Operation and Qualification of Stability Chamber IV

SYSTACARE REMEDIES, AMRITSAR
STANDARD OPERATING PROCEDURE

OPERATION MONITORING AND QUALIFICATION OF STABILTIY
SOP Title
CHAMBER - IV
SOP No. SYS/SOP/QC/73/00 Version No. 00 Page 1 of 22
Section General
Signature/
Role Designation Name
Date
Prepared By Officer
Reviewed By QC Head
Approved By QA Head
Authorized By Plant Head
Issuing Department Quality Assurance
Supersedes NIL
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 - IV in Quality control 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 control department
at Systacare Remedies, Amritsar.
3.0 RESPONSIBILITIES:
Roles Responsibilities
Quality control  All the personnel working in Quality control department are
Department responsible for Operation and Qualification of Stability Chamber
(Officer/Executiv - IV.
e/ Sr. Executive)
Department  Quality control Manager to provide proper Training as per the
Head/ procedure.
authorized  Quality control Manger is responsible to ensure the compliance
designate by the with this SOP.
Head
Engineering  Engineering supervisor is responsible for maintenance
designate by the with this SOP.
Head
CONFIDENTIAL DOCUMENT – DO NOT COPY

OPERATION MONITORING AND QUALIFICATION OF STABILTIY
SOP Title
CHAMBER - IV
Section General
Engineering  Engineering supervisor is responsible for maintenance

Department
Quality  To review and approve the SOP.
Assurance  To issue the controlled copy of SOP to respective 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. : NLWH777SU1
4. Serial No. : NLHC-0322-0151
5. Location : (QAD-004) Stability room
6. Power : 230 Volts AC
7. Capacity : 21780 Liters
8. Instrument ID No. : SYS/STBC/04
9. Temp. & Humidity : 30 ̊C±2 ̊ C & 75 % ±5% RH
5.2. General Instructions:

5.2.1 Ensure that the apparatus is always clean and free from dust.
5.2.2 Always ensure the availability of water in heating tanks.
5.2.3 The electrical supply should be as per equipment specification.
5.2.4 The environment should be properly ventilated with exhaust fan or air conditioning.
5.2.6 Do not block the air passage area with samples.
5.3 Start –up of the Humidity Chamber:

5.3.1
5.3.1 Before starting the equipment ensure the below mentioned prerequisite shall be
available:
5.3.2 Stabilized electric supply to the equipment.
5.3.3 UPS supply connection to PLC and display.
5.3.4 Soft / purified / DM water supply to the water inlet point in the equipment.
5.3.5 Connection of the equipment drainage and water overflow to the drainage line.
5.3.6 Room temperature must be maintained within 22.0°C to 30°C.
CONFIDENTIAL DOCUMENT – DO NOT COPY

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

Section General
5.3.7 After the above prerequisites are fulfilled switch on the UPS supply and main supply
to the equipment.
5.4 Loading of samples in humidity chamber:

5.4.1 Take the key from the authorized person
5.4.2 Unlock the outer door and locate the place where the samples have to be place.
5.4.4 While loading the sample following care to be taken.
5.4.5 Samples has to stay in confirmed area of Rack.
5.4.6 Free space on the side of the trays should not be blocked by the sample.
5.4.7 Air circulation of the chamber should not be blocked.
5.4.8 Sensors should not be covered with samples.
5.4.9 Opening chamber should correlate with a temp/humidity spike in Data log which
usually returns to normal within just a few minutes.
5.4.10 Now close the inner glass door properly and close the door latch tightly.
5.4.11 Now close the outer door, lock it and return the key to the authorized person.
5.5 Unloading samples in humidity chamber:

5.5.1 Take the key from the authorized person.
5.5.2 Unlock the door and locate the sample, which has to be removed.
5.5.3 Open the inner door and remove the samples.
5.5.4 Now close the inner door properly and close the door latch.
5.5.5 Now close the outer door, lock it and return the key to the authorized person.
5.6 Running NEWTRONIC ICDAS 2.1 Application

5.6.2 Click on the web browser Google chrome, and type URL for the login screen.
(localhost/icdas2/index.aspx)
5.6.3 The following login screen would appear as displayed in the Figure 01. Login with
Username and password to open ID.
Prepared By Reviewed By
Sign/Date
CONFIDENTIAL DOCUMENT- DO NOT COPY

Section General
Figure 01
5.6.4 This Menu allows User view the details of the added equipment in Grid view format or
List view format along with its communication status.
5.6.5 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
Privilege QC QC QA Engineering
Reviewer Approver Administrator Administrator
Create User NO NO YES YES
Id
Edit NO NO YES YES
ID/Password
Data Review YES NO YES YES
Approve NO YES YES YES
Data
Privilege QC QC QA Engineering
Reviewer Approver Administrator Administrator
Alarm YES YES YES YES
Acknowledg
Sign/Date

