Alarm Verification Protocol for Incubators

TABLE OF CONTENT

1. Protocol Approval
2. Objective
3. Scope
4. Responsibility
5. Equipment Details
6. System Description
7. Reason of Qualification
8. Frequency of Qualification
9. Pre Qualification Requirements
10. Qualification Methodology & Tests Performed
11. Checklist of all Test and Checks
12. References
13. Documents to be Attached
14. Non Compliance
15. Deviation
16. Change Control
17. Abbreviations

1. PROTOCOL APPROVAL

PREPARED BY:

Designation	Name	Signature	Date
Officer/Executive (Quality Assurance)

REVIEWED BY:

Designation	Name	Signature	Date
Operating Manager (Quality Assurance)
Head (Quality Control /Microbiology)
Head (Engineering)

APPROVED BY:

Designation	Name	Signature	Date
Head (Quality Assurance)

2. OBJECTIVE

• To provide documented evidence that the installed Audio Visual Alarm System is working consistently, repeatedly and reproducibly to provide the alarm when temperature inside the Incubation chamber/area goes beyond the specified limit and the results meet the pre-defined acceptance criteria.
• To confirm the suitability of the Standard Operating Procedures for all routine activities associated with the system.

ALSO READ: Performance Qualification Protocol and Report for Autoclave

3. SCOPE

This Protocol is prepared to Challenge the Audio Visual Alarm system in Incubation chamber/areas of Microbiology Laboratory at PharmaGuide Ltd.

4. RESPONSIBILITY

The Verification Group, comprising of a representative from each of the following Departments, shall be responsible for overall compliance of this Protocol:

Quality Assurance

• Preparation, review and approval of cleaning Verification protocol.
• Protocol training.
• To monitor all alarm Verification activities and ensuring the Alarm Verification & Challenge as per the protocol.

Quality Control

• Review of Verification Protocol.
• Execution of alarm verification activity in coordination with Engineering and Quality Assurance.

Engineering

• Review of Verification Protocol.
• To co-ordinate and support Verification Activity.
• Responsible for Trouble shooting during execution (If Occurs).

5. EQUIPMENT DETAILS

Following are the key detail of incubator and temperature limit.

Sr. No.	Incubator ID.	Temp. Limit
1		55-60°C
2		35-39°C
3		42-44°C
4		20-25°C
5		30-35°C

6. SYSTEM DESCRIPTION

The Temperature monitoring system contains Control Panel box, Temperature Sensors and Audio Visual Alarm Unit in Incubation chamber/area. The Audio visual alarm system is provided to indicate the user when temperature of the incubator chamber goes beyond specific temperature.

The System consists of following Parts:

• Temperature Sensors
• Control Panel Box
• Audio Visual Alarm Unit in Incubation chamber/area. (Audio alarm with red light indicator)

Alarm Mechanism

The System is designed to provide the Alarm in audio visual form when fluctuation in temperatures occurs beyond the set point or min./max. set value of temperature. There is a provision for setting up of a upper and lower limit inside the control panel box beyond which the system provide audio visual alarm (audio alarm with red light indicator) at the respective incubation Chamber panel.

Sensor Location

There are two Temperature sensors which are located in each incubation Room at the Hot Point. Details of sensor as per below table:

Incubator ID.	Temperature Sensor

7. REASON FOR QUALIFICATION

New Alarm system installed in Microbiology Section, at PharmaGuide Ltd.

ALSO READ: Sterility Test Validation Protocol

8. FREQUENCY OF QUALIFICATION

Initially

After major modification.

9. PRE–QUALIFICATION REQUIREMENTS

The below mentioned activities should be completed prior to commencing the performance qualification activity for temperature Controller.

Training:

Training shall be imparted to the all concerned person and record shall be maintained with the qualification report.

Verification of Documents:

Verify the relevant documents such as relevant SOP for their existence and Record the observations for documents in the below mentioned table.

Calibration Status

Before Start the activity, ensure the calibration status of the temperature sensors.

10. QUALIFICATION METHODOLOGY & TESTS PEROFRMED

Alarm Verification

Method:

Alarm system should be verified, Challenge the system by increasing the temperature beyond the limit and checked the system for alarm, similarly Challenge the system by dropping the temperature below set point and checked the system for alarm.

Challenge of lower Limit of temperature

Deliberately, Set the lower limit value more than the display temperature value in control panel box, alarm will blow. This is the alarm for lower limit challenge.

Challenge of Upper Limit of temperature

Deliberately, Set the Upper limit value less than the display temperature value in control panel box, alarm will blow. This is the alarm for Upper limit challenge.

Sr. No.	Incubator Id.	Temp. Limit	Case	Method
1		55-60°C	When Challenge Lower Limit value of temperature.	Set the lower limit value more than the display value. Alarm will blow for lower limit challenge.
			When Challenge Upper Limit value of temperature.	Set the Upper limit value less than the display value. Alarm will blow for Upper limit challenge.
2		35-39°C	When Challenge Lower Limit value of temperature.	Set the lower limit value more than the display value. Alarm will blow for lower limit challenge.
			When Challenge Upper Limit value of temperature.	Set the Upper limit value less than the display value. Alarm will blow for Upper limit challenge.
3		42-44°C	When Challenge Lower Limit value of temperature.	Set the lower limit value more than the display value. Alarm will blow for lower limit challenge.
			When Challenge Upper Limit value of temperature.	Set the Upper limit value less than the display value. Alarm will blow for Upper limit challenge.
4		55-60°C	When Challenge Lower Limit value of temperature.	Set the lower limit value more than the display value. Alarm will blow for lower limit challenge.
			When Challenge Upper Limit value of temperature.	Set the Upper limit value less than the display value. Alarm will blow for Upper limit challenge.
5		20-25°C	When Challenge Lower Limit value of temperature.	Set the lower limit value more than the display value. Alarm will blow for lower limit challenge.
			When Challenge Upper Limit value of temperature.	Set the Upper limit value less than the display value. Alarm blow for Upper limit challenge.

* Photographs of execution of challenge method shall be taken and attached along with report.

ALSO READ: Microbial Limit Test Validation Protocol

Acceptance Criteria

• When temperature drops below the limit and alarm should be generated.
• When temperatures reach above the limit and alarm should be generated.

11. CHECKLIST OF ALL TESTS AND CHECKS

Alarm Verification

12. REFERENCES

• Validation Master Plan
• SOP title “Daily Temperature monitoring of Walk in Type Incubator”

13. DOCUMENTS TO BE ATTACHED

• Calibration certificate.
• Any other relevant data

14. NON-COMPLIANCE

In case of any Non-compliance observed during performance requalification, same shall be handled through SOP for Handling of Non-Compliance.

15. DEVIATION

In case of any deviation observed during performance requalification, same shall be handled through SOP for Handling of Deviation.

16. CHANGE CONTROL

If any change is required during performance requalification, same shall be handled through SOP for Change Control.

17. ABBREVIATIONS

SOP : Standard Operating Procedure

QC : Quality Control

GNP : General protocol number

H : Plant code for Pure & Cure

CC : Change Control

INS : Instrument

PC : Pure & cure

℃ : degree centigrade

QA : Quality Assurance

ML : Microbiology

ALSO READ: Report for Disinfectant Efficacy Validation