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STANDARD OPERATING PROCEDURE

Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

1.0 Overview
1.1 Objective

To lay down a procedure for operation and monitoring of EMS system.

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

External Agency/  Shall be responsible for performing, supervising of


Engineering Associates operation and monitoring of EMS system.

Department In charge  To verify the operation and monitoring of the EMS.

Quality Assurance  To ensure that the SOP is followed and documented.

1.4 Definitions and Acronyms


Definitions in Abbott Corporate Quality System Glossary apply.
Please visit http://glossary.web.abbott.com to access published glossaries.

Table 2: Definitions and Acronyms

Acronym/Term Definition
SOP Standard Operating Procedure
MDC Mumbai Development Center
EMS Environmental Monitoring System
GES Global Engineering Services
NA Not Applicable

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

Acronym/Term Definition
AHU Air Handling Unit
NMT Not More Than
NLT Not Less Than
2.0 References

2.1 User Manual


2.2 SOP: MRD-ES-E003

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

Pic 3.1.3.1, Trend 963 Application Icon

3.1.4 Go to the navigator and select the authorized access/login level, as

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

per Pic No. 3.1.4.1

Pic no. 3.1.4.2, Access level screen

3.1.5 There are Four access levels (OPERATOR, ENGINEER,


MANAGER, ADMINISTRATOR) and the respective person shall
login with its own LOGIN ID / PASSWORD as per below Roles
and Privileges.

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

Function Operator Engineer Manager Administrator


Layout screen Yes Yes Yes Yes
Selection screen Yes Yes Yes Yes
Summary screen Yes Yes Yes Yes
Audit trail ON/OFF No No No Yes
Trend Yes Yes Yes Yes
Data Deletion (Post archival No No No Yes
& QA approval)

3.1.6 A window will appear by clicking on the LOGIN icon shown


in Pic 3.1.6.1 where the USER will enter the ID / Password.

Pic 3.1.6.1 Login Dialog Box

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.

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

Pic 3.1.7.1 Area Overview Screen

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.

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

Pic 3.1.9.1 Area Layout

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.

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

3.1.11 The operation for entire HVAC shall be maintained as per following acceptance criteria.

Operational Requirement Product Specific Requirement


Existing New
Sr. Relative Differential Relative Differential
Room Existing Room Name Room Temperature Temperature
No. Humidity Pressure Humidity Pressure
Number Number (ºC) (ºC)
(%) (Pa) (%) (Pa)
Third Floor
AHU ID: RD/E-0331 (AHU-L4-01)
1. 440 Airlock-2 3-PP-22 NA NA NLT 10 NA NA NLT 10
2. 443 Dispensing Room 3-PP-25 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
3. 445 Airlock 3-PP-27 NA NA NLT 10 NA NA NLT 10
4. 444 Sampling Room 3-PP-26 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
AHU ID: RD/E-0332 (AHU-L4-02)
5. 441 Dispensed Hold 3-PP-23 NMT 25 NMT 55 NLT 10 NMT 25 NMT 55 NLT 10
6. 426 1.50m wide Corridor A 3-PP-09 NA NA NLT 10 NA NA NA
Secondary Gents Change
7. 423 3-PP-06 NA NA NLT 15 NA NA NLT 15
Room
8. 446 Janitor 3-PP-28 NA NA NA NA NA NA
Secondary Ladies Change
9. 424 3-PP-07 NA NA NLT 10 NA NA NLT 10
Room
10. 422 Equipment wash 3-PP-05 NA NA NLT 10 NA NA NLT 10
11. 418 Clean Vessel Hold 3-PP-23 NA NA NA NA NA NA
12. 429 IPQC + Office 3-PP-12 NA NA NLT 10 NA NA NLT 10
13. 428 Tool Room 3-PP-11 NA NA NLT 10 NA NA NLT 10
14. 427 Tablet Inspection Room 3-PP-10 NA NA NLT 10 NA NA NLT 10
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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

