AQD-52 Operation of Stabilty Chamber (I) - 22-01-2022

SYSTACARE REMEDIES, AMRITSAR
STANDARD OPERATING PROCEDURE
SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

SOP No. SYS/SOP/QA/52/00 Version No. 00 Page 1 of 21
Section General
Role Designation Name Signature/Date
Prepared By Sr. Executive/ Executive -QC Ms. Sukhmandeep Kaur
Reviewed By Manager/Designee-QC Mr. Rajendra Kumar
Approved By Head Quality Mr. Shashikant Sharma
Authorized By Plant Head Mr. Arjun Seth
Issuing Quality Assurance

Department
Supersedes SYS/SOP/QC/43/01
Effective Date: Next Review Date:
1.0 OBJECTIVE:
The purpose of this SOP is to provide a procedure for Operation and Qualification of
Stability Chamber - III in Quality Assurance department at “Systacare Remedies,
Amritsar” facility. Adherence to the instructions stated in this procedure will ensure to
maintain the accuracy in all respects.
2.0 SCOPE:
This procedure is applicable to all the personnel working in Quality Assurance
department at Systacare Remedies, Amritsar.
3.0 RESPONSIBILITIES:
Roles Responsibilities
Quality  All the personnel working in Quality Assurance department are
Assurance responsible for Operation and Qualification of Stability Chamber -
Department(Off III.
icer/Executive/
Sr. Executive)
Department  Quality Assurance Manager to provide proper Training as per the
Head/ procedure.
authorized  Quality Assurance Manger is responsible to ensure the
designate by compliance with this SOP.
the Head
Engineering  Engineering supervisor is responsible for maintenance.
Department
Quality  To review and approve the SOP.
Assurance  To issue the Assuranceled copy of SOP to respective

Section General
Department department.
4.0 DEFINITIONS:
This section is not applicable for this SOP.
5.0 INSTRUMENT DESCRIPTION
5.1 Instrument Details:
1. Equipment Name : Newtronic Stability Chamber
2. Make : Newtronic Lifecare Equipment
3. Model No. : NLHC71S1
4. Serial No. : NLHC-0320-0239
5. Location : (QC-004) Stability Chamber room
6. Power : 230 Volts AC
7. Capacity : 1000 Liters
8. Instrument ID No. : SYS/STBC/01 and SYS/STBC/03
9. Temp. & Humidity : 25 ̊C±2 ̊ C & 60 % ±5% RH / 30 ̊C±2 ̊ C & 75 % ±5% RH/
40 ̊C±2 ̊ C & 75 % ±5% RH
5.2 OPERATION PROCEDURE:
5.2.1 General Instructions:
5.2.1.1 Ensure that the apparatus is always clean and free from dust.
5.2.1.2 Always ensure the availability of water in heating tanks.
5.2.1.3 The electrical supply should be as per equipment specification.
5.2.1.4 The environment should be properly ventilated with exhaust fan or air conditioning.
5.2.1.5 Do not place anything on the top of the equipment or do not stand on the top of the
equipment.
5.2.1.6 Do not block the air passage area with samples.
5.2.2 Start –up of the Humidity Chamber:
5.2.2.1 Before starting the equipment ensure the below mentioned prerequisite shall be
available:
5.2.2.2 Stabilized electric supply to the equipment.
5.2.2.3 UPS supply connection to PLC and display.
5.2.2.4 Soft/purified/DM water supply to the water inlet point in the equipment.
5.2.2.5 Connection of the equipment drainage and water overflow to the drainage line.
5.2.2.6 Room temperature must be maintained within 22.0°C to 30°C.
5.2.2.7 After the above prerequisites are fulfilled switch on the UPS supply and main supply
to the equipment.

Section General
5.2.2.8 Loadig of samples in humidity chamber:

5.2.2.9 Take the key from the authorised person.
5.2.2.10 Unlock the outer door and locate the place where the samples has to be place.
5.2.2.11 Open the inner door and load the sample( previuosly labels).The left door inner
should always be opened while loading as it is master door and will give Door open
alarm.
5.2.2.12 While loading the sample following care has to be taken.
5.2.2.13 Samples has to stay in confirmed area of tray
5.2.2.14 Free space on the side of the trays should not be blocked by the sample.
5.2.2.15 Air circulation holes at the top and bottom back side of the chamber should not be
blocked.
5.2.2.16 Sensors should not be covered with samples.
5.2.2.17 Opening chamber should correlate with a temp/humidity spike in Data log which
Usually returns to normal within just a few minutes.
5.2.2.18 Now close the inner glass door properly and close the door latch tightly.
5.2.2.19 Now close the outer door, lock it and return the key to the authorised person.
5.2.2.20 Unloading samples in humidity chamber:
5.2.2.21 Take the key from the authorised person.
5.2.2.22 Unlock the outer door and locate the sample, which has to be removed.
5.2.2.23 Open the inner door and remove the samples.
5.2.2.24 Now close the inner door properly and close the door latch.
5.2.2.25 Now close the outer door, lock it and return the key to the authorised person.
5.2.3 Running NEWTRONIC ICDAS 1.2 Application

