FACTORY ACCEPTANCE TEST FOR BIN BLENDER

FACTORY ACCEPTANCE TEST FOR BIN BLENDER

machine name:BIN BLENDER (600 LTRS)
Client Name & address:SAIMACH PHARMATECH PVT LTD
document name:factory acceptance test
PROTOCAL no.:SCT/FAT/002
Revision no.:00
MACHINE SR. NO.:

Table of Contents

1.0 SYSTEM DESCRIPTION 

2.0 Physical Check

2.1 Basic Component Verification

3.0 VERIFICATION OF SAFETY & INTERLOCK FEATURE

4.0 TRAIL REPORT

5.0 VENDOR & CLIENT REMARK

1.0 SYSTEM DESCRIPTION :

The Bin Blender is basically designed by the manufacturer for batch processing to blend (mix) the pharmaceutical bulk powders. The capacity as designed can hold a maximum of 600 liters as its bowl volume. The working volume however will be 480 liters.

All the contact parts will made out of SS 316. Effective sealing arrangements at the impeller shafts further support this. The special design of Impeller helps in efficient blending of the material.

Limit switch is provided for the interlocking system for Motor.

The purpose of container bin blender is to mix various substances in dry powder and / or granular form. Mixing can be achieved by selecting suitable RPM and suitable time period depending on the product characteristic. Following setting can be done in the VFD;-

  • RPM setting.
  • Soft start.
  • Soft stop

Complete machine can be divided in following sub sections: –

Drive shaft with bearing housing of speed reduction system consisting of brake motor& worm &worm wheel  reduction gear box, container holding arm, hydraulic power pack & cylinder, main electric panel& safety railing with operating panel

PLC    Description

The main function of a PLC is to translate the instruction into the digital or analog codes needed to operate the device or machine. The main function of this PLC system is to collect data from field instrumentation & display the information on the operator station. The instruments are connected to the system equipment and piping. The collected data will be utilized by the PLC for process control.

The user interface based in a PV 300 (Allen Bradley), will assist the operator to supervise and control the process. Based on the displayed information the operator, by means of the user interface, can provide commands to the PLC. The PLC then executes the operator instructions.

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 RPM meter ,Timer-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

 

________(L) X ________ (W) X_________ (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: Banner

l   Qty.: 1 No.

Visually

Via Tag

Yes

No

 

Sr. No.Test DescriptionAcceptance

Criteria

Test

Method

ObservationAcceptance

Criteria

fulfilled

Checked

by

Verified

by

lBowl·     600 Liter Bin

·     Manufactured from Stainless Steel 316.

·     Bin Shape

Visually

Via Tag

Yes

No

lBowl Lid·     Manually Opening.

·     Handle for opening and charging manually.

Visually

Via Tag

Yes

No

lImpeller·     Stainless Steel 316.

·     Mounted on a double ball bearing assembly.

Visually

Via Tag

Yes

No

lDrive·     Motor, 5.0 HP, 1440 RPM, Non-Flame Proof.

·     Drive transferred via a gearbox.

Visually

Via Tag

Yes

No

 

Sr. No.Test DescriptionAcceptance

Criteria

Test

Method

ObservationAcceptance

Criteria

fulfilled

Checked

by

Verified

by

lControl Panel·     One control panel –  MOC – Stainless steel 304, mounted on structure consisting of

·     Motor Contactors.

·     Indication lamps.

·     MCB.

·     Isolator Switch.

·     No cables or pneumatic piping is supplied along with standard supply.

Visually

Via Tag

Yes

No

lStructure·     Mild Steel cladded with Stainless Steel 304 & guards where necessary.Visually

Via Tag

Yes

No

lGeneral Finishing Requirement·     Inner Surface: Mirror Polished

·     Outer Surface: Matt Polished

Visually

Via Tag

Yes

No

 

Sr. No.Test DescriptionAcceptance

Criteria

Test

Method

ObservationAcceptance

Criteria

fulfilled

Checked

by

Verified

by

lBowl Volume600 Liters.Visually

Via Tag

Yes

No

lWorking Volume Minimum180 Liters.Visually

Via Tag

Yes

No

lImpeller RPM2-12 RPMVisually

Via Tag

Yes

No

lElectrical Power Specifications.Voltage: – 380 + or – 10%

Phase: – 3 Phase

Frequency: 50/60 Hz

Visually

Via Tag

Yes

No

lFor operator safetyControl On / Off SwitchVisually

Via Tag

Yes

No

lFor Machine SafetyLimit SwitchVisually

Via Tag

Yes

No

 

Sr. No.Test DescriptionAcceptance

Criteria

Test

Method

ObservationAcceptance

Criteria

fulfilled

Checked

by

Verified

by

lElectric MotorsCrompton or equivalentVisually

Via Tag

Yes

No

lElectrical ComponentsSchinderVisually

Via Tag

Yes

No

lIndication LampsSchinder, Teknic, Telemechanique or compatible.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 machine will stop. Yes

 □ No

  

Performed by: _____________________ Verified by: ____________________________

6.0 TRAIL REPORT :

Machine Operational & Performance Verification (Trial- I):

Machine Speed

(RPM)

TrialLimit: Should Be sameDone By
02 RPMRun – I  
Run – II  
Run – III  

Verified by:___________________________________ 

Machine Operational & Performance Verification (Trial- II)

Machine Speed

(RPM)

TrialLimit: Should Be sameDone By
08 RPMRun – I  
Run – II  
Run – III  

 Performed by: _______________________  Verified by:___________________________________

 Machine Operational & Performance Verification (Trial- III): 

Machine Speed

(RPM)

TrialLimit: Should Be sameDone By
12 RPMRun – I  
Run – II  
Run – III  

 

 

Performed by: ______________________          Verified by: ____________________________

7.0 VENDOR & CLIENT REMARK:

  • SUPLLIER Remark :

________________________________________________________________________________

___________________________(Sign/date)

  • CLIENTRemark :

________________________________________________________________________________

___________________________ (Sign/date)

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

FACTORY ACCEPTANCE TEST FOR BLISTER PACK MACHINE

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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