Operational Requirement Product Specific Requirement


Existing New
Sr. Relative Differential Relative Differential
Room Existing Room Name Room Temperature Temperature
No. Humidity Pressure Humidity Pressure
Number Number (ºC) (ºC)
(%) (Pa) (%) (Pa)
Third Floor
AHU ID: RD/E-0333 (AHU-L4-03)
15. 436 Granulation 3-PP-19 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
16. 431 Coating 3-PP-14 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
17. 430 Solution Preparation 3-PP-13 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
AHU ID: RD/E-0334 (AHU-L4-04)
18. 410 Change room-1 3-ML-01 NA NA NLT 15 NA NA NLT 15
19. 411 Media preparation 3-ML-02 NMT 25 NMT 55 NLT 10 NMT 25 NMT 55 NLT 10
20. 417 Wash & Decontamination 3-ML-12 NA NA NLT 10 NA NA NLT 10
21. 416 Incubation 3-ML-11 NA NA NLT 10 NA NA NLT 10
22. 412 Sterilization 3-ML-03 NMT 25 NMT 55 NLT 10 NMT 25 NMT 55 NLT 10
23. 414 Change Room-1 3-ML-05 NA NA NLT 10 NA NA NLT 10
24. 414D Airlock-1 3-ML-09 NA NA NLT 10 NA NA NLT 10
25. 413 Cooling zone 3-ML-04 NMT 25 NMT 55 NLT 15 NMT 25 NMT 55 NLT 15
26. 415 MLT 3-ML-10 NA NA NLT 15 NA NA NLT 15
27. 414A Ch. Room-2 3-ML-06 NA NA NLT 10 NA NA NLT 10
28. 414B Ch. Room-3 3-ML-07 NA NA NLT 10 NA NA NLT 10
29. 414C Ch. Room-4 3-ML-08 NA NA NLT 10 NA NA NLT 10
AHU ID: RD/E-0335 (AHU-L4-05)
30. 437 Primary Packing 3-PP-20 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
31. 433 Ancillary Store 3-PP-16 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
32. 432 Compression 3-PP-15 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
33. 435 WIP-1 3-PP-18 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

Operational Requirement Product Specific Requirement


Existing New
Sr. Relative Differential Relative Differential
Room Existing Room Name Room Temperature Temperature
No. Humidity Pressure Humidity Pressure
Number Number (ºC) (ºC)
(%) (Pa) (%) (Pa)
Third Floor
34. 434 Capsulation Prep Area 3-PP-17 NMT 25 NMT 55 NLT 10 NMT 25 NMT 30 NLT 10
AHU ID: RD/E-0336 (AHU-L4-06)
35. 425 1.75m wide corridor A and B 3-PP-08 NA NA NA NA NA NA
36. 419 Gents Primary Change Room 3-PP-01 NA NA NA NA NA NA
37. 420 Ladies Primary Change Room 3-PP-02 NA NA NA NA NA NA
38. 439 Secondary Packing 3-PP-21 NA NA NA NA NA NA
39. 421 Airlock 3-PP-03 NA NA NA NA NA NA
40. 438 Trash - NA NA NA NA NA NA
41. 447 Wash 3-PP-29 NA NA NA NA NA NA
42. 442 PPM & Entry Capsule 3-PP-24 NA NA NA NA NA NA
Fifth Floor
AHU ID: RD/E-0339 (AHU-L6-01)
43. 609 Cooling Zone 5-ML-05 NMT 25 NMT 55 NLT 15 NMT 25 NMT 55 NLT 15
44. 610 Air Lock 5-ML-06 NA NA NLT 10 NA NA NLT 10
45. 610A Change Room - 1 5-ML-07 NA NA NLT 10 NA NA NLT 10
46. 610B Change Room – 2 5-ML-08 NA NA NLT 10 NA NA NLT 10
47. 610C Change Room – 3 5-ML-09 NA NA NLT 10 NA NA NLT 10
48. 610D Change Room – 4 5-ML-10 NA NA NLT 10 NA NA NLT 10
49. 611 MLT Room 5-ML-11 NMT 25 NMT 55 NLT 15 NMT 25 NMT 55 NLT 15
AHU ID: RD/E-0340 (AHU-L6-02)
50. 605 Air Lock 5-ML-01 NA NA NLT 15 NA NA NLT 15
51. 606 Change Room 5-ML-02 NA NA NLT 10 NA NA NLT 10
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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

