Kirti shukla gmp ppt incubator

sop for incubator

1. GOOD MANUFACTURING PRACTICES PROJECT PRESENTATION ON Generation and validation of SOP for Incubator . DRx . KIRTI SHUKLA BACHELOR IN PHARMACY

2. laboratory-incubator

3. Introduction Incubators  are necessary equipment for any laboratory conducting cell culture and tissue culture work. Incubators protect cells from changes in temperature, humidity, CO2 and O2. Temperature can be regulated by water or air jackets

4. Principal incubators  are based on the concept that when organisms are provided with the optimal condition of temperature, humidity, oxygen, and carbon dioxide levels, they grow and divide to form more organisms. The temperature is maintained by utilizing the heating and no-heating cycles.

5. Incubator Is a device used to grow and maintain microbiological cultures. The incubator maintains optimal temperature humidity and other conditions such as the carbon dioxide and oxygen content ot the atmosphere inside

6. Types of incubators There are two types of Incubators Dry incubator Humid CO2 incubator Dry incubators are more economical , but required the cell cultures to be incubated in sealed flask to prevent evaporation. They do not allow precise control of atmospheric condition in the incubator Humid CO2 incubator are more expensive , but allow superor control of culture condition. They can bee used to incubate cells cultured cells cultured in petri or multi-well plates which require a controlled atmosphere of high humidity and increased CO2 tension

7. SOP FOR OPERATION AND MAINTENANCE OBJECTIVE To ensure that the incubator performs satisfactorily and maintain accurate temperature for Microbial growth. SCOPE The SOP covers procedure for operation and calibration of incubator and is applicable to Quality Control Department formulation Units RESPONSIBILITY Microbiologist.

8. ACCOUNTABILITY Department Head. PROCEDURE 1- Ensure that the power supply to the incubator is switched ‘OFF’. 2- Dedust the incubator daily externally with a clean dry cloth. 3- Once a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent. 4- Once in a month clean the interior surfaces with 2.5 % savlon solution using a clean cloth.

9. OPERATING PROCEDURE 1- Ensure that the incubator is properly connected to the power supply. 2 -Switch on the main . 3- Turn on the red colour power knob towards 0-1. 4 -Turn on the cooling knob towards 0-1. 5 -To set the incubator at 22°C , set the lower temperature 21 OC by pressing the ‘SET POINT -1’ and simultaneously adjust the temperature with the help of screw of SET and RST by screw driver. 6 -Set the higher temperature 23 OC by pressing the ‘SET POINT -2’ and simultaneously adjust the temperature with the help of screw of SET and RST by screw driver. 7- In the same manner the incubator can be set to 37°, 44° and 55°C whenever required by setting the lower temperature to 36°,43° and 54° C respectively and by setting the higher temperature to 38°,45° and 56° C respectively. 8- Record the temperature twice daily. i.e. in the morning and in the evening. The temperature should not differ ± 2° C from the set temperature.

10. Trouble shooting problems and remedial action : 1- The temperature display is not glowing. 2- Check for power supply and proper electrical connections of instruments with power point. 3- Temperature is not even in the incubator. The air circulating fan may not be functioning. Check for it. 4- Report any discrepancy observed during operation or temperature monitoring to Q.C. Executive and notify the defect to Maintenance Department.

11. CALIBRATION 1- Set the incubator temperature to 22°C. Wait till the set temperature is reached. 2- Take a calibrated thermometer and dip it in a 500 ml beaker filled to 3/4 of the volume with Glycerol AR grade. 3- Keep the beaker inside, at the center of the incubator. close the incubator door. Allow the temperature to equilibrate for 30 minutes. 4 -Observe the temperature shown by the thermometer. The temperature shown by the display and by thermometer shall not differ by more than 0.5°C. 5- Record the temperature at two time intervals ( with a gap of 6 hours) in the temperature record. 6- By following the same procedure as above carry out calibration by setting the incubator temperature to 37°C, 44°C and 55°C. 7 -Record any discrepancy observed during operation or during temperature monitoring to Quality Control Executive and notify the defect to technical assistant for rectification. Affix “BREAK DOWN” label on the instrument.

12. VALIDATION Perform the validation of B.O.D. Incubator once in a year. Follow the operating procedure for operation after altering set temperature perform the temperature mapping inside the chamber. Five calibrated thermometers are kept in different places inside the incubator. All the thermometers should maintain the temperature of ± 2 °C of set temperature for 8 hours. Maintain the records of validation.

13. Temperature range These BOD incubator by patel scientific are come in temperature ranges from 0° C to 60°C with temperature accuracy of +/-0.1°Cand temperature uniformity of +/- 0.5C. The temperature is totally microprocessor P.I.D. controlled for accu rate temperature. Other features: these are come with easy to view Led/ LCD display, door lock interior lamp, S.S nichrome heating system and run with 220 volts power supply.

14. Salient featiure Reliable Aesthetically design P.I.D. temperature control Microprocessor control system Interior electrical outlet Hermetically sealed compressor Led display of set point and chamber protection Fan assisted/forced air circulation It has bulk data storage capacity with high data retention life

15. APPLICATION For performing biochemical oxygen demand (BOD) tests Also used in plant and insect studies. For chemical oxygen demand determination test in different laboratory applications.

16. Thank you