building management systems for pharma, healthcare & life sciences
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BUILDING MANAGEMENT SYSTEMS21 CFR Part 11 Compliant Systems for Lifesciences & Healthcare Industry
ISO 9001 : 2008
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www.gmptech.netIntegrated Building Management Systems
IBMS
GMPs Building Systems business specialises in providing integratedsolutions for pharmaceuticals, biotech and healthcare building
facilities encompassing monitor & control of temperature, relative
humidity, pressure differentials, indoor air quality, airborne
particulate count (for ISO classified areas) Building Management
Systems based on open protocols like Lonworks, BACnet, Modbus
along with the 21 CFR Part 11 compliant software and documentation
as per GAMP ensures facility managers are ready for audits of USFDA ,
MHRA, MCC, MCA, TGA. As an engineering solutions provider GMP
takes responsibility for design, supply, installation, commissioning
and maintenance, offering end-to-end solutions, energymanagement /conservation and comfort throughout the life-cycle of
the building.
An Emerging Leader
GMP Technical Solutions is an emerging leader inIBMS Technologies that enables utility and industry
customers to improve performance while lowering
environmental impact. The GMP group of
companies has a pan India presence and employ
over 500 people. GMP serves its customers with
complete range of IBMS technologies. The company
has a good installation base and has a countrywide
marketing and service presence.
Differential
PressureControl
Integrated Building
SolutionsElectrical
(External & Internal)
Power &
Control
Cables
Distribution
Boards
Sub
Station with
RMU & CSS
Back - up
Power
(DG+UPS)
Electrical
Wiring
Accessories
Line
Protection
Devices
LighteningProtection
Power Distribution and Management
Power
QualityImprovement
EnergyManagement EarthingSystemsSurgeProtection
HVAC & Cleanroom
BuildingAutomation System
Integrated Building Management Systems (IBMS)
AccessControl
CC TVMATV
PLC &SCADA
EvacuationSystem
Lightingcontrols
& EIB
TenantBilling
Indoor Climate
Solution
Ventilation
Systems &
CO Control
Conta-
mination
& Odour
Control
Noise
Control
Energy
Saving
VAV
Systems
VRV
Systems
Clean RoomsTemperature &
Humidity Control
FireDetection
and SmokeControl
PA &BGM
Parking &Visitor
Managment
IT &CommunicationInfrastructure
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www.gmptech.netIntegrated Building Management Systems
GMP designs and engineers complete automation of the air-conditioning and ventilation systems including supply, erection
and commissioning, which helps monitor & control critical parameters like temperature, relative humidity, pressure
differentials, cleanliness & carbon dioxide. State-of-the-art clean room technology ensures contamination control - a critical
requirement for pharmaceutical, biotechnology and healthcare. Together with energy management / conservation and
security systems seamlessly integrated with web based building automation; our solutions are designed for facilities to
function smoothly & efficiently.
BMS in Lifesciences and Healthcare Industry
Close control of
Temp/RH
Air cleanliness &
quick removal of dust
Cross contamination/
air particulate contentDocumentation,
Validation
Control of pressure
regimes
Operation Theatres
Customised Operation
Theatre Solutions & Clean
Room Technologies
Control & monitor of
critical parameters like
Temperature
Relative HumidityDifferential Pressure
Airborne Particulate
Count
CO2 Levels
Sterile Laboratories
Individual lighting control
temperature and demand
driven ventilation need to
suit varying patient &personnel requirements
Wards
Monitoring of
environment parameters
like temperature,
humidity and differentialpressure for critical
studies
Size
Functionality
Perf
orm
ance
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RS StandardRoom sensor
www.gmptech.netIntegrated Building Management Systems
GMP's open architecture offers immense integration possibilities and complies with internet and web standards offering full
flexibility to communicate with any computer via the world wide web (www). This allows the user to view the entire system ona single screen shot facilitating effective and convenient monitoring and control of all systems simultaneously from a remote
location at the click of a mouse. Software is compliant to the USFDA 21 CFR Part 11 norms and can be used to easily integrate all
the systems on Lonworks, BACnet, Modbus RS232/485 etc.