Operational Requirement Product Specific Requirement


Existing New
Sr. Relative Differential Relative Differential
Room Existing Room Name Room Temperature Temperature
No. Humidity Pressure Humidity Pressure
Number Number (ºC) (ºC)
(%) (Pa) (%) (Pa)
Third Floor
52. 607 Media Prep. Room 5-ML-03 NMT 25 NMT 55 NLT 10 NMT 25 NMT 55 NLT 10
53. 608 Sterilization 5-ML-04 NMT 25 NMT 55 NLT 10 NMT 25 NMT 55 NLT 10
54. 612 Incubation 5-ML-12 NMT 25 NMT 55 NLT 10 NMT 25 NMT 55 NLT 10
55. 613 Wash + Decontamination 5-ML-13 NA NA NLT 10 NA NA NLT 10
56. 626 Micro lab Office Area 5-SR-11 NA NA NA NA NA NA
57. 627 1.50m. Wide Corridor 5-ML-14 NA NA NA NA NA NA
58. 631 1.80 M Wide Corridor 5-SR-13 NA NA NA NA NA NA
59. 625 Cabin 5-CA-02 NA NA NA NA NA NA

* Note: The Acceptance Criteria mentioned here as per the monitoring instruments but rest of the areas are controlled by respective
AHUs.

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STANDARD OPER ATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

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.

3.2 Handling of Temperature, Relative Humidity or DP Alarms in EMS.


3.2.1 In case of any abnormality with respect to acceptance criteria for
Temperature, Relative Humidity or Differential Pressure happens,
an auto generated Pop-Up message appears on the system screen.
3.2.2 Soon on observation of the pop-up message the operator /executive
Shall acknowledge the alarm and shall intimate to the
supervisor/manager and appropriate rectification shall be done.
3.2.3 In case the alarms cannot be rectified within 30 minutes to 4 hrs.
then the engineering operator/engineer shall raise the Maintenance
Work Request (MWR) as per SOP: MRD/ES/E003-F04 and
document the respective information and intimation to the
respective department.
3.2.4 In case the extended alarms are observed more than 4 hrs time,
Excursion to be initiated as per format no. MRD-ES-E006-F01
followed by raising exception.
During the excursion period if no activity is ongoing in the related
area, then based on No impact on the product, exception may not be
initiated however the action shall be taken as per 3.2.3.
3.2.5 In case still the alarms continued to persist more than 24 hrs then
exception to be initiated followed by appropriate corrective and
preventive action shall be taken as per site quality system.
3.2.6 The alarm of high DP, Low RH & Low Temperature has no impact
on the product, thus action may not be required for the same.

The summary of the actions to be taken in case of alarms is as below:


S. No. Alarm Duration Intimation To Action to be Taken
1 Alarm rectified with 30 Concern Department Rectification of system
min. shall be done
2 Alarm extending 30 Concern Department Appropriate action to be
min. to 4 hrs. taken per 3.2.3

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

3 Alarm extending 4 to 24 Concern Department Appropriate action to be


hrs. taken per 3.2.3 and 3.2.4
4 Alarm more than 24 hrs. Concern Department Exception to be initiated
and QA followed by appropriate
CAPA

3.2.7 Post rectification of the problem, the engineering executive shall


further update the Excursion review form as per MRD-ES-E006-
F01 for documenting the excursion start and end time with reason
and action.
3.2.8 The excursion review form shall be then reviewed by Engineering
Manager for the reason and action.

3.3 Actions to be taken for different Alarms Handling

3.3.1 Alarms in differential pressure across rooms


3.3.1.1 In case the alarms in differential pressures of the rooms are
observed, intimation shall be given to concern department
and ensure that the doors of the room are closed properly,
visually ensure the cleanliness of riser filters and necessary
actions shall be taken accordingly.

3.3.2 Alarms in Temperature and Relative Humidity in the rooms


3.3.2.1 In case alarms in Temperature and Relative Humidity of the
rooms are observed, then intimation shall be given to the
concern department and it shall be ensured that the hot water
and chilled water system is functioning properly and system
will automatically restore the set environmental conditions.

