Hot Air Oven

PRACTICAL ASSIGNMENT PROTOCOL
Name – Pradnesh P Sandikar

Roll no. - 545
Department – QAT
Qualification
equipement - Hot Air Oven
1 Name of Equipment Hot Air Oven

2 Location of Equipement Pimpri
3 Equipement Identification no. DYP/PV/QAT/2020-21
4 Model no.
5 Make
6 Date of purchase 15/06/21
Table of Content -
1.Introduction of Hot Air Oven

2.Principle of Hot Air Oven
3.Mechanism of air circulation in Hot Air Oven
4.Design Qualification ( DQ )
5.Installation Qualification ( IQ )
6.Operational Qualification ( OQ )
7.Performance Qualification ( PQ )
1. INTRODUCTION-
 An hot air oven is an equipment which is utilised to provide the dry heat
medium & it must be validated to ensure that the system is able to
provides strile & depyrogenated components , on a reproducible basis .
 The validation of an Oven used to dry wet granulation & intermediate
excipients will be described here .
 Product is placed on drying trays that are stacked on racks .
 The racks & trays are rolled into the Oven ,and the granulations or
intermediates are dried at specified temperatures .
Examples – Granules , Powders , Glasswares , etc .
2. PRINCIPLE OF HEAT TRANSFER & CIRCULATION :
 CONVECTION :- Heat flows from one body to another due to the

temp difference between them .
 RADITATION :- Photon propogation will transfer thermal energy to the
object & increase the surface temperature .
 CIRCULATION :- Booster fans or blowers are used in
the oven to increase the circulation of heat throughout the
load.
3.0 MECHANISM OF HOT AIR OVEN -

DR. D. Y. PATIL INSTITUTE OF PHARMACEUITICAL SCIENCE & RESEARCH ,
PIMPRI , PUNE .
DESIGN QUALIFICATION REPORT
Instrument : Hot Air Oven
REPORT NO. DYP/QAT/PV/DQ/RP007/2020- EFFFECTIVE
21 DATE
REF. PROTOCOL NO. DYP/QAT/PV/DQ/PC007/ PAGE NO.
2020-21
DESIGN QUALIFICATION REPORT FOR
HOT AIR OVEN
Prepared By Checked By Approved By
Name & MINAL KAD

designation
Sign & Date 15/06/21
PIMPRI , PUNE .
REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE
07/2020-21
REF. PROTOCOL NO. DYP/QAT/PV/DQ/PC0 PAGE NO.
07/ 2020-21
INSTRUMENT DETAILS
Name of Equipment Hot Air Oven

Name of department Qauality Assurance Technique
Location of instrument QAT Research Laboratory
Model no. DYP/PV/QAT/2020-21
Year of Purchase 2021
Make
TABLE OF CONTENTS
1.Objective
2.Scope
3.Responsibility
4.User Requirement Specification
5.FAT procedure
6.Design Qualification Approval
7.Reference Documents
1. Objective -
To perform DQ Of Hot Air Oven & assure that the machine is
manufactured as per the URS & it complies with the scope of supply .
2. Scope -
Name & MINAL KAD

designation
PIMPRI , PUNE .
Instrument : Hot Air Ove

07/2020-21
07/ 2020-21
i) The scope of this qualification document is limited to the design

qualification of Hot Air Oven .
ii) The equipment shall be used for Sterilization of Media, glassware's,
product , etc.
iii) It is used for the drying purpose of various powders & granules .
3.Responsibility -
Roll no.- 539
Name -Minal Manik kad
Class – F. Y. M. Pharm ( SEM II )
Department- QAT
4. USER REQUIREMENT SOECIFICATION -

DESCRIPTION SPECIFICATION OBSERVATIONS
Type Vertical
Temperature control Digital temperature control
Size (dimension) 18 inch × 18 inch× 18 inch
Inner chamber made up of Stainless steel
Insulation Glass wool
Sensor CR IAL
Accuracy ± 1 0C
Heater coil Best Quality nichrome wire
Voltage 230 V AC
Rating KW 1750 watts
Temperature range 50 0C – 250 0C

Name & designation MINAL KAD
PIMPRI , PUNE .

