Factory Acceptance Test for Tablet Compression
Factory Acceptance Test for Tablet Compression
| machine name | : | FALCON B4 TYPE 35 STN “B” TOOLING TAB, MACHINE |
| Client Name & address | : | FALCON, AHMEDABAD, INDIA |
| document name | : | factory acceptance test |
| PROTOCOL no. | : | |
| Revision no. | : | 00 |
| MACHINE SR. NO. | : |
Table of Contents
1.… SYSTEM DESCRIPTION :…………………………………………………………………………………………………..
2.… SYSTEM CHECKES :………………………………………………………………………………………………………….
2.1 Physical Check :……………………………………………………………………………………………………………..
2.2….. Basic Component Verification :…………………………………………………………………………………..
- VERIFICATION OF SAFETY & INTERLOCK FEATURE :…………………………………………………..
- FUNCTIONAL VERIFICATION :…………………………………………………………………………………………
4 .1 Basic Challenge Test :…………………………………………………………………………………………………..
- ACCESS LEVEL SECURITY:……………………………………………………………………………………………….
- TRAIL REPORT :………………………………………………………………………………………………………………..
- FALCON & CLIENT REMARK:…………………………………………………………………………………….
- SYSTEM DESCRIPTION :
The major components of the equipment are identified us:-
- Powder Feeding unit.
- Powder transfer unit
- Compression unit
- Hydraulic power pack assembly
- Discharge unit
- Lubrication unit
The Tablet Compression B4 Type 35 Station. “B” Tooling Tab, Machine, supplied by FALCON., a double rotary high speed tablet press, is a machine in incorporated with the force-feeding arrangement, auto-lubrication, electromagnetic clutch, power level sensor and rejection / sampling port.
Powder feeding unit has S.S. 316 Hopper of capacity 16 Liters. rests on top of the machine which holds the powder in it and delivers to the feeding assembly through a butterfly valve which control the flow of the powder between the hopper and the feeding assembly. The hopper consists of an agitator, which enhanced the powder flow. A barrel –type powder level sensor is mounted on a bracket and fixed against the sight glass of the hopper.
Powder transfer unit Consists S.S. 316 inlet connector, which links the hopper and the force feeder, the force feeder has two counter rotating paddles of S.S. 316, driven by reduction gearbox and variable frequency AC drive motor. The tail over die is an essential feature of the high – speed tablet press. The function of the tail over die is to keep the filled die covered until the last moment before the upper punch enters the die.
Drive unit has main motor of 5HP drives a very high reduction gearbox unit using an electromagnetic clutch and a timing belt. The gearbox unit consists of a Phosphorus bronze worm wheel and a worm shaft. Turret is a three piece structure having the center die tablet of S.S. 316 and upper and lower piece of cast iron of SG 400/15. The upper piece holds the upper punches, which rests on the upper cam tracks with the cam plate. Similarly, the lower piece holds the lower punches that travel on the lower cam tracks and Dozer.
Compression unit comprises upper main pressure roll assembly having a roll centre, pressure roll and pressure roll pin. The roll centre holds the pressure roll and is locked by using external circlips upper punch penetration assembly is responsible for the entry height of the upper punch in the die. Tablet thickness assembly is responsible in deciding the tablet thickness.
Weight dozer assembly is responsible for adjusting the weight of the tablet by varying the depth of fill. The depth of fill is adjusted by the upward and downward movement of the weight adjusting head through a dozer adjusting screw with the help of dial.
Hydraulic power pack assembly system control the safety overload mechanism, which governs the maximum pressure, level, at which particular tablets are being made. The oil reservoir for this system is located in front LH corner within lower cabinet. It can be accessed by removing the lower side guard (LH). The oil level in the reservoir should be checked regularly through the oil level indicator.
Tablet discharge unit comprises of ejection cam, tablet scrapper assembly & tablet discharge chute. The height of the ejection cam needs to be set in such a way that the tip of the lower punch is slightly above the die so as to avoid tablet-chipping problem. As soon as the tablet is ejected out it strikes the tablet scrapper assembly, which directs the tablet to the discharge chute. Tablet discharge chute is made S.S. 316 with acrylic cover. Tablets slide out through this chute to the container.
Auto lubrication system provided for the lubrication of all critical pinpoints like roll pins, it comprises of a lubrication tank, a motorized pump, distribution manifold and pipelines. This pump operates on timer set in the PLC. It should be noted that the ON time should be less then the OFF time, to prevent the oil flooding. The dozing of oil respective critical points can be throttled through the distribution manifold.
