building management systems for pharma, healthcare & life sciences

7/27/2019 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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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


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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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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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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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

Manufacturing FacilityGunia Road Mandhala, Via Barotiwala,

Dist. Solan, H.P. - 174103, INDIA.Tel : +91 1792 253101Kasauli,

Hyderabad2nd Floor, Patel Trade World,Karbala Maidan, Off. M.G.Road,Behind Hotel Moksha,Secunderabad - 500 003

Goa

Bangalore1st Floor, 365, 38th Cross, 9th Block,Jayanagar, Bangalore - 560069

Plot - L - 73, Behind Betts India Pvt. Ltd.,Verna Industrial Estate, Verna Salcette,

Goa - 403722

AhmedabadD-43, Konark Krishna,Opp. Renuka Hall,Vastrapur, Ahmedabad - 380015

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

2nd Floor

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