Oven Purpose
To dry all properly cleaned glassware which is subject to use in chemical analysis & also to sterilize cleaned glassware which is subject to use in different microbiological analysis.
Oven Scope
This SOP applied for operation of Oven, which model is: UNE600 in QC Section, Microbiology Section & Product Development Section of at XX Pharmaceuticals Limited.
Definition/Abbreviation
N/A
Responsibilities
The roles and responsibility is as follows
Executive, Microbiology/ Executive, QC
Operation, cleaning & disinfection and performance checking of oven.
Assistant Manager, Microbiology
- Ensure Operation, cleaning & disinfection and performance checking.
- Ensure that oven is calibrated.
- Checking that SOP is technically informative.
Head of Quality Assurance
Take initiative to Approval of SOP
Procedure
Instructions
- Never enter open hands in the chamber of oven.
- To keep or remove glassware, wear temperature resistance gloves.
- Avoid to keep glassware into chamber with water or any other solution.
- Do not dry plastic materials using oven.
- Always keep door closed & avoid opening door for long period.
Operating Procedure
Sterilization of Glassware for Microbiological Analysis
- To put on the main power switch, Press push/turn control key in front of the instrument. Oven will start in normal mode with the display of the chamber temperature, timer, alarm temperature.
- Turn the push/turn control key by hold down the SET key & at the clockwise or anti clockwise for setting date, local time, operating temperature, alarm temperature. After setting, SET key will be released the display briefly flashes the set point.
- To select the programme, Press & hold down SET key and rotate push/turn control key at clockwise and select “Ramp timer” mode.
- Set the work days group using the push/turn control by holding down the SET key and Press push/turn control to select the ramp segment “t1” If the day is not required, it will be off position.
- Set the time using push/turn control by hold down the set key &
- Use the push/turn control, to Select ramp segment “t2”. Hold down SET key and using the push/turn control set the time.
- Until the temperature display is flashing, Turn push/turn control clockwise. Set the required temperature setpoint using push/turn control
- Select setpoint waiting time by hold down the SET key. Hold down SET key and set on using the push/turn control. After the SET key has been released the function for setpoint waiting time is stored.
- Hold down SET key & set time using the push/turn control then Select hold time “t3”.
- Hold down SET key & set time using push/turn control after selecting cooling time “t4”.
- Select program repeats “loop”. Hold down the SET key and set 2 for repeats using the push/turn control.
- To set the air changes, select the fan speed. Turn the push/turn control clockwise until the fan symbol is flashing. Set fan speed 50% suing the push/turn control holding down the SET key.
- Turn the push/turn control clockwise until monitor temperature display is flashing. Set the alarm temperature using the push/turn control holding down the SET key & select alarm temperature.
- Turn push/turn control at clockwise until the fan symbol flashing to move the air slider opens & closes the air valve to control the supply and discharge of air.
- Turn the push/turn control clockwise until the stop symbol ▀ is flashing. Select start ► using the push/turn control holding down the SET key and On releasing the SET key the program starts to run
Glassware Drying
- To put on main power switch. Press push/turn control key in front of the instrument. The oven will start in normal mode with display of chamber temperature, timer, alarm temperature.
- Select operating mode “Normal operation” holding down SET key (approximately 3 seconds) the current operating is flashing.
- Select temperature set point by hold down the SET key & use the push/turn control to select required temperature set point. After the SET key has been released the oven briefly flashes the temperature setpoint. Heating is indicated by the orange heater symbol.
- Select fan speed. Turn push/turn control clockwise until fan symbol is flashing while the holding down the SET key. To set 50% fan speed use the push/turn control
- Turn the push/turn control clockwise until the monitor temperature display is flashing. Select the alarm temperature. Use the push/turn control to set the alarm temperature by holding down the SET key.
- 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.
- Remove dried glassware from oven at the end of drying,
Cleaning of Oven
- Clean the inner benches of Oven with a cleaned cloth.
- Use 70% IPA or ethanol to disinfect the inner surfaces.
- Clean the outer surfaces with dry cleaned cloth.
- Disinfect the outer surfaces with 5% Dettol /Savlon solution.
Calibration of Oven
- Insert standard thermocouples or thermometer into the chamber.
- At least 6 position to be consider to place different location of chamber.
- Press & hold down SET key until the normal mode light blinking.
- To reach SETUP light, turn push/turn control key clock wise.
- Select Calibration to rotate push/turn control key.
- Use the following temperature for calibration:
- 1 : 1500C
- 2 : 2000C
- 3 : 2500C
- Select required calibration temperature in SETUP key & set the corresponding calibration correction to 0.00
- Under the steady conditions, using a reference instrument, measure the deviation from the selected calibration temperature.
- If the measured reference temperature is too low, the calibration correction setting is negative sign, set the calibration correction in SETUP key.
- The correction value should not more than ±10C.
- Adjust the temperature if require from adjusting value of calibration temperature (CAL), carry out the check measurement using the reference thermometer.
- Carry out others two calibration temperatures in the same manner.
- Calibrate incubator once in a year.
- Record calibration in Oven Calibration Record, Annexure-II.
Maintenance
Inform to supplier or Engineering Department for maintenance, If Oven shows any mechanical, electrical or any others problem, after maintenance, recalibrate the oven.
Download all Annexure here
Annexure I Oven Calibration Record