Lower punch lubrication system helps mainly for smooth and easy ejection of tablets. In addition the tablet gets a clean, smooth surface at the web. The lower punch has an extractor groove below the tip for the lubrication support, which may be a lubrication felt or woolen thread winding. In order to avoid lubricant, the scraper mechanism is built in. the stripper oil is collected in a collecting tray. The scraper keeps the external diameter of the die plate and lower punch guide clean. From the collecting tray the oil is transported downward through a funnel and a hose line and returned back into the tank.
The working principle of compaction force control is whenever the powder is compressed to from a tablet an impact is generated. The oil in the hydraulic cylinder absorbs this impact. The load cell, which is mounted between the upper roll lever and the hydraulic cylinder, senses the load received. The value is transferred to the data control screen through the MP55 transducer and the PLC. The data control screen displays the individual force of all the punches.
- SYSTEM CHECKES :
2.1 Physical Check :
| Method | Description | Acceptance Criteria | Observation | Sign/date |
| Outer Surface finish verification | Check Outer surface of machine | -Matt finish -Curved corner -No dent -No visible spot of welding | ||
| AC/DC panel checking | Visual check | -Should be available -Proper wiring | ||
| Document verification | Verification of calibration certificate of Digital Pressure Indicator, Pressure Gauge. | -Calibration certificated should be available | ||
| Document verification | Verification of MOC certificate | -MOC certificated should be available |
Performed by:____________________ Verified by:_____________________
2.2 Basic Component Verification :
| Sr. No. | Test Description | Acceptance Criteria | Test Method | Observation | Acceptance Criteria fulfilled | Checked by | Verified by |
| l | Machine Dimensions | 1880 (L) X 2040 (W) X 2000 (H)MM
| Machine Dimensions | □ Yes □ No | |||
| l | G.A. Drawing | l Machine construction should meet with G.A. drawing. | □ Visually □ Via Tag | □ Yes □ No | |||
| l | Main switch (ON/OFF) | ON/ OFF function l Qty.: 01 no. | □ Visually □ Via Tag | □ Yes □ No | |||
| l | Emergency switch (ON/OFF) | l Make: l Qty.: 1 No. | □ Visually □ Via Tag | □ Yes □ No |
| Sr. No. | Test Description | Acceptance Criteria | Test Method | Observation | Acceptance Criteria fulfilled | Checked by | Verified by |
| ELECTRIC MOTORS (MAIN MOTOR) | |||||||
| l | MAKE
| CROMPTON
| □ Visually □ Via Tag | □ Yes □ No | |||
| l | SR. NO.
| SLGM02984 | □ Visually □ Via Tag | □ Yes □ No | |||
| l | RPM
| 1440
| □ Visually □ Via Tag | □ Yes □ No | |||
| l | VOLTAGE
| 415 V
| □ Visually □ Via Tag | □ Yes □ No | |||
| l | HP/KW
| 5HP./3.3KW/ FOOT MOUNTED | □ Visually □ Via Tag | □ Yes □ No | |||
| l | PHASE | 3 PH | □ Visually □ Via Tag | □ Yes □ No | |||
| l | FREQUENCY | 50 Hz | □ Visually □ Via Tag | □ Yes □ No | |||
| Sr. No. | Test Description | Acceptance Criteria | Test Method | Observation | Acceptance Criteria fulfilled | Checked by | Verified by |
| AC VARIABLE FREQUENCY DRIVE FOR MAIN MOTOR | |||||||
| l | MAKE
| EMOTRON | □ Visually □ Via Tag | □ Yes □ No | |||
| l | MOTOR RATING
| 5 HP
| □ Visually □ Via Tag | □ Yes □ No | |||
| l | MODEL
| □ Visually □ Via Tag | □ Yes □ No | ||||
| l | SR. NO.
