FEROZSONS LABORATORIES LIMITED

Standard Operating Procedure

SOP No. QC 047-01

Effective Date:
Review Date:
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Procedure For Operation & Cleaning of Universal Incubator UN-260

Title Signature Date
Written by A.M. Microbiology

Reviewed & Quality Control Manager

Approved by
Reviewed & Sr. Manager Quality
Approved by Assurance
Approved by Director Quality Operations

1. OBJECTIVE
Objective of this SOP is to describe the procedure for operation of Universal Incubator
(Memmert).

2. SCOPE
This SOP describes the execution of operation of universal incubator in which
environmental conditions can be controlled for growing microbial cultures; this SOP is
applicable to microbiology laboratory.

3. GLOSSARY
Temp. = Temperature
SS = Stainless Steel
C = Degree Centigrade
SOP = Standard Operating Procedure

Incubator = an apparatus in which environmental conditions such as temperature can be

controlled for growth of microbial cultures.

Temp. = the degree or intensity of heat present in a substance or object, especially as

expressed according to a comparative scale and shown by a thermometer or
perceived by touch.

SOP = is a set of step-by-step instructions compiled by an organization to help workers

carry out routine operations.

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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Standard Operating Procedure

SOP No. QC 047-01

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Procedure For Operation & Cleaning of Universal Incubator UN-260

SS = a form of steel containing chromium, resistant to tarnishing and rust.

C = a unit of measurement of temperature on a specified scale also known as Degree

Celsius.

4. RESPONSIBILITIES
General Manager:
- To provide adequate resources for the implementation of this SOP as defined.

Director Quality Operations:

- To ensure that the SOP is followed and should be placed and user should be trained
accordingly.

Quality Assurance Manager:

- To assure through periodically audits that the SOP is valid and followed accordingly.

Quality Control Manager:

- To ensure that the SOP placed at the proper place and user should be trained
accordingly.

A. M. Microbiology:
- To follow the instructions laid down by this SOP.
- To keep the relevant SOPs valid and updated.

Microbiologist:
- To interface this SOP to the actual practices of flow patterns.
- To ensure that the SOP is updated & reflects the actual execution.
- To review the SOP in case of any change or whenever it is due for revision.

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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 FEROZSONS LABORATORIES LIMITED
Standard Operating Procedure

SOP No. QC 047-01

Effective Date:
Review Date:
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Procedure For Operation & Cleaning of Universal Incubator UN-260

5. REQUIREMENTS
5.1 Universal Incubator, Memmert, Model IN-260

2 9
3
Universal Incubator
4 Components

1- Control COCKPIT with Capacitive

5 Function Keys
2- On/Off Button
3- Temperature Sensor
4- Ventilation Flap
8 5- Stainless Steel Shelves
6- Working Chamber
7- Nameplate Covered
8- Door Handle
6 9- Turn Controller with
Confirmation Key

Figure 1: IN-260 Universal Incubator

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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FEROZSONS LABORATORIES LIMITED
Standard Operating Procedure

SOP No. QC 047-01

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Procedure For Operation & Cleaning of Universal Incubator UN-260

5.2 OPERATING PROCEDURE
5.2.1 Ensure that the instrument is clean and free from dust and placed in a safe area.

5.2.2 Lay the power cable, so that, it doesnt come into contact with any hot part.

5.2.3 Plug the provided power cable into the rear of the appliance and connect it.

5.2.4 Turn the power switch on by pressing the On/Off switch on the front of the sterilizer, see
figure 2.

Figure 2: Switch-on the Incubator

5.2.5 First start-up display appears on the screen, set the desired temperature by pressing the
activation key on the left or right of the respective display, figure 3.

Figure 3: Set the Temperature

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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Standard Operating Procedure

SOP No. QC 047-01

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Procedure For Operation & Cleaning of Universal Incubator UN-260

5.2.6 By turning the knob to the left or right, adjust the set value (e.g. 23.0 C & 33.0 C),
figure 4a & figure 4b..

Figure 4a: Turn the knob left or right

Figure 4b: Turn the knob left or right

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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FEROZSONS LABORATORIES LIMITED
Standard Operating Procedure

SOP No. QC 047-01

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Procedure For Operation & Cleaning of Universal Incubator UN-260

5.2.7 Save the set value by pressing the center button of the knob (confirmation key), the
display returns to normal figure and the sterilizer begins adjusting to the defined set
value, figure 5a for bacterial incubation & figure 5b for fungal incubation.

Figure 5a: Save the set value by pressing the knob

Figure 5b: Save the set value by pressing the knob

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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FEROZSONS LABORATORIES LIMITED
Standard Operating Procedure

SOP No. QC 047-01

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Procedure For Operation & Cleaning of Universal Incubator UN-260

5.2.8 Turn the power switch off by pressing the On/Off switch on the front of the incubator
after setting the temperature parameters, see figure 6.

Figure 6: Switch-off the Incubator

5.2.9 Open the door completely by pulling the door handle from right side to the left, figure 7.

Figure 7: Opening the door

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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Standard Operating Procedure

SOP No. QC 047-01

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Procedure For Operation & Cleaning of Universal Incubator UN-260

5.2.10 After testing desired materials incubate agar plates and broth media bottles properly,
place them carefully inside the incubator at the temperature ranges 20 C 25 C for
fungal microorganisms & 30 C 35 C for bacterial microorganisms respectively.

