B-207

NP-250 Rotary Tablet Press

Section B — Manufacturing Revision 4 10 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 -
the NP-250 Rotary Tablet Press.
2.0 Scope
This procedure applies to all NP-250 Rotary Tablet Presses in operation at Ion Labs, Inc.
3.0 Responsibility
3.1 It is the responsibility of Production (Compression) personnel to follow this procedure.
3.2. It is the responsibility of the department supervisor/manager to implement this
procedure and to ensure that this procedure is being followed.
4.0 Definitions
4.] QC — Quality Control
4.2 IPA -70% Isopropyl Alcohol

4.3 Alconox — A powdered precision concentrated cleaning anionic detergent

5.0 References

5.1 Tablet Press Owner’s Manual

5.2 _B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment

5.3 B-103, SOP, Small Parts Cleaning and General Sanitation

[SOP

Standard Operating Procedure SOP No | Rev
B-207 4 Page 2 of 10
NP-250 Rotary Tablet Press

6.0 Procedure

6.1 General Operations Break Down

6.1.1 Tools needed

6.1.1.1 Forked Punch Removal Tool

6.1.1.2 Plastic Tipped Steel Rod

6.1.1.3. T-Handled Allen Wrench or Standard Allen Wrench

6.1.1.4 7/16" Wrench

6.1.1.5 Flat Head Screw Driver

6.1.1.6 Short Shank 90° Allen Key 5/16" for the Upper Punch Take-out Plate

6.2 Operating Steps:

6.2.1 Turn Press off and lock out and tag out (LOTO) power.

6.2.2 Remove Dust Collector Hose from Dust Collector Nozzle & move Dust
Collector with Press Cart for cleaning.

6.2.3 Remove Hopper and place into Press Cart.

6.2.4 Remove Feed Frame with Hand Crank and place into Press Cart — check lower

section of Feed Frame for wear. Report any wear including pits or metal
scrapings or any distinguishable marking on Feed Frame or Turret Head to

immediate Supervisor.

6.2.5 Open Lower Swing Arm by loosening Hand Crank.

6.2.6 Remove Upper Punch Take-out Plate by loosening bolt and tapping free with
plastic end of Plastic Tipped Steel Rod. Once free, remove bolt and pry out

plate. Place plate and bolt inserted onto Press Cart.

[SOP

Standard Operating Procedure SOP No | Rev
NP-250 Rotary Tablet Press B-207 | 4 Page 3 of 10

Note: Be careful while handling and removing punches and dies. They can be
damaged if dropped or handled incorrectly.

6.2.7 Remove upper punches lined up with the take out plate section individually and
place on press cart for cleaning (Punch fork removal tool).

6.2.7.1 ROUND PUNCHES — Move to next step.

6.2.7.2 SHAPED PUNCHES — Remove the Phenolic Lower Punch Retainer

Pins from spring slots and place onto Cart for cleaning and storage.

6.2.8 Remove Lower Punch Drop Out Plug - BE CAREFUL while removing so the
Punch in the first location does not fall onto ground and get damaged.

6.2.9 CAREFULLY rotate head with counter balance and remove each Lower Punch
individually (Punch Removal Forked Tool) - may need assistance.

6.2.10 Place dirty lower Punches in Press Cart for cleaning.

6.2.11 Loosen Die Locking Screws individually by rotating press with counter balance

(T Handled Allen Wrench).

6.2.12 Remove dies for die seats individually by inserting Plastic Tipped Steel Rod up

through Lower Punch Drop-out Plug and place Dies & Die Lock Screws into

Press Cart with Punches for cleaning (Plastic Tipped Rod).

6.2.13 Move Dust Collector and Hoses, Tablet Deduster and Press Cart into

Maintenance Shop for storage during cleaning.

6.3 Cleaning

6.3.1 Refer to SOPs B-111 Cleaning of Manufacturing/Production Areas and
Equipment and SOP B-103 Small Parts Cleaning and General Sanitation for

applicable cleaning procedures for this type of equipment.

