Site Acceptance Test Protocol for Sifter 36” Vibro Type

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Site Acceptance Test Protocol for Sifter 36” Vibro Type 

Machine Name:SIFTER 36” VIBRO TYPE
Client Name & Address:FALCON, AHMADABAD, INDIA
Document Name:Site Acceptance Test Protocol
PROTOCOL No.:
Revision no.:00
MACHINE SR. NO.:

Table of contents

Sr. No.TitlePage No.
1.0         Approval Sheet03
2.0         Purpose04
3.0         Scope04
4.0         Responsibilities04
5.0         System description05
6.0   SAT Procedure06
7.0            Deficiency & Corrective Action Report07
8.0            SAT Summary, report and Certification of SAT08

 

  • APPROVAL SHEET:

Prepared by:

NameDesignation/DepartmentSignatureDate

 

Reviewed by:

NameDesignation/DepartmentSignatureDate

 

Approved by:

NameDesignation/DepartmentSignatureDate

 

  • PURPOSE:

The Objective of this site acceptance test is to verify that the Sifter 36” Vibro Type, Falcon machinery, Ahmadabad, India is delivered to Pharmaceutical  Industry without any discrepancy along with appropriate documents.

  • SCOPE:

The Scope of this document is applicable to perform the Site acceptance test of Sifter 36” Vibro Type. Sifter 36” Vibro Type is to be installed at a Pharmaceutical Company.

  • 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 :

 Sifter 36” Vibro Type is used for screening of raw materials (active ingredients and excipients) and dried granules, using Stainless Steel circular sieves of desired mesh size, resulting in powder or granules of specified particle size distribution. The oversize material is retained over the stainless steel sieve and the undersize passes through the sieve due to vibratory action of sifter.

Vibro sifter works on gyro principle. The required gyratory motion is obtained from specially designed gyro motor, which is fitted underneath the vibrating assembly. The complete vibrating assembly is isolated from the base by means of specially designed rugged springs. Gyro-motor is fitted with the top & bottom eccentric weights designed as per required centrifugal force. This whole assembly is covered by S.S. plate. The deck hopper is fabricated from S.S. 316 sheet. To collect the discharge tangential, discharge port is provided on the hopper. Conical shape top lid is provided with charging port. Screen is fitted in between the hopper & top lid. The machine inner & outer surfaces are mirror polished.

•  SAT PROCEDURE:

Falcon, Ahmedabad, India representatives have performed SAT at the Pharmaceutical Company after delivery of Sifter 36” Vibro Type, recorded all the data in the prescribed SAT checklist as per details given below:

  • Design SAT Verification Check list:
Sr. No.DescriptionAcceptance CriteriaObservation    Complies/

 Does Not   Complies

Checked by(EG): Sign/Date
1.Purchase orderShould be available.

2.Installation, Operational and maintenance manualShould be available.

3.Qualification documentsShould be available

4.Component PackingAll the component should be packed properly to avoid any damage during transportation.

5.Any physical damage to the equipmentNo 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 the 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     DepartmentDesignationSign/Date
1
2
3