5.2.3.1 Double clickon the Newtronic Icon present on the desktop as is Figure 01
Figure01
5.2.3.2 The newtronic Software Version 1.2 opens up. The following screen would appear as
displayed in the Figure 02. Select login option present on right side of software , Fill
Prepared By Reviewed By
Sign/Date
CONFIDENTIAL DOCUMENT- DO NOT COPY

Section General
Username and password to run the software.
.
Figure02
5.2.3.3 This Menu allows User view the details of the added equipment in Grid view format or
List view format along with its communication status.
5.2.3.4 The following rights have been granted to concerned persons:
1. Manager/Designee QA and maintenance department - Administrator
2. Head/Designee QC - Approver
3. Executive/ officer QC - Reviewer
5.2.3.5 The admin can grant rights to different groups in User group menu as following.
5.2.4 Login ID creation:

5.2.4.1 The administrator has rights to create Login ID.
5.2.4.2 Clicking on Admin User Tab in Administrator Menu below window will open from where
Admin User window so as to view/add new users as required.
5.2.4.3 In Application User Window User add the following details.
 User Name: Enter User Name.
 Login Name: Enter Login Name
 Password: Enter User password
 Comm. Group: Select Comm. Group
Sign/Date

Section General
 Accessible Department: Select Accessible Department to the defined admin

 UserGroup: Select user rights Group (Administrator, Reviewer and Approver)
 Set Password Duration: Enter Password duration
 Status: Select the status of equipment.
5.2.4.4 Then Click on Add button which is on the top left side of window.
5.2.4.5 Fill the Annexure-I on creation/modification/deletion of new ID.
5.2.5 Editing Login ID:
5.2.5.1 This option is available in Admin user menu.
5.2.5.2 Select the parameters which are to be edited.
5.2.5.3 Add or remove particular rights group. And click save to save the changes.
5.2.5.4 In case of deletion follow steps 5.2.5.1 to 5.2.5.3.
5.2.5.5 Select the ID which is to be removed, the Figure01 will appear.
5.2.5.6 Click on delete option on top right side.
5.2.6 Procedure:
5.2.6.1 To review daily log data:
5.2.6.2 Reviewer shall login with username and password by selecting login option on left
hand side tool bar as in Figure03
Figure03
5.2.6.3 Once login in is complete, click on Report button just above the LOGIN button in tool
bar as in Figure04
Figure04
5.2.6.4 The page for the report review appears on the screen. Select the equipment ID Number,
and Date and time of review. Select the time (9:00) and date and click Report button
present at the bottom to see the data.Refer Figure05.
Figure05
5.2.6.5 The data log appears; review the temperature and humidity readings within the selected
Sign/Date

Section General
time duration. In case of any fluctuation in reading, and inform the approver.
5.2.6.6 Now Click on Print button, a print preview appears, verify the printer by selecting Print
icon on tool bar.
5.2.6.7 Then, click on Print icon again and press OK.
5.2.6.8 The reviewer sign the print out of data log and must point out any excursions in data
and report it to approver.
5.2.6.9 Not necessary to apply action for every excursion eg when chamber doors are opened.
Excursions are allowed if required conditions are restored within 24 hours.
5.2.6.10 If the excursion does not restored after 24 hours then a deviation report should be
raised by the reviewer and samples should be transferred to the stand by chamber.
5.2.6.11 The excursions which require alertness and not justifiable, should be reported to
maintenance department. Refer Table 02.
5.2.6.12 Due to certain reason if Stand-By chamber is not functioning or it is full in capacity or it
is unavailable, based on its deviation taken, the sample should be transferred into the
Assurance sample room with a designated place with proper identification.
5.2.6.13 It is to be mentioned in the deviation report that the stability time would be extended
after last time station for the equal days it is stored in control sample room. Once the
chamber is in an appropriate condition, it is resifted.
5.2.7 To approve daily log data:
5.2.7.1 Approver shall approve the data which is taken out by the reviewer by signing it.
5.2.7.2 He/She shall ensure integrity of data log.
5.2.8 Managing Alarm logs