Open Systems - Freedom to all
Basic Functions
Equipment scheduling (operating equipment as
required)
Optimum start / stop (running of HVAC equipment
only during occupancy)
Operator adjustment (accessing of set point to tune
the system)
Monitoring (logging of temperature, trends,
equipment start & run time, operator log on etc.)
Alarm reporting (notify failed equipment, out of limit
temperature / pressure)
Provide status of specialised system like SCADA, lighting
control, load management, access control, etc
Typical System Architecture
LGR Routeror ME-LGRRouter/Controller
ToThird PartyEquipment
BACnet /IP, 100Base-T Ethernet
Ethernet, ARCNET, EIA-485, EIA-232
XML/SOAP HTML/HTTP
BACnet MS/TP, ARCNET
WML/WAP WML/WAP HTML/HTTP
Internet
Server
Enterprise System
Web Browser CellPhone
Web Browser
PDA
ME lineController
SE lineController
Room Sensor
Room Sensor
ZN lineController
Room Sensor
ME812u-EController
RoomController
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www.gmptech.netIntegrated Building Management Systems
GMP Building Management Systems provide Control, Monitoring and
Alarming of a range of environmental parameters like temperature, relativehumidity, pressure differentials & air borne particle count. These solutions are
modular and scalable and can be used for a single room to plant wide
applications.
They are ideal for :
Implementing new system
Enhancing existing systems
It offers the options for :
Centralised BMS
Network of local stand alone BMS units
Combination of centralised and local systems to increase
availability and ease of use
Scalable, Modular & Flexible BMS Solutions
Sensor
GMP can offer a range of the above sensors or alternatively provide interface to sensors provided by
the user.
Sensors communicate measurement & status information
from the process to the control & monitoring modules of
the BMS system.
Sensors include :
Temperature
Relative Humidity
Air Pressure or Differential pressures
Luminescence (light level)
Particle counters
Air Flow patterns
Gas Level
Noise
Water Leak Detection
Door Status
Fire Detectors
HVAC healthy status
For hazardous rooms intrinsically safe devices must beused including :
Intrinsically Safe Sensors
Intrinsically Safe Barriers
Intrinsically Safe IO modules
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www.gmptech.netIntegrated Building Management Systems
Data Logging and Audit Trail Designed to Satisfy 21 CFR Part 11
Data logging
Data logging is a key requirement for BMS Systems. 21 CFRPart 11 requires that logged data will be tamper proof and
will include crit ical environmental parameters
(temperature, humidity, pressure, particulate, sizes etc),
with audit trails including:
Accurate time and date stamps
Alarms and events
User actions and details (e.g. Set point changes)
User notes
Login/ Logout
BMS log plant data to tamper proof files and SQL relationaldatabases.
Data logging can be offered as:
Local logging (Tamper proof file)
Central logging (SQL database)
Local and central logging (Tamper proof files and S Q L
database)
The availability of logged data can be significantly
increased by the local and central logging option. This
allows data collection in multiple devices to further protect
vital plant data.
Typically a BMS system comprise of a number of
distributed units where each unit has its own internal clock.
Time synchronisation is included to ensure accurate time
and date stamps as required by 21 CFR Part 11 to a known
clock source
The BMS system offers provisions for electronicallycopying data for archive and export facility to common
packages (e.g. Excel, PDF, Word etc.) for viewing of secure
records in human readable format. Other features of the
system includes :
Power and network recovery automatic
procedures
FTP server to put the data on a central server
Scheduled transfers
The system can be configured to provide logging for non-
critical parameters including; System events
Equipment failure
Equipment performance and maintenance
Energy usage
Security Manager
Security Manger offers significant operation cost savings
and ease of use by allowing maintenance of user
accounts and passwords from one or multiple locations.
If a user needs to change their password they can do so
on a local instrument or PC and this will be automatically
distributed across all systems to which they have access.
A common security tool across multiple product
ranges
Change in one place, deploy to many
Support for multiple security zones
Built-in audit trail for 21 CFR part 11 validation
Automatic version control
Support for electronic signatures
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www.gmptech.netIntegrated Building Management Systems
An important feature of the BMS is its Alarms and Eventsfunctionality. All alarms and events are time stamped and
logged for long term retention and validation to 21 CFR Part
11. Individual plant data can be configured to have one or a
combination of the following alarms:
Absolute alarms
Deviation alarms
Rate of Change alarms
Delayed alarms
Excursion alarms
Alarms can be configured as critical, non-critical or as an
event. Critical alarms will require manual acknowledgement
and non-critical will be auto-acknowledged. Alarm selection
and set point settings are available to the users with the
appropriate access level and critical alarms can be
configured to require an Electronic Signature for changes.