| 010202531895090002A | □ Visually □ Via Tag | □ Yes □ No | |||
| GEARBOX [MAIN DRIVE] | |||||||
| l | MANUFACTURE
| FALCON
| □ Visually □ Via Tag | □ Yes □ No | |||
| l | TYPE
| WORM & TEETH RING
| □ Visually □ Via Tag | □ Yes □ No | |||
| l | REDUCTION STAGE | SINGLE
| □ Visually □ Via Tag | □ Yes □ No | |||
| Sr. No. | Test Description | Acceptance Criteria | Test Method | Observation | Acceptance Criteria fulfilled | Checked by | Verified by |
| LUBRICATION OIL PUMP | |||||||
| l | MANUFACTURE
| DROPCO ENG
| □ Visually □ Via Tag | □ Yes □ No | |||
| l | MODEL
| DMHT-600-5 (Dx)
| □ Visually □ Via Tag | □ Yes □ No | |||
| l | LUBRICATINO SYSTEM
| ONE SHOT LUBRIATION (MANUAL HANDEL TYPE PUMP)
| □ Visually □ Via Tag | □ Yes □ No | |||
Performed by: _________________________Verified by:__________________________
3. VERIFICATION OF SAFETY & INTERLOCK FEATURE :
| Sr. No. | Test Description | Acceptance criteria | Observation | Acceptance criteria fulfilled/Remark | Checked by | Verified by |
| l | Emergency Stop | “Emergency Stop Activated” Alarm message should display on monitor screen and inspection will stop. Tower lamp should glow with red color and buzzer should get ON. | □ Yes □ No |
Performed by: ________________________ Verified by:___________________________
4.0FUNCTIONAL VERIFICATION :
4 .1 Basic Challenge Test :
| Sr. No. | Test | System Result | Remedial Action | Observation | Sign/date |
| l | Upper guards [when interlock mode is selected for machine function]
| Open any of the upper guard
| Machine will stop immediately and can not be restarted till the guard is open guard open indicator lamp will be “on” | ||
| l | Main pressure overload
| Increase depth of fill and/or decrease tablet thickness either L.H.S. OR R.H.S.
| Main set pressure overload indicator lamp will be “on” | ||
| l | At the time of providing password if admin set the password in non-alphanumeric nature | “Password should be min 8 character and must contain at least one number, small case letter, upper case letter and each” Message should be displayed. | Provide password as per note given on system display | ||
| l | At the time of providing password if admin set the password less than 8 digit | “Password should be min 8 character and must contain at least one number, small case letter, upper case letter and each” message appears on screen. | Provide password as per note given on system display | ||
| l | If user expire by date | “USER:USER1 password has been expired. Do you want to change password”. Message should be displayed on screen. | Contact to admin and Renew date from your admin | ||
| l | At the time of login if you enter 3 times wrong password | “your account has been locked. Please contact to admin to unlock” message should be displayed on screen.
| Contact to admin and unlock the account from your account | ||
| l | Power Failure | Machine stopped and after resume power should not loss the data. | Power Backup Facility (UPS) |
Performed by: __________________________ Verified by:_______________________
- ACCESS LEVEL SECURITY:
| Sr. No | Feature | Acceptance Criteria | Observations | Sign/Date |
| 1 | Admin | System should allow to create 30 Admin | ||
| 2 | Supervisor | System should allow to create 30 Supervisor | ||
| 3 | Operator | System should allow to create 50 Operator |
- TRAIL REPORT :
Machine Operational & Performance Verification (Trial- I):
| Machine Speed (RPM) | Trial | Weight Variation | Friability (% w/w) | Hardness (Kg/cm2) | Thickness (mm) | |
| Wt. of 20 Tablets (gm) | Individual* (mg) | |||||
| NMT ±2% of target weight | NMT ±5% of target weight | NMT 1% | NLT 2.0 Kg | To monitor | ||
| 5 | Sample #1 | |||||
| Sample #2 | ||||||
| Sample #3 | ||||||
Performed by: __________________________ Verified by:__________________________
Machine Operational & Performance Verification (Trial- II)
| Machine Speed (RPM) | Trial | Weight Variation | Friability (% w/w) | Hardness (Kg/cm2) | Thickness (mm) | |
| Wt. of 20 Tablets (gm) | Individual* (mg) | |||||
| NMT ±2% of target weight | NMT ±5% of target weight | NMT 1% | NLT 2.0 Kg | To monitor | ||
| 15 | Sample #1 | |||||
| Sample #2 | ||||||
| Sample #3 | ||||||
Performed by: __________________________ Verified by:__________________________________
Machine Operational & Performance Verification (Trial- III):
| Machine Speed (RPM) | Trial | Weight Variation | Friability (% w/w) | Hardness (Kg/cm2) | Thickness (mm) | |
| Wt. of 20 Tablets (gm) | Individual* (mg) | |||||
| NMT ±2% of target weight | NMT ±5% of target weight | NMT 1% | NLT 2.0 Kg | To monitor | ||
| 25 | Sample #1 | |||||
| Sample #2 | ||||||
| Sample #3 | ||||||
Performed by: __________________________ Verified by:__________________________________
- CLIENT & COMPANY REMARK:
- CLIENT Remark :
________________________________________________________________________________
___________________________(Sign/date)
- Company Remark :
________________________________________________________________________________________________________________________________________________________________
___________________________ (Sign/date)
| Sr. No. | COMPANY | CLIENT | ||
| Name | Sign & Date | Name | Sign & Date | |
| 1 | ||||
| 2 | ||||
| 3 | ||||
