Level Based Training Outline

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FETTE America, Inc400 Forge WayRockaway, NJ 07866Tel: (973) 586-8722

Level Based Certification Training

We have developed a new, progressive training model, with tiered levels of assessment

and certification. Participants must successfully complete the assessment, both writtenand practical, before they can move on to the next level. This type of level basedcertification was created to ensure that customers are adequately trained in operating andmaintaining Fette equipment. To this end, Fette requires that all participants achieve a100% score on both the written and practical assessments, to be administered at eachlevel. To help meet the needs of individuals on all learning levels, we will allow the useof hand written notes and other training materials to be used during the written and handson portions of the certification assessments. To achieve the full certification wouldrequire successfully completing all five levels, which would take approximately threeweeks. However, it is not a mandatory requirement that the levels be completed in directsuccession. Fette encourages you to take time in between each level to utilize and become

familiar with the skills and knowledge previously learned.

For learning purposes and to ensure that each participant receives individual attention,Fette will limit the total number of participants per class to six (6) attendees per class.

The Total System Controller (TSC) has been configured with security levels reflective of the corresponding levels of certification. As the requirements of each level aresuccessfully met, the appropriate security access will be granted.

What follows is a description of each level and the corresponding security access levels.Competency and proficiency guidelines are described for each level.

Leitz Metalworking Technology Group

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Level One - Basic User (Approximately three days) Basic user certification will not only cover basic press operation, but will also include an in-depthreview of compression theory. It is intended for operators with little to no experience in makingtablets and press operation. Although the program is geared for new users, we require that all

press operators and maintenance personnel receive this training.

The program will be conducted in both the classroom and at the press site. More time will bespent in the classroom for level one certification than subsequent levels. The learning objectivesare to understand and demonstrate competency in the following areas:

Knowledge of: The compression cycle bulk in hopper through tablet ejection Feeding principles Fill cam function, selection criteria and relationship to filling depth Terminology and function of punches and dies

Role of scraper and tail-over-die Re-circulation and dust extraction Role of upper and lower compression stations punch tip position relative to

turret surface and effect on finished tablet Role of pre-compression Role of main compression Penetration Tablet ejection and checking for proper adjustment Tablet take off arm function and checking for proper adjustment Discharge chute and slow gate function Automatic weight/force control loop Location and function of

Powder hopper sensor Fill-o- matic position sensor Fill cam switches Ejection cam switch E-stops

- Safety- Basic GMPs

Window flap switches Lubrication pumps and circuits Access and utilize F4 Reports

Certified to:

Log on/Log off Select existing formulations Create a new batch Adjust tablet weights in SETTING RUN Adjust thickness and hardness in SETTING RUN Monitor and establish limits for SREL (standard deviation) Establish pre and main compression force values Activate automatic weight/force control Adjust tablet weights in STANDARD RUN


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Adjust thickness and hardness in STANDARD RUN


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Adjust press and Fill-o-matic speeds Actual Diagnosis/Change and Batch reports Access graphic screens for individual compression forces

Troubleshoot using the previous two reports

PARAMETERS ASSIGNED TOLEVEL ONE BASIC USER

1 TABLETS PER HOUR2 ROTOR SPEED3 FILL-O-MATIC SPEED RPM5 MAIN COMPRESSION FORCE MV KN6 TABL FILLING DEPTH MM8 MAIN COMPRESSION FORCE SREL %9 MAIN COMPRESSION FORCE SREL MAX %

13 PRE COMPRESSION FORCE MEAN VALUE KN14 GOOD PRODUCTION15 BAD PRODUCTION16 FILLING QUANTITY X 100018 TABLET CYLINDRICAL HEIGHT MAIN COMPRESSION MM19 TABLET CYLINDRICAL HEIGHT PRE COMPRESSION MM20 PENETRATION MAIN COMPRESSION MM21 PENETRATION PRE COMPRESSION MM32 ADJUST ON 1/2/3

33 REJECT ON =1/2/3/434 GRATEX SPEED RPM49 EXTRACTION VACUUM HPA

OTHER FUNCTIONS ASSIGNED TOLEVEL ONE

COMPUTER RUNSETTING RUNFORMULATION LISTBATCH CHANGEF4 REPORTS100 INDIVIDUAL FORCESSTANDARD RUNPARAMETER LISTLOAD FORMULATIONLUBRICATIONFILL-O-MATICROTOR INCHINGPUNCH TO PUNCHSTART/STOP


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Level Two - Advanced User (Approximately three days)

YOU MUST BE A CERTIFIED LEVEL ONE BASIC USER BEFORE STARTING

LEVEL TWO!