Section General
e
Alarm Audit YES YES YES YES
Trial
Instrument NO NO YES YES
Audit trail
View YES YES YES YES
Review/Appr
oved Data
System NO NO YES YES
configuration
5.6.6 The admin can grant rights to different groups in User group menu as following
Figure02.
Figure 02
5.7 Login ID creation:
5.7.1 The administrator has rights to create Login ID.
5.7.2 Clicking on Admin User Tab in Administrator Menu below window will open from were
Admin User window so as to view/add new users as required.
5.7.3 In Application User Window User add the following details.
 User Name: Enter User Name.
Sign/Date

Section General
 Login Name: Enter Login Name

 Password: Enter User password
 Comm. Group: Select Comm. Group
 Accessible Department: Select Accessible Department to the defined admin
 User Group: Select user rights Group (Administrator, Reviewer and Approver)
 Set Password Duration: Enter Password duration
 Status: Select the status of equipment.
5.7.4 Then Click on Add button which is on the top left side of window.
5.7.5 Fill the Annexure-I on creation/modification/deletion of new ID.
5.8 Editing Login ID:

5.8.1 This option is available in Admin user menu.
5.8.2 Select the parameters which are to be edited.
5.8.3 Add or remove particular rights group. And clicks save to save the changes.
5.8.4 In case of deletion follow steps 5.8.1 to 5.8.3
5.8.5 Select the ID which is to be removed, the Figure01 will appear.
5.8.6 Click on delete option on top right side.
5.9 Procedure to review daily log data:

5.9.1 Reviewer shall login with username and password as in Figure03
Sign/Date

Section General
Figure 03
5.9.2 Now click on tab Data log analysis present at left side of the software. From this tab
select Manage Data Log > Review Data Log as in Figure-04
Figure 04
5.9.3 The page for the review appears on the screen. Select the equipment name, and last
date and time of review appears automatically. Select the time (9:00) and date and click
print button to see the data. Refer Figure05.
Sign/Date

Section General
Figure 05
5.9.4 The data log appears in the form of pdf file, review the temperature and humidity
readings within the selected time duration. In case of any fluctuation in reading, and
inform the approver.
5.9.5 Now close the file, click the review button, a pop up for confirmation appears 2 times.
Click ok.
5.9.6 Review page appears, Fill username, password and comment. Give the reason for
review or any fluctuation in data.
5.9.7 The reviewer must point out any excursion in data and report it to approver.
5.9.8 Click login to complete the review process as in Figure06
Figure 06
Sign/Date

Section General
5.10 To approve daily log data:

5.10.1 Approver shall login with username and password.
5.10.2 Now click on tab Data log analysis present at left side of the software. From this tab
select Manage Data Log > Approve Data Log as in Figure-07
Figure 07
5.10.3 The page for the Approval appears on the screen. Select the equipment name, the data
which is already reviewed appears automatically. Click on print key.
5.10.4 The data log appears in the form of pdf file, approve the temperature and humidity
readings within the selected time duration. In case of any fluctuation in reading, and
inform the maintenance department.
5.10.5 Now close the file, click the Approve button, a pop up for confirmation appears 2
times. Click ok.
5.10.6 Review page appears, Fill username, password and comment. Give the reason for
approval or any fluctuation in data.
5.10.7 Click login to complete the approval process.
5.11 Managing Alarm logs

5.11.1 Click on Alarm Log Tab below window will open from where User can view/print and
acknowledge the alarms log of registered for particular equipment as in figure 08
5.11.2 Select the alarm which is to be acknowledged, and click save.
For anyone reviewing stability chamber, shall be aware of temperature and humidity
Sign/Date

Section General
excursions and shall give reason for the alarms as per Table 02.
Figure 08
5.11.3 A confirmation page will appear where user shall login and give reasons for the
alarms in comment section.
The following table provide the alarms and its justification:
Alarm Cause Action Justification
Temperature low This alarm will Monitor the This alarm could be
Alarm generate if the chamber for after Door open or
measured few minutes to after Power Failure.
temperature see if the
remains lower temperature
than set low limit automatically
for more than 10 restores.
minutes.
Temperature This alarm will Monitor the This alarm could be
high Alarm generate if the chamber for after Door open or
temperature see if the
remains higher temperature
than set high automatically
limit for more restores.
Sign/Date

Section General
than 10 minutes.
Temperature When the None After excursion in
withing 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 be
generate if the chamber for after Door open or
humidity remains see if the
lower than set humidity
low limit for more automatically
than 10 minutes. restores. If not
inspect the
water tank for
water supply.
Rh high Alarm This alarm will Monitor the This alarm could be
generate if the chamber for after Door open or
humidity remains see if the
higher than set humidity
high limit for automatically
more than 10 restores.
minutes.
Door Open and The audible door Close the door Maintenance or
Door Close open alarm is after sample sample withdrawal
Sign/Date

