This Statement of Purpose outlines the procedures and guidelines for the proper SOP for Calibration and Operation of Cool Incubator at pharmaegg.com. The cool incubator is essential for maintaining low-temperature conditions for various biological and chemical experiments, making it crucial to adhere to strict calibration and operational protocols. Adhering to these protocols ensures accurate and reliable results, contributing significantly to the scientific integrity of our research activities.

PURPOSE

To describe procedures for operation and calibration of Cooled Incubator. The primary objective of this SOP for Calibration and Operation of Cool Incubator is to establish a standardized approach for the calibration and operation of the cool incubator. By following these guidelines, we aim to maintain consistent and precise experimental conditions, fostering reliable outcomes in our research and development endeavors.

SCOPE

This procedure is applicable for operation and calibration of Cooled Incubator at microbiological laboratory of QCD.

RESPONSIBILITIES & AUTHORITIES

1. It is the responsibility of QC analyst to follow this SOP as it is written.
2. It is the responsibility of QC manager to review and update this SOP as necessary and to ensure that this SOP is followed in its entirety.
3. The responsibility for adhering to this SOP lies with all personnel involved in the calibration and operation of the cool incubator. The laboratory manager or designated personnel will oversee the implementation and compliance of this protocol.

REFERENCE & REQUIREMENTS

1. Code of Federal Regulations, July 1, 1990.40 CFR part 160 Good Laboratory Practice Standards.
2. SOP for Operation of Data Logger.

DEFINITIONS & ABBREVIATIONS

1. Incubator: A stainless steel chamber that provides an environment for maintaining a microbial culture at a particular temperature for a set length of time, in order to measure microbial growth.
2. Calibration: Calibration means the set of operations that establish under specific conditions the relationship between values indicated by an instrument or measuring system for especially weighing, recording and controlling or the values represented by a material measure and the corresponding known values of a reference standard and the limits for acceptance of the results of measuring.

PROCEDURES

Sr. No.	Name of the Machine / Equipment	Manufacturer	ID.No
01	Cool incubator	Memert(Germany)	QCMI-000

Materials And Equipment’s

1. Cooled Incubator, memmert or equivalent
2. Insulated gloves
3. Tongs
4. Data logger, Escort or equivalent
5. Isopropyl alcohol, Merck or equivalent
6. Duster

Safety Considerations

1. Wear insulated gloves during handling of apparatus and materials
2. Use tongs for sensitive apparatus
3. Never stand in front of an open operating Cooled Incubator
4. Use safety glasses

Connect to main electricity supply

1. Turn on the main switch
2. Set the Regulatory control knob to indicate the required temperature
3. Set the “Low Safety Thermostat” 5ºC lower than the desired operating temperature
4. Set the “High Safety Thermostat” 5ºC higher than the desired operating temperature
5. The lamp beside the relevant control knob lights when the temperature inside the incubator is below or above the setting
6. When cooling is required press down the button “Cooler On”

Check Pilot Lights

1. Green pilot light indicates “Instrument Is Ready”
2. Yellow pilot light indicates “Cooling is ON”
3. Open the Cooled Incubator door by pulling the door handle
4. Place the materials on the shelf adequately separated from one another in the Cooled Incubator
5. Close the Cooled Incubator door by pushing the door handle
6. To switch off the instrument press up the button “Mains On”
7. After the work performed, remove the material
8. Wipe the interior surface of the Cooled Incubator by using wet duster fortnightly or whenever required in switch off condition

NOTE: Prior to perform any activity; disinfect the inner surfaces of the Cooled Incubator using Isopropyl alcohol

Temperature record

1. Record the temperature twice daily for days in use, readings separated by at least 4 hours
2. Note down the readings in the log book

Bio burden Record

Note down results in Log Sheet form of Bio burden of different manufacturing areas

Calibration

1. Cooled Incubator is calibrated internally after three months and externally on annual basis or whenever required
2. Internal calibration
3. Upload the data logger as per SOP for Operation of Data Logger
4. Place the data logger in the Cooled Incubator for one hour
5. After one hour remove the data logger from Cooled Incubator
6. Download the data logger readings and check any deviation
7. Print out the readings

NOTE: Cooled Incubator is externally calibrated on annual basis or whenever required

Precautions

1. Do not place apparatus and materials directly on bottom plate of the Cooled Incubator.
2. This will disturb the performance and furthermore, the internal temperature and will cause malfunctions. Be sure to utilize the shelves provided
3. Put the apparatus and materials on flat surface. If using stand, then make sure that the surface is leveled
4. Care must be exercised that no items should be placed directly against any of the heating ribs either to the sides, top or bottom of the Cooled Incubator
5. For wet loads a dry tray should be placed at the bottom
6. Reduce the number and lengths of the periods for which the door is opened for the purpose of adding or removing apparatus and materials
7. It is advisable to monitor the first 2 – 3 minutes of operation to ensure that the Cooled Incubator is functioning correctly before leaving it to run without supervision
8. When units are used for sterilization, it is important to close the ventilation slide after loading