Studied, Analyzed and Written by:

Edgardo P. Aliño

Director of Manufacturing

VARIABLES THAT AFFECTS

MANUFACTURING PRODUCTION

There are 5

variables:

1.) Raw Materials

2.) Tooling

3.) Environment

4.) Training

5.) Equipment

1.) Raw Materials

Density of the raws – materials comes in three (3) types.

(A) Powder – it has all the parts of the tree and they are not consistent in their density (it requires roller

compaction).

(B) Extract – pure and their density is very consistent

(no roller compaction is required).

(C) Root, Bark, Leaf, Branch – in a very raw form, it requires milling then roller compaction (double handling).

Granulation size – if the granularity is not consistent the process of tableting will be a challenge and will produce products that will not conforms to our AQL (Acceptable Quality Level).

2.) Tooling

Worn out or out of spec set. – manufacturer set the min/max parameters for each type. These parameters needs to be followed to ensure that the set is in excellent condition.

Precise engineering measurement is required. – in order to have a desired result tooling needs to be digitally measured to get their precise measurement that will conforms to the spec.

Reach the end of use for old tooling. – every time you use the sets, it needs to be documented and the result should be captured in a database. Once the maximum usage is reach that set needs to undergo into the 7 stages of robust PM program (Preventive Maintenance) for tooling before putting them back to service.

(1. CLEAN 2. ASSESS 3. REPAIR 4. MEASURE 5. POLISH 6. LUBRICATE 7. STORE)

Step 1. CLEAN Punch and die cleaning is essential for the removal of residue to avoid

product contamination. Cleaning allows for accurate assessment of

tooling condition during the inspection /assessment phase. Ultrasonic

baths are recommended for cleaning as they allow for consistent

cleaning results, reduced processing and operator time and reduced

risk of tablet contamination. Current cleaning time is about 5 minutes

per punch times the number of stations). This will be greatly reduced

to just 45 minutes total including setting them up on the tray up to

taking them out. Importantly, ultrasonic cleaning allows for the whole

punch to be cleaned including in and around the embossing.

“SEVEN (7)

STAGES:”

Step 2. INSPECT / ASSESS Following cleaning, punches and dies should be visually assess to

determine their general condition allowing the user to identify the

repair and polishing work required if any. Inspection and assessment

can be carried out visually using an eye glass (not recommended) or a

high magnification camera/lens (recommended). Visual inspection

importantly allows for tooling life to be monitored and potential failure

predicted. It also ensures that tablet detail and definition are

maintained and helps to validate the cleaning maintenance

procedures.

Step 3. REPAIR The repair stage allows the user to rectify any damage to the tooling

before polishing.

Various Form of Damage Include:

* Damaged to the head/dwell flat – caused by contact with the

compression roller.

* Damaged to the under head angle – caused by punches running

tight in the press

and causing heavy contact

with cams.

Minor damage and corrosion can be repaired using a motorized chuck. If

damage is excessive, tools must be replaced. In all cases it is

important to remember that repair to punches and dies should only be

carried out when absolutely necessary as this can potentially change

tooling dimensions resulting in other tableting problems. Regular

maintenance and repair work will help to extend tooling life, maintain

tablet image and definition, optimize tooling productivity and prevent

tooling breakages.

Step 4. MEASURE

Measuring is essential after polishing and repair to ensure that critical tooling dimensions have stayed within tolerance. Critical Dimensions Include: Head form, Barrel diameter, Tip diameter, Overall length

Die outer diameter, Die bore diameter.

Measurement can be carried out manually using conventional equipment but they are not 100% accurate and the risk of error will make your PM useless. But by using digital equipment interfaced with special software , the data can be captured and analyzed. The use of digital measurements systems allow for measurements to be taken consistently, reducing the risk of manual data entry and reading errors.

Measurement is essential for validating the tooling specification and maintaining tablet weights thus avoiding non-conforming tablet production. It also allows for the proactive monitoring of the tooling inventory and the prediction of tooling replacements resulting in an improved return of investment.

Step 5. POLISH

Automated polishing is recommended to ensure punches are evenly

polished to a consistent finish. Automated polishing ensures optimum

and consistent tooling condition for maximum productivity, a reduced

risk of damage compared to manual processes, reduced sticking, and

saved labor costs from re-work. Automated polishing should result in a

mirror finish and smooth tooling surface consistently.

Step 6. LUBRICATE

When storing tooling it is important to protect with a preservative or

rust inhibitor to prevent corrosion. Prior to this, it is important to ensure

that the tools are perfectly dry as any remaining moisture may be

sealed in by the coating of oil. Lubrication helps to optimize the

interface between the tooling and the press avoiding increased press

down time.