Section General
generated if the withdrawal. Give the Product

chamber door Excursions name and batch
remains open for could result number from
more than 5 from this alarm. chamber.
minutes but login
to the software is
immediate.
MAINS fail and When the main Ensure the Mains power failure.
resume supply of supply is And
chamber fails restore 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
in the humidifier. water tank water supply. Or
there is problem in
float switch in heater
bank.
Water Level Ok This alarm is Happen after Water level restored.
generated when water low.
the water level is
restored.
Table 02
5.12 To view reviewed/approved data log:

5.12.1 Select view review/approve data option from the data log analysis tab.
5.12.2 The user can anytime see the reviewed/approved data by selecting equipment and
date.
Sign/Date

Section General
5.13 To view audit trail log

5.13.1 The audit trail log can be viewed by clicking on the Audit trail tab.
5.13.2 Select the user of which audit trail log is to be viewed. As in figure-09
Figure 09
5.14 Running PLC base Unit
5.14.1 The controlling system is PLC base unit with Ethernet port for communication with
Newtronic ICDAS. The control unit records the measure temperature and humidity t
regular interval defined by user.
5.14.2 PLC program Features:
5.14.3 Main menu:
5.14.4 From main menu window user can go to following windows for details. Refer
Figure10.
Figure 10
5.14.5 Set parameters:
Temperature, Humidity, Alarm, login intervals can be viewed. Refer Figure 11
Sign/Date

Section General
Figure 11
5.14.6 PID parameters
Values of PID Parameters which affect control accuracy for temperature and
Humidity. Refer Figure 12
Figure 12
5.14.7 Company Information
In this window address and contact details of Newtronic are provided. Refer Figure 13
Sign/Date

Section General
Figure 13
5.14.8 Monitor
This window displays values of temperature and humidity sensors which are installed
in the equipment. Refer Figure 14. If the control parameter is out of acceptable range
than the parameter will be blinking and its background will change.
Figure 14
5.14.9 Scanner
This window displays values of temperature and humidity sensors which are installed
in the equipment. Figure 15. In case the value of any sensor is out of acceptable
(alarm) range than display of those sensors will be blinking and its background will
change.
Sign/Date

Section General
Figure 15
5.14.10 Alarm History
This history shows alarm history. Refer Figure 16. This window displays details of
alarm history like date, time and message for respected alarms. This display indicates
maximum 100 alarms.
Figure 16
5.14.11 I/O status
This window displays status of controller’s inputs and outputs. Refer Figure 17
Sign/Date

Section General
Figure 17
5.14.12 Help
This window displays quick help for the users for operation and troubleshooting.
Refer Figure 18
Figure 18
5.14.13 Service guide
This window displays help for service. Refer Figure 19
Sign/Date

Section General
Figure 19
5.15 Cleaning of Stability Chamber:
5.15.1 Chamber shall be cleaned monthly and details shall be recorded as per Annexure-I
5.15.2 Cleaning agent: 70 % Isopropyl Alcohol.
5.15.3 Weekly: Clean the chamber outside wall every week.
5.15.4 Monthly: All racks shall be cleaned on monthly basis by using 70 % IPA.
5.15.5 After cleaning all samples shall be properly stored in previous place.
5.15.6 NOTE: Do not clean the electrical parts with wet cloth.
5.15.7 Clean sensors properly.
5.15.8 Close the chamber door properly.
5.15.9 Cleaning of water tanks: The water tanks should be cleaned periodically to avoid
the limit scale on the heating road and tank.
5.16 Qualification:
5.16.1 The stability chamber shall qualify on yearly basis for consistency in temperature and
humidity in the stability chamber.
5.16.2 The qualification of the equipment shall be done by the external party and qualification
certificate shall be provided by them.
5.16.3 Qualification certificate shall be safely maintained by the quality assurance department.
5.16.4 Qualification frequency: Yearly ± 1 month.
5.16.5 If the response of the instrument is not satisfactory, then put label ‘UNDER
Sign/Date