07/2020-21
07/ 2020-21
5. FAT Procedure -
After the completion of erection work of the machine , client
shall be informed to perform the FAT.
Client shall perform the FAT at the manufacturer site and record all the data in
the prescribed FAT document as per details given below :
-Test criteria
-Design verification check list
-Deficiency and corrective action report
-Pre installation requirement
-Final report
6. Design Qualification Approval -
According to the data collected as a result of this study, the

equipment has been properly designed & qualified in accordance with
standards and is now available for process qualification.
Suppliers name Position Signature Date

15/06/21
Customer -
Student name Roll No. Signature Date

Minal M. Kad 539 15/06/21
7. Reference Documents -
a) Manufacture's Brochure
b)DQ protocol no.
Written BY Signature Date

15/06/21
Checked BY Signature Date

15/06/21
Approved BY Signature Date

15/06/21

PIMPRI , PUNE .
INSTALLATION QUALIFICATION REPORT

07/2020-21
07/ 2020-21
INSTALLATION QUALIFICATION PROTOCOL

FOR HOT AIR OVEN
Name & MINAL KAD

designation
PIMPRI , PUNE .
REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE 15/06/21

07/2020-21
REF. PROTOCOL NO. DYP/QAT/PV/DQ/PC0 PAGE NO. 1 TO 40
07/ 2020-21
INTRUMENT DETAILS
Name of Equipment Hot air oven

Location of the Equipment
Equipment Identification No. DYP/PV/QAT/20-21
Model no.
Make
Date of Purchase 15/06/20
TABLE OF CONTENTS -
1.0 Pre- Approval

2.0 Purpose
3.0 Scope
4.0 Responsibility
5.0 Requalification
6.0 System Description
7.0 Installation Qualification Procedure
8.0 Autoclave Major Component Results.
9.0 Conclusion
10.0 Appendix
Name & MINAL KAD

designation
PIMPRI , PUNE .

07/2020-21
07/ 2020-21
1.0 PRE- APPROVAL :

Signing of this approval page of Installation Qualification Protocol No.
DYP/QAT/PV/IQ/PC007/2020-21, indicates agreement with the installation
qualification approach described in this document. If modifications to the
installation qualification become necessary, an addendum will be prepared and
approved.
Written by Signature Date
15/06/21
Checked by Signature Date
15/06/21
Approved by Signature Date
15/06/21
Name & MINAL KAD

designation
PIMPRI , PUNE .

07/2020-21
07/ 2020-21
2. PURPOSE -
2.1 To provide record of the key features of the equipment and components as
currently installed.
2.2 To ensure that there is sufficient information available to enable the
equipment to be operated and maintained safely, effectively and
consistently.
2.3 To verify the installation attributes of theHOT AIR OVENcritical to serve
the intended purpose of the equipment.
2.4 To establish the suitability of the draft SOP prepared for the operations of
equipments.
2.5 To document the observation for future reference.
3. SCOPE -
The scope of this qualification protocol is limited to the installation

qualification of HOT AIR OVEN.This qualification protocol is part of a
validation activity.
4. RESPONSIBILITY - Roll no.- 539

Name -Minal kad
Department-QAT
Name & MINAL KAD

designation
PIMPRI , PUNE .

07/2020-21
07/ 2020-21
5.REQUALIFICATION -
Installation qualification to be repeated in case of :

 Replacement of any major component/ instrument.
 Major modification in the existing equipment.
 During monitoring, if equipment is found to be malfunctioning.
 Shifting of equipment from one location to another.
6.SYSTEM DESCRIPTION -
Sr. PARTS / COMPONENTS

No.
1. Air Port
2. Insulator
3. Fan
4. Ceramic Insulator, Up
5. Ceramic Insulator, Down
6. Cushion
7. Motor
8. Fan
9. Heater
10. Switch Over – heat Prevention
11. Clamp, Heater
12. Chamber
LOCATION :
PIMPRI , PUNE .

07/2020-21
07/ 2020-21
7.INSTALLATION QUALIFICATION PROCEDURE :
1. Verify the approved purchase order.