3.4 Procedure for alarm report generation


3.4.1 Engineering executive shall take the print out of alarm for pervious
24 hrs. (including working day, weekends & holidays) on next
working day from 7:00AM to 7:00AM.

3.5 Procedure for daily alarm and data review


3.5.1 The engineering operator/engineer shall go through the printed 24
hrs. alarm for any excursions.
3.5.2 Engineering operator/engineer shall highlight the alarms of the more
than 30 minutes duration and shall ignore the alarms rectified within
30 min.

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

3.5.3 The engineering operator/engineer shall review the highlighted


alarms and shall verify that all has been addressed and rectified in
the excursion review per format MRD-ES-E006-F01.
3.5.4 In case if any alarm is found missed to be addressed in the excursion
review form more 24 hrs excursion, then it shall be evaluated
through site quality management system for exception followed by
CAPA.

3.6 Procedure for Excursion Trend review


3.6.1 To monitor the performance and health of the HVAC system, the
excursions trend review shall be done on quarterly basis as per
format MRD-ES-E006-F02. The trend review schedule shall be
followed as per below table.
Trend Review Months Review Month (by 15th
Quarter of scheduled month
Q1 Jan to Mar April
Q2 Apr to June July
Q3 Jul to Sep October
Q4 Oct to Dec January

3.6.2 The trend review shall be further verified by engineering manager


and Manager Quality.
3.6.3 The trend review shall be done based on the types/number of alarms
vi: Low DP, High temperature and High RH, and the root cause of
the excursion. Repeated alarms of the same root cause may require
immediate corrective actions however, the alarm of the less
frequency may be further trended to decide the appropriate CAPA.

3.7 EMS Data/Alarm Reports Archival


3.7.1 The daily alarm reports, excursion review forms and the trend
review forms shall be archived and retained for a period of six years.
3.7.2 The periodic backup shall be done and archived by site IT
department after each quarter & records shall be maintained as per
MRD-ES-E006-F03.

3.8 Calibration frequency of EMS instruments shall be once in a year.

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

3.9 Flow Chart

4.0 Attachments:

Annexure No. Format Title Format No.


Annexure - I EMS Excursion Review Form MRD-ES-E006-F01
Annexure - II EMS Excursion Trend Review MRD-ES-E006-F02

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STANDARD OPERATING PROCEDURE
Procedure for Monitoring of Process Area through Environmental Monitoring System (EMS)

Annexure No. Format Title Format No.


Annexure - III EMS Alarm Data Archival MRD-ES-E006-F03
records

5.0 Revision History:

Version Author Changes Made


1.0 Murarilal, Rajjak New SOP

*END OF DOCUMENT*

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ANNEXURE - I
ABBOTT HEALTHCARE PRIVATE LIMITED, MUMBAI
Title: EMS Excursion Review Form
Format No.: MRD-ES-E006-F01 DARIUS No.:
Version No.: 1.0

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

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ANNEXURE - II
ABBOTT HEALTHCARE PRIVATE LIMITED, MUMBAI
Title: EMS Excursion Trend Review Form
Format No.: MRD-ES-E006-F02 DARIUS No.:
Version No.: 1.0

Area: AHU No:

Review Period (dd/mm/yyyy): to Review Frequency: Quarterly

Alarm Type Total No. of Alarms Root Cause No. of Action Required Remarks
Alarms

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ANNEXURE – II

ABBOTT HEALTHCARE PRIVATE LIMITED, MUMBAI


Title: EMS Excursion Trend Review Form
Format No.: MRD-ES-E006-F02 DARIUS No.:
Version No.: 1.0

Conclusion of the Excursions trend review:

Function Comments (If Any) Name Sign & Date

Done By
(Engineering)

Reviewed By
(Engineering Manager)

Verified By
(Manager -QA)

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ANNEXURE - III
ABBOTT HEALTHCARE PRIVATE LIMITED, MUMBAI
Title: EMS Alarm Data Archival Record
Format No.: MRD-ES-E006-F03 DARIUS No.:
Version No.: 1.0

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.

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