Operational Qualification Protocol OF Vacuum Tray Dryer

OPERATIONAL QUALIFICATION
PROTOCOL
OF
VACUUM TRAY DRYER
TABLE OF CONTENTS
1.0 PROTOCOL APPROVAL SHEET.....................................................................................3

2.0 REVISION HISTORY..........................................................................................................4
3.0 TITLE......................................................................................................................................4
4.0 OBJECTIVE...........................................................................................................................4
5.0 SCOPE....................................................................................................................................4
6.0 RESPONSIBILITIES............................................................................................................5
7.0 VALIDATION TEAM...........................................................................................................5
8.0 SYSTEM/EQUIPMENT DESCRIPTION...........................................................................6
9.0 ACCEPTANCE CRITERIA:................................................................................................7
10.0 STANDARD OPERATING PROCEDURES REFERNCES............................................7
11.0 VALIDATION TEST PROGRAM......................................................................................8
12.0 DEVIATION REPORT.........................................................................................................9
13.0 REQUALIFICATION CRITERIA:...................................................................................10
14.0 DOCUMENTATION...........................................................................................................10
15.0 OPERATIONAL QUALIFICATION SUMMARY REPORT........................................10
1.0 PROTOCOL APPROVAL SHEET:
The Operational Qualification Protocol of the System/ Equipment shall be prepared, reviewed and
approved by the concerned personnel’s. It shall be signed and dated as shown below.
Prepared By:
Name Designation Signature Date
Satyam Shah Shift Incharge-Production
Reviewed By:
Bela Patel Executive-QA
Mayur Donga Manager-Production
Haresh Patel Operation-Head
Approved By:
Komal Sojitra Sr. Executive-QA
2.0 REVISION HISTORY
Reason for Revision/Change

Revision Revision Date Revised By
Request
00 NA New Document NA
3.0 TITLE
Sifter used for the separate mass composition of solids from solids and for gradation of material as per
particle size.
4.0 OBJECTIVE
This protocol shall verify that the operate components are the ones specified and properly identified as
stated in the operational Qualification of Sifter SI-01-002.
5.0 SCOPE
The scope of this Protocol shall be limited for blender which is located in PP Area at Darsh
Pharmachem Pvt. Ltd. Mahemdabad - Nadiad highway, Gujarat.
6.0 RESPONSIBILITIES
 Production: Responsible for preparation & review of the operational Qualification Protocol and
operate the equipment.
 Engineering: Responsible for review of the operational Qualification Protocol.
 Quality Assurance: Responsible for review and finally approve the installation qualification
protocol and report.
7.0 VALIDATION TEAM
This shall mention the details of personnels from different departments involving the qualification
study.

Nitin Panchal Sr. Officer-Engineering
Mayur Donga Manager-Production
Haresh Patel Operation-Head
Komal Sojitra Sr. Executive-QA

8.0 SYSTEM/EQUIPMENT DESCRIPTION
To define the requirements for operation of the equipment installed. To ensure that the equipment
operation meets the acceptance criteria.
Construction:
The shelves are constructed hollow with baffles cum stiffeners placed in between shelves. Every shelf
has an inlet & outlet nozzle and is connected to an inlet and outlet header through these nozzles. A hot
medium reaches the shelf through the inlet header and flows through the shelves in a uniformity zig-
zag pattern ensuring faster heat transfer to the surface. This intern heats up the trays on the shelves.
The hot medium flows out from the shelf through the outlet heard. The dryer chamber are constructed
from heavy duty plated to prevent the plates from buckling during the vacuum operation.
Working:
In dryer the material is placed on trays, which put on the hot plates in the drying cabinet. A vacuum
tray dryer works under vacuum condition on the conduction principles, inside the dryer are several
shelves having trays on which the products are placed. The top most shelf is a dummy shelf placed
there to ensure proper heating to prevent the dried powder from escaping into the solvent extraction
system.
9.0 ACCEPTANCE CRITERIA:
 All operating inputs provided on the equipment when tested shall-successfully comply and
meet the tolerance limit.
 The equipment should successfully perform when operated as per SOP
 Critical gauges/indicators provided on the equipment are calibrated.
 The equipment when operated shall not produce abnormal sound and show any discrepancy in
its smooth operation.
10.0 STANDARD OPERATING PROCEDURES REFERNCES:
This shall provide a list of Standard Operating Procedures and which are verified.
Procedure SOP Title SOP No.

