RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 1 of 13
IOQ/DHS/001 00
Number: No.
Installation and Operational Qualification Protocol cum
Report
For Dry Heat Sterilizer
(Equipment ID: CRY/DHS-01)
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 2 of 13
IOQ/DHS/001 00
Number: No.
TABLE OF CONTENTS
S.
Title Page No.
No
1. Approval 03
2. Object 04
3. Scope 04
4. Reference Document 04
5. System Description 04
6. Responsibility 06
7. Acceptance Criteria 06
8. Installation Verification 07
9. Operational Verification 09
10. Deficiency and Corrective Action Taken 12
11. Requalification Criteria 12
12. Summary Report and Conclusion 12
13. Post Approval 12
14. Abbreviations 12
15. Change History Details 13
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 3 of 13
IOQ/DHS/001 00
Number: No.
1.0 Approval
This protocol cum report is prepared by the Validation team for the Installation and Operational
Qualification of Dry heat sterilizer in “Integrated Sterile Bulk Formulations Facility” of Rajasthan
Antibiotics Limited Unit-I, under the authority of QA Head. Hence this document before being
effective shall be approved by the QA Head.
PREPARED BY
NAME/FUNCTIONAL AREA DESIGNATION SIGNATURE /DATE
PRODUCTION
CHECKED BY
NAME/ FUNCTIONAL AREA DESIGNATION SIGNATURE /DATE
PRODUCTION
ENGINEERING
QUALITY ASSURANCE
APPROVED BY
NAME/ FUNCTIONAL AREA DESIGNATION SIGNATURE /DATE
QUALITY ASSURANCE – HEAD
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 4 of 13
IOQ/DHS/001 00
Number: No.
2.0 Objective
The Objective of this document is to provide a written guideline for the execution of the combined
Installation/Operational Qualification (IOQ) of Dry Heat Sterilizer for static attribute to verify that.
The instrument/equipment has been installed in accordance with the design and user
requirements and meets the set acceptance criteria and cGMP requirements as stipulated in
this document.
Each installed components complies with the engineering design and equipment data
sheets/specification.
All supporting utilities are properly connected & equipment operations are verified for its
intended use.
3.0 Scope
The Scope of this protocol is limited to the combined Installation/Operational Qualification (IOQ) of
Dry Heat Sterilizer (Equipment ID: CRY/DHS-01) is safely installed in Production Department
(SHS and DHS Loading Room (CPR-31).
4.0 Reference Document
Following documents are referred during preparation of the protocol:
Document Name Document Number
User Manual
Design qualification protocol
Supplier document
Installation qualification protocol
Operation qualification protocol
5.0 System Description
5.1 Use
Dry Heat Sterilizer shall be used to sterilize the empty glass vials, Machine parts, Primary packaging
material (Canisters & Tear off seals), Sampling Aids, VTD Trays, etc., in the Grade A area.
5.2 Capacity
Internal Chamber Dimensions: 1100 mm (W) X 1550 mm (H) x 1550 (D) mm
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 5 of 13
IOQ/DHS/001 00
Number: No.
5.3 Operation & Design Feature
The Dry Heat Sterilizer Equipment number CRY/DHS-01, is designed to sterilize and Depyrogenation
of the Primary packaging material (Canisters & Tear off seals), Sampling Aids, VTD Trays & other
Accessories.
The Sterilization Chamber is made up of SS sheet, which is welded with U-Profile SS Jacket. The
Depyrogenation Chamber is provided with two doors .Loading & Unloading side for placement of
articles. Door interlocks are provided to prevent simultaneous opening of both the doors and process
lock to prevent opening of the door during the operation.
The DHS chamber is insulated with resin-bonded glass wool, which helps in reducing the heat loss to
the environment and ensuring uniform distribution of temperature inside the chamber. This insulation is
covered with SS covered plate.
To ensure leak-tight partition between the aseptic area and washing & preparation zone an SS flush-
panel is provided on the partition wall and the outer cover of the DHS. All Joints, Crevices are filled
with Silicon sealant to prevent any leakage.