2. Verify invoice.
3. Check the manufacturer and supplier.
4. Verify the model no. and serial no.
5. Prepare a checklist for all the components and parts, including the spare
parts according to the purchase order and manufacturer’s specifications.
6. Record the information for each part, component, auxiliary equipment,
supporting facilities and compare to manufacturer’s specifications.
7. Installation should be done as per the instructions provided in the
manual.
8. Record any deviations.
9. Prepare a deviation report including the justification of acceptance and
impact on the function.
10. Prepare an IQ report.
8.HOT AIR OVEN MAJOR COMPONENTS RESULTS :
EQUIPMENT IDENTICATION :
sr. no. Required Information As – Found conditions

1 Manufacturer Any oven code
2 Purchase order name 8750
3 Model number Ss11.14
4 Serial number 9182
5 Equioment number 1520
6 Location Room no 5
MAJOR COMPONENTS :
DESCRIPTION SPECIFICATION ACTUAL DONE BY DATE

AirPort
Insulator
Fan
Ceramic Insulator,
Up
Ceramic Insulator,
Down
Cushion
Motor
Fan Motor
Fan, axel
Heater
Switch Over – heat
Prevention
MANUFACTURERES MANNUALS & DRAWINGS :
Sr. no. Number Description Date

1 101 D Oven Instructions Manual 01/05/20
2 102 D Electrical Schematic 01/05/20
3 103 D P&ID 01/05/20
4 200 D Class B Oven Configuration 01/05/20
5 300 D Room Layout 01/05/20
UTILITIES :
Sr.no. Utility Specified Measured Results Acceptable

( yes /no )
1 Volts Motor = +/- 10 % 459 Yes
2 Amps Blower Motor =4.5 20 cicuit rating Yes
3 Compressed 100-115 psig 110 psig Yes
Air
4 Saturated air 55 psig +/- 10% 52 psig Yes
5 Chilled air 47 degree +/- 10 % 45.5 degree Yes
INSTRUMENT USED :
Sr. no. Test Instrument Identification number Calibration due date

1 Air pressure gauge ME-025 02/01/21
2 Water pressure gauge PG- 102 02/01/21
MAJOR COMPONENTS WITH DESCRIPTION :
Sr no. Components As- Found Conditions

1 Oven Cabinet Material: 304 stainless steel
2 Blower motor, front Manufacturer: Any Motor Co.
Model number: EM366IT
Serial number: W5-19
Volts: 460
Amperes: 4.5
Phases: 3
Cycles: 60 Hz
rpm : 1725
3 Blower motor, rear Manufacturer: Any Motor Co.
Volts: 460
Amperes: 4.5
Phases: 3
Cycles: 60 Hz rpm: 1, 725
4 Blower motor, exhaust Manufacturer: Any Motor Co.
Volts: 460
Amperes: 4
Phases: 3
Cycles: 60 Hz
rpm : 1725
LUBRICANTS :
Sr.no. Where Used Type Manufacturer Product

Contact
(Yes/No)
1 Motors SAE-02 Oil Any Oil Co. No
2 Pump motor Lithrom #2 Grease Any Oil Co. No
Other parameters to be consider during installing an equipment -
1. Structural – Check diamensions , Presence of identification plates , proper

in sulation ,presence of seals & inspect for structural damage .
2. Filters – All filters used in the system must be recorded , such as those used
with airs ( supply or recirculating ) or in other utilities ( e.g. Steam water )
3.Electrical – Ensure conformance to national electrical code standards .
4. Air Supply – Identify air source and dust size .
5. Ventilation – Check the ventilation exahust and dust exahusr &

identify the method used to prevent back flow .
6. Heaters – Record the manufacturer model number , & number of heating
elements .
7. Lubricants – Make sure that lubricants used cannot contaminate the

material being sterilized or contaminated .
8. Blower – The blower must be mechanically sound ,Blades should be rotate

in proper direction & speed .
9. CONCLUSION -
The Hot air ovenis qualifying the installation qualification test as per the
guidelines described in this Protocol no. DYP/QAT/PV/IQ/PC007/2016-17.
The operation qualification can be followed now.
10 POST APPROVAL -
NAME SIGNATURE DATE
Written By : MINAL KAD 15/06/21

Checked By: 15/06/21
Approved By: 15/06/21
11. APPENDIX :
12. SOP : Standard Operating Procedure
13. IQ : Installation Qualification
14. QA : Quality Assurance
15. GMP : Good Manufacturing Practices
16. Acceptance criteria : The product , equipment, and / or process

specifications nad limits, such as acceptance quality level and
unacceptable quality level, that are necessary for making a decision to
accept or reject.
17. Installation Qualification : Documented verification that the
system or subsystem is installed satisfactorily as per the
recommendations of the manufacturers.
18. Validation : Establishing documented evidence that is system does
what it purports to do.
19. Revalidation : Repetition of the validation process or a specific
portion of it .
Name & MINAL KAD

designation
DR. D. Y . PATIL INSTITUTE OF PHARMACEUITICAL SCIENCE & RESEARCH ,
PIMPRI , PUNE
OPERATIONAL QUALIFICATION REPORT
ISTRUMENT : HOT AIR OVEN

