MPK | SOP FOR PERFORMANCE QUALIFICATION (PQ) OF INCUBATORS IN MICROBIOLOGY LAB

 STANDING OPERATION PROCEDURE (SOP) OF PERFORMANCE QUALIFICATION (PQ) OF INCUBATORS IN MICROBIOLOGY LAB

1.0.      Purpose

The purpose of this SOP is to provide the guideline for executing Performance Qualification (PQ) of Incubators in order to demonstrate that the unit is capable of maintaining overall temperature uniformity and stability through out its intended operating requirement

 

Microbiological incubators

2.0.      Scope

This SOP is applicable to all Incubators used in the Microbiology Laboratory.

3.0.      Responsibilities

Action	Responsibility
Conducting the qualification testing as per approved protocol, documentation of results and the preparation of report.	Microbiologist
Calibration of thermocouple and temperature recording device and assistance in carrying out related tests	Maintenance Dept.
Compliance of SOP	Laboratory Incharge

 

4.0.      Policy Statement or Legal Requirements

            N/A

            General Requirements

4.1.      Equipment Instrumentation Calibration – All equipment instrumentation associated with the incubators must be calibrated and remain in calibration during the qualification test period. The unit should be placed on a preventative maintenance (PM) program prior to initiating the performance qualification.

4.2.      Test Instrumentation Calibration – All test instrumentation used for the execution of the PQ must be calibrated (i.e. Thermocouple & Temperature Recording Device) and remain in calibration during the qualification test period.

 5.0.      Frequency

Performance Qualification of incubators is carried out on annual basis in Microbiology Laboratory.

 6.0.      Procedure

 6.1. Performance Qualification of Incubator NO ….(QC- 000)

S. No	Action	Responsibility
6.1.1	Place Five calibrated thermocouples at different locations within  the chamber according to map drawing in Annexure  I - 2	Engineering Dept. Microbiologist
6.1.2	Plugged the main switch for power supply.	Microbiologist
6.1.3	Press the ''GUIC ‘‘knob to ON the instrument indicated by Red light, Heater is also “ON”.
6.1.4	Adjust the temperature by pressing “+” or “-”button to increase or   decrease the set temperature indicated on display monitor in the whole number i.e. 22. 00C.
6.1.5	To “ON” fan inside press “Sigorta” Button indicated by orange light.
6.1.6	Allow the chamber to heat up until steady readings are observed.
6.1.7	Temperature data will be recorded for a period of 12 hours with temperature being logged at appropriate predefined   time intervals.
6.1.8	All the temperature distribution reading will be obtained graphically/charted during test length.
6.1.9	After completion of the temperature mapping, the final   accumulated   mean temperature at each location monitored   during the test period will be calculated in Annexure-1.
6.1.10	Acceptance Criteria: The final accumulated mean temperature of each location monitored during the dwell period should be within + 2.5 oC of set point for unit.

 

 

Digital Incubator

 6.2. Performance Qualification of Incubator NO….  (QC- 000)

S. No	Action	Responsibility
6.2.1	Place Five calibrated thermocouples at different locations within the chamber according to map drawing in Annexure -4	Engineering Dept. Microbiologist
6.2.2	Plugged the main switch to power supply. Make sure the power supply by blinking the green light of “on” “off” button.	Microbiologist
6.2.3	Switch on the incubator by pressing the button mark as “off”, directed from “o” to “I”
6.2.4	Adjust the temperature by pressing the buttons mark as “+” (for increase the digits) and “—“(for decrease the digits).
6.2.5	Start stirrer (if required) by pressing the button mark as “stirrer” directed from “0” to “I”
6.2.6	Allow the chamber to heat up till steady readings are observed.
6.2.7	Temperature data will be recorded for a period of 12 hours with temperature being logged at appropriate predefined time intervals.
6.2.8	All the temperature distribution readings will be obtained graphically/charted during test length.
6.2.9	After completion of the temperature mapping, the final accumulated mean temperature at each location monitored during the test period will be calculated in Annexure –
6.2.10	Acceptance Criteria: The final accumulated mean temperature of each location monitored during the dwell period should be within + 2.5oC of set point for unit.

 

 6.3. Performance Qualification of Incubator NO….. (QC- 000)

S. No	Action	Responsibility
6.3.1	Place Five calibrated thermocouples at different locations within the chamber according to map drawing in Annexure.	Engineering Dept. Microbiologist
6.3.2	Plugged the main switch to power supply.	Microbiologist
6.3.3	Turn “ON” the '' ON '' “OFF” knob, directed from “o” to “I”
6.3.4	Adjust the temperature by rotate the temperature rotatory knob as required temperature.
6.3.5	Allow the chamber to heat up until steady readings are observed. The chamber temperature has stabilized when there is uniform cycling of the control green pilot light.
6.3.6	Temperature data will be recorded for a period of 12 hours with temperature being logged at appropriate predefined time intervals.
6.3.7	All the temperature distribution reading will be obtained graphically/charted during test length.
6.3.8	After completion of the temperature mapping, the final accumulated mean temperature at each location monitored during the test period will be calculated in Annexure-
6.3.9	Acceptance Criteria: The final accumulated mean temperature of each location monitored during the dwell period should be within + 2.5oC of set point for unit.

 

 6.4. Performance Qualification of Incubator NO…..(QC- 000)

S. No	Action	Responsibility
6.4.1	Place Five calibrated thermocouples at different locations within the chamber according to map drawing in Annexure -8.	Engineering Dept. Microbiologist
6.4.2	Switch on the power supply by pressing the ”ON”, OFF” knob of main control panel.	Microbiologist
6.4.3	Press the power switch to “ON” the incubator.
6.4.4	Adjust the set temperature (required temperature) by pressing “UP” and “DOWN” keys of main control panel.
6.4.5	Check the “keep warm” and “Disinfecting” status by pressing “KEEP WARM” and “DISINFECTING” knob and confirm by blinking the “ keep warm light” (yellow light) and “disinfecting light” (red light),present at the base of incubator.
6.4.6	Temperature data will be recorded for a period of 12 hours with temperature being logged at appropriate predefined time intervals.
6.4.7	All the temperature distribution reading will be obtained graphically/charted during test length.
6.4.8	After completion of the temperature mapping, the final accumulated mean temperature at each location monitored during the test period will be calculated in Annexure-
6.4.9	Acceptance Criteria: The final accumulated mean temperature of each location monitored during the dwell period should be within + 1.0 oC of set point for unit.

7.0.      Definitions

Term/word/statement	Meaning/Description
Performance qualification	Identification of equipment attributes related to the performance of a particular function or functions and allocation of certain limits or restriction to those attributes.

 8.0.        References Used

S. No	Description
1.	N/A

 9.0.      List of Records Generated

S. No	Description of Record
1.	N/A

 10.0.   Referred Document(s)

Document No	Description
	N/A

 11.0.   Annexures

S. No	Description of Annexure
1.	Temperature Recording during P.Q of Incubator Name  (QC-00)
2.	Thermocopule Position Map of Incubator name (QC- 000)
3.	Temperature Recording during P.Q of Incubator name (QC- 000)
4.	Thermocopule Position Map  of Incubator name (QC- 000)
5.	Temperature Recording during P.Q of Incubator name (QC- 000)
6.	Thermocopule Position Map  of Incubator name (QC- 000)
7.	Temperature Recording during P.Q of Incubator name (QC - 000)
8.	Thermocopule Position Map of Incubator name (QC - 000)

 

Distribution List:

1.    Head Quality Assurance

2. Incharge Microbiology