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Invensys offers
proven Environmental
Monitoring System (EMS)
solutionsfrom Entry up
to High Availabilityto
help customers meet
the particular challenges
of the Life Sciences
Industry.
Business Value
The FDA, EMEA and
other Life Sciences
regulatory bodies
require monitoring
environmental critical
process parameters that
affect product quality
and patient health.
Environmental Monitoring
System (EMS) At A Glance
Monitoring environmental parameters might seem as easy as simply recording
some low frequency data. This is not the case. Life Sciences regulatory bodies
call significant attention to environmental critical process parameters. If a
pharmaceutical company is not able to show a proper audit trail for relevant
data, a medicine cannot be released. Hence, secure data management and
storage are vitally important.
Proper reporting, alarm management and sensor calibration are each
relevant and contribute to simple, effective solutions. Ease of expansion
and integration with HVAC or building management systems help minimize
life-cycle costs. Modular, incremental validation based on proven code
fragments and functions maximizes process availability when changes
are introduced. Invensys EMS Industry Solution Blueprint provides a
structured environment designed to promote rapid innovation and to avoid
reinventing the wheel by learning from past experiences and leveraging
the contribution of all involved parties to help deliver a risk-free, on-time
and on-budget EMS solution.
RULES TO BE APPLIED
Some regulatory
rules in place:
21 CFR Part 203, 211, 600
and 820
ICH Q7A
It is possible to monitor, record, and/or alarm with portable or other instrumentation, which is not
part of the HVAC control system C-7.4.2
It may be preferable that the monitoring and documenting of these GMP Critical Parameters
should be isolated from any HVAC (Building Management System: BMS) control systems, to avoid
qualification complications D-5.8.2
When specifying systems to control HVAC, the following should be considered:
HVACs industrial nature in cleanroom applications may not justify use of PLC- or DCS-based solutions
pharmaceutical HVAC can be controlled satisfactorily using HVAC industry control systems
Other factors that may support use of PLC- or DCS-based systems; however, these are unlikely to offer
baseline solutions. D-8.7.1
The implementation of independent monitoring systems also may bring the added benefit in terms of
minimizing the risk of simultaneous failure of control and monitoring functions.3
Adopting Invensys unique software marshaling results in avoiding sensor duplication for ease of
maintenance, increased precision and quality data to the BMS, while maintaining the EMS and BMS
systems segregated for ease of validation compliance.
________________________________________
ISPE GPG - HVAC - Page 180 (8.5.1).
ISPE GPG HVAC - Page 188 (8.5.6).
3
ISPE PE Use of BMSs and EMSs in Regulated Environments (Vol. 25, No. 5) Page 13, 1st sentence.
1
2
Additional parameters:
Door status
External temperature
AHU(s) status
AHU(s) operating mode
Room occupancy
________________________________________
ISPE GPG - HVAC (2.2.1), (8.5.6.1)
ISPE Guide Volume 1: Bulk Pharmaceuticals Chemicals 1st Ed. Jun 1996 (6.4, Table 6-1), (6.8)
6
ISPE Guide Volume 2: OSD Forms 2nd Ed. Nov 2009 - (3.1.1), (3.1.2.3), (3.1.2), (6.3.6), (7.1), (7.4.1)
7
ISPE Guide Volume 3: Sterile Manufacturing Facilities 1st Ed. Jan 1999 (5.4.2), (5.8.1), (5.8.2), (8.2.1), (12.1.2), (12.2), (12.2.1)
8
ISPE GPG HVAC - Page 35 (2.3.1).
4
5
SOLUTION ARCHITECTURES
Expand/maintain leveraging
the compliance oriented
area-room based code
fragments made available
by Invensys EMS blueprint.
DOCUMENTATION
A key requirement for EMS solutions is validation. Where environmental conditions (e.g. temperature,
humidity, differential pressure, air flow, sterility, containment) have a direct impact on product purity,
safety, quality or efficacy, they need to be monitored against predetermined limits and logged. In this
case, the BMS/EMS system used for collecting and logging the data needs to be validated.
Each EMS project will require the following sets of documentation:
Project Planning Documents: AF&IDs, Design Basis, Air Balance, Critical Instruments Specification,
Health & Safety Procedures. Many of these docs are Critical master documents and to be provided
as as-build versions.
GEP and Validation Documents: Risk Assessment, Traceability Matrix, User Requirements, Project
Plan, Quality Plan, Design Specification, Test Protocols, IQP, OQP, PQP, and Thermal Mapping
Other GEP Documents: Drawings Package, Bill of Material, Calibration SOP, Handover Checklist,
Operator Manuals, Contractual Ts&Cs, Sub-contractors Quality Systems, Expediting-InspectingDelivery Control Procedures
Commissioning & Qualification Documents: Test Protocols and Test Results, Acceptance Criteria
Most of these documents will be part of the EMS Blueprint. Invensys Compliance Services Team is
available during project planning and execution.
For additional information, refer to Heating, Ventilation, and Air Conditioning (HVAC), Section 6,
Documentation Requirements, ISPE Good Practice Guide, September 2009.
Initial Risk
Assessment
Iteration as
required
Functional Risk
Assessment
User Req.
Specification
Requirements
Testing
Functional
Specification
User Testing of
Controls & Procedures
Functional
Testing
Configuration
Specification
Configuration
Testing
Module (Unit)
Specification
Testing of System
Controls
Module (Unit)
Testing
Code Modules
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