5.2.8.1 Click on Alarm Log Tab on right hand side tool bar, window will open from where User
can view/print and
acknowledge the alarms log of registered for particular equipment as in Figure08
5.2.8.2 Select the alarm which is to be acknowledge add comments and click ACK.
Figure08
5.2.8.3 The following table provide the alarms and its justification:
Sign/Date

Section General
Alarm Cause Action Justification

Temperature low This alarm will Monitor the This alarm could
Alarm generate if the chamber for few be after Door
measured minutes to see if open or after
temperature the temperature Power Failure.
remains lower automatically
than set low limit restores.
for more than 10
minutes.
Temperature This alarm will Monitor the This alarm could
high Alarm generate if the chamber for few be after Door
temperature the temperature Power Failure .
remains lower automatically
than set high limit restores.
for more than 10
minutes.
Temperature When the None After excursion n
within range temperature temperature, it
condition is restored.
maintained within
set limits, this
alarm generates.
RH low Alarm This alarm will Monitor the This alarm could
generate if the chamber for few be after Door
humidity remains the humidity Power Failure.
lower than set automatically
low limit for more restores. If not
than 10 minutes. inspect the water
Sign/Date

Section General
tank for water

supply.
RH high Alarm This alarm will Monitor the This alarm could
generate if the chamber for few be after Door
humidity remains the humidity Power Failure.
lower than set automatically
high limit for restores.
more than 10
minutes.
Door Open and The audible door Close the door Maintenance or
Door Close open alarm is after sample sample
generated if the withdrawal. withdrawal.
chamber door Excursions could Give the product
remains open for result from this name and batch
more than 5 alarm. number withdrew
minutes but login from chamber.
to the software is
immediate.
MAINS fail and When the main Ensure the Mains power
resume supply of supply is failure. And
chamber fails restored within resumption.
and resumes. 15 minutes.
Water level low This alarm is Ensure the Water level low
generated when adequate water due to
water level is low supply to the inadequate water
in the humidifier. water tank supply. Or there
is problem in
float switch in
Sign/Date

Section General
heater bank.
Water level OK This alarm is Happen after Water level
generated when water level low. restored.
the water level is
restored.
Table 02
5.2.11 Running PLC base Unit
5.2.11.1 The controlling system is PLC base unit With Ethernet port for communication with
Newtronic ICDAS .The control unit records the measured temperature and humidity at
regular interval defined by user.
5.2.12 PLC program Features:
5.2.12.1 Main Menu:
5.2.12.2 From main menu window user can go to following windows for details. Refer
Figure10.
Figure10
5.2.12.3 SET PARAMETERS:
Temperature, Humdity, Alarm, login intervals can be viewed. Refer Figure11
Sign/Date

Section General
Figure11
5.2.12.4 PID PARAMETERS
Values of PID Parametrs ehich affect control accuracy fpr temperature and
Humidity.Refer Figure12
Figure12
5.2.12.5 COMPANY INFORMATION
In this window address and contact details of Newtronic are provided.Refer Figure13
Sign/Date

Section General
Figure13
5.2.12.6 MONITOR
This window displays values of temperature and humidity sensors which are installed
in the equipment.Refer Figure14.If the control parameter is out of acceptable range
than the parameter will be blinking and its background will change.
Figure14
5.2.12.7 SCANNER
This window displays values of temperature and humidity sensors which are installed
in the equipment. Figure15. In case the value of any sensor is out of acceptable
(alarm) range than display of those sensors will be blinking and its background wll
change.
Sign/Date

Section General
Figure15
5.2.12.8 ALARM HISTORY
This window shows alarm history. Refer Figure16 This window displays details of
alarm history like date, time and massage for respected alarms. This display indicates
maximum 100 alarms.
Figure16
5.2.12.9 I/O STATUS
This window displays status of controller’s inputs and outputs.Refer Figure17
Sign/Date

Section General
Figure17
5.2.12.10 HELP
This window displays quick help for the users for operation and troubleshooting.Refer
Figure18
Figure18
5.2.12.11 SERVICE GUIDE
This window displays help for service.Refer Figure19
Sign/Date

