MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

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VIBRO SIFTER
30” DIA. (GMP MODEL)

OPERATING QUALIFICATION

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

PARTY’S REF. (P.O) NO.

MONTH & YEAR OF MFG. 2009-2010

LOCATION Panvel
OUR REF. NO.

JOB NO.
521006
MODEL NO.
30VS

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
 MANUFACTURES OF PAHRMACEUTICAL EQUIPMENT

PROTOCOL APPROVAL COVER PAGE

The signatures below indicate approval of this protocol.

Once signatures are obtained, execution of the protocol may begin.
Department Authorized Signature Date
Person

Initiated by

Reviewed
by

Approved
by

CONTENTS

Sr.
No. TITLE
1.0 Introduction
2.0 Rationale
3.0 Responsibilities
4.0 Equipment Critical to Study
5.0 Qualification Description
5.1 Prerequisites
5.2 Start Up
5.3 Emergency Stop
5.4 Power Failure
6.0 Criteria For Acceptability
7.0 Conclusion

OQ Data Sheets
Operational Qualification Approval Page

1.0 INTRODUCTION

1.1 The objective of this Protocol is to provide guidelines for the installation of the
Vibro Sifter.

1.2 Installation details for the Vibro sifter are available in installation qualification
Protocol (II/PP/RPT/QUA/18). The operation of the equipment is described in the
SOP titled operation of Vibro sifter SOP No. II/PP/SOP/OPR/3

1.3 The objective of this study is to assess the ability of the sifting equipment to
operate correctly as per the designed parameters. The study will also assess the
electrical operations.

2.0 RATIONALE FOR QUALIFICATION PROGRAMME

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The sifter functions by imparting vibratory energy to the granules in the bowl by means
vibrating motor. The amount of energy imparted is proportional to the motor speeds. These
functions of the equipment will be challenged within the anticipated operational limits. Also,
all electrical and sealing operations of the equipment shall be qualified. The equipment will
be validated for the following functions in manual and auto mode:

2.1 Critical operating parameters:

2.1.1 Leakage
2.1.2 Material movement
2.1.3 Vibration.

2.2 Power Failure

3.0 RESPONSIBILITIES

3.1 The responsibility of the Validation Team is overall adherence to this protocol.
Specific duties include:

3.1.1 Monitoring Protocol completeness, accuracy, technical excellence and

applicability.
3.1.2 Scheduling and Operational Qualification activity
3.1.3 Maintenance and calibration of validation equipment
3.1.4 Conducting the Operational Qualification activity
3.1.5 Data review of validation Protocol preparation
3.1.6 Approval of Protocol

3.2 The responsibility of the Q.A. Department includes:

3.2.1 Issue validation data sheet to the validation team

3.2.2 Review of validation data
3.2.3 Approval of validation Protocol

3.3 The responsibilities of Formulation Development are as follows:

3.3.1 To make critical equipment available for validation. (The

equipment is listed in Section 4 of this protocol)
3.3.2 Review of data and approval of Protocol

3.4 Exceptional Conditions and Deviations

Any minor changes or deviations that are necessary to comply with this protocol
will be documented in the final Protocol. Any significant changes or deviations
altering the scope or intent of this protocol require prior approval by the original
signatories and documentation in the final Protocol.

4.0 EQUIPMENT CRITICAL TO STUDY

4.1 Calibrated Stopwatch (tag no IIE 29)
4.2 Calibrated Technometer (tag no. IIE 30)
4.3 Vibro Sifter (Tag no IIE - 55)

5.0 QUALIFICATION PROGRAMME

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5.1 Prerequisites

5.1.1 Confirm that the equipment/system is installed, the Installation Qualification

completed and installation package approved, and is ready for operation.
5.1.2 Confirm that the operating SOP exists, in draft or approved form, to support
operational testing.
5.1.3 Verify that all instruments associated with this equipment/system, including
those to be used for testing, have been calibrated and that the re-calibration
dates will not expire before execution of this protocol has been completed.
5.1.4 Verify that all materials and test equipment are available for the execution of
this Protocol.

5.2 Start-Up
5.2.1 Ensure that the main electrical supplies are ‘ON’
5.2.2 Switch ‘ON’ the power at the main switch cabinet.
5.2.3 Ensure that equipment is cleaned before operation.
5.2.4 Checks that sieving screen fits properly.
5.2.5 Ensure that all gaskets are closed.
5.2.6 Ensure that material moves in circulation motion
5.2.7 Start the sifting operation
5.2.8 Run the machines for 30 mins.

ACCEPTANCE CRITERIA: All operations should be smooth.

5.3 Noise Generation

5.3.1 Run the Vibro Sifter for some time and observe for generation of noise.

ACCEPTANCE CRITERIA: No noise generation.

5.4 Direction of Rotation

5.4.1 check the direction of motor

5.5 Seals
5.5.1 Visually check for leaks from top lid and top deck.
5.5.2 Visually check for leaks from ‘C’ Clamp.
ACCEPTANCE CRITERIA: No leakage

6.0 CRITERIA FOR ACCEPTABILITY

The Operations Qualification of Vibro Sifter shall be considered acceptable if individual
operating parameters fall within anticipated acceptable limits. If the results do not meet
anticipated acceptance limits, the review team shall meet and agree corrective actions.

7.0 CONCLUSION
The collected data shall be analyzed, evaluated and reviewed against the acceptable
limits for operation. The conclusions shall be drawn based on review of data and
suggestions shall be made to optimize the operational efficiency of equipment.

DRAWING - I

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OQ DATA SHEETS

IDENTIFICATION OF PERSONNEL PERFORMING OPERATIONAL QUALIFICATION

DEPARTMENT SIGNATURE DATE

OQ DATA SHEET

RECORDED ACCEPTANCE
STEP REQUIRED
CRITERIA
Confirm equipment /
system installed, I.Q. IQ documents reviewed and
5.1.1
complete and ready for approved.
operation.

5.1.2 Confirm SOP exists SOP exists

Confirm instruments
5.1.3 calibrated and re-
calibration date not All instruments calibrated.
expired.
Verify all materials and
5.1.4 test equipment available Test equipments available

Verify electrical supplies All utilities available in right

5.1.5
are “ON” capacity.
5.1.6 Verify equipment cleaning Should be cleaned
5.1.7 Sieving screen Fits properly
Should not generate noise
5.1.8
from damp and feed No noise
hopper
5.1.9
Material should move in Material movement in
circulation direction circulation direction
Continuous material
movement through Material moves out of
5.1.10
discharge chute discharge chute continuously

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OPERATIONAL QUALIFICATION APPROVAL PAGE

OBSERVATION:

CONCLUSION:

SUGGESTION:

_________________ _________________ _________________

PREPARED BY: REVIEWED BY: APPROVED BY:
(Formulation Technologist) (Manager Formulation Development) (Quality Assurance Dept)

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