07/2020-21
REF. PROTOCOL NO. DYP/QAT/PV/DQ/PC0 PAGE NO. 1 TP 40
07/ 2020-21
OPERATIONAL QUALIFICATION PROTOCOL
FOR HOT AIR OVEN
Name & MINAL KAD

designation
PIMPRI , PUNE

07/2020-21
07/ 2020-21
INSTRUMENT DETAILS -
Name of Equipment. Hot Air Oven

Name of department. Pharmaceutic
Location of the Equipment 34178
Model no. BIT-29
Make Biotechnic
Date of Purchase 2020-21
TABLE OF CONTENTS
1.Pre- Approval
2.Purpose
3.Responsibility
4.Requalification
5.System Description
6.Installation Qualification Procedure
7.Training
8.Key Functionality
9.Sop Verification
10.Deficiency (If Any)And Corrective Action Report
11.Acceptance Criteria
12.Concsion
Name & MINAL KAD

designation
PIMPRI , PUNE

07/2020-21
07/ 2020-21
1. PRE APPROVAL :
Written by Signature Date
MKNAL Kad 15/06/21
Checked by Signature Date
15/06/21
Approved by Signature Date
15/06/21
2. PURPOSE :
i) To verify the operational attributes .

ii) To establish suitability of SOP .
iii) To documents the observation for future use .
1. Calibration Requirements
2. Equipment Cantrol Functions – Switches & Push buttons
3. Equipment Operation -
a) Practical sequencing
b) Open door leak
c) Timer Operation
d) Circulation air flow
e) Exhaust Airflow
f) High Temp . Limit
g) Oven door open
3. RESPONSIBILITY :
Roll no, - 539

Name – Minal kad
Dept .- QAT
4. REQUALIICATION :
Operation qualification to be repeated in case of :
i) In case of replacement of any major component .

ii) In case of major modification in the existing equipement.
iii) During monitoring , if instrument is found to be malfunctioning.
iv) Shifting of instrument from one locaton to another .
STANDARD OPERATING PROCEDURE -
Sr. no Description Date

1 Oven set up & Operation 01/05/20
2 Oven Cleaning Procedure 01/05/20
5.SYSTEM DESCRIPTION :
Equipment Control Function Test Results -
Sr. no. Test Function Expected Results Accceptable

yes /no
1 Power disconnect When the switch is pressed, the oven goes on and yes
switch operation off and the control panel door can be opened.
2 On switch operation When the on switch is pressed, the drying cycle yes
starts
3 Off switch operation When the off switch is pressed, the drying cycle yes
stops.
4 Door switch When the door is open, the oven maintains yes
operation normal operation.
5 Bell silence selector When the switch is pressed, the end-of-the-cycle yes
switch operation bell is disabled.
6 Exhaust airflow When the switch is pressed, the heat is de- yes
switch operation energized, an audible alarm sounds, and the
exhaust air failure light goes on.
7 Circulation airflow When the switch is pressed, the circulation yes
switch operation blower is de-energized, an audible alarm sounds,
and the exhaust failure light goes on.
8 High limit reset When the switch is pressed, after a high limit yes
switch operation failure, the high limit controller is reset.
9 High limit When oven temperature exceeds a preset limit, yes
temperature the heaters are de-energized and an alarm sounds.
controller
Indicator Lights Test Results -
Sr. no. Test Function Expected Results Acceptable (Yes/No)

1 Oven in operation When the oven is in operation, verify yes
that the indicator light goes on.
2 Oven on When the oven is on, verify that the yes
indicator light goes on.
3 Exhaust air failure When there is an exhaust failure, verify yes
that the indicator light goes on.
4 Cycle complete When a cycle is complete, verify that the yes
indicator light goes on.
5 Circulation air failure When there is a circulation air failure yes
#1 #1, verify that the indicator light goes
on.
6 Circulation air failure When there is a circulation air failure yes
#2 High temperature #2, verify that the indicator light goes
on.
7 High temperature When there is a high temperature alarm, yes
alarm verify that the indicator light goes on.
Cycle Sequencing Verification Test Results -
Sr,. no. Item Results