Alarm acknowledgement and all changes to alarm settings
are automatically logged as required by 21 CFR Part 11.
All alarms and events are reported through local, central,
and remote HMI panels. They are displayed in the Alarm
Summary and Alarm History pages that provide a sort facility
for the information. Alarms can be grouped by their
criticality and function to ensure individual alarms can be
quickly accessed.
Other features of the BMS alarm system include:
Audible alarm notification
Notification of alarm conditions to designated users on a
designated telephone number
Local printing alarms events
Alarms and Events Reporting
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Monitoring
BMS offers a wide range of options for monitoring theplant. Information can be monitored locally, centrally and
remotely. Access to the system is protected. Users must
login to gain access to functionality, defined by their access
level.
Plant information is monitored through standard and
custom displays and includes :
Live data
Mimics with live data
Multi language support
Information received from the plant is grouped together invarious forms to allow the users to rapidly access the
required information. The system utilises an easy to use,
hierarchical methodology of presenting the necessary
information to the users including :
Plant overview
Area Overview
Individual room overview
Individual control loop view
Individual sensor overview
Grouping by type (e.g. temperature, humidity, pressure)
Data collected from the plant are linked together and
displayed as trends using online and historical trending
within the system. Trended data are available in various
groups e.g. by room, by type (temperature, pressure etc.)
The monitoring facility also provides the user with access
to standard features of the system according to their
access level, access control with password protection for
individual user accounts, inactivity timeout and password
expiry, including :
Alarms
Trends Alarm set point configuration
Control parameter configuration
Calibration facilities
Maintenance facilities
Batch displays
Electronic signatures
Configuration utilities
It offers standard control functionality, e.g. PID loops, toaccurately control the various environmental conditions of
the room.
It also provides the functionality required to control
devices such as pumps, motors and valves, e.g. start/stop
with necessary interlocks. Operation can be configured to
be automatic, semi-automatic, manual or any combination
of these.
Individual room/areas may be operated in different modes;
the selection of which is access controlled by authorised
users:In operation: Automatic control of critical parameters
Maintenance: Automatic and Manual control of critical
parameters. This mode is also used for calibration of
sensors.
BMS offers the facility for adjusting control parameters
(e.g. set points, alarm limits, tolerances and time delays) in
order to achieve the desired condition in each room. This
feature is only available to users with the appropriate
access permissions. The system provides a full audit trail of
these changes including electronic signatures.
Accurate Control
Control
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BMS provides a comprehensive review and reportingsystem. The system offers two methods for collecting data:
Local data collection - Data collected locally in a secure
format and archived centrally in a filing system
Central data collection - Data collected in a central
historical SQL relational database
These methods may be combined and, in both cases, the
system provides the facility to create reports for individual
rooms. A number of standard report templates are
provided along with the facility for users to create their
own reports.
Review and Reporting
Information can be automatically transferred and accessedfrom standard Microsoft Office packages.
Realtime and historical trends
Multiple data plots
Search by batch or by room
Batch trend analysis
Golden Batch analysis
Standard and custom SQL queriesTM TM Direct insertion to Excel , Word
Quick report generation with standard templates
Easy to Use, Comprehensive Reporting
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BMS PROJECT CYCLE
USER
Approval
SUPPLIER
Why BMS
Where environmental conditions could reasonably beexpected to have an adverse effect on product quality,
the manufacturer shall establish and maintain procedures
to adequately control these environmental conditions.
Environmental control system(s) shall be periodically
inspected to verify that the system, including necessary
equipment, is adequate and functioning properly. These
activities shall be documented and reviewed. FDA 21 CFR
Part 820.70 Production and Process Controls, section c.
Validation
A key requirement for BMS solutions is validation. Whereenvironmental 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 system used for collecting
and logging the data needs to be validated. According to
ISPE guidelines, it is good practice to monitor the
performance of equipment such as fans, coil and control
components, but it is not a regulatory requirement.
