logo. Updated responsibilities. Updated CC- cleaning. | 22-0163 | K. Burris |