1 Setpoint = 110°F ± 10°F Setpoint = 110°F with high limit at 120°F
2 Dry time = 30 min Dry time was set for 30 min.
3 Control points around setpoint (timer Timer began to elapse when the temperature
start or heat-up) reached 100°F
OPEN DOOR LEAK TEST RESULTS -
Sr. no Test Functuion Results
1 Top of the oven door The smoke was not blown away from or drawn into the oven.
2 Left side of the oven The smoke was not blown away from or drawn into the oven
door
3 Bottom of the oven door The smoke was not blown away from or drawn into the oven.
4 Right side of the oven The smoke was not blown away from or drawn into the oven.
door
DIFFERENTIAL PRESSURE TEST RESULTS -
Sr. no Test Function Results Acceptable

1 Differential pressure The oven differential pressure was yes
negative with respect to the area outside
the oven.
2 Average differential 25 in. w.c. yes
pressure in w.c.
INSTRUMENT USED -
Sr. no. Test Instrumentation Identification Number Calibration Due Date

1 Differential pressure gauge 100GPD9182
TIMER OPERATION TEST RESULT -
Sr. no. Test Function Results Acceptable

yes/no
1 Oven in operation Oven operation light was on during the cycle. yes
2 Cycle complete Cycle complete light was on at the end of the cycle yes
3 Audible alarm on The audible alarm was on at the end of the cycle. yes
4 Heat off When the temperature recorder dropped 10°F, the yes
heat went off.
5 Timer stops The timer stopped at the end of the cycle. yes
INSTRUMENT USED :
Sr. Test Instrument Identification Number Calibration Due Date

no
1 Scale 01/05/20
2 Data recorder 01/05/20
CIRCULATION AIR FLOW TEST RESULTS :
Sr. Test Function Results Acceptable

no (Yes/No)
1 Timer operation After the tubes were disconnected, the timer yes
stopped.
2 Alarm on After the tubes were disconnected, the alarm was yes
audible.
3 Circulation airflow After the tubes were disconnected, the circulation yes
failure light airflow light went on.
4 Heat off When the temperature recorder dropped more than yes
10°F, the heat went off.
5 Oven and timer After the tubes were reconnected, the oven and yes
operation timer started operating.
EXAUST AIR FLOW TEST RESULTS :
Sr. Test Function Results Acceptable

no. (Yes/No)
1 Timer operation After the key was turned to a vertical position, the yes
timer stopped.
2 Alarm on After the key was turned to a vertical position, the yes
alarm was audible
3 Exhaust airflow failure After the key was turned to a vertical position, the yes
light exhaust airflow light went on.
5 Oven and timer After the key was turned to a horizontal position, yes
operation the oven and timer started operating
HIGH TEMPERATURE LIMIT FAILURE TEST RESULTS :
Sr.n Test Function Results Acceptable

o (Yes/No)
1 Timer operation After the high temperature limit was passed, the yes
timer stopped.
2 Alarm on After the high temperature limit was passed, the yes
alarm was audible.
3 Exhaust airflow After the high temperature limit was passed, the yes
failure light alarm was audible.
5 Oven and timer After the high temperature limit was passed, the yes
operation oven and timer started operating.
6.OPERATIONAL QUALIFICATION PROCEDURE :
i) A draft SOP should be prepared on the basis of supplier guide /mannual for
operation before the qualification testing .
ii) Before operating the instrument , personnel should be well trained .
iii) Operate the instrument as per SOP , & Record the changes if any .
7.OPERATING PROCEDURE :
i) Switch on the instrument .

ii) Placed the material to be dried or sterized inside the stainless steel
chamber .
iii) Close the main door .
iv) Set the required temperature .
v) After requireed time period ( 60 min ) switch off the instrument .
vi) Wait until half hour till it cools .
vii) Remove the material.
viii) In case of sterilization of the petrrry plate & other glass ware first
wrapped in suitable paper & then put it into the oven for further process .

