Qualifications & Validations

Factory Acceptance Test for Blister Pack Machine

Factory Acceptance Test for Blister Pack Machine

machine name:BLISTER PACK MACHINE.
Client Name & address:M/S BLISCARE MACHINES, MUMBAI.
document name:factory  acceptance test
PROTOCOL no.:
Revision no.:
MACHINE SR. NO.:

Table of Contents

1.SYSTEM DESCRIPTION & SALIENT FEATURES :…………………………………………………………….

2.SYSTEM CHECKS :……………………………………………………………………………………………………………

2.1 Physical Check :……………………………………………………………………………………………………………..

  1. TECHNICAL SPECIFICATIONS:……………………………………………………………………………………….
  2. TECHNICAL SPECIFICATIONS OF SUBCOMPONENTS/BOUGHTOUTS :……………………………
  3. MATERIAL OF CONSTRUCTION:………………………………………………………………………………………..
  4. FALCON & CLIENT REMARK:………………………………………………………………………………………

Blister Pack Machine

SYSTEM DESCRIPTION :

Sr. No. Description
The basic WEP3600 consists of the following subassemblies:
IStructure Assembly

The structure is enclosed on three sides are closed by frame and only back side covered with removable doors. Removing the knob side to access the machine back side assembly and Control Panels. The filter regulator for Main air inlet, dial Pressure Pneumatic solenoid valve assembly and Induction Motor with Worm reducer Gear Box Geared Motor for main drive assembly. Pack transport conveyor assembly..

IIForming Station Assembly

This consists of the main shaft with water jacketed housing and Vacuum, Vacuum ring assembly, Blister forming roller mounting main shaft with locking long Blot. Adjusting with forming roller assembly the Contact heater assembly will be there for Uniformly producing heat and transferred the same amount of heat to the forming foil to get Form the cavity uniformly.

IIIFeeding Station Assembly

This assembly consists of Variable vibration controlled Linear Vibrator assembly with Product Hopper and Universal Feeding Box with Feeding channel mounting holder. Below the Feeding Channel mounting assembly the dust collection point.

IVGuide Track Assembly

The Guide track assembly has 3 pieces of Guide Track length of 405mm with Impression plate assembly before sealing station

VSealing Station Assembly

The sealing station assembly with the Counter sealing roller mounting shaft with cylindrical lock nut and pressure sealing roller mounted shaft. The drive side of Sealing station has a pneumatic cylinder for control the sealing pressure with flow control knob.

VILinear Indexing Station Assembly

This consists of Linear Pusher assembly with eccentric stroke adjustable assembly with tie rod. The pusher assembly mounted on Linear indexing platform. Suitable size pusher use to fit in the assembly.

VIIPunch Station Assembly

This assembly consists of Punch Tool mounting assembly bracket and four mounting pillar for tool mounting Punch Tool Assembly. The Punch tool assembly has punch guide plate so called as stripper plate, which guide the sealed web to punch and die plate. After punched the Blister strip the excess Trim will get cut by trim cutter blade mounted in punch tool assembly.

VIIIPack Transport Conveyor Assembly

The Pack track Conveyor assembly consists of endless conveyor belt with beck support conveyor. The conveyor basic drive connected with main machine drive to get a synchronize speed of conveyor for maintain the conveyor speed.

 

  1. SYSTEM CHECKS :

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  

Verified by:_____________________           Performed by: _____________________

  1. TECHNICAL SPECIFICATIONS
Maximum Base Foil Width320mm – PVC/ PVC COATED PVDC Thickness Up to 350 Micron
Maximum Lidding Foil Width320mm, All Heat Sealable Aluminum Foils with 9gsm HSL.
Minimum – Maximum Punch Index30 – 110mm (Optional 136mm)
Minimum – Maximum Form Depth3mm to 16mm
SpeedUp to 120 Punching Cycle
Product FeedingAutomatic – By Universal Feeder

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  1. TECHNICAL SPECIFICATIONS OF COMPONENTS/BOUGHT OUTS
Sr No Description Speciation
1. Main Structure
MaterialStainless steel, SS 304
Surface FinishMate Finished Pre Buffed Sheets
2. Main Frame/ Forming/ Sealing and Punching Station with Form Heaters Assembly
Position.Above main structure
ManufacturerBliscare Machines
SpecificationForming/ Sealing and Punching Station
MaterialAluminum HE 30 Grade
Surface FinishGround Finish with Anodizing
3. Drive Assembly of Form/ Seal and Punch Assembly
Manufacture Bliscare MachinesPosition in the Station Drive Zone
Made ofMS Harden Mild Steels with 60 HRC
FinishBlacking
 

4. Indexing Station Drive Assembly

 

Position.Between Sealing and Punching Station
ManufacturerMechanical Linear Indexing
SpecificationLinear Type
MaterialTimer Belt Continental
Surface FinishAnodizing and ENP coating.
 

5. Station Drive Assembly

 

Position.Below Station assembly
ManufacturerBliscare Machines
Surface FinishWire Cutting & ENP Coating

 

  1. MATERIAL OF CONSTRUCTION
  2. All Product Contact Parts are made by SS 304 and Aluminum HE 30 Grade
  3. All SS 304 / Aluminum HE 30 Grade materials from India’s reputed Suppliers
  1. FALCON & SANO CITO REMARK:
  • Falcon Remark :

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

___________________________(Sign/date)

  • Sano Cito Remark :

_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ (Sign/date)

Sr. No.SANO CITOFALCON
NameSign & DateNameSign & Date
1 

 

   
2 

 

   
3 

 

   

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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