Incubator Operation, Cleaning and Calibration Procedure

Incubator; Purpose

To operate, clean & calibrate incubator in order to support the bacterial growth in microbiological test.

Incubator; Scope

This SOP applies for operation, cleaning and calibration of Incubator, Model : INE500 & INE600 in Microbiology Section At  XX Pharmaceuticals Ltd.

Definitions/Abbreviation

[] CAL.1: Calibration Temperature 1

[] CAL.2: Calibration Temperature 2

[] CAL.3: Calibration Temperature 3

Responsibilities

The roles and responsibility is as follows

Executive/ Senior Executive, Microbiology

• Follow the instructions of this procedure correctly.

Assistant Manager, Microbiology

• Confirm that this procedure is kept up to date.
• Confirm appropriate personnel from the section are trained on this procedure.
• Confirm that SOP is technically sound and reflects the required working practices.

Head of Quality Assurance

Take initiative to Approval of this SOP

Procedure

Instructions

• Do not wipe with damped cloth at on position.
• Use only 70% IPA or Ethanol to wipe chamber with any disinfectants
• Never overload the chamber with tested items.
• Do not keep the items those may produce inflammation with air.
• Keep all tested items to avoid the touch inner surface of the chamber.
• Do not move the incubator at on position. Severe vibrations may cause serious damage of the temperature probes.

Operation Procedure

• To the front of the instrument, Press push/turn control key to put on the main power switch. The incubator will start in normal mode with display of the timer, chamber temperature, alarm temperature (red color indication).
• Turn the push/turn control key by holding down SET key, at the clockwise or anti clockwise for setting date, local time, operating temperature, and alarm temperature. After setting, SET key will be released the display briefly flashes the set point.
• The display then changes to the actual current temperature & starts to the setting temperature. The temperature will be automatically augmented at setting temperature and display the setting temperature digitally.
• Observe display temperature until its 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 incubator.
  1. Normal Operation
  2. Weekly Programmer
  3. Ramp time Programme Operation­­­

• Select required programme & set as per operation manual.
• Select fan speed to set air changes.
• Turn the push/turn control at clockwise until the fan symbol flashing to move air slider opens & closes the air valve to control supply and discharge of air.
• Check chamber temperature using by a calibrated digital thermometer, when setting Temperature reaches.
• Keep required materials inside incubator.
• Incubator will automatically control Temperature.
• Instrument will automatically adjust the temperature. When the temperature exceed the setting temperature, “off” light will illuminate and if the temperature decrease the “on” light will illuminate.

Cleaning & Disinfection Procedure

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

Performance Check

• Check chamber temperature daily once.
• Record chamber temperature in Daily temperature Record, Annexure-I.
• Temperature range ± 2.5° C from set temperature.

Calibration Procedure

• Press and hold down SET key until 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 : Temperature calibration at low temperature
• 2 : Temperature calibration at medium temperature
• 3 : Temperature calibration at high temperature
• Select required calibration temperature in SETUP key & set corresponding calibration correction to 0.0⁰
• Measure the deviation from selected calibration temperature under the steady conditions, using a reference instrument.
• Set calibration correction in SETUP key. If measured reference temperature is too low, calibration correction setting is negative sign.
• Adjust temperature if require from adjusting value of calibration temperature (CAL). Correction value should not more than ±10C.
• Carry out check measurement using reference thermometer.
• Carry out others two calibration temperatures in the same manner.
• Calibrate incubator once in a year ± 15 days.
• Record calibration in Calibration Record, as per Annexure-V of Engineering SOP

Maintenance

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

Download All Annexure Here:

Annexure I Daily Temperature Record of Instrument

Annexure II Incubator Operation Log Book