Cooled incubator, Operation, cleaning and calibration procedure

Cooled incubator Purpose

To operate, clean and calibrate Cooled Incubator in order to support the growth of Yeast and mould in Microbiological analysis.

Cooled incubator Scope

This SOP applies for operation, cleaning and calibration of Cooled Incubator, Model: ICP600 in Microbiology Section of at XX Pharmaceuticals Limited.

Definitions/Abbreviations

N/A

Responsibilities

The roles and responsibility is as follows

Executive/ Senior Executive, Microbiology

Operation, cleaning & calibration

Assistant Manager, Microbiology

Ensure Operation, cleaning, calibration and application of sound information.

Head Quality Assurance

Take initiate to approval of SOP

Procedure:

Instructions

• Do not wipe with damped cloth at on position.
• Use only 70% IPA or ethanol to wipe chamber
• Do not overload chamber with tested items.
• Do not keep items those may produce inflammation with air.
• Keep all tested items to avoid touch inner surface of the chamber.
• Do not move the Cooled Incubator at on position. Severe vibrations may cause serious damage of the temperature probes.

Operating Procedure

• Press push/turn control key to put on main power switch in front of instrument. The Cooled Incubator will start in normal mode with display of timer, chamber temperature, alarm temperature (red color indication).
• Hold down SET key & turn the push/turn control key at the clockwise or anti clockwise for setting date, local time, operating temperature at [23.5± 2.5]⁰C, alarm temperature at 30⁰ After setting, SET key will be released the display briefly flashes the set point. The display then changes to the actual current temperature and starts to the setting temperature. The temperature will be automatically increased at setting temperature and display the setting temperature digitally.
• Observe the display temperature until stable position.
• Hold down the SET key (approximately 3 seconds) to select the operation mode, if require. The current operating mode will be flashed on the display. There are three operating mode in the Cooled Incubator:
• Normal Operation
• Weekly Programmer
• Ramp time Programme Operation
• Select required programme and set as per operation manual.
• Select fan speed to set air changes. Selected position of fan speed will show in display.
• Turn the push/turn control at clockwise until fan symbol flashing to move the air slider opens and closes the air valve to control the supply and discharge of air.
• Check chamber temperature using by a calibrated digital thermometer, when the setting Temperature reaches.
• Keep the required materials inside the chamber.

Cleaning & Disinfection :

• Switch off Cooled Incubator and disconnect the power plug.
• Remove all test flasks and others items from chamber.
• Clean inside of chamber initially with dry cloth and wipe finally with 70% IPA wetted cloth.
• Clean outside of chamber with dry cloth.
• Disinfect all surfaces with 5% Savlon solution and dry the outer surface.
• Reload all items into chamber when reach to dry the chamber surface.
• At the end of cleaning, connect the power plug and switch on.
• Clean the chamber once in a month.
• Clean the outer surface every day.

 Performance Check

• Check chamber temperature daily once.
• Record chamber temperature in Daily temperature Record
• Temperature range ± 2.5C from the set temperature.

Calibration of Cooled Incubator

• Insert standard thermometer or thermocouples into chamber.
• Place at different location of chamber at least 6 position.
• Press & hold down SET key until the normal mode light blinking.
• Turn push/turn control key clock wise to reach SETUP light.
• Select Calibration to rotate push/turn control key.
• Use three calibration temperatures as below :
• 1 : 15⁰C
• 2 : 22⁰C
• 3 : 30⁰C
• Select required calibration temperature in SETUP key & set the corresponding calibration correction to 0.0⁰
• Measure deviation from selected calibration temperature under the steady conditions, using a reference instrument.
• Set calibration correction in SETUP key. If the measured reference temperature is too low, the calibration correction setting is negative sign.
• Adjust temperature if require from adjusting value of calibration temperature (CAL). The correction value should not more than ±10C.
• Carry out check measurement using the reference thermometer.
• Carry out others two calibration temperatures in the same manner.
• Calibrate the incubator once in a year ± 15 days.
• Record calibration in Calibration Record, as per Annexure-V of Engineering SOP

 Maintenance

• If Cooled Incubator shows any mechanical, electrical or any others problem, inform to supplier or Engineering Department for corrective action.
• After corrective action, recalibrate Cooled Incubator.

Download Annexure Here

Annexure I Cooled Incubator Operation Log Book