FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (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 written and practical, before they can move on to the next level. This type of level based certification was created to ensure that customers are adequately trained in operating and maintaining Fette equipment. To this end, Fette requires that all participants achieve a 100% score on both the written and practical assessments, to be administered at each level. To help meet the needs of individuals on all learning levels, we will allow the use of hand written notes and other training materials to be used during the written and hands on portions of the certification assessments. To achieve the full certification would require successfully completing all five levels, which would take approximately three weeks. However, it is not a mandatory requirement that the levels be completed in direct succession. 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 are successfully 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

FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

Level One - Basic User (Approximately three days) Basic user certification will not only cover basic press operation, but will also include an in-depth review of compression theory. It is intended for operators with little to no experience in making tablets 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 be spent in the classroom for level one certification than subsequent levels. The learning objectives are 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 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 Adjust thickness and hardness in STANDARD RUN
Leitz Metalworking Technology Group

Certified to:

FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

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 TO LEVEL ONE BASIC USER 1 TABLETS PER HOUR 2 ROTOR SPEED 3 FILL-O-MATIC SPEED RPM 5 MAIN COMPRESSION FORCE MV KN 6 TABL FILLING DEPTH MM 8 MAIN COMPRESSION FORCE SREL % 9 MAIN COMPRESSION FORCE SREL MAX % 13 PRE COMPRESSION FORCE MEAN VALUE KN 14 GOOD PRODUCTION 15 BAD PRODUCTION 16 FILLING QUANTITY X 1000 18 TABLET CYLINDRICAL HEIGHT MAIN COMPRESSION MM 19 TABLET CYLINDRICAL HEIGHT PRE COMPRESSION MM 20 PENETRATION MAIN COMPRESSION MM 21 PENETRATION PRE COMPRESSION MM 32 ADJUST ON 1/2/3 33 REJECT ON =1/2/3/4 34 GRATEX SPEED RPM 49 EXTRACTION VACUUM HPA OTHER FUNCTIONS ASSIGNED TO LEVEL ONE COMPUTER RUN SETTING RUN FORMULATION LIST BATCH CHANGE F4 REPORTS 100 INDIVIDUAL FORCES STANDARD RUN PARAMETER LIST LOAD FORMULATION LUBRICATION FILL-O-MATIC ROTOR INCHING PUNCH TO PUNCH START/STOP

Leitz Metalworking Technology Group

FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

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 operators with experience in compression operation, specifically Fette machinery. Although the program is geared for advanced users, we require that all press operators and maintenance personnel receive this training before moving on to subsequent levels. The program will be conducted in both the classroom and at the press site. The learning objectives 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 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

Certified to:

Leitz Metalworking Technology Group

FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

4 7 10 11 12 34 35 36 37 38 39 41 45 46 47 48 50 51 52 53 54 55 56 57 58 59 60 61 62 64 65 66 67 68 69 70 81 83

PARAMETERS ASSIGNED TO LEVEL TWO ADVANCED USER In addition to the Level 1 parameters, the following will be assigned: PERMISS PUNCH LOAD KN MAIN COMPRESSION FORCE MV MAX % DETERMINATION INDIVIDUAL VALUE LIMIT UPPER % INDIVIDUAL VALUE LIMIT LOWER % INDIVIDUAL LIMIT MAX % GRATEX SPEED TABLET DIAMETER MM OBLONG NARROW SIDE MM OBLONG LONG SIDE MM TABLET FORM 1,2,3,4,5,9 FILL CAM MULTI PUNCH TIMES PUNCH STIFFNESS TOP N PUNCH STIFFNESS BOTTOM N LUBRICATION CYCLE 1 SECONDS LUBRICATION CYCLE 2 SECONDS MAIN MOTOR CURRENT A FILL-O-MATIC MOTOR CURRENT A PERMITTED BAD TABLETS SAME PUNCH BAD PER NUMBER OF TABLETS PERMITTED METAL PULSES PER NUMBER OF TABLETS X 100 STATISTIC NUMBER OF TABLETS PRESS FORCE MOVING AVERAGE FILLING DEPTH REGULATION NUMBER PRE COMPRESSION FORCE MEAN VALUE MAX % PRE COMPRESSION FORCE TOP MAX % (PUNCH SAVING) PRE COMPRESSION FORCE BOTTOM MAX % STARTING RELIEF PUNCH CHECK % NUMBER OF PUNCHES ROTOR DOUBLE LAYER ON DISCHARGE GATE DELAY SECONDS FILL-O-MATIC PRE RUN S FILL-O-MATIC POST RUN S ADJUSTMENT DELAY SECONDS REJECT DELAY DEGREES