Advanced user certification will cover the complete press operation. It is intended for operatorswith experience in compression operation, specifically Fette machinery. Although the program isgeared for advanced users, we require that all press operators and maintenance personnel receivethis training before moving on to subsequent levels.

The program will be conducted in both the classroom and at the press site. The learningobjectives are to understand and demonstrate efficiency in the following areas:

Knowledge of: Fast gate set-up and operation

Feeding principles and Fill-o-matic operation Dosing station description and function Maintenance and inspection of punches and dies Identification of upper and lower cam tracks both IPT 19 and IPT 1 Lubrication system Process troubleshooting Function of pre-compression Function of main compression Function of penetration Discharge chute and slow gate adjustments Advanced automatic weight/force control loop Location and function of

Upper and lower punch stiffness strain-gauges Load cells Encoders Vacuum sensor Servo-motors Main power cabinet Main motor FOM motors Printer

Certified to: Create formulations Establishing over-load limits In-put missing punches Go to reference marks Enter safety parameters Enter statistical monitoring parameters Set limits (%) Print functions / F7 Change lubrication times


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PARAMETERS ASSIGNED TOLEVEL TWO ADVANCED USER

In addition to the Level 1 parameters, the following will be assigned:4 PERMISS PUNCH LOAD KN7 MAIN COMPRESSION FORCE MV MAX % DETERMINATION

10 INDIVIDUAL VALUE LIMIT UPPER %11 INDIVIDUAL VALUE LIMIT LOWER %12 INDIVIDUAL LIMIT MAX %34 GRATEX SPEED

35 TABLET DIAMETER MM36 OBLONG NARROW SIDE MM37 OBLONG LONG SIDE MM38 TABLET FORM 1,2,3,4,5,939 FILL CAM41 MULTI PUNCH TIMES45 PUNCH STIFFNESS TOP N46 PUNCH STIFFNESS BOTTOM N47 LUBRICATION CYCLE 1 SECONDS48 LUBRICATION CYCLE 2 SECONDS50 MAIN MOTOR CURRENT A51 FILL-O-MATIC MOTOR CURRENT A52 PERMITTED BAD TABLETS53 SAME PUNCH BAD54 PER NUMBER OF TABLETS55 PERMITTED METAL PULSES

56 PER NUMBER OF TABLETS X 10057 STATISTIC NUMBER OF TABLETS58 PRESS FORCE MOVING AVERAGE59 FILLING DEPTH REGULATION NUMBER60 PRE COMPRESSION FORCE MEAN VALUE MAX %61 PRE COMPRESSION FORCE TOP MAX % (PUNCH SAVING)62 PRE COMPRESSION FORCE BOTTOM MAX %64 STARTING RELIEF65 PUNCH CHECK %66 NUMBER OF PUNCHES ROTOR67 DOUBLE LAYER ON68 DISCHARGE GATE DELAY SECONDS69 FILL-O-MATIC PRE RUN S70 FILL-O-MATIC POST RUN S81 ADJUSTMENT DELAY SECONDS83 REJECT DELAY DEGREES


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OTHER FUNCTIONS ASSIGNED TOLEVEL TWO ADVANCED USER

In addition to the Level 1 functions, the following will be assigned:GO TO REFERENCE MARKSMISSING PUNCHESPUNCH NUMBER TO REJECTCHECKMASTER SET-UPPRINT / F7

Level Three - Advanced User with Turret Change (Approximately three days)

YOU MUST BE A CERTIFIED LEVEL TWO ADVANCED USER BEFORESTARTING LEVEL THREE!

Advanced user with turret change certification will cover the complete changeover process. Thissection is intended for operators with advanced experience in compression operation, specificallyFette machinery. Although the program is geared for turret changeover, we require that all pressoperators and maintenance personnel who will do turret changes receive this training.

The program will be conducted in both the classroom and at the press site. This will be a step-by-step explanation of the changeover process, including the disassembly of the machine, removal of various parts, cleaning of the machine and installation and reassembly of the machine.

