STANDARD OPERATING PROCEDURE

SOP Number QCS/FORM/004 Prepared By: Khushboo Date: 31-07-15

Revision Number 01 Checked By: Amitabh Date: 31-07-15
By Amitabh at 5:37 am, Mar 16, 2016

Effective Date 31-07-15 Approved By: Aradhana Date: 31-07-15

Page Number 1 of 5

Circulation: PKG, FML, QAS

TITLE: TO SET UP AND USE OF WALK IN STABILITY CHAMBERS ( MACRO SCIENTIFIC)

1.0 SCOPE: This procedure is used to test and store a wide range of products in specific temperature and
humidity conditions of Walk in Chambers ( i.e. 4°C, 25°C & 40°C) in the laboratory.

MAKE : SELEC
MODEL: MM1012

2.0 ASSOCIATED DOCUMENTS

Document Revision Record Appendix 1

Instrument Calibration Record Appendix 2

3.0 INTRODUCTION AND BENEFITS

3.1 INTRODUCTION

Walk-in stability chamber are cost effective and a reliable solution for high volume test applications for
stability studies. These chambers are used to detect humidity and temperature ranges. They are
fundamentally used in pharmaceuticals industry and involve a lot of research as the entire life of the product
is dependent on this chamber. This SOP tells about the method of using and calibration of the walk in
chambers, used for the development testing (RM, PM & Bulk) under standard storage condition.

3.2 BENEFITS

These stability chambers are used to test and store a wide range of products in specific temperature and/or
humidity conditions. Applications include shelf life testing, stability testing, expiration date testing, and other
testing for pharmaceutical, packaging, personal care, medical, biomedical storage, research, and more.

4.0 PROCEDURE

Location : QC Lab
SOP Number: QCS/FORM/004 Prepared By: Khushboo Date:31-07-15
Revision Number: 01 Checked By: Amitabh Date:31-07-15
By Amitabh at 5:37 am, Mar 16, 2016

Effective Date: 31-07-15 Approved By: Aradhana Date:31-07-15

Page Number: 2 of 5

4.1 TEMPERATURE ADJUSTMENT

I. Switch on the mains supply through a indicating type rocker switch marked “Mains” at the top of the
panel.
II. Set the desired temperature through the digital temperature controller. If the set
temperature is above the inner chamber temperature then heating will start automatically &
in case the set temperature is below the inner chamber temperature then cooling will start
automatically.
III. System will start as per setting of item, i.e. cooling will start if the desired temp. is less than
ambient and heating will start vice versa.
IV. When the required temperature is achieved, the system (Cooling / Heating) will stop. When
the temperature changes from set temperature then the system will restart after few
minutes.
V. For adjusting the temperature of concern walk in chamber press set once the digital temperatures
window shows& blink 1st digit of S.V. Press F1 shift once now the 2nd digit blink, press F2 or F3 to
change the desire digit of temperatures & now again press F1 shift once. Now
the 3rd digit blink. hence again press F2 or F3 to change the 3rd digit for desire temp. Again press
F1.
VI. Shift now the 4th digit blink & press F2 or F3. Now press ENT. Now the display shows.

RH P V Temp.

25.0
S V Temp.

4.2 RH ADJUSTMENT

4.2.1 Press F3 for 10 second the window shows.

CO 0.1

GAP 1
GAPGAP

4.2.2 Press F3 for once the window shows.

GET 0.1

GAP

GAPGAP
SOP Number: QCS/FORM/004 Prepared By: Khushboo Date:31-07-2015
Revision Number: 01 Checked By: Amitabh Date:31-07-2015
By Amitabh at 5:37 am, Mar 16, 2016

Effective Date: 31-07-2015 Approved By: Aradhana Date:31-07-2015

Page Number: 3 of 5

4.2.3 Press F3 the window shows.

COL 40

DEL1

GAPGAP
4.2.4 Press F3 for once the window shows.

