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Factory Acceptance Test for Automatic Strip Packing Machine

Factory Acceptance Test for Automatic Strip Packing Machine

machine name : AUTOMATIC STRIP PACKING MACHINE
   
Client Name & address : M/S.
   
document name : factory acceptance test
   
PROTOCAL no. : SCT/FAT/000
   
Revision no. : 00
   
MACHINE SR. NO. :
 

Table of Contents

Sr. No. Title Page No.
1.0         Purpose
2.0         Scope
3.0         Responsibilities
4.0         System description
5.0   Test and inspection
6.0            Trail report
7.0            Fat remark
  • PURPOSE:

The Objective of this Factory acceptance test is to verify and inspection of Automatic Strip Packing Machine, by representative of ____________ at fabrication site of ____________________.

  • SCOPE:

The Scope of this document is applicable to perform the factory acceptance test of Automatic Strip Packing Machine at __________________________. before deliver to ________________________________.

  • RESPONSIBILITIES:
    • Engineering:
      • To prepare and review of factory acceptance test document.
      • To execute the FAT activity.
  • Manufacturing:
    • To review the factory acceptance test document.
    • To Co-ordinate with engineering department during FAT activity. 
  • Quality Assurance:
    • To review the factory acceptance test document.
    • To Co-ordinate with engineering department during FAT activity. 
  • Head Quality/Designee
    • To approve the factory acceptance test document.
  • SYSTEM DESCRIPTION :

The Strip Packing Machine is designed for packing of Tablet and Capsule within two heat sealable foil. The machine has been designed to use cellophane Film, Cellophane Lumithene, Aluminum Foil, Polythene Film Laminates and all heat sealing papers for sealing purpose.

The Tablet / Capsules are charged into the hopper. Tablets / Capsules are automatically fed to vibrating bowl. Individual Tablets passes vertically through chute provided and are enclosed between pockets formed by two plies of film. These two films are heat sealed when pass through the sealing roller. These rollers are provided with heaters.

Horizontal cutting of the strip is done by the knife and vertical cutting is done by vertical cutter.

The major component of the equipment are identified us:-

  • Feeding System
  • Sealing System
  • Batch Coding Unit
  • Cutting System

Feeding System:-Product is fed into the hopper from where it is guided into the Bowl mounted on a Vibrator. The product on the bowl is evenly distributed and guided through the Tracks on the Bowl into the Chute Channel and the feed rate of the product from the Bowl to the Chute channel is controlled by the vibrator. The Product from the chute is released onto the Sealing Roller by the Cam Operated Released Pin.

Sealing System: – The set of Sealing Rollers drawn the heat sealing Packing Material from two set of front adjustment type of friction brake system Foil holding Assembly and Foil Running Tube. The Sealing Roller is are heated to the required temperature by the Cartridge Heaters inserted into the individual Roller. Adequate pressure is applied onto the Sealing Rollers so that both the foil get sealed at the time of contact while passing through the Sealing Roller. At this stage the product which is released onto the cavity of the Roller gets packed and sealed in the foil.

Batch Coding Unit:- The left hand foil before being drawn by the Sealing Rollers passes through the Batch Coding Unit where the Batch No., Mfg. Dt., Exp. Dt. Etc is printed on the foil.

Cutting System:- The packed and sealed strip from the sealing roller passes through the Brush and Slitter Shaft which cuts the Strips vertically. These vertically cut strips then passes through the Cam operated Cutter assembly which cuts the Strip Horizontally into the desired Strip Length. The desired Strip Length can be achieved by using the appropriate Cutting Gear and Toe Cams.

The machine equipped with basic drive unit controlled by Servo Drive. Linear- Indexing servomotor is controlled by servo- drives. A freely Programmable Logic Controller, interfaced with digital display unit (Man-Machine Interface), controls the multiple functions on the machine.

The PVC, PVDC and ALU-ALU cold forming film can be used as Forming / Base film, in which blister cavities are formed by compressed air and mechanical pressure.

Draw the forming film from the forming reel feed and passes between the Forming die & blow head through forming heating platen in case of thermo-formable material and forming tool in case ALU-ALU cold forming foil (Change Part) through the dancing arm to the linear indexing station via forming, sealing Station, Perforation Station.

The movement of unwinding of forming film draw motor is controlled by proximity switch for start of the unwinding and stop of the unwinding of the foil from the reel feed.

