ISO 9001 : 2008

BUILDING MANAGEMENT SYSTEMS

21 CFR Part 11 Compliant Systems for Lifesciences & Healthcare Industry

Integrated Building Management Systems

www.gmptech.net

An Emerging Leader
GMP Technical Solutions is an emerging leader in IBMS 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.

IBMS
GMPs 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.

Building Automation System Fire Detection and Smoke Control PA & BGM Parking & Visitor Managment

Access Control

CC TV MATV

PLC & SCADA

Evacuation System

Lighting controls & EIB

Tenant Billing

IT & Communication Infrastructure

Integrated Building Management Systems (IBMS)

Integrated Building Solutions

Electrical (External & Internal) Indoor Climate Solution

Power & Control Cables

Distribution Boards

Sub Station with RMU & CSS Line Protection Devices

Energy Saving

VAV Systems

VRV Systems

Back - up Power (DG+UPS) Surge Protection

Electrical Wiring Accessories

Ventilation Systems & CO Control

Contamination & Odour Control Temperature & Humidity Control

Noise Control Differential Pressure Control

Power Energy Quality Management Improvement

Earthing Systems

Lightening Protection

Clean Rooms

Power Distribution and Management

HVAC & Cleanroom

Integrated Building Management Systems

www.gmptech.net

BMS in Lifesciences and Healthcare Industry

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.

Sterile
Control & monitor of critical parameters like Temperature Relative Humidity Differential Pressure Airborne Particulate Count CO2 Levels

Laboratories
Monitoring of environment parameters like temperature, humidity and differential pressure for critical studies

Wards
Individual lighting control temperature and demand driven ventilation need to suit varying patient & personnel requirements

Operation Theatres
Customised Operation Theatre Solutions & Clean Room Technologies

Size

Control of pressure regimes

Close control of Temp/RH

Air cleanliness & Cross contamination/ quick removal of dust air particulate content

Documentation, Validation

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Integrated Building Management Systems

www.gmptech.net

Open Systems - Freedom to all

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.

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

Enterprise System

Web Browser PDA Server

Cell Phone

Web Browser

XML/SOAP

HTML/HTTP

WML/WAP Internet

WML/WAP

HTML/HTTP

BACnet /IP, To Third Party Equipment

100Base-T Ethernet

Ethernet, ARCNET, EIA-485, EIA-232

LGR Router or ME-LGR Router/Controller

ME 812u-E Controller

BACnet MS/TP, ARCNET

ME line Controller

SE line Controller

ZN line Controller

Room Controller

Room Sensor
RS Standard Room sensor

Room Sensor

Room Sensor

Integrated Building Management Systems

www.gmptech.net

Scalable, Modular & Flexible BMS Solutions

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

Sensor
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

GMP can offer a range of the above sensors or alternatively provide interface to sensors provided by the user.

Integrated Building Management Systems

www.gmptech.net

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 will include critical 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 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 noncritical 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

Integrated Building Management Systems

www.gmptech.net

Alarms and Events Reporting

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 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

Integrated Building Management Systems

www.gmptech.net

Accurate Control
Monitoring
BMS offers 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, 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

Control
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 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.

Integrated Building Management Systems

www.gmptech.net

Easy to Use, Comprehensive Reporting

Review and Reporting
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. 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 queries Direct insertion to ExcelTM, WordTM Quick report generation with standard templates

Integrated Building Management Systems

www.gmptech.net

Validation as per GAMP

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.

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
SYSTEM DESIGN SPECIFICATIONS USER REQUIREMENTS PQ Test Plan SYSTEM TEST SPECIFICATIONS PERFORMANCE QUALIFICATION

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.

FUNCTIONAL DESIGN

OQ Test Plan

OPERATIONAL QUALIFICATION

DETAILED DESIGN

IQ Test Plan

INSTALLATION QUALIFICATION

IMPLEMENTATION

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

BMS PROJECT CYCLE

USER
Master Validation Plan Equipment Validation Plan Explanation to Supplier (Living Document) User Requirements (URS) Specification

SUPPLIER
User Audit of Supplier User Initiates

RFQ

RFQ
Pr o op sa

Proposal Quality Plan Project Plan

P.O.
Proposal Analysis

Functional Specification (Traceable to URS)

Approval
Review Functional Specification

Detailed Design Documentation (Traceable to Functional Specification)

Review Detailed Design

Approva

System Acceptance Test Specifications (IQ/OQ) Hardware Software

Review System Acceptance Test Specifications

Approva

System Acceptance Testing and Results (User Witness Optional)

Integrate with Validation Documentation (as appropriate)

Maintenance & Support Documentation

Integrated Building Management Systems

www.gmptech.net

Total Lifecycle Support

Remote Alarm Notification
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 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
RESPONS

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
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LAN
LIF

Approved off-the-shelf voice modem

Multimedia speaker or intercom systems

Radios Telephones PCS and GSM E-mail Phone

Numeric Alphanumeric pagers Pagers

Cellular Phones

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.

ME ET I

Technology Partners
IP Based CCTV Systems

Access Control Systems

Fire Detection and Alarm System

Fire Suppression System

Public Address System

Smoke Aspiration System

Building Automation System

Contamination Control Products

Our Esteemed Clientle

ISO 9001 : 2008

Registered Office

GMP Technical Solutions Private Limited

309-316, 3rd Floor, Swastik Disa Business Park, Behind Wadhani Industrial Estate, L.B.S. Marg, Ghatkopar (W), Mumbai - 400 086, Maharashtra, INDIA Tel : +91 22 66083700 Fax : +91 22 66083737 Email : enquiry@gmptech.net Website : www.gmpcleanrooms.com, www.gmptech.net Manufacturing Facility Gunia Road Mandhala, Via Barotiwala, Kasauli, Dist. Solan, H.P. - 174103, INDIA. Tel : +91 1792 253101

Hyderabad 2nd Floor, Patel Trade World, Karbala Maidan, Off. M.G.Road, Behind Hotel Moksha, Secunderabad - 500 003 Goa Plot - L - 73, Behind Betts India Pvt. Ltd., Verna Industrial Estate, Verna Salcette, Goa - 403722 Bangalore 1st Floor, 365, 38th Cross, 9th Block, Jayanagar, Bangalore - 560069

Ahmedabad D-43, Konark Krishna, Opp. Renuka Hall, Vastrapur, Ahmedabad - 380015 Noida RS-1/3, 2nd Floor, Savitri Market, Sector 18, Noida (U. P) - 210 310 Pune 2nd floor, Vascon Almonte Building, Near Radisson Hotel, Kharadi-Hadapsar Bypass Road, Yashwant Nagar Chowk, Kharadi, Pune - 411014