The Dry Heat Sterilizer is provided with the following systems and accessories for the desired
functioning.
One motor is provided for air circulation within the chamber.
48 Nos of Heating Elements are provided for Heating of Inlet Air.
Supply & Return dampers for Control of In let & outlet Air velocity to get ISO Class 5 environment.
HEPA filters. (For air inlet, Chamber and exhaust)
5.4 Operating Parameter:
[Link]. Set Parameters
01 Moisture Removal Temperature 100.0°C
02 Moisture Removal Time 10 Min
03 Heater Bank 2 OFF Temperature 248.0°C
04 Ster. Hold Temperature 250.0°C
05 Ster. Hold Time 60Min
06 Overshoot Temperature 270.0°C
07 Ster. Stop Temperature 245.0°C
08 Ster. Reset Temp. 240.0°C
09 Process End Temperature 90.0°C
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 6 of 13
IOQ/DHS/001 00
Number: No.
6.0 Responsibility
Responsibilities of different department/personnel involved in different activities related to the
Combined Installation/Operational Qualification of the Dry Heat Sterilizer are defined below:
Functions Responsibility
Preparation of Protocol Production
Review of the Protocol Quality Assurance, Engineering & Production
Approval of the Protocol Head Quality Assurance
Execution of activity as per
Quality Assurance, Engineering & Production
Protocol
Preparation of Report Production
Review of the Report Quality Assurance, Engineering & Production
Approval of the Executed Protocol
Head Quality Assurance
and Report
7.0 Acceptance Criteria
The equipment shall be complying with the specification.
All supporting utilities of specified capacities are to be near the place of installation.
All the specified installation checks are to be complied.
The equipment and its components shall be operated as per its specified operating instructions
mentioned in the protocol.
All sops for the equipment should be checked and verified.
All the functionality of equipment components, safety features, utility requirements to be checked
and verified.
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 7 of 13
IOQ/DHS/001 00
Number: No.
8.0 Installation Verification
Equipment Description
Equipment Name : Dry Heat Sterilizer
Equipment ID : CRY/DHS-01
Instruction of filling checklist:
For Installation checklist of the equipment and utilities use the word “Yes” to show its presence and
use “NO” to indicate the absence.
For Identification of the components of the equipment and utilities use the word “Comply”
otherwise use “Does not Comply” to indicate non-compliance along with the mode of verification.
Give the detailed information in the summary and conclusion part of the Installation Qualification
Report. Whichever column in blank or not used “NA” shall be used.
8.1 Installation Checklist:
Installation Checklist is as follows:
Checked By Verified By
[Link] Statement Yes/No
(Sign & Date) (Sign & Date)
1 Verify that Dry Heat Sterilizer is
securely anchored and shock proof
2 Verify that there is no observable
physical damage
3 Verify that all electrical connections
are done properly
4 Safe electrical connections
5 Equipment is vibration free and
there is no any abnormal sound
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 8 of 13
IOQ/DHS/001 00
Number: No.
8.2 Verification of Equipment Description
Equipment Description
Equipment Name : Dry Heat Sterilizer
Equipment ID : CRY/DHS-01
Equipment/ Actual Checked by Verified by sign
[Link] Specification
components observation sign & date & date
1 Manufacturer
2 Model
3 Serial number
4 Capacity
5 Location
6 Air Intake
7 Compressed Air
8 Electricity
9 Connected Load
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 9 of 13
IOQ/DHS/001 00
Number: No.
8.3 Identification of Supporting Utility
Utility Properly Identified& Checked By Sign & Verified By Sign &
Connected (Yes/No) Date Date
Air Intake
Compressed Air
Electricity
Connected Load
8.4 Identification of Safety Features
Safety Features Checked By Verified By Sign
[Link] Function
Description Sign & Date & Date
1 Earthing To Avoid Electrical shocks
8.5 Identification of Standard Operating Procedure
The following Standard Operating Procedures were identified as importance for effective
Operation & Performance of Dry Heat Sterilizer
S.N Identified By Sign Verified By Sign &
SOP Title
o & Date Date
1 SOP on Cleaning and Operation of Dry Heat
Sterilizer
9.0 Operational Verification
Instruction for filling the checklist
Incase of the compliance of the Operational test use either ‘comply or actual function/operation
/value to show its presence/completion and use ‘Not comply to indicate the absence of the identity
or Non conformance.