Knowledge of: Press disassembly Turret removal Placement of turret on service stand Turret disassembly Cleaning and lubrication Turret assembly Turret installation Press assembly Safety issues

- Potential hazards- Safe work habits

Certified to: Activate Test Run

Disassemble the press Rotor at position 1 Remove the turret go to rotor out Turret disassembly and changeover Machine cleaning Turret installation leave rotor out Reassemble press Utilize handling system and service stand Proper use of specialty tools


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PARAMETERS ASSIGNED TOLEVEL THREE ADVANCED USER with TURRET CHANGE

In addition to the Level 2 parameters, the following will beassigned:

42 UPPER PUNCH LENGTH SPECIAL MM43 LOWER PUNCH LENGTH SPECIAL MM44 SPECIAL CYLINDRICAL HEIGHT MM

OTHER FUNCTIONS ASSIGNED TOLEVEL THREE ADVANCED USER with TURRET CHANGE

In addition to the Level 2 functions, the following will be assigned: TEST RUNROTOR AT POSITION 1GOT TO ROTOR OUT POSITIONLEAVE ROTOR OUT POSITION


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Level Four Maintenance and Electrical (Approximately four days)

YOU MUST BE A CERTIFIED LEVEL THREE ADVANCED USER WITH TURRETCHANGEOVER BEFORE STARTING LEVEL FOUR!

Maintenance and Electrical certification will cover all preventative maintenance and calibration procedures. This section is intended for operators, mechanics and electrical technicians withadvanced experience in compression operation, specifically Fette machinery. Although the

program is geared for advanced operators and mechanics, we require that all maintenance personnel who will maintain and calibrate your Fette equipment receive this training.

The program will be conducted in both the classroom and at the press site.

Knowledge of: Preventative maintenance procedures

- Machine specific procedures- Turret procedures

Calibration- Mechanical calibration- Force (Load Cell) calibration- Amplifier calibration- Turret RPM calibration- FOM RPM calibration

Advanced troubleshooting knowledge Basic electrical safety

Certified to:

Perform preventative maintenance procedures Calibrate machine to specifications Troubleshoot, specifically for the following issues:

- Mechanical- Electrical- Granulation- Machine set-up- Machine operation- Punches and dies (tooling)- Diagnostic system

OTHER FUNCTIONS ASSIGNED TO

LEVEL FOUR MAINTENANCE / ELECTRICAL In addition to the Level 3 functions, the following will be assigned:

AMPLIFIERSZERO BALANCEGO TO DRIVE OUTLEAVE DRIVE OUT POSITIONCLEAR MEMORY

ADJUST REFERENCE MARKS


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Level Nine System Administrator (Approximately two days)

AT A MINIMUM, YOU MUST BE CERTIFIED UP TO AND INCLUDING LEVEL 4BEFORE BECOMING THE SYSTEM ADMINISTRATOR!

The system administrator is the highest attainable level assigned in this level based program. Thisis the individual responsible for maintaining system security and monitoring the administration of the program according to the machine functions and internal standard operating procedures(SOPs).

Knowledge of all aspects of Fettes operating structure.


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Certified to: Change Parameter 79 Memory Cycle

Change Parameter 86 Warning Time, feeding level Utilize all Extra Function keys Maintain security distribute PIN# and Passwords Maintain batch administration Import / Export and delete products and batches Terminal / Set-up heights for operators Deactivate Diagnosis Computer virus hazards

PARAMETERS ASSIGNED TOLEVEL NINE SYSTEM ADMINISTRATOR

In addition to the Level 4 parameters, the following will beassigned:

79 MEMORY CYCLE X 100086 WARNING TIME FEEDING LEVEL

OTHER FUNCTIONS ASSIGNED TOLEVEL NINE SYSTEM ADMINISTRATOR

In addition to the Level 4 functions, the following will be assigned:

WASHMACHINE NUMBER, DATE AND TIMEDEACTIVATED DIAGNOSISTIGHT DOSING

STOP PROGRAM AUTO T LIMITSDELETE BATCHIMPORT BATCHEXPORT BATCHIMPORT / EXPORT PRODUCTDRIVEDELETE PRODUCTTIMERUNTIGHT ROTORGALENIC

REMOTELOCALPRODUCT INFO

ADDITIONAL TEXT DATENBERNAHME


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The above-described level based training program is intended to certify the operators,

maintenance personnel, and supervision in your solid dose processing department to operate,maintain and utilize Fette tabletting equipment to its intended high-standards.

When the program is successfully completed, Fette machinery will operate to its optimal performance capability. Additionally, this program will instruct all who are certified that currentsafety procedures should be adhered to when operating and maintaining Fette equipment. Allspecific company internal safety SOPs must also be implemented and followed.

The system administrator, once certified, is solely responsible for maintaining the security of theFette tablet press and its documentation.

Any new operators must be certified, utilizing the same process spelled out in this outline. Acertified, Fette Technician should do this training and certification.

Fette recommends that each operator and mechanic be re-certified to his or her current level atleast every 2 years. If the operator or mechanic does not have regular, daily contact with the pressoperation for a period of 6 months, Fette recommends refresher training to his or her specificlevel.

The certificate received at the conclusion of each level will be recognized by Fette America, andwill be maintained in our database for future reference.

Level Based Training Outline

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