GET 5

DEL2

GAPGAP

4.2.5 Press F3 for once the window shows.

Set Humidity
SET 85

humidity

4.2.6 Press SET key for once the shows.

st
1 digit blink.
SET 0085

humidity

rd
4.2.7 Press F1 shift key now the second digit blink, press again F1 shift key the 3 digit blinks now
can set the desire humidity with F2 or F3 (for blink digit)

4.2.8 Press ENT Key once the window shows.

Desire Set Humidity

SET 85

humidity

GAPGAP
SOP Number: QCS/FORM/004 Prepared By: Khushboo Date:31-07-15
Revision Number: 01 Checked By: Amitabh Date:31-07-15
By Amitabh at 5:37 am, Mar 16, 2016

Effective Date: 31-07-15 Approved By: Aradhana Date:31-07-15

Page Number: 4 of 5

5.0 ROUTINE OPERATION

5.1 Open the door of the stability chamber; keep the material (standards & development testing
purpose) inside and close the door.
5.2 When the period is over, remove the material and close the door.
5.3 Temperature & Humidity monitoring of the system to be done once in the morning, Mid-day &
evening on regular basis .

6.0 TEMPERATURE & HUMIDITY MONITORING UNIT

Location :

Monitoring Unit : QC Lab (Table Top )

Sensor : Inside walk in stability chamber

6.1 The temperature & Humidity is monitored through a controlling unit.

6.2 Temperature & Humidity data is automatically displayed in the system per hour basis.
6.3 OPERATION : START> All programs> Eurotherm> Review> Instrument> Auto
Backup + Transfer >Transfer Now> Yes> close> Ok.

7.0 PRECAUTIONS

7.1 Allow at least 1" space between objects (racks, flasks, individual stacks of plates etc.)
placed in the walk in chambers.
7.2 Do not keep the door of the incubator open for more than 1 min. at a time.
7.3 Allow opening of the chamber for 30 min between 11.00 - 11.30 a.m. in the day & between 4.30 –
5.00 p.m. in the evening in working days.
SOP Number: QCS/FORM/004 Prepared By: Khushboo Date:31-07-15
Revision Number: 01 Checked By: Amitabh Date:31-07-15
By Amitabh at 5:37 am, Mar 16, 2016

Effective Date: 31-07-15 Approved By: Aradhana Date:31-07-15

Page Number: 5 of 5

8.0 CARE AND CALIBRATION PROCEDURE

8.1 Clean and disinfect the incubator after every 3 months or as per requirement.
8.2 To validate the accuracy of temperature on digital display of concern walk in chamber, place a
certified thermometer inside the chamber for 10 minutes and note down the temperature. It should
be ± 2°C from the fixed temperature showing on the display of the concern walk in chamber. If the
difference of the temperature more than ± 2°C between the two, means temperature display needs
to be calibrated.
NOTE : In 40°c stability chamber whenever the door is opened for 10 seconds and humidity drops from
70%-48% it would taking 45-50 minute to recover the same .

9.0 RESPONSIBILITY

9.1 Quality/development team member deputed in the lab is responsible for compliance of this SOP.

10. REFERENCE

Reference : Instruction Manual Stability chamber.

Document Number: QCS/FORM/004 Appendix Number: 1 Rev. no. : 1 Page 1 of 1

DOCUMENT REVISION RECORD

Revision Reviewed Date Changes Approved Date Reason For Revision

No. By Yes / No By
1 Khushboo 31.07.201 yes Aradhana 31-07-2015 Text matter is changed in
Kumari 5 Introduction & Benefits
Text matter modified in
Routine operation,
Precaution & care &
calibration procedure.
Temperature & humidity
monitoring unit description.
Introduction & Benefits
revised
Document Number: QCS/FORM/004 Appendix Number: 2 Rev. no. 1 Page 1 of 1

INSTRUMENT CALIBRATION RECORD

INSTRUMENT : STABILITY CHAMBER (4°C, 25°C & 40°C)
MAKE & MODEL : SELEC- MM1012
LOCATION : Q.C. LAB
CAL. FREQUENCY: QUARTERLY
Ref No. : QCS/FORM/004

DATE ACTUAL TEMP.°C & DISPLAY PERFORMED BY CHECKED BY NEXT. CAL. DATE
RH % TEMP.°C &
RH%