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 :…………………………………………………………………………………..

  1. VERIFICATION OF SAFETY & INTERLOCK FEATURE :…………………………………………………..
  2. FUNCTIONAL VERIFICATION :…………………………………………………………………………………………

4 .1 Basic Challenge Test :…………………………………………………………………………………………………..

  1. ACCESS LEVEL SECURITY:……………………………………………………………………………………………….
  2. TRAIL REPORT :………………………………………………………………………………………………………………..
  3. FALCON & CLIENT REMARK:…………………………………………………………………………………….
  1. 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. 

  1. SYSTEM CHECKES :

2.1 Physical Check :

MethodDescriptionAcceptance CriteriaObservationSign/date
Outer Surface finish verificationCheck Outer surface of machine-Matt finish

-Curved corner

-No dent

-No visible spot of welding

  
AC/DC panel checkingVisual check-Should be available

-Proper wiring

  
Document verificationVerification of calibration certificate of Digital Pressure Indicator, Pressure Gauge.-Calibration  certificated should be available  
Document verificationVerification of MOC certificate-MOC certificated should be available  

 Performed by:____________________  Verified by:_____________________

2.2       Basic Component Verification :

Sr. No.Test DescriptionAcceptance

Criteria

Test

Method

ObservationAcceptance

Criteria

fulfilled

Checked

by

Verified

by

lMachine

Dimensions

1880 (L) X 2040 (W) X 2000 (H)MM

 

 

Machine

Dimensions

Yes

No

lG.A. Drawingl   Machine construction should meet with G.A. drawing.Visually

Via Tag

Yes

No

lMain switch (ON/OFF)   ON/ OFF function

l   Qty.: 01 no.

Visually

Via Tag

Yes

No

lEmergency switch (ON/OFF)l   Make:

l   Qty.: 1 No.

Visually

Via Tag

Yes

No

 

Sr. No.Test DescriptionAcceptance

Criteria

Test

Method

ObservationAcceptance

Criteria

fulfilled

Checked

by

Verified

by

ELECTRIC MOTORS (MAIN MOTOR)
lMAKE

 

CROMPTON

 

Visually

Via Tag

Yes

No

lSR. NO.

 

SLGM02984Visually

Via Tag

Yes

No

lRPM

 

1440

 

Visually

Via Tag

Yes

No

lVOLTAGE

 

415 V

 

Visually

Via Tag

Yes

No

lHP/KW

 

5HP./3.3KW/ FOOT MOUNTEDVisually

Via Tag

Yes

No

lPHASE3 PHVisually

Via Tag

Yes

No

lFREQUENCY50 HzVisually

Via Tag

Yes

No

 

Sr. No.Test DescriptionAcceptance

Criteria

Test

Method

ObservationAcceptance

Criteria

fulfilled

Checked

by

Verified

by

AC VARIABLE FREQUENCY DRIVE FOR MAIN MOTOR
lMAKE

 

EMOTRONVisually

Via Tag

Yes

No

lMOTOR RATING

 

5 HP

 

Visually

Via Tag

Yes

No

lMODEL

 

Visually

Via Tag

Yes

No

lSR. NO.

 

010202531895090002AVisually

Via Tag

Yes

No

GEARBOX [MAIN DRIVE]
lMANUFACTURE

 

FALCON

 

Visually

Via Tag

Yes

No

lTYPE

 

WORM & TEETH RING

 

Visually

Via Tag

Yes

No

lREDUCTION STAGESINGLE

 

Visually

Via Tag

Yes

No

 

Sr. No.Test DescriptionAcceptance

Criteria

Test

Method

ObservationAcceptance

Criteria

fulfilled

Checked

by

Verified

by

LUBRICATION OIL PUMP
lMANUFACTURE

 

DROPCO ENG

 

Visually

Via Tag

Yes

No

lMODEL

 

DMHT-600-5 (Dx)

 

Visually

Via Tag

Yes

No

lLUBRICATINO 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

ObservationAcceptance criteria fulfilled/RemarkChecked

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.TestSystem ResultRemedial ActionObservationSign/date
lUpper 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”

lMain 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”

lAt 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
lAt 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
lIf 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
lAt 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
lPower FailureMachine stopped and after resume power should not loss the data.Power Backup Facility (UPS)

Performed by: __________________________  Verified by:_______________________

  1. ACCESS LEVEL SECURITY:
Sr. NoFeatureAcceptance CriteriaObservationsSign/Date
1AdminSystem should allow to create 30 Admin
2SupervisorSystem should allow to create 30 Supervisor
3OperatorSystem should allow to create 50 Operator
  1. TRAIL REPORT :

Machine Operational & Performance Verification (Trial- I):

Machine Speed

(RPM)

TrialWeight VariationFriability

(% w/w)

Hardness

(Kg/cm2)

Thickness

(mm)

Wt. of 20 Tablets

        (gm)      

Individual*

(mg)

NMT ±2% of target weightNMT ±5% of target weightNMT 1%NLT 2.0 KgTo monitor
5Sample #1    
Sample #2    
Sample #3    

Performed by: __________________________                      Verified by:__________________________

Machine Operational & Performance Verification (Trial- II)

Machine Speed

(RPM)

TrialWeight VariationFriability

(% w/w)

Hardness

(Kg/cm2)

Thickness

(mm)

Wt. of 20 Tablets

        (gm)      

Individual*

(mg)

NMT ±2% of target weightNMT ±5% of target weightNMT 1%NLT 2.0 KgTo monitor
15Sample #1    
Sample #2    
Sample #3    

Performed by: __________________________  Verified by:__________________________________

Machine Operational & Performance Verification (Trial- III):

Machine Speed

(RPM)

TrialWeight VariationFriability

(% w/w)

Hardness

(Kg/cm2)

Thickness

(mm)

Wt. of 20 Tablets

        (gm)      

Individual*

(mg)

NMT ±2% of target weightNMT ±5% of target weightNMT 1%NLT 2.0 KgTo monitor
25Sample #1    
Sample #2    
Sample #3    

Performed by: __________________________ Verified by:__________________________________

  1. CLIENT & COMPANY REMARK:
  • CLIENT Remark :

________________________________________________________________________________

___________________________(Sign/date)

  • Company Remark :

________________________________________________________________________________________________________________________________________________________________

___________________________ (Sign/date)

Sr. No.COMPANYCLIENT
NameSign & DateNameSign & Date
1    
2    
3    

Vitamin with Ginseng 200 mg Capsules

About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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