6.4 Tablet Setup & Operation

[SOP

Standard Operating Procedure SOP No Rev
B-207 Page 4 of 10
NP-250 Rotary Tablet Press

6.4.1 Setup and Operation procedure will be used for after a preventative
maintenance, cleaning or machine storage.

6.4.2. Tools needed:

6.4.2.1 90 Weight Gear Oil

6.4.2.2 Barrel Oil

6.4.2.3 H1 Food Grade Grease

6.4.2.4 Die Alignment Tool

6.4.2.5 Plastic Tipped Steel Driving Rod

6.4.2.6 Short Shank 90° Allen Key

6.4.2.7 15lbs per foot Torque Wrench

6.4.2.8 Allen Key Set

6.4.3. Setup Procedure

6.4.3.1 Tooling Lubrication:

e Barrel Oil

e A light film of H1 Food Grade Grease is recommended for the

punch heads. DO NOT use an excessive amount of grease.

e A light film of Barrel Oil (1-2 drops) should lubricate the punch

barrels beginning 1” above the punch tip and up to the punch neck.
NEVER use grease on the punch barrel.

6.4.3.2 Die Installation (Round) — Punches and Dies need to be handled with
the utmost care in order to prevent damage to finish.

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Standard Operating Procedure SOP No | Rev eS
NP-250 Rotary Tablet Press B-207 4 age 5 of 10

e Double check die pockets to be sure die pockets are clean of all
residues from previous cleaning process (Die Alignment Tool).

e Utilizing the Die Alignment Tool to keep dies straight, place each

die into pockets.

e Tap down the die until it is solidly seated into the pocket utilizing

the Plastic Tipped Steel Driving Rod. This is done by placing the
Driving Rod through the corresponding Upper Punch Guide and

tapping (Plastic Tipped Steel Driving Rod).

e Utilize the counter balance to rotate the turret and install all
punches in the same format.

e Tighten all of the die lock screw using a torque wrench provided.
Be sure the wrench is rated at 15lbs per foot of torque. DO NOT

OVER TIGHTEN, strike each die one last time and retighten the
die screws individually, using the counter balance to manually

rotate the head. DO NOT INSTALL WITHOUT LIGHT

MINERAL OIL LUBRICATION ON THREADS.

6.4.3.3 Lower Punch Installation (Round)

e Do not install punch without making sure the punches are
lubricated as the procedure stated above.

e Rotate the counter balance until each lower punch guide is aligned
with the plug and install each punch into the corresponding

location.

e When installing the last punch be sure it is pushed high enough so
the drop out plug can be reinstalled. Check to see if the plug is

seated properly before beginning operation.

e Reinstall gear guard cover (Lower Swing Arm).

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Standard Operating Procedure SOP No | Rev
NP-250 Rotary Tablet Press B-207 | 4 | Page6ofl0

6.4.3.4 Upper Punch Installation (Round)

e Do not install punch without making sure the punches are

lubricated as the procedure stated above.

e Without force, install punches through upper punch guides rotating
the head to make available each punch guide. Lower each punch

gently until it reaches the dwell cam.

e Reinstall the Upper Punch take out.

6.4.3.5 Installation of Shared Tooling — This type of tooling must be installed
in a different than round tooling. The upper punch guides of the turret

have key ways and the upper punches are keyed. This keeps the

punches and dies accurately aligned.

e Do not install punch without making sure the punches are

lubricated as the procedure stated above.

Note: If punches do not slide freely into punch guides by the force

of their own weight, examine them for nicks, burrs or dirt.
NEVER force the punches.

e In the gap left by the removal takeout plate, insert the punches

individually. As with round punches check for the free movement
of the punches.

e Place the die under the punch and insert the punch in the die.

e Lower both the punch and die in the die pocket keeping clockwise

pressure on the punch head, this is the direction of force during
normal operation (Die Alignment Tool).

e Use the punch to begin seating the die until the punch head comes
close to contacting the turret. Remove the punch and tap the die

[SOP

Standard Operating Procedure SOP No | Rev
NP-250 Rotary Tablet Press B-207 4 | Page 7 of 10

down with the plastic tipped steel driving rod until fully seated in
the die seat (Plastic Tipped Steel Driving Rod).

e Carefully lower the punch back into the die. Make sure to maintain

clockwise pressure to check for proper alignment. The punch
should enter the die without any difficulty.

e If the punch has difficulty, remove the punch and die and reinstall
with instructions above.

e After all punches and dies are installed, install the takeout plate,

making sure to line it up carefully with the cam body and tighten
the screw securely.

e After correcting the alignment, tighten but do not force the die lock
screw with the punch remaining in the die. Use the 15lbs per foot

torque wrench to tighten the die, DO NOT OVER TIGHTEN
(15lbs per foot Torque Wrench). DO NOT INSTALL WITHOUT

LIGHT MINERAL OIL LUBRICATION ON THREADS.

e Align each set the same way and tighten all die screws.

e After all lower punches are installed; return the lower dropout plug

into its proper place.

e Lower punch installations refer to the Lower Punch Installation

(Round) procedure.

e Install the lower gear guard swing arm and install the remaining

parts:

o Prepare the hopper.