Step 7. STORE There are many methods for storing punches and dies from specially

designed plastic storage boxes to custom designed and built storage

cabinets. Correct storage facilitates good tooling management and

ensures less press downtime as a result of poor handling and

storage.

SUMMARY

The 7 stages/steps process is essential for maximizing the tooling

life and producing quality tablets. Investment in the correct

equipment and training will pay dividends in the long term, enabling

the tablet press to be more productive and tooling life to be

extended.

3.) Environment

Moisture content – this can happen when raws are delivered, from nature or from the wet granulation during mixing. It needs to be known prior to processing in manufacturing so that we can calculate if any additional or reducing them is necessary. This will play a big role in determining the result in advance and can eliminate or minimize sticking issue (too wet) or broken tablets (too dry).

Room temperature – this condition affects the moisture of the products from mixing to press because it contributes to the moisture contents of the products.

Humidity condition – this is an integral part of environment that contributes to the success of the run. If they are too low it makes the air more drier and the broken tablets condition occurs. If they are too high the

4.) Training > This is one important variable that can make the process of tablet

manufacturing more difficult to achieve “Right the First Time”.

The science of tablet making can be compared to a complicated mathematical solution that can produced 2 different answers.

Not 2 of the same products is a mirror image of one another.

Proper training of all personnel from the warehouse up to the wash room is mandatory. There is no short cut because it will put our products to more processing and worse it can be exposed to cross-contamination. It also includes equipment functionality and proper operational training.

Execution of the training plan is mandatory and needs to be followed by each leader to ensure compliance. This needs to be done in a formal setting not on a hallway meeting.

SOP training for each process will be done prior to putting a new team member on the line. This will prevent miscommunication and confusion about the process.

cGMP training will also be taught to all employees to prevent non-compliance.

Lean Tools training will be provided by Supervisor and Technician on their new hires within 90 days of employment.

Once a team member becomes an expert on their primary process (TBD), they can start cross training on other process.

Versatility chart for each shift is mandatory to identify team member that needs more time to train and learn (example of the chart is on the next page).

4.) Training * Example of Versatility Chart *

1

2

3

4

25% = Know the element

50% = Know the element and can do the job with supervision

75% = Know the element can do the job with out supervision

100% = Know all of the above and able to trouble shoot and train

NAVis

ion

Mat

eria

l Han

dling

Mill

ing

Liquid

Pro

duct

Mix

ing

Rolle

r Com

pacto

r

Rib

bon ble

nd wet

& d

ry

Com

press

ion

Encapsu

latio

n

Mac

hine

set-up

Coat

ing

Proce

ssin

g Bat

ch s

heets

Sanita

tion &

Was

h Room

Team

Lea

der

Total

Rafael Guerrero1 3 3 2 1 2 1 1 1 4 4 1 1 4 4 32

2 4 4 4 1 4 4 4 3 1 1 1 1 4 36

3 2 1 2 1 1 3 1 2 2 4 2 1 4 26

4 3 2 4 1 4 4 2 2 1 1 4 4 4 36

5 0 1 3 1 3 4 3 1 0 2 0 0 4 22

6 0 1 3 2 3 3 3 0 1 2 0 0 4 22

7 0 1 3 2 3 3 3 0 0 0 0 0 4 19

1 0

0

13 21 9 20 22 17 9 9 14 8 7 28 4 0 0

Rafael Guerrero

Randy Lau

Total

Eduardo Rivera

Todd Plumlee

Cesario Cueva

Emanuel Melo

Cesar Rojas

5.) Equipment

This last piece of the puzzle will make it impossible to produce quality products and all of the above mention variables useless. If machines are not properly maintained and documented it will be difficult to practice what they learned.

A well maintained equipment will make better quality products.

Capture each usage for every run to identify product suitable for the equipment.

Dedicated tooling for each machine minimize the needs for expensive repair and re-work.

Product dedicated machine is also required so that the predictability of result is more consistent.

Regular preventive maintenance is mandatory especially equipment that is on service for more than a decade.

Overhaul equipment that are no longer capable of producing good results. This can be determined by setting up parameters for reject percentage, (> 50%).

5.) Equipment

PRESS # DESCRIPTIONTOOLING

SIZE

TOOLING

ID

TOOLING

BRAND

Back up

Tooling in

stock

TOOLING

NEW / OLD

USAGE

(RUNS)

Tooling

first day of

use

Tooling

Last day of

use

Tooling

Quote #

REJECT

RATE %

OUTPUT

/ HR

8 HRS shift

(7hrs)

