Building Management Systems Final White

BUILDING MANAGEMENT SYSTEMS

www.gmptech.netIntegrated Building Management Systems

IBMSGMP’s Building Systems business specialises in providing

integrated solutions 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, energy management /conservation and comfort

throughout the life-cycle of the building.

An Emerging Leader GMP Technical Solutions is an emerging leader in

IBMS Technologies that enable 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.

DifferentialPressureControl

Integrated BuildingSolutions

Electrical(External & Internal)

Power &ControlCables

DistributionBoards

SubStation withRMU & CSS

Back - upPower

(DG+UPS)

ElectricalWiring

Accessories

LineProtectionDevices

LighteningProtection

Power Distribution and Management

PowerQuality

Improvement

EnergyManagement

EarthingSystems

SurgeProtection

HVAC & Cleanroom

BuildingAutomation System

Integrated Building Management Systems (IBMS)

AccessControl

CC TVMATV

PLC &SCADA

EvacuationSystem

Lightingcontrols& EIB

TenantBilling

Indoor ClimateSolution

VentilationSystems & CO Control

Conta-mination& OdourControl

NoiseControl

EnergySaving

VAVSystems

VRVSystems

Clean RoomsTemperature &

Humidity Control

FireDetection

and SmokeControl

PA &BGM

Parking &Visitor

Managment

IT &CommunicationInfrastructure


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 Pharma

Close control ofTemp/RH

Air cleanliness &quick removal of dust

Cross contamination/air particulate content

Documentation,Validation

Control of pressureregimes

Operation Theatres

Customised Operating

theatre Solutions &

Clean Room

Technologies

Control & monitor of

critical parameters like

Temperature

Relative Humidity

Differential 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 differential pressure

for critical studies

Siz

eFunctionality

Perf

orm

ance


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 on a 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

INTERN

CellPhone

HTML/HT HTML/HT

PDA

Server

WML/WAP XML/SOAP

Network Switch

MODBUS/BACN

LON/BACN

To Third Party

Programmable Controller - 2

Field

Remote

Field

Programmable

Network OPC/

Web Browser

Web Browser

Enterprise System

BACNET/IP, 100 BASE-T Ethernet/LON/MODBUS/Wireless

WML /WAP

Typical System Architecture

RS StandardRoom sensor


GMP Building Management Systems provide Control, Monitoring and

Alarming of a range of environmental parameters like temperature, relative

humidity, 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 be

used including,

• Intrinsically Safe Sensors

• Intrinsically Safe Barriers

• Intrinsically Safe IO modules


Data Logging and Audit Trail Designed to Satisfy 21 CFR Part 11

Data logging

Data logging is a key requirement for BMS Systems. 21 CFR

Part 11 requires that logged data will be tamper proof and

wil l 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 relational

databases.

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 electronically

copying 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 include.

• 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


An important feature of the BMS is its Alarms and Events

functionality. 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 which 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


Monitoring

BMS offer a wide range of options for monitoring the plant.

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 in

various 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, including:

Access Control with password protection for individual

user accounts, inactivity timeout and password expiry

• 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, to

accurately 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 selecting 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 offer 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 a full

audit trail of these changes including electronic signatures.

Accurate Control

Control


The BMS provides a comprehensive review and reporting

system. 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 accessed

from 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


BMS PROJECT CYCLEUSER

Approval

SUPPLIER

Why BMS

“Where environmental conditions could reasonably be

expected 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. 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 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 through

the 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 Supplier•User 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 Requirements Specification

(URS)

Review Functional Specification

Equipment Validation Plan• Explanation to Supplier

(Living Document)

Master Validation Plan

Review Detailed Design

RFQ

RFQ

Proposal

P.O.

Approval

Approval

GMP’s validation approach helps all pharmaceutical environment managers keep their records as per ISO regulations and USFDA regulated 21 CFR PART 11 compliance

FUNCTIONAL DESIGN

USER REQUIREMENTS PERFORMANCEQUALIFICATION

OPERATIONALQUALIFICATION

PQ Test Plan

OQ Test Plan

SYSTEM DESIGN SPECIFICATIONS SYSTEM TEST SPECIFICATIONS

IQ TestPlan INSTALLATION

QUALIFICATIONDETAILED DESIGN

IMPLEMENTATION

Validation as per GAMP


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

conditions via the telephone system. The system offers:

•Real-time alarm notification triggered from the plant

system

• Ensured the 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

commissioning, and for the lifetime of the system.

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 GMP’s 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 OEM’s

• 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 on open protocols of

BACnet, LONworks, MODBUS TCP/IP, RS232/485,

Ethernet.

PERFOR

MA

NC

E

LIFETIME

ES

NO

PS

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Our Esteemed Clientle

Goa OfficeBanglore Office

306, 3rd Floor Santa Clara Apartment

18th Main Road Jayanagar, 4th ‘T’ Block

Banglore 560041

Hyderabad Office

Flat no D, 1st Floor Patel Trade World

5-4-187/3&4/10/SF10, Karbala Maidan

M.G.Road, Secunderabad – 500003

Technology Partners

Fire Detection and Alarm System

Access Control Systems

IP Based CCTV Systems

Building Automation System

Public Address System

Smoke SystemAspiration

Fire Suppression System

Contamination Control Products

Documents

Building Management Systems Final White