Documentation
Validation documentation needs to be provided throughthe life cycle of the BMS system. GMP can offer a range of
documentation services following GAMP guidelines and in
accordance with customer requirements;
User requirement Specification
Functional Specification
Design Specification
Hardware testing
Code Review
Factory Acceptance test
Installation Qualification Operational Qualification
Periodic review
User Audit of SupplierUser Initiates
Proposal Quality Plan Project Plan
Functional Specification(Traceable to URS)
Detailed Design Documentation(Traceable to Functional Specification)
System Acceptance TestSpecifications (IQ/OQ)
Hardware
Software
System Acceptance Testing and Results(User Witness Optional)
Maintenance & SupportDocumentation
Integrate with ValidationDocumentation (as appropriate)
Review SystemAcceptance Test Specifications
Proposal Analysis
User RequirementsSpecification
(URS)
Review Functional Specification
Equipment Validation Plan Explanation to Supplier
(Living Document)
Master Validation Plan
Review Detailed Design
RFQ
RFQ
Prop
osal
P.O.
Approval
Approval
GMPs validation approach helps all pharmaceutical environment managers keeptheir records as per ISO regulations and USFDA regulated 21 CFR PART 11 compliance
FUNCTIONAL DESIGN
USER REQUIREMENTSPERFORMANCEQUALIFICATION
OPERATIONALQUALIFICATION
PQ Test Plan
OQ Test Plan
SYSTEM DESIGN SPECIFICATIONS SYSTEM TEST SPECIFICATIONS
IQ TestPlan INSTALLATION
QUALIFICATIONDETAILED DESIGN
IMPLEMENTATION
Validation as per GAMP
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Remote Alarm Notification
LAN
Approved off-the-shelfvoice modem Multimedia
speakeror intercomsystems
Telephones PCS and GSMPhone
E-mailNumericPagers
Cellular PhonesAlphanumericpagers
Radios
Total Lifecycle Support
Nominated users can be quickly notified of alarm conditionsvia the telephone system.
The system offers :
Real-time alarm notification triggered from the plant
system
Ensured delivery of the messages
Easy to configure tools
Login facilities and security patterns
Redundancy options
Services need to be provided from the beginning of the
project, through the project development and
Services
GMP offers a complete range of services such as: Expertise to assist with the user requirement
Specification
Project, Application and Validation engineering
Commissioning (e.g. Calibration) and Qualification
engineering
Training courses covering Products, Control theory,
Validation etc.
Helpdesk and On call services
Product services
GMP Advantage
Advantages of GMPs BMS Projects methodology
Concept to Commissioning
Design, Build & Validate
In-depth knowledge of the subject
Project management in a timely manner
Good Team Strength to handle customer
requirements at various stages of the project
Trained & Certified engineers by OEMs
Experience of Pharmaceutical projects
Validation know how as per cGMP, GAMP etc
Flexibility in maintaining clean environment
Documentation as per requirement of International
Auditing agencies like MHRA, TGA, MCC, MCA &
USFDA
Updated with the latest technology means you get
the best available in the market
Turnkey Solutions at a single point
Building Management Systems based on open
protocols of BACnet, LONworks, MODBUS TCP/IP,
RS232/485, Ethernet.
PERFORMANCE
LIFETIME
ESN
OPSER
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Technology Partners
ISO 9001 : 2008
Registered Office
GMP Technical Solutions Private Limited309-316, 3rd Floor, Swastik Disa Business Park,Behind Wadhani Industrial Estate, L.B.S. Marg,Ghatkopar (W), Mumbai - 400 086, Maharashtra, INDIATel : +91 22 66083700 Fax : +91 22 66083737Email : [email protected] : www.gmpcleanrooms.com, www.gmptech.net
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Goa
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Plot - L - 73, Behind Betts India Pvt. Ltd.,Verna Industrial Estate, Verna Salcette,
Goa - 403722
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NoidaRS-1/3, , Savitri Market,Sector 18, Noida (U. P) - 210 310
Pune2nd floor, Vascon Almonte Building,Near Radisson Hotel,Kharadi-Hadapsar Bypass Road,Yashwant Nagar Chowk,Kharadi, Pune - 411014
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