PIMPRI , PUNE

07/2020-21
07/ 2020-21
8.TRAINING :
NAME OF TRAINEE : DATE :
Sr .no Name of the Trainee Employee number Signature

1.
2.
3.
4.
Name & MINAL KAD

designation
9. KEY FUNCTIONALITY :
A. PURPOSE :
To demonstarte that the cantrol panel & other mannual
operations of Hot Air Oven .
B. TESTING :
1. Check installation of machines for power supply, Temperature,

Time and lids.
2. Check all the displays on the panel are identified.
3. Turn on the power from the electrical panel.
4. Set the control(s) on the panel. Start button on control panel with
the help of Temperature controller, set required Temperature of
inner chamber and set the Time required.
5. Verify functionality of each component on the control panel against
its specified functions.
6. Observe and record the responses .
C .TEST DATA SHEET :
Sr Parameter Specification Observation Compliance

no (yes/no)
1 Main switch ON – instrument ON- instrument YES
ON/OFF gets switch on gets switch on
OFF- instrument gets OFF- instrument
switch off gets switch off
2 Temperature set Set temperature must Set temperature 50 YES
be equal to C. Attained
temperature attained. temperature – 50 C
3 Time set As per requirement 60 YES
Name & MINAL KAD

designation

PIMPRI , PUNE

07/2020-21
07/ 2020-21
10. SOP VERIFICATION :
TITLE : HOT AIR OVEN
i) Operate the equipment as per SOP .

ii) Record the deails given below :
Operated By : Checked By :
Changes Required ( if any ) : SOP to be revised :
Rrmarks : SOP confirmed / not confirmed
Verified By :
Signature :
Date :
Name & MINAL KAD

designation
DR.D.Y.PATIL INSTITUTE OF PHARMACEUITICAL SCIENCE &

RESEARCH , PIMPRI , PUNE
OPERATIONAL QUALIFICATION
INSTRUMENT NAME – HOT AIR OVEN
REPORT NO. DYP/PV/QAT/202 EFFECTIVE 15/06/21
1-20 DATE
REF PROTOCOL DYP/PV/QAT/PC/ PAGE NO. 1 TO 40
NO 2020-21
DEFICIENCY IF ANY & CORRECTIVE ACTION REPORT :
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:
ACCEPTANCE CRITERIA :
It is considered as acceptable , when it meets all the specification.
COCLUSION :
i) Hot Air Oven is qualifyimg its operational qualification test as per

guidelines in this protocol no. DYP/PV/QAT/2020-21.
ii) Hot Air Oven can be tested for its performance qualification as per
guideline in this protocol no. DYP/PV/QAT/2020-21.

OPERATIONAL QUALIFICATION
07/2020-21
07/ 2020-21
PREPARED BY CHECKED BY APPROVED BY

Name & MINAL KAD
Designation

PERFOMANCE QUALIFICATION
07/2020-21
07/ 2020-21
PERFOMANCE QUALIFICATION PROTOCOL

FOR HOT AIR OVEN

Name & MINAL KAD
Designation

PERFORMANCE QUALIFICATION
07/2020-21
07/ 2020-21
TABLE OF CONTENTS
1. Pre Approval
2. Objective
3. Performance Test Qualification : Procedure
4. Performance Test Qualification Resutls
5. Requalification
6. Responsibility
7. Conclusion

Name & MINAL KAD
Designation

07/2020-21
07/ 2020-21
1.1 PRE APPROVAL :
Signing of this approval page of PQ protocol no. DYP/PV/QAT/2020-21

, indicates agreement with the PQ approach described in this document .
If nodifications to the PQ become necessary , an adendum will be prepared &

approved .
Written By Signature Date

15/06/21
Checked By Signature Date

15/06/21
Approved By Signature Date

15/06/21

Name & MINAL KAD
Designation

07/2020-21
07/ 2020-21
2. OBJECTIVE :
i) To collect sufficient data to establish that hot air oven performs to meet
the desired product quality in the consistent manner , when operate as per
SOP.
ii) PQ protocol shall provide the methodology of qualification .
3.RESPONSIBILITY :
Roll no -539
Name- Minal Kad
Class – F. Y. M. Pharm Department – QAT
4. PERFORMANCE QUALIFICATION TEST : PROCEDURE
4.1 Precautions :
i) Ensure that the equipment is connected to electrical service

according SOP .
ii) Always use gloves & handle to remove the substance out of the
chamber ,
iii)Strictly Prohibit the dirct body contact .
4.2 Procedure :
i) First set temperature prior to time .
ii) Set the time & temperature.
iii)Press SELECT button to select the HOUR setting & minute setting
on digital meter.
iv)Preset your desired time by pressing SET TIME .
v) Threr is knob to increase or decrease the temperature.

