B-606

Viking Masek ST560 8 Lane Stick Packing Machine

Section B — Manufacturing 5 pages

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1.0 Purpose

This procedure defines the process for the setup, operation, and cleaning of the Viking Masek
ST560 8 Lane Stick Packaging machine, associated Intech INT698-IML1-70 check weigher,
and Whisper Loader vacuum conveying system.

2.0 Scope

This procedure applies specifically to the Viking Masek ST560 8 Lane Stick Packaging
Machine and associated support equipment in operation at Ion Labs.

3.0 Responsibility

3.1 It is the responsibility of Production personnel to follow the operation and cleaning
sections of this procedure.

3.2 It is the responsibility of Maintenance personnel to follow the preparation, assembly,
and setup sections of this procedure. Maintenance personnel is also responsible for
maintaining the equipment in accordance with either manufacture recommended

maintenance schedules or maintenance schedules derived from actual operational
requirements.

3.3. ‘It is the responsibility of Production supervisors to implement this procedure, to ensure
that this procedure is being followed, and to ensure that production personnel are
adequately trained in the operation of the equipment.

3.4 It is the responsibility of QC personnel to ensure that this procedure is being followed.

4.0 Definitions

4.1 Auger — rod with helical flutes which moves and meters the product

4.2 Forming Tube — wraps cut foil to create a stick-shape and conveys the product to the
formed stick with the auger

4.3. QC- Quality Control

[SOP B-606 | Page 2 of 5]

Standard OpeOrpeartatiinng g P Procedure SOP No Rev Page2 of5

Viking Masek ST560 8 Lane Stick Packaging Machine eee 0

5.0 References

5.1 A-108, SOP, Good Manufacturing Practices and Personal Hygiene

5.2 B-103, SOP, Small parts Cleaning and General Sanitization

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

5.4 G-104, SOP, Lockout/Tagout Procedure

5.5 G-105, SOP, Lockout/Tagout Devices

6.0 Procedure

6.1 Machine Preparation and Assembly

Note: Machine setup and assembly shall only be executed by a qualified
mechanic in the maintenance department

6.1.1 It should be noted that the machine is set for 30mm foil width and set up

instructions for width adjustment, such as slitter setup, may be ignored. Foil
width adjustment may only be conducted by adequately trained personnel and
preferentially foil width should be fixed to an individual piece of equipment.

6.1.2 Always ensure the machine is locked out before assembly begins. The
machine’s primary electrical lockout point is the Eaton service disconnect on the

back of the equipment. The machine’s primary pneumatic lockout may be
achieved by disconnecting all pressurized air service lines.

Note: This piece of equipment utilizes heat blocks which may remain at high
temperature after the equipment is de-energized. Always allow
adequate time for the heat blocks to cool before working on the

equipment after the machine has been in operation

6.1.3 Ensure the forming tubes, augers, hopper agitators, and Whisper Loader
pneumatic conveyor are set up in accordance with the manual(s) provided with
the Viking Masek Machine Manual.

6.1.4 Mount the foil roll on the foil spindle and thread according to the provided
threading diagram. Ensure the film is passing through the tracking sensor and

the wenglor sensor is properly set up to see the “tick marks” on the foil.

[SOP B-606 | Page 3 of 5]

Standard Operating Procedure SOP No | Rev
Viking Masek ST560 8 Lane Stick Packaging Machine let Y nage2.ol»

Note: There are two extraneous foil rollers (18 and 19) which are not utilized

in the threading diagram. These rollers may be utilized if the specific
foil’s physical properties necessitate it.

6.1.5 Make initial machine adjustments for the length of stick, cutting wheels, and
knife assembly. A counter wheel for length adjustment is present. If the intended

stick length has previously been run it should have been recorded and that
record may be referenced for initial setup. Further details on machine
adjustments are available in the operation manual provided by Viking. Note that
the use of a photo eye with “tick marks” requires the jaws be set 5-8mm longer
than the length of the stick pack.

6.1.6 Connect the cleated side-discharge conveyor, check weigher HMI/Logic Control
Module, and Check weigher.

6.1.7 Set and assemble the Whisper Loader vacuum conveyor atop the hopper as
described in the instruction manual.

6.2 Machine Startup and Operation

6.2.1 Energize the equipment by throwing the power disconnect on the back of the

equipment, connecting all pneumatic lines, and rotating the main powder switch
to the “ON” position.

Note: The emergency stop of the cleated side discharge conveyor requires a
key to unlock.

6.3 Cleaning

6.3.1 Minor Cleaning

6.3.1.1 Cycle the machine until no product remains in either the hopper or
forming tubes. Empty stick packs may be generated.

6.3.1.2 De-energize the equipment by rotating the main powder switch to
“OFF”, throwing the disconnect on the back of the equipment, and
disconnecting any pneumatic lines.

6.3.1.3 Allow sufficient time for the equipment’s heating elements to cool.

Note: The heating elements are a point of hazardous stored energy.

6.3.1.4 Remove all product and paperwork from the previous batch.

[SOP B-606 | Page 4 of 5]

Standard Operating Procedure SOP No | Rev
Viking Masek ST560 8 Lane Stick Packaging Machine #OU0 0 Page 4 of 5

6.5:1.5 Vacuum residual product from accessible product contact surfaces of

the equipment.

6.3.2 Major Cleaning

6.352.) Cycle the machine until no product remains in either the hopper or
forming tubes. Empty stick packs may be generated.

6.3.2.2 De-energize the machine per 6.3.1.1 and 6.3.1.2. Refer to and follow

SOP G-104 Lockout/Tagout Procedure and SOP G-105
Lockout/Tagout Devices.

6.3.2.3 Dismount and disassemble the Whisper Loader vacuum conveyor and
carefully place the parts, including the transport hose, on a provided

transport cart.

6.3.2.4 Disassemble product augers and forming tubes. CAREFULLY place
equipment pieces on provided “Crash Cart”. Damage to the augers and
filling tubes may render the machine inoperable.

6.3.2.5 Disassemble the hopper, agitators, etc. and place the parts on a
provided transport cart.

6.3.2.6 Remove the film from the equipment and stage for return to the label
control area.

6.3.2.7 Transport parts from 6.3.2.3, 6.3.2.4, and 6.3.2.5 to the small parts
cleaning area. Follow SOP B-103 Small Parts Cleaning and General
Sanitation.

6.3.2.8 Vacuum any incidental powder from the surfaces of the machine.

6.3.2.9 Damp-cloth wipe-down is allowed, if necessary. If damp-cloth wipe
down is necessary the electrical and communication connections for
the cleated side discharge conveyor, check weigher control module,
and check weigher must be unplugged, carefully cleaned, wrapped
with an water resistant barrier, and the female connection ports closed

and latch to prevent ingress of moisture.

Note: The HMI Touch-Screen may only be wiped down with a
damp cloth. Avoid the use of detergents and sanitizers.

6.3.2.10 Wipe the equipment down with IPA.

[SOP B-606 | Page 5 of 5]

Standard Operating Procedure SOP No | Rev Pacaape
Viking Masek ST560 8 Lane Stick Packaging Machine | 36% : :

Note: Do not wipe the touch screens with IPA.

6.3.2.11 Document cleaning in the cleaning logbook.

6.3.2.12 Contact QC inspector to verify equipment cleanliness and to check the
cleaning logbook.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 11/22/21 | New procedure. N/A C. Fryman | - | - |