This blister formed web moves over the web guide track and at this station the products are fed into the blisters through individual feeding devices. The formed web along with the tablet or capsules moves to the sealing station, where it is fused to the aluminium foil, which has been drawn from an aluminium reel – feed station. That printed sealed web is transferred to mechanically driven perforation station (If Applicable) through Linear Indexing. The punching tool punches out the specified pack, which is transferred to the out feed conveyor.

The waste web is then transferred to the trim winding station passing over the dancing arm and guide rollers where the trim is wound on the trim-winding roller.

All the operational controls and sequences of the machine are arrayed by Man- Machine Interface (MMI) which is conveniently located in front of the machine and rotary encoder, which determines the positional accuracy of the machine with the feedback.

All parametric changes can be done with controls through the Man-Machine- Interface, which has multiple levels of password protection.

Products to be packed on the machine are specifically pharmaceutical products such as Tablets and Capsules. Different types of product can be fed into the blister formed cavities on the formed web over the web guide track at the feeding zone.

The output capacity of the machine depends upon the product characteristics like size and shape of the products and on the type of feeding device.

TEST AND INSPECTION:

  • 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 RPM meter ,Timer -Calibration certificated should be available    
Document verification Verification of MOC certificate -MOC certificated should be available    

 Performed by: ____________________                                          Verified by: _____________________

Basic Component Verification :

Sr. No. Test Description Acceptance

Criteria

Test

Method

Observation Acceptance

Criteria

fulfilled

Checked

by

Verified

by

l Machine

Dimensions

3870 (L) X 1182 (W) X 1965 (H) mm + 2% mm Machine

Dimensions

Yes

No

l G.A. Drawing Machine construction should meet with G.A. drawing. Visually

Via Tag

Yes

No

l Main switch (ON/OFF) ON/ OFF function

Qty.: 01 no.

Visually

Via Tag

Yes

No

l Emergency switch (ON/OFF) Make: Banner

Qty.: 1 No.

Visually

Via Tag

Yes

No

l Hopper 40 + 1 Visually

Via Tag

Yes

No

l Vibrator plate 1.25 + 0.025 Visually

Via Tag

Yes

No

 

Sr. No. Test Description Acceptance

Criteria

Test

Method

Observation Acceptance

Criteria

fulfilled

Checked

by

Verified

by

l Model Name Visually

Via Tag

Yes

No

l Serial Number Visually

Via Tag

Yes

No

l Wiring reference Visually

Via Tag

Yes

No

l Type of forming Flat, Intermittent Visually

Via Tag

Yes

No

l Base material reel feeds One Number □ Visually

□ Via Tag

□ Yes

□ No

l Reel change over Manual □ Visually

□ Via Tag

□ Yes

□ No

l Base Foil unwinding Pneumatically operated brake belt for reel feed and loop control by driven motor □ Visually

□ Via Tag

□ Yes

□ No

 

Sr. No. Test Description Acceptance

Criteria

Test

Method

Observation Acceptance

Criteria

fulfilled

Checked

by

Verified

by

l Method of forming Mechanical compressive plug assisted cold Forming.

Compressed air Thermo forming. (For Thermo-formable material)

Visually

Via Tag

Yes

No

l Type of feeding Automatic feeding system.

Product specific – Feeder can be changed.

Consisting of Product Hopper, Linear Vibrator, Rotary Vibrator, Bowl dish, Feeding track sector, Vertical Feeding channel with Release pin mechanism.

Visually

Via Tag

Yes

No

l Lidding material unwind

 

With brake belt.

 

Visually

Via Tag

Yes

No

l Type of sealing Flat, Intermittent.

 

Visually

Via Tag

Yes

No

 

Sr. No. Test Description Acceptance

Criteria

Test

Method

Observation Acceptance

Criteria

fulfilled

Checked

by

Verified

by

l Password protection There are levels of user authorization to Control the accessibility of parameters. Visually

Via Tag

Yes

No

l Jog mode / inch mode Inch/Jog mode for machine setting adjustments Visually

Via Tag

Yes

No

l Run Mode  For Indication of ready Inputs.

 For Indication of Safety interlocks.

 For starting of main motor in smooth mode.

 For building up of speed up to set speed.

Visually

Via Tag

Yes

No

l Cyclic operation To define cyclic operation:

 Stamping

 Base foil draw

 Indexing

 Punching

Visually

Via Tag

Yes

No

l Emergency  For stopping machine immediately.