Section General
Figure19
5.3 Cleaning of Stability Chamber:
5.3.1 Chamber shall be cleaned monthly and details shall be recorded as per Annexure-I
5.3.2 Cleaning agent: 70 % IPA
5.3.3 Weekly : Clean the chamber outside wall every week.
5.3.4 Monthly: All racks shall be cleaned on monthly basis by using 70 % IPA.
5.3.5 After cleaning all samples shall be properly stored in previous place.
5.3.6 NOTE: Do not clean the electrical parts with wet cloth.
5.3.7 Clean sensors properly.
5.3.8 Close the chamber door properly.
Cleaning of Water tanks:The water tanks should be cleaned periodically to avoid the
lme scale on the heating road and tank.
5.4 Qualification:
5.4.1 The stability chamber shall qualify on yearly basis for consistency in temperature and
humidity in the stability chamber.
5.4.2 The qualification of the equipment shall be done by the external party and qualification
certificate shall be provided by them.
5.4.3 Qualification certificate shall be safely maintained by the quality assurance department.
5.4.4 Qualification frequency : Yearly
5.4.5 If the response of the instrument is not satisfactory, then put label ‘UNDER
MAINTENANCE’ on the instrument and intimate maintenance department by
Sign/Date

Section General
providing Breakdown intimation slip.
5.5 Caution:
5.5.1 Water requirement: A continous supply from DM Water, Purified water and Soft water
free from impurities.
5.5.2 The surrounding should be clean and free from dust.
5.5.3 The electrical supply should be stable and free from any surges.
5.5.4 Proper grounding of equipment is must for satisfactory working of chamber.
5.5.5 Do not block air passage area with samples
5.5.6 Do not place anything of top of equipment or do not stand on the top of the
equipment.
5.5.7 A continuous suplly of water is necessary or boiler will turn OFF and humidity will go
down when water level in the boiler tank goes below minimum level.
5.6 Maintenance:
5.6.1 Initiate the breakdown request in case of any system failure. Refer SOP No.
SYS/SOP/MTN/49/01
5.6.2 In case the chamber is out of order , affix Under maintenance label on the instrument.
5.6.3 Only in case of major breakdown which cannot be restored until the visit from service
personnel, the chamber should be evacuated. Incident shall be raised in such condition.
7.0 REFERENCES
IH, Instrument DQ,PQ,OQ and manual.
8.0 ABBREVIATIONS
SOP- Standard Operating Procedure
No.- Number
NA- Not Applicable
QA- Quality Assurance
QC- Quality control
Sign/Date

Section General
9.0 LIST OF ANNEXURES

ANNEXURE FORMAT TITLE FORMAT NUMBER NUMBER
NUMBER OF PAGES
Annexure-I User ID Creation Record of Stabilty SYS/SOP/QC/45- 1
Chamber-III F01/00
10.0
REVISION HISTORY
Supersedes Effective Date Reason for Revision
SOP Number
01 -------------- New document
11.0
ENVIRONMENT, HEALTH AND SAFETY ASPECT
This section is not applicable for this SOP
Annexure-I

User ID Creation/Modifcation/Deletion Record of Stabilty Chamber-III
SOP Ref. No.: SYS/SOP/QC/45/01Format No.:SYS/SOP/QC/45-F01/00
Name
Designation
Department
User ID
Date of Creation/Modi/Del
Rights granted/added
Training
Sign/Date

Section General
I certify that the information submitted in this application is true and correct to the best of my
knowledge. I further understand that any false statements may result in denial or revocation
of the duty. I will not disclose my password to anyone during my work tenure and will ensure
that the information in the instrument remain confidential.
UserSignature/ Date
QA Administrator Remarks
Signature/Date
Sign/Date

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SYSTACARE REMEDIES, AMRITSAR

STANDARD OPERATING PROCEDURE

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

Role Designation Name Signature/Date

Prepared By Sr. Executive/ Executive -QC Ms. Sukhmandeep Kaur

Reviewed By Manager/Designee-QC Mr. Rajendra Kumar

Approved By Head Quality Mr. Shashikant Sharma

Authorized By Plant Head Mr. Arjun Seth

Issuing Quality Assurance

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

5.2.2.8 Loadig of samples in humidity chamber:

5.2.3 Running NEWTRONIC ICDAS 1.2 Application

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

Username and password to run the software.

5.2.4 Login ID creation:

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

 Accessible Department: Select Accessible Department to the defined admin

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

5.2.8 Managing Alarm logs

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

Alarm Cause Action Justification

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

tank for water

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

providing Breakdown intimation slip.

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

9.0 LIST OF ANNEXURES

This section is not applicable for this SOP

SYSTACARE REMEDIES, AMRITSAR

SOP Ref. No.: SYS/SOP/QC/45/01Format No.:SYS/SOP/QC/45-F01/00

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - I

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