MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

TAMIZADOR
GMP MODEL 30DIA.
CALIFICACION DE DISEO

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: admin@alliedworld.in

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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

TABLE OF CONTENTS
1.0

Pre-Approval

2.0

Overview
2.1
2.2
2.3
2.4

Purpose
Responsibility
Requalification
System Description

2.5
3.0

Performance Qualification Procedure

3.1
3.2

Test procedures.
Deficiency (if any) and corrective Action Report

4.0

Acceptance Criteria

5.0

Remarks (if any)

6.0

Summary
6.1
6.2
6.3

7.0

Conclusion
Post Approval

Appendix
7.1
7.2

Abbreviations
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

Signature

Date

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

A Approved By
______________________________
(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
Width
Length

900 mm
900 mm
1200 mm
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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

Net Weight
3.0
3.1

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

Performance Qualification Procedure

Test procedures.
Output capacity Test
Procedure

:-

Acceptance Criteria :-

Make all the initial setting of the machine to get desired

capacity
Machine should be capable of doing the set parameter

Output Quality Chart

Sr.No Processed material at
regular interval

Accepted

Rejected

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
Whether acceptance criteria of

Observations
Yes/No

Remarks

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)
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MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

7.0

Appendix

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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