Procedure for Operation & Cleaning of Vacuum
Operational PG007
Tray Dryer
Calibration Calibration of Instruments EG002
Preventive Preventive And Breakdown Maintenance of
EM001
maintenance Equipment
Training:
Purpose To train all personnel involved in the execution of this

requalification protocol for following topics.
Name Of Participant Area Of Operation Sign/Date

11.0 VALIDATION TEST PROGRAM:
Following test functions shall be checked in this section.
Each Operational Qualification individual test procedure shall typically be described and documented
by the following information.
Title : This shall include the name of the test being performed.
Test Objective : The objective(s) of the test being performed.
Acceptance Criteria : This shall list the operating parameters of the System/ Equipment with
acceptance limit in order to acceptable for the individual test
procedure.
Test Procedure : The test procedure to be followed regarding how to challenge the
system shall be outlined in the respective protocols.
Test Results : The test data obtained shall be recorded during the testing.
Checked by
Description Acceptance Criteria Actual Observation
(Sign/Date)
To verify that all
Operate properly as per
switches and push
manufacturing procedure.
buttons on dryer.
Drying chamber SS 316
Trays SS 3016
Rack SS 316
Hot Plates SS 316
Header SS 304
Stiffeners Leak Proof
Vacuum Line Leak Proof
Gauges Should be calibrated
Vacuum Pressure Within norms
Unwanted heating
No Heat
of Parts
Surface finish of
Should be uniform
dryer
Remarks:
12.0 DEVIATION REPORT
This shall document any non-conformances observed during the verification of the Operational
Qualification of System/ Equipment along with the correction and compliance report.
12.1 Deviations observed:
Probable
Sr. No. Specifications Actual Checked by
reasons
1.
2.
3.
4.
12.2 Corrective Actions of Non Conformance:
Sr. No. Corrective Action Done Done by Checked by

1.
2.
3.
4.
12.3 Compliance Report:
Sr. No. Description of conformance Checked by Remarks

1.
2.
3.
4.
13.0 REQUALIFICATION CRITERIA:
The System/ equipment shall be requalified in the following cases
 When there is change in location.

 When there is major modification.
 When there is major breakdown, which have direct impact on operation of the System/
Equipment.
14.0 DOCUMENTATION:
This shall include all the forms of documentation such as calibration certificates, test certificates,
training records etc.
15.0 OPERATIONAL QUALIFICATION SUMMARY REPORT:
This shall summarize the Operational Qualification effort and shall present conclusion as to
qualification status based on the OQ data.

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OPERATIONAL QUALIFICATION

1.0 PROTOCOL APPROVAL SHEET.....................................................................................3

Name Designation Signature Date

Satyam Shah Shift Incharge-Production

Name Designation Signature Date

Bela Patel Executive-QA

Mayur Donga Manager-Production

Haresh Patel Operation-Head

Name Designation Signature Date

Komal Sojitra Sr. Executive-QA

2.0 REVISION HISTORY

Reason for Revision/Change

7.0 VALIDATION TEAM

Name Designation Signature Date

Mayur Donga Manager-Production

Haresh Patel Operation-Head

Komal Sojitra Sr. Executive-QA

9.0 ACCEPTANCE CRITERIA:

10.0 STANDARD OPERATING PROCEDURES REFERNCES:

Procedure SOP Title SOP No.

Purpose To train all personnel involved in the execution of this

Name Of Participant Area Of Operation Sign/Date

Following test functions shall be checked in this section.

12.1 Deviations observed:

12.2 Corrective Actions of Non Conformance:

Sr. No. Corrective Action Done Done by Checked by

12.3 Compliance Report:

Sr. No. Description of conformance Checked by Remarks

The System/ equipment shall be requalified in the following cases

 When there is change in location.

15.0 OPERATIONAL QUALIFICATION SUMMARY REPORT:

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