Section General
MAINTENANCE’ on the instrument and intimate maintenance department by

providing Breakdown intimation slip.
5.17 Caution:
5.17.1 Water requirement: A continuous supply from DM Water, Purified water and soft
water free from impurities.
5.17.2 The Surrounding should be clean and free from dust.
5.17.3 The electrical supply should be stable and free from any surges.
5.17.4 Proper grounding of equipment is must for satisfactory working of chamber.
5.17.5 Do not block air passage area with samples
5.17.7 A continuous supply 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.
5.18 Management of stability chamber:
5.18.1 It is responsibility to ensure that chambers are maintaining the required temperature/
humidity over the duration of study. There shall be documented evidence of condition as
Annexure-XI of SOP SYS/SOP/QAD/048/01.
5.18.2 The qualification of stability chamber shall be done once in a year ± 1 month.
5.18.3 IQ, OQ and PQ shall be done on the new chamber or change in place of current
chamber with proper change control & PQ in case of change in condition of the
chamber.
5.18.4 Performance records shall be maintained by QA department.
5.18.5 It is important to maintain chamber log books for accessing chamber.
5.18.6 Opening chamber shall correlate with temperature/Humidity spike in record and shall be
maintained in Annexure-VIII of SOP SYS/SOP/QAD/048/01.
5.18.7 Not necessary to apply action for every excursion e.g., when chamber doors are
opened. Excursions are allowed if required conditions are restored within 24 hours.
5.18.8 If the excursion does not restore after 24 hours, then a deviation report should be raised
by the reviewer and samples shall be transferred to the stand by chamber.
5.18.9 The excursions which require alertness and not justifiable, should be reported to
maintenance department. If required it shall be rooted through an incident based on the
condition or reply from the maintenance department only if it affects the product
Sign/Date

Section General
quality.
5.18.10 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
control sample room (25°C) with a designated place with proper identification.
5.18.11 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 re-shifted.
5.18.12 Deviation report shall be raised if the above condition does not apply.
5.18.13 Evacuation shall be required if a) chamber is switched off b) excursions lasts for more
than 24 hours c) Chamber breaks down and cannot be repaired for reasonable time.
5.18.14 Manual Data logger shall be employed in case of sensor malfunction for the time till the
chamber is serviced with an incident report.
5.18.15 Dealing with power outrages: Chamber has back up with UPS connection which control
logic the system in same position. In case the power failure lasts for more than 15
minutes, action shall be taken immediately.
5.18.16 For security: There shall be restricted access to chamber and chamber shall be kept
locked and keys shall be under custody of QA department. Whenever the chamber is
required to open, QA personnel shall accompany QC personnel.
5.19 Maintenance:
5.19.1 Initiate the breakdown request in case of any system failure. Refer SOP No.
SYS/SOP/MTN/49/01
5.19.2 In case the chamber id out of order, affix Under maintenance label on the instrument.
5.19.3 Only in case of major breakdown which cannot be restored until the visit from service
personnel, the chamber should be evacuated. Incident and deviation shall be raised in
such condition.
6.0 REFERENCES
IH, Instrument, DQ, PQ, OQ and manual.
Sign/Date

Section General
7.0 ABBREVIATIONS
SOP- Standard Operating Procedure
No.- Number
NA- Not Applicable
QA- Quality Assurance
QC- Quality control
DQ- Design Qualification
IQ- Installation Qualification
PQ- Performance Qualification
OQ- Operational Qualification
DM- De-mineralized
8.0 LIST OF ANNEXURES

ANNEXURE FORMAT TITLE FORMAT NUMBER NUMBER
NUMBER OF PAGES
Annexure-I User ID Creation Record of Stability SYS/SOP/QC/45- 1
Chamber-III F01/00
9.0
REVISION HISTORY
Supersedes Effective Date Reason for Revision
SOP Number
01 -------------- New document
10.0
ENVIRONMENT, HEALTH AND SAFETY ASPECT
10.1
Don not Clean the electrical parts with wet cloth.
10.3
Let the water tank to cool down before cleaning.
Sign/Date

Operation and Qualification of Stability Chamber IV

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SYSTACARE REMEDIES, AMRITSAR

STANDARD OPERATING PROCEDURE

Authorized By Plant Head

Issuing Department Quality Assurance

Effective Date: Next Review Date:

CONFIDENTIAL DOCUMENT – DO NOT COPY

Engineering  Engineering supervisor is responsible for maintenance

5.2. General Instructions:

5.3 Start –up of the Humidity Chamber:

CONFIDENTIAL DOCUMENT – DO NOT COPY

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

5.4 Loading of samples in humidity chamber:

5.5 Unloading samples in humidity chamber:

5.6 Running NEWTRONIC ICDAS 2.1 Application

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

 Login Name: Enter Login Name

5.8 Editing Login ID:

5.9 Procedure to review daily log data:

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

5.10 To approve daily log data:

5.11 Managing Alarm logs

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

generated if the withdrawal. Give the Product

5.12 To view reviewed/approved data log:

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

5.13 To view audit trail log

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

MAINTENANCE’ on the instrument and intimate maintenance department by

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

SOP Title OPERATION AND QUALIFICATION OF STABILTIY CHAMBER - IV

8.0 LIST OF ANNEXURES

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