6.5 Operation Sequence Procedure

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Standard Operating Procedure SOP No | Rev
NP-250 Rotary Tablet Press B-207 4 | Page 8 of 10

6.5.1 Before operating check to see if these steps have been completed:

6.5.1.1 All moving parts have been thoroughly lubricated.

6.5.1.2 Check to make sure the tonnage overload spring pressure indicating
system is on the proper setting for your tools.

6.5.1.3 All adjustments described in previous section have been made.

6.5.1.4 Hopper has been filled and flow adjusted.

6.5.1.5 The press has been turned through at least one revolution by hand
compression.

6.5.2 General Operating Factors

6.5.2.1 The quality of the punches and dies

6.5.2.2 The material being compressed

6.5.2.3 Free flowing material that does not stick to punch faces, pack in the

feed frames or bind in the dies

6.5.2.4 Tablet size & shape

6.5.2.5 Proper adjustment of fill, compression point, pressure, hopper and feed

frame

6.5.2.6 Correct operating speed

6.5.2.7 Proper Lubrication

6.5.3 Installation and Adjustments of Feed Frames

6.5.3.1 Set the feed frame on the leveling screw in its correct position.

6.5.3.2 Tighten feed frame clamp, set screws.

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Standard Operating Procedure SOP No | Rev
NP-250 Rotary Tablet Press B-207 4 | Page 9 of 10

6.5.3.3 The scraper blades are held in place by spring and should be free to
float. Be sure to check them periodically during operation.

6.5.3.4 Adjust the table take off bar so that they just clear the lower punch.
This should enable to excess granulation to enter the feed frame for use

again.

6.5.3.5 By hand, rotate the press through one cycle to ensure the punches, dies
or feed frames are not colliding with anything prior to use.

6.5.4 Hopper Setting

6.5.4.1 Install the hopper onto the hopper spindle.

6.5.4.2 Adjust the hopper spindle nuts to the correct adjustment so there is
enough granulation gravity fed to keep the feed frame filled with

powder without overflowing the feed frame.

6.5.4.3 Tighten the hand lock knob located on the hopper bracket to ensure

there is no further movement.

Note: If the feed frame is not provided with enough powder, the tablet

made will be underweight and inconsistent weight. Too much

material will cause an overflow, so watch feed frame level
during normal operation and adjust hopper as needed.

6.5.5 Lower Pressure Roller Adjustment

6.5.5.1. Turn the hand wheel to rotate the turret until the filled die passes

between the upper and lower pressure rolls.

6.5.5.2 There should be resistance. If not, adjust the pressure adjusting wheel

toward increase pressure.

6.5.5.3 AFTER the punches and dies have passed between the rolls, turn the

adjusting wheel until a tablet of the desired density has been

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Standard Operating Procedure SOP No Rev
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NP-250 Rotary Tablet Press

accomplished. If necessary, small adjustments can be made during
normal operation. Note: Increasing pressure will decrease tablet

thickness.

6.5.6 Adjusting Upper Punch penetration and Lower Punch Height Adjuster

6.5.6.1 See Owner’s Manual

6.5.7 Lubrication

6.5.7.1 Fill the upper oil reservoir to half height with 90 weigh gear oil.

6.5.7.2 Upper & Lower Pressure Rolls after cleaning, between batches and
during storage.

6.5.7.3 Ring and worm gear after cleaning, between batches and during
storage.

6.5.7.4 Worm bearing after cleaning, between batches and during storage.

6.5.7.5 Pivot Pins after cleaning, between batches and during storage.

6.5.7.6 All thread and Hinge Points at after cleaning, between batches and
during storage.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 08/02/10 | New ; = | - | - |
| 1 | 04/02/13 | New format, update SOP setup, Operation, Cleaning and Maintenance, changed SOP name | 13-205 | B. Mosall |
| 2 | 09/28/15 | Biennial Review: updated SOP format. | 15-0547 | P. Zittere |
| 3 | 01/14/19 | Scheduled review: Added reference to SOP B-1111 and SOP B- 103. Revised section 6.3. | 19-0041 | K. Burris |
| 4 | 04/15/22 | Revise machine model numbers to reflect what we currently have CC- on-site and use in production. | 22-0187 | J. Mireles |