 For indication on tower lamp.

Visually

Via Tag

Yes

No

 

 

Sr. No. Test Description Acceptance

Criteria

Test

Method

Observation Acceptance

Criteria

fulfilled

Checked

by

Verified

by

l Print registration control (If Applicable)  

 To detect and correct Eye mark position.

 

Visually

Via Tag

Yes

No

l Sealing Heater temperature control  For On-Off control for heater temperature control.

 For Interlock with machine operation.

Visually

Via Tag

Yes

No

l Control of individual motor for sub-drives  In-feed motor control.

 Conveyor motor control.

 Vibrator controller.

Visually

Via Tag

Yes

No

l Feeding control.  To control the level of product in Bowl dish

 To control the vibrator.

Visually

Via Tag

Yes

No

 

Sr. No. Test Description Acceptance

Criteria

Test

Method

Observation Acceptance

Criteria

fulfilled

Checked

by

Verified

by

PLC INTERLOCKS VERIFICATION
l Low temperature of sealing heater Inter locked with Machine working in ‘RUN‘ mode Sealing temperature Low

 

Yes

No

l High temperature of sealing heater Interlocked with Machine working in ‘RUN’ mode Sealing

temperature high

Yes

No

l Emergency switch Inter locked with Machine working in ‘RUN’ mode and

Inch mode.

1.Emergency

Pressed –Press

Reset

2. Index servo error No. Press Reset

3. Main servo error No. Press Reset

Yes

No

l Lid foil presence Inter locked with Machine working in ‘RUN‘ mode Lidding foil over Yes

No

l Base foil presence Inter locked with Machine working in ‘RUN‘ mode Base foil over

 

Yes

No

 

Sr. No. Test Description Acceptance

Criteria

Test

Method

Observation Acceptance

Criteria

fulfilled

Checked

by

Verified

by

PLC INPUT/OUTPUT DETAILS
l PLC make B&R Industrial Automation Visually

Via Tag

Yes

No

l Serial number A1590180513 Visually

Via Tag

Yes

No

l Model 4PP420.0571-75 Visually

Via Tag

Yes

No

l Display Graphical Colour (tft) Visually

Via Tag

Yes

No

l Supply voltage 24 V DC Visually

Via Tag

Yes

No

l Memory 64/128 MB DRAM Visually

Via Tag

Yes

No

 

Sr. No. Test Description Acceptance

Criteria

Test

Method

Observation Acceptance

Criteria

fulfilled

Checked

by

Verified

by

MOC (Material of Construction)
· Machine body cladding SS 304 Visually

Via Tag

Yes

No

· Basic machine body SS 304 Visually

Via Tag

Yes

No

· Hopper SS 316L Visually

Via Tag

Yes

No

· Vibrator SS 316L Visually

Via Tag

Yes

No

· Conveyor Belt Polyvinyl Chloride Visually

Via Tag

Yes

No

· Feeding unit rubber roller Silicon Rubber Visually

Via Tag

Yes

No

· Machine Front Cover Guard Polycarbonate Visually

Via Tag

Yes

No

Performed by: __________________________ Verified by:_____________________________

 TRAIL REPORT:

Machine Operational & Performance Verification (Trial- I):

Effect of machine speed:  

S. No. Machine Speed

(Cuts / Min.)

Sealing Temp.

(°C)

Vibrator Speed Description
Knurling Impression of Strips Leak test failure % Pocket integrity failure % Batch Coding
1.  
2.
3.

 Performed by: __________________________   Verified by:___________________________________ 

Machine Operational & Performance Verification (Trial- II):

Effect of Sealing Temperature:  

S. No. Sealing Temp. (°C) Machine Speed

(Cuts / Min.)

Vibrator Speed Description                              
Knurling Impression of Strips Leak test failure % Pocket integrity failure % Batch Coding
1.  
2.
3.

 Performed by: __________________________  Verified by:___________________________________ 

Machine Operational & Performance Verification (Trial- III):

Effect of Vibration:  

S. No. Sealing Temp. (°C) Machine Speed

(Cuts / Min.)

Vibrator Speed Description                              
Knurling Impression of Strips Leak test failure % Pocket integrity failure % Batch Coding
1.  
2.
3.

 Performed by: __________________________  Verified by:___________________________________

 FAT REMARK:

Vendor Remark :

Client Remarks :

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit 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. He 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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