Qualifications & ValidationsBlister Machine

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

Table of Contents

SYSTEM DESCRIPTION & SALIENT FEATURES

SYSTEM CHECKS :

Physical Check :

TECHNICAL SPECIFICATIONS

TECHNICAL SPECIFICATIONS OF SUBCOMPONENTS/BOUGHTOUTS

MATERIAL OF CONSTRUCTION

VENDOR & CLIENT REMARK

 SYSTEM DESCRIPTION :

The basic WEP3600 consists of the following subassemblies:

Structure 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..

Forming 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.

Feeding 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.

Guide Track Assembly

The Guide track assembly has 3 pieces of Guide Track length of 405mm with Impression

plate assembly before sealing station

Sealing 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.

Linear 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.

Punch 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.

Pack 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.

SYSTEM CHECKS :

Physical Check :

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

3.0 TECHNICAL SPECIFICATIONS

Maximum Base Foil Width

320mm – PVC/ PVC COATED PVDC Thickness Up to 350 Micron

Maximum Lidding Foil Width

320mm, All Heat Sealable Aluminum Foils with 9gsm HSL.

Minimum – Maximum Punch Index

30 – 110mm (Optional 136mm)

Minimum – Maximum Form Depth

3mm to 16mm

Speed

Up to 120 Punching Cycle

Product Feeding

Automatic – By Universal Feeder

 4.0 TECHNICAL SPECIFICATIONS OF COMPONENTS/BOUGHT OUTS

1. Main Structure

Material

Stainless steel, SS 304

Surface Finish

Mate Finished Pre Buffed Sheets

2. Main Frame/ Forming/ Sealing and Punching Station with Form Heaters Assembly

Position.

Above main structure

Manufacturer

Bliscare Machines

Specification

Forming/ Sealing and Punching Station

Material

Aluminum HE 30 Grade

Surface Finish

Ground Finish with Anodizing

3. Drive Assembly of Form/ Seal and Punch Assembly

Manufacture Bliscare Machines

Position in the Station Drive Zone

Made of

MS Harden Mild Steels with 60 HRC

Finish

Blacking

4. Indexing Station Drive Assembly

Position.

Between Sealing and Punching Station

Manufacturer

Mechanical Linear Indexing

Specification

Linear Type

Material

Timer Belt Continental

Surface Finish

Anodizing and ENP coating.

5. Station Drive Assembly

Position.

Below Station assembly

Manufacturer

Bliscare Machines

Surface Finish

Wire Cutting & ENP Coating

MATERIAL OF CONSTRUCTION

All Product Contact Parts are made by SS 304 and Aluminum HE 30 Grade

All SS 304 / Aluminum HE 30 Grade materials from India’s reputed Suppliers

SUPPLIER & CLIEENT REMARK:

SUPPLIER Remark :___________ (Sign/date)

Client Remark :______ (Sign/date)

PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION

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