Give the detained information in the summary and conclusion part of the operational qualification
report.
9.1 Operational Qualification Test
[Link]. Acceptance Comply/Not Checked By Verified By Sign
Functions/Parameter
Criteria Comply Sign & Date & Date
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 10 of 13
IOQ/DHS/001 00
Number: No.
1 On Switching Main Main power
Switch to ON position supply to
machine should
be ON
2 OFF – Switching Main Main Power
Switch to OFF position supply to
machine should
be OFF
3 Vibration during Should be free
Operation from vibration
9.2 Verification of Supporting Utility
Properly Identified &
Verified By
Utility Connected Checked By Sign & Date
Sign & Date
(Yes/No)
Electricity:
9.3 Verification of Safety Features
Verified
Checked By
[Link]. Safety Features Description Function By Sign
Sign & Date
& Date
1 Earthing To Avoid Electrical
shocks
2 Connect the power cord to the Power of DHS shall be
mains outlet and switch ON the ON.
mains power
3 Door Simultaneous opening
of both door
4 Heaters Heaters do not get on
when main motor is off
in auto mode.
5 Alarm checks Over shoot
temperature/sterilizatio
n stop
temperature/sterilizatio
n reset temperature/
main motor trip.
9.4 Operational Test
checked by
S.N Test Acceptance Criteria Actual Done by
Sign &
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 11 of 13
IOQ/DHS/001 00
Number: No.
o Observations sign & date Date
Too remove the
Moisture removal
1 moisture from the wet
temperature
load
Time for removing
Moisture removal
2 the moisture from wet
time
load
Heater bank 2 off
3 --
temperature
To sterilize the
Sterilization hold
4 sterilization
temperature
temperature
Sterilization hold
5 control --
temperature
To maintain the
Sterilization hold
6 sterilization
temperature
temperature
Overshoot To generate alarm and
7
temperature put off the heaters
9.5 Verification of Standard Operating Procedure:
S.N Availability Checked By Sign & Verified By Sign &
SOP Title
o (Yes/No) Date Date
1 SOP on Cleaning and
Operation of Dry Heat
Sterilizer
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 12 of 13
IOQ/DHS/001 00
Number: No.
10.0 Deficiency and Corrective Action Taken
Following Deficiency was identified and corrective actions taken in consultation with the
Engineering Department.
Description of the deficiency
Corrective Action(S) Taken
11.0 Requalification Criteria
The Dry Heat Sterilizer has to be Requalified if
There are any major changes which affect the operation of the equipment
After major breakdown maintenance
As per Requalification Frequency
Transfer/Shifting of Equipment
12.0 Summary Report and Conclusion
In order to close the IOQ, the tests results are evaluated. During the review it is necessary to
assess to what extent all tests were successfully completed. GMP critical deviations are
completely fulfilled before releasing equipment for routine activity.
13.0 Post Approval
The IOQ report for Dry Heat Sterilizer Combined Installation/Operation Qualification is to be
prepared, reviewed and approved.
14.0 Abbreviations
Abbreviation Detail
IOQ Installation and Operational Qualification
GMP Good Manufacturing Practices
SOP Standard Operating Procedure
EN Engineering
15.0 Change History Details
Version No. Reason for revision CRF No. Effective date
RAJASTHAN ANTIBIOTICS LIMITED UNIT-1
STERILE BULK FORMULATION FACILITY
INSTALLATION AND OPERATIONAL QUALIFICATION PROTOCOL
Title:
CUM REPORT FOR DRY HEAT STERILIZER (DHS) (CRYSTALLINE)
Equipment : DRY HEAT STERILIZER Effective Date
Name/System ID: CRY/DHS-01
Document Version Page No. 13 of 13
IOQ/DHS/001 00
Number: No.
00 New NA