vi)After starting of equipment green light glows .while at the
stoppping of intsrument red light glows .
vii) Once open the door after temperature is stabilized , timer will
suspend counting automatically. Memory will store the elapsed
time & start to count down again for the rest of time until lock the
door .
Viii) The equipment starts to timing once the actual temperature is set .
ix)Then lamp STERILIZATION OR INCUBATION starts to

glow .
x) Thus , after completion , after 30 min remove the material from

the oven .
xi)Memory will store the previous temperature & time convinent

for the fresh operation if user keep plugging after the operation .
5.PERFORMANCE QUALIFICATION TEST RESULTS :

PART I – Test of perfomance test
Sr. no. Test Specification Observation Done By

1 Sterilization
Test
2 Heat
Penetration
Test

Name & MINAL KAD
Designation

07/2020-21
07/ 2020-21
Part II – Type of Error
Sr.no. Error / Problem Observation Done By

( yes / no )
1 Erratic temperature
2 Can not heat
3 Can not power up
4 Unacceptable Uniformity
5 Failure Set Temperature
6 PV fluctuated
4. REQUALIFICATION :
Perfomance qualification repeated in case of following condition :
i)Replacement of any major component.

ii)Major modification in the existing equipement.
iii)Shiftinfg of equipement from one location to another .
5. CONCLUSION :
Done the performance qualification for HOT AIR OVEN .

Name & MINAL KAD
Designation

Hot Air Oven

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PRACTICAL ASSIGNMENT PROTOCOL

Name – Pradnesh P Sandikar

1 Name of Equipment Hot Air Oven

1.Introduction of Hot Air Oven

Examples – Granules , Powders , Glasswares , etc .

2. PRINCIPLE OF HEAT TRANSFER & CIRCULATION :

 CONVECTION :- Heat flows from one body to another due to the

3.0 MECHANISM OF HOT AIR OVEN -

DESIGN QUALIFICATION REPORT FOR

HOT AIR OVEN

Prepared By Checked By Approved By

Name & MINAL KAD

Name of Equipment Hot Air Oven

Prepared By Checked By Approved By

Name & MINAL KAD

REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE

i) The scope of this qualification document is limited to the design

4. USER REQUIREMENT SOECIFICATION -

Prepared By Checked By Approved By

REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE

6. Design Qualification Approval -

According to the data collected as a result of this study, the

Suppliers name Position Signature Date

Student name Roll No. Signature Date

Written BY Signature Date

Checked BY Signature Date

Approved BY Signature Date

DR. D. Y. PATIL INSTITUTE OF PHARMACEUITICAL SCIENCE & RESEARCH ,

REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE

INSTALLATION QUALIFICATION PROTOCOL

Prepared By Checked By Approved By

Name & MINAL KAD

REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE 15/06/21

Name of Equipment Hot air oven

1.0 Pre- Approval

Prepared By Checked By Approved By

Name & MINAL KAD

REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE 15/06/21

1.0 PRE- APPROVAL :

Written by Signature Date

Checked by Signature Date

Approved by Signature Date

Prepared By Checked By Approved By

Name & MINAL KAD

REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE 15/06/21

The scope of this qualification protocol is limited to the installation

4. RESPONSIBILITY - Roll no.- 539

Prepared By Checked By Approved By

Name & MINAL KAD

REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE 15/06/21

Installation qualification to be repeated in case of :

Sr. PARTS / COMPONENTS

REPORT NO. DYP/QAT/PV/DQ/RP0 EFFFECTIVE DATE 15/06/21

7.INSTALLATION QUALIFICATION PROCEDURE :

1. Verify the approved purchase order.

8.HOT AIR OVEN MAJOR COMPONENTS RESULTS :

sr. no. Required Information As – Found conditions

DESCRIPTION SPECIFICATION ACTUAL DONE BY DATE

MANUFACTURERES MANNUALS & DRAWINGS :

Sr. no. Number Description Date

Sr.no. Utility Specified Measured Results Acceptable

Sr. no. Test Instrument Identification number Calibration due date

MAJOR COMPONENTS WITH DESCRIPTION :