Leitz Metalworking Technology Group

FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

OTHER FUNCTIONS ASSIGNED TO LEVEL TWO ADVANCED USER In addition to the Level 1 functions, the following will be assigned: GO TO REFERENCE MARKS MISSING PUNCHES PUNCH NUMBER TO REJECT CHECKMASTER SET-UP PRINT / F7

Level Three - Advanced User with Turret Change (Approximately three days) YOU MUST BE A CERTIFIED LEVEL TWO ADVANCED USER BEFORE STARTING LEVEL THREE! Advanced user with turret change certification will cover the complete changeover process. This section is intended for operators with advanced experience in compression operation, specifically Fette machinery. Although the program is geared for turret changeover, we require that all press operators 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-bystep 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: 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 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

Leitz Metalworking Technology Group

FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

PARAMETERS ASSIGNED TO LEVEL THREE ADVANCED USER with TURRET CHANGE

In addition to the Level 2 parameters, the following will be assigned: 42 UPPER PUNCH LENGTH SPECIAL MM 43 LOWER PUNCH LENGTH SPECIAL MM 44 SPECIAL CYLINDRICAL HEIGHT MM
OTHER FUNCTIONS ASSIGNED TO LEVEL THREE ADVANCED USER with TURRET CHANGE

In addition to the Level 2 functions, the following will be assigned:

TEST RUN ROTOR AT POSITION 1 GOT TO ROTOR OUT POSITION LEAVE ROTOR OUT POSITION

Leitz Metalworking Technology Group

FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

Level Four Maintenance and Electrical (Approximately four days) YOU MUST BE A CERTIFIED LEVEL THREE ADVANCED USER WITH TURRET CHANGEOVER 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 with advanced 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:

AMPLIFIERS ZERO BALANCE GO TO DRIVE OUT LEAVE DRIVE OUT POSITION CLEAR MEMORY ADJUST REFERENCE MARKS

Leitz Metalworking Technology Group

FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

Level Nine System Administrator (Approximately two days) AT A MINIMUM, YOU MUST BE CERTIFIED UP TO AND INCLUDING LEVEL 4 BEFORE BECOMING THE SYSTEM ADMINISTRATOR! The system administrator is the highest attainable level assigned in this level based program. This is 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.

Leitz Metalworking Technology Group

FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

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 TO LEVEL NINE SYSTEM ADMINISTRATOR

In addition to the Level 4 parameters, the following will be assigned: 79 MEMORY CYCLE X 1000 86 WARNING TIME FEEDING LEVEL
OTHER FUNCTIONS ASSIGNED TO LEVEL NINE SYSTEM ADMINISTRATOR

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

WASH MACHINE NUMBER, DATE AND TIME DEACTIVATED DIAGNOSIS TIGHT DOSING STOP PROGRAM AUTO T LIMITS DELETE BATCH IMPORT BATCH EXPORT BATCH IMPORT / EXPORT PRODUCT DRIVE DELETE PRODUCT TIMER UNTIGHT ROTOR GALENIC REMOTE LOCAL PRODUCT INFO
ADDITIONAL TEXT

DATENBERNAHME

Leitz Metalworking Technology Group

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FETTE America, Inc 400 Forge Way Rockaway, NJ 07866 Tel: (973) 586-8722

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 current safety procedures should be adhered to when operating and maintaining Fette equipment. All specific company internal safety SOPs must also be implemented and followed. The system administrator, once certified, is solely responsible for maintaining the security of the Fette tablet press and its documentation. Any new operators must be certified, utilizing the same process spelled out in this outline. A certified, Fette Technician should do this training and certification. Fette recommends that each operator and mechanic be re-certified to his or her current level at least every 2 years. If the operator or mechanic does not have regular, daily contact with the press operation for a period of 6 months, Fette recommends refresher training to his or her specific level. The certificate received at the conclusion of each level will be recognized by Fette America, and will be maintained in our database for future reference.

Leitz Metalworking Technology Group

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