MACHINE

STATUSESRECOMMENDATION

1

Stokes B2

16 stations M/R 4J AEM 1 OLD 42 21,850 152,950

S/R P NATOLI 1 NEW 18 17,700 123,900

M/C L NATOLI 3 NEW 10 18,400 128,800

2

Colton Vector

16 stations S/R NNN NATOLI 0 NEW 13 49,500 346,500

M/R 1A AEM 0 NEW 10 37,640 263,480

L/O 4G NATOLI 0 OLD 25 19,450 136,150

M/O FFF NATOLI 1 OLD 22 16,630 116,410

M/C S NATOLI 1 OLD 28 22,500 157,500

5/8 C NATOLI 1 NEW 13

3

Stokes BB2

27 stations M/R B AEM 2 OLD 27 28,400 198,800

S/R 3L AEM 0 OLD 30 25,200 176,400

M/C 85469 27,900 195,300

S/R 4B EC 0 OLD 25 85463

4

Colton Vector

12 stations M/O 2N AEM 0 NEW 10 14,340 100,380

L/O 4T NATOLI 0 NEW 8 15,300 107,100

M/C 3V AEM 1 OLD 46 16,200 113,400

1" ZZ NATOLI 0 OLD 28

7/8 HH NATOLI 0 NEW 17

5/8 EEE NATOLI 0 NEW 15

5

Colton Vector

12 stations M/C 14,800 103,600

M/O 1H AEM 0 NEW 15 14,340 100,380

L/O 3J AEM 0 NEW 10 14,050 98,350

7/8 AAA NATOLI 0 NEW 10

5/8 CCC NATOLI 0 NEW 10

6

Colton Vector

12 stations M/C F AEM 0 OLD 60 85444 14,340 100,380

M/O CC NATOLI 0 OLD 40 85440 17,120 119,840

L/O 4C AEM 0 OLD 45 85451 15,300 107,100

7/8 2P AEM 0 NEW 0

5/8 DDD NATOLI 0 NEW 5

7

Colton Vector

12 stations M/C 3W AEM 0 OLD 38 85445 21,500 150,500

M/O 4Y NATOLI 0 NEW 0 15,650 109,550

L/O 4B AEM 0 OLD 50 85448 16,600 116,200

7/8 BBB NATOLI 0 NEW 0

5/8 Y AEM 0 NEW 0

8

Stokes D3

16 stations M/R 2D NATOLI 1 NEW 8 14,600 102,200

M/C T NATOLI 0 OLD 29 12,680 88,760

M/O Q NATOLI 1 NEW 0 14,040 98,280

L/O 4H AEM 0 NEW 10 12,550 87,850

5/8 OOO NATOLI 1 NEW 10

9

Colton Vector

12 stations M/O 2M AEM 1 NEW 19 19,800 138,600

M/C 4V NATOLI 0 NEW 0 14,280 99,960

L/O 2Z AEM 0 OLD 50 85452 16,750 117,250

7/8 2Q AEM 0 NEW 0

5/8 GG NATOLI 0 NEW 0

10

Stokes D3

16 stations M/C 1D AEM 2 OLD 28 9,050 63,350

L/O Q AEM 2 NEW 6 11,950 83,650

S/R MMM NATOLI 2 NEW 15

5/8 PPP NATOLI 0 NEW 0

Weight jumping,

Poor Flow, NO

tablet shooting

slide, no de-dust

suction pipe.

Set centerline, locking

device for weight

adjuster, buy a tablet

shooting slide, install

a de-dust suction

pipe, buy new

hopper.

C O M P R E H E N S I V E P R E S S T O O L I N G I N V E N T O R Y

Buy a tablet shooting

slide, install a de-dust

suction pipe.

Bad flow, no

tablet shooting

slide, no de-dust

shooting pipe.

Weight jumping,

Poor Flow, NO

tablet shooting

slide, no de-dust

suction pipe.

Set centerline, locking

device for weight

adjuster, buy a tablet

shooting slide, install

a de-dust suction

pipe, buy new

hopper.

Weight jumping,

Poor Flow, NO

tablet shooting

slide, no de-dust

suction pipe.

Set centerline, locking

device for weight

adjuster, buy a tablet

shooting slide, install

a de-dust suction

pipe, buy new

hopper.

Bad flow, no

tablet shooting

slide, no de-dust

shooting pipe.

Buy a tablet shooting

slide, install a de-dust

suction pipe.

No de-dust

suction pipe

causing the

product build

upon the lower

punch.

Install a de-dust

suction pipe.

Hopper issue Buy a new hopper.

Hardness dial-

using vise grip to

lock KP.

Fix Hardness dial to

prevent weight from

jumping.

Upper pressure

roll heats up

Replace upper

pressure roller to

prevent heating.

Hopper issue bent

Tip, tablet

shooting slide, de-

dust pipe not

working.

Set centerline, locking

device for weight

adjuster, buy a tablet

shooting slide, install

a de-dust suction

pipe, order a new

hopper.

5.) Equipment

These 5 variables that we discussed can be addressed by discipline and a well

designed approach utilizing the lean manufacturing techniques.

The End! Thank you!