Site Acceptance Test Protocol for Blister Pack Machine

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Site Acceptance Test Protocol for Blister Pack Machine

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

Table of contents

Sr. No. Title Page No.
1.0         Approval Sheet 03
2.0         Purpose 04
3.0         Scope 04
4.0         Responsibilities 04
5.0         System description 05
6.0   SAT Procedure 06
7.0            Deficiency & Corrective Action Report 07
8.0            SAT Summary, report and Certification of SAT 08
  • APPROVAL SHEET: 

Prepared by:

Name Designation/Department Signature Date

 

Reviewed by:

Name Designation/Department Signature Date

 

Approved by:

Name Designation/Department Signature Date
  • PURPOSE:

The Objective of this site acceptance test is to verify that the Blister Pack Machine at Pharmaceutical Industry without any discrepancy along with appropriate documents.

  • SCOPE:

The Scope of this document is applicable to perform the Site acceptance test of  Blister Pack machine is to be installed at Pharmaceutical Industry.

  • RESPONSIBILITIES:
    • Engineering:
      • To prepare and review of Site acceptance test document.
      • To execute the SAT activity.
  • Manufacturing:
    • To review the Site acceptance test document.
    • To Co-ordinate with engineering department during SAT activity.
  • Quality Assurance:
    • To review the Site acceptance test document.
    • To Co-ordinate with engineering department during SAT activity.

      • Head Quality/Designee

→  To approve the site acceptance test document.

  • SYSTEM DESCRIPTION :
Sr. No. Description
The basic WEP3600 consists of the following sub assemblies:
I 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..
II 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.
III 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.
IV Guide Track Assembly

The Guide track assembly has 3 pieces of Guide Track length of 405 mm with Impression plate assembly before sealing station
V 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.
VI 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.
VII 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.
VIII 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.

 

  • SAT PROCEDURE:

M/S Bliscare Machines, Mumbai. representatives have performed SAT at the Pharmaceutical Industry. After delivery of Blister Pack Machine recorded all the data in the prescribed SAT checklist as per details given below:

  • Design SAT Verification Check list:
Sr. No. Description Acceptance Criteria Observation        Complies/Does Not  Complies Checked by(E G): Sign/Date
1. Purchase order

Should be available.

2. Installation, Operational and maintenance manual

Should be available.

3. Qualification documents

Should be available

4. Component Packing

All the component should be packed properly to avoid any damage during transportation.

5. Any physical damage to the equipment

No physical scratches or damage should be observed.

  

  • Deficiency & Corrective Action report:

In case there is any deficiency followed during stage of SAT, corrective action should be taken and same shall be recorded as given below:

Description of Deficiency (an extra sheet can be used if space is insufficient)

 

Raised by……………………                                                       

(Sign/date)

 Corrective Action :( an extra sheet can be used if space is insufficient)

 Approved By:     

Name of the Person    
Sign    
Date    

  

  • SAT Summary, Report and Certification of SAT:

 ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

 

Certificate of Site Acceptance Test

This is to certify that the ___________________________________

Has successfully completed the Site Acceptance Test.

This Site Acceptance Test has been performed by:

Sr. No. Name      Department Designation Sign/Date
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2
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