MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

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VIBRO SIFTER
GMP MODEL – 30”DIA.

DESIGN QUALIFICATION

CLIENT M/s. Milan Laboratories India Pvt. Ltd,

LOCATION Panvel
YEAR OF MFG. 2009-2010

Allied
MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT
Unit No. 17, Param Industrial Estate, Naik Pada, Waliv,
Vasai (East), District Thane- 401 208, Maharashtra,
India. Fax: 0250 –: 2451675 Tel : 6451697,
6454301, 2451674
Email: [email protected]
 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

TABLE OF CONTENTS

1.0 Pre-Approval

2.0 Overview
2.1 Purpose
2.2 Responsibility
2.3 Requalification
2.4 System Description
2.5
3.0 Performance Qualification Procedure
3.1 Test procedures.
3.2 Deficiency (if any) and corrective Action Report

4.0 Acceptance Criteria

5.0 Remarks (if any)

6.0 Summary
6.1 Conclusion
6.2 Post –Approval
6.3

7.0 Appendix
7.1 Abbreviations
7.2 List of documents

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 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

1.0 Pre-Approval

Signing of this Approval page of Performance Qualification Protocol No. 04 indicates

agreement with the Performance Qualification approach described in this document. Should
Modifications to the Performance Qualification become necessary; an addendum will be
prepared and approved.

Written By Signature Date

_______________________ S
(Manager - Project)

C Checked By Signature Date

_______________________
(Manager - Engineering)
_______________________
(Manager - Plant)

A Approved By Signature Date

______________________________
(Sr. Manager – Quality Assurance)

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 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

2.0 Overview

2.1 Purpose:

The purpose of this protocol is to provide an outline for the Performance of

equipment for static attributes to verify that:

♦ Machine is performing as per functional requirement mention in design

specifications.

2.2 Responsibility:

The validation group comprising of a representative from each of the following departments
shall be responsible for the overall compliance with this protocol:
♦ Project Department
♦ Engineering Department
♦ Production Department
♦ Quality Assurance Department

The Projects and Engineering Department shall be responsible for checking proper
process validation and recording validation data as per the procedures outlined in this
protocol.

The Quality Assurance Department shall be responsible for the final review of the
qualification documents and its compliance to meet the acceptance criteria of the
Performance Qualification protocol.

The summary report shall be approved by the head of Project, Engineering, Production
and Quality Assurance.

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 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

2.3 Requalification:

Performance Qualification to be re-qualified on:

♦ Replacement of major component of the equipment with a new component.

♦ Any major modification in the existing equipment.
♦ Any change in validation parameter.
♦ Shifting of the equipment from one location to another.

2.4 System Description

Ribbon Blender is used for mixing dry or dump materials and used for tablet
granulation. It consists of a 'U' shaped trough, solid SS end plates, SS shaft with
specially designed paddles. The shaft is coupled with heavy duty gear box & motor.
The shaft is supported on heavy duty bearing blocks at both the ends and provided
with Teflon seals & stuffing box.

Top cover is provided with SS grill structure for easy visibility during mixing
operation. The motor- gear box assembly is completely covered in enclosure
on/off push button box is provided with the machine with DOL starter. All SS parts
are polished to mirror finish from inside mirror and outside parts are matt finished.

Salient Features

• Standard and GMP model with contact parts in SS 316 quality.

• Top cover with SS lid.
• Solid stainless steel end covers and frame work on the trough in even standard
models for long trouble free life of the machine.

Technical specifications

Model BPE-VS-30

Main Motor 0.5 HP/1440, RPM FLP, Good Earth Make

Electrical Services 415 V/3 Phase, 50 Hz.AC Supply.

Output 100 Kgs./hr. or depend upon density of your product

Overall Dimension

Height 900 mm
Width 900 mm
Length 1200 mm

Net Weight 100 Kgs/hr.(Approx.–Depend upon density of powder)

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 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

3.0 Performance Qualification Procedure

3.1 Test procedures.

Output capacity Test

Procedure :- Make all the initial setting of the machine to get desired
capacity

Acceptance Criteria :- Machine should be capable of doing the set parameter

Output Quality Chart

Sr.No Processed material at Accepted Rejected

regular interval

Remarks:-

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 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

3.2 Deficiency (if any) and Corrective Action Report

If there is no deficiency, then write N. A.

Description of deficiency and date observed :

__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________

Person, responsible for corrective action and date assigned:

__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________

Corrective actions taken and date conducted :

__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________
__________________________________________________________________

Conducted By : ___________________ Approved By : ___________________

Date : ___________________ Date : ___________________

Checked by
(Project) Name Sign. Date

Verified by
(Engineering) Name Sign. Date

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 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

4.0 Acceptance Criteria

Performance Qualification shall be considered acceptable when all the conditions

specified in various forms under section 3.0 have been met.
Any deviation from the acceptance criteria of the specific check point shall
be reported and decision should be taken for the rejection, replacement or
rectification of the equipment/component.
5.0 Remarks (if any) :

_________________________________________________________________________
_____________________________________________________________________

6.0 Summary:

Checks Observations Remarks

Whether acceptance criteria of Yes/No
the protocol and Specific check
points are met.

6.1 Conclusion :

Mass Mixer bearing Mac No. ------ Is / Is Not qualifying the performance qualification test
as per the guideline described in this Protocol No. 04 can Be / Not Be tested for its
performance qualification.

6.2 Post-Approval Signatures

Name Signature Date

_________________________
(Manager – Project)
_________________________
(Manager - Engineering)
_________________________
(Manager - Plant)
___________________________
(Sr. Manager – Quality Assurance)

7.0 Appendix
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 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

7.1 Abbreviations

7.2 List of Documents

1. M.O.C. of S.S. 316 & 304 Quality Material

2. Motor Certificate
3. Gasket Certificate
4. G.A. Drawing

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