5.2.11 Do not load the chamber too tightly, so that the air circulates properly inside the working
chamber, also do not place any material on the chamber floor or touching the chamber
side walls, figure 8.

Figure 8: Correct Placement of Chamber Load

Note: If the door is open while the sterilizer is in operation, the incubator may overheat
and pose a fire hazard. Do not leave the door open during operation.

Note: Do not load such materials which produce poisonous explosive vapors or gases, if
there is any doubt then they must not be loaded into to the incubator.

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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FEROZSONS LABORATORIES LIMITED
Standard Operating Procedure

SOP No. QC 047-01

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Procedure For Operation & Cleaning of Universal Incubator UN-260

5.2.12 After loading the desired materials into the incubator, push the door handle from left side
to the right for closing the door, figure 9.

Figure 9: Closing the door

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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FEROZSONS LABORATORIES LIMITED
Standard Operating Procedure

SOP No. QC 047-01

Effective Date:
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Procedure For Operation & Cleaning of Universal Incubator UN-260

5.3 MAINTENANCE & CLEANING PROCEDURE
5.3.1 Be sure to start maintenance or service work after the incubator has been unplugged.

5.3.2 A temperature sensor is installed near to ventilation flap at the top of the chamber, be
careful not to damage this sensor during cleaning the chamber, if sensor comes loose
from the fixing clip, reattach it.

5.3.3 Gently wipe stains from the body with a soft cloth, to remove stubborn stains, wring a
cloth moistened with neutral detergent diluted with water, and wipe off the stains with it.

5.3.4 Do not use benzene or thinner or any volatile substances to clean the body as these
substances may deteriorate the body or strip the paint, and also wipe off any moisture
with a dry cloth.

5.3.5 If rust spots appear on the surface of the working chamber due to impurities, the affected
area must be immediately cleaned and polished.

5.3.6 Grease the moving parts of the door (hinges and lock) with thin silicone grease and
check that the hinge screws are not loose, once a year.

5.4 ASSOCIATED RISKS & SAFETY PRECAUTIONS

5.4.1 Hazards to Staff:
5.4.1.1 Risk of burns from hot incubators.
5.4.1.2 Risk of melting plastic objects causing fire.
5.4.1.3 Risk of drying material catching fire.
5.4.1.4 Risk of electrical shock.
5.4.2 Safety Precautions:
5.4.2.1 The incubator chamber is made of stainless steel never attempt to use liquids containing
substances that corrosive to stainless steel, such as concentrated acid, salts & alkalis.

5.4.2.2 Take care when operating chamber as electric shock may be hit when opened.

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

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Standard Operating Procedure

SOP No. QC 047-01

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Procedure For Operation & Cleaning of Universal Incubator UN-260

5.4.2.3 Be careful not to pinch hands when closing the door.

5.4.2.4 Do not pile specimen on top of one another, sufficient air should be allowed to circulate
round the material so that heat does not build-up and the materials combust.

5.4.2.5 Heat Labile plastic objects do not be placed inside the incubator.

5.5 DOCUMENTATION
Sterilization cycles (time) & cleaning entries are written in the following LOGs:

a) LOG Sheet No. FZ-202 (Temperature Monitoring Cycle = 30 35 C)

b) LOG Sheet No. FZ-203 (Temperature Monitoring Cycle = 20 25 C)
c) Form No. FZ-204 (Cleaning Record)

Retention Period:
The original reports will be retained in Microbiology Section for Three (3) years.

6. TRAINING
Training of the concerned SOP shall be given to the personnel who will be exercising the
SOP, and will be documented on the attached appendix-II.

7. APPENDICES
1) LOG Sheet No. FZ-202 (Temperature Monitoring Cycle = 30 35 C)
2) LOG Sheet No. FZ-203 (Temperature Monitoring Cycle = 20 25 C)
3) Form No. FZ-152 (Cleaning Record)
3) Training Record

8. REFERENCE
British Pharmacopoeia 2017.
Memmert Manufacturers Manual
United States Pharmacopoeia USP 40, NF 35 2017.
District Laboratory Manual Monica Cheesebrough Vol. 1.

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

COPY NO.
FEROZSONS LABORATORIES LIMITED
Standard Operating Procedure

SOP No. QC 047-01

Effective Date:
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Procedure For Operation & Cleaning of Universal Incubator UN-260

9. HISTORY
Date Reason of Change
Change of Standard Operating Procedure format.
th Revision of Standard Operating Procedure and Reference.
09 October, 2017
Inclusion of Pictures & Glossary.

10. DISTRIBUTION AND RETRIEVAL

Distribution Retrieval
Title Signature Date Copy No. Signature Date

Reviewed & Approved by: Sr. MQA Sign: Date

All or part of the information contained in this document should be treated as the confidential property of Ferozsons Laboratories
Limited. It cannot be published or divulged for whatever purpose to unauthorized persons, or 3 rd parties, in any form without the prior
written permission from DQO Ferozsons Laboratories Limited.

COPY NO.