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Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)
1.0 Overview
1.1 Objective
1.2 Scope
This SOP is applicable to Abbott MDC Mumbai. The scope of activity involves
Monitoring of applicable process area (Rooms) through Environmental Monitoring
System (EMS).
1.3 Responsibilities
Table 1: Responsibilities
Function Responsibility
Acronym/Term Definition
SOP Standard Operating Procedure
MDC Mumbai Development Center
EMS Environmental Monitoring System
GES Global Engineering Services
NA Not Applicable
Acronym/Term Definition
AHU Air Handling Unit
NMT Not More Than
NLT Not Less Than
2.0 References
3.0 Procedure
3.1 For Starting of the EMS system
3.1.1 Only authorized personnel shall operate Environmental Monitoring
System (EMS)
3.1.2 The trend 963 application is continuous running application.
3.1.3 If system is turned ON and trend 963 application display in the
bottom of windows operations, the application can also be started
by opening it from the desktop, an authorized user must click on the
963 open Icon to start application as shown in Pic 3.1.3.1
3.1.7 After correct LOGIN from the HOME page the OVERVIEW screen will
appear as shown in Pic 3.1.7.1 from where area/level wise navigation shall
be done directly by clicking on the icon.
3.1.8 In the selection menu (overview screen) the user shall go to the level
(floor) screen and the level area layout/ screen will open as shown in Pic
3.1.9.1 (area layout).
3.1.9 From this area layout screen, user shall scroll to other area/ screen from
NEXT and BACK buttons and operation can be monitored.
3.1.10 The data recording interval in the system shall record every 30 min.
however operator shall take the print out of critical parameter i.e.
Temperature, Rh and DP reading for pervious day (including working
day, weekends & holidays) on next working day.
3.1.11 The operation for entire HVAC shall be maintained as per following acceptance criteria.
* Note: The Acceptance Criteria mentioned here as per the monitoring instruments but rest of the areas are controlled by respective
AHUs.
3.1.12 In case of any product specific requirement, the Relative humidity shall be
maintained NMT 30%. After completion of the batch the Relative Humidity
shall be changed to normal limit i.e. NMT 55%.
3.1.13 The data recording interval in the system shall record every 30 min.
however operator shall take the print out of critical parameter i.e.
Temperature, Rh and DP reading for pervious day (including working day,
weekends & holidays) on next working day from 7:00AM to 7:00AM.
4.0 Attachments:
*END OF DOCUMENT*
Date Room Differential Temperature Relative Time of Duration Reason Action Recorded Reviewed AHU
Name Pressure (0C) Humidity (%) Excursion of for Taken By (Sign By (Sign & NO.
(Pascal) Excursion Excursion & Date) Date)
DP DP Temp. Temp. RH RH From To
Set actual set actual set actual
value value value Value value value
Alarm Type Total No. of Alarms Root Cause No. of Action Required Remarks
Alarms
Done By
(Engineering)
Reviewed By
(Engineering Manager)
Verified By
(Manager -QA)
Area: Equipment:
Date Time Data Base Total Data Base Data Base Data Archival Remark Done By Verified By
Capacity (GB or Current Storage % Required (Date & Sign) (Date & Sign)
TB) Storage (BG (Yes / No)
or TB)
*Note: Data Archival Shall be done whenever the storage capacity reached up to 75% of maximum storage capacity of the data base.