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“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.
BMS and EMS Solutions
Control and monitoring of storage and production environments has become an important issue within the Pharmaceutical Industry. The FDA, EMEA and other regulatory bodies require accurate measurement and storage of room parameters and, if the storage medium is electronic, the methods used must comply with 21 CFR Part 11.
The FDA also states in its 21 CFR part 203.32 that:
“Manufacturers; authorised distributors of record and their representatives shall store and handle all drug samples under conditions that will maintain their stability, integrity and effectiveness and ensure that the drug samples are free of contamination, deterioration, and adulteration.”
Other FDA rules related to environmental control and monitoring include:
- 211.42: Design and construction features (section 10)
- 211.46: Ventilation, air filtration, air heating and cooling
- 211.142: Warehousing procedures (section b)
- 820.70: Production and process controls
- ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (sections 4.2 and 10)
The Eurotherm BMS/EMS system is designed to satisfy the requirements of regulatory bodies including 21 CFR Part 11 and it offers:
- Scalable from a single room to a plant wide solution
- Simplifies validation using flexible and modular standard functions
- Accurate and effective control of HVAC systems and other related equipment
- Centralized and/or remote control of facilities and equipment
- Real time Monitoring of BMS performance
- Intelligent alarm capability for early warning of process deviations
- Corrective strategies when stability factors go outside the specification
- Secure management and storage of environmental data and audit trails
- Predictive maintenance planning
- Energy management
Scalable BMS/EMS Solutions from Eurotherm
Eurotherm Building Management Systems provide control, monitoring, recording and alarming of a range of facilities within a plant including:
- Production facilities including Aseptic areas
- Laboratory facilities
- Warehouse facilities
- Cold storage facilities
- Environmental Chambers
- Office facilities
- Fire and alarm security systems
- Water purification systems
Not all existing BMS systems offer a logging facility and, for these systems an independent monitoring system, EMS, will be needed. Typically an EMS will provide independent
monitoring and logging of the critical environmental parameters for GMP, GLP and GDP facilities.
Flexible and Modular BMS/EMS Solution
Eurotherm BMS/EMS Standard Modules
Eurotherm BMS/EMS solutions are modular and scalable. They offer all the functionality required to control, monitor, record and alarm, for a single room to a plant wide application.
They are ideal for
- Implementing a new system
- Enhancing existing systems
- EMS for an existing BMS
It offers the options for:
- Centralised BMS/EMS
- Network of local standalone BMS/EMS units
- Combination of centraliZed and local systems to increase availability and ease of use
Sensors communicate measurement and status information from the process to the control and monitoring modules of the BMS/EMS system. Sensors include:
- Relative Humidity
- Air pressure or differential Pressures
- Luminescence (light level)
- Particle counters
- Air Flow patterns
- Gas Level
- Water leak detection
- Doors status
- Fire detectors
- HVAC healthy status
For hazardous rooms intrinsically safe devices must be used including:
- Intrinsically Safe sensors
- Intrinsically Safe barrier
- Intrinsically Safe IO modules
Eurotherm can offer a range of the above sensors or alternatively provide interface to sensors supplied by the user.
Accurate Control with Redundancy Option
BMS/EMS 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 view
- 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
- Alarm set point configuration
- Control parameter configuration
- Calibration facilities
- Maintenance facilities
- Batch displays
- Electronic signatures
- Configuration utilities
- Multi language support
The purpose of this component is to provide the control of the necessary parameters for each individual room/area. 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 rooms/areas may be operated in different modes; the selecting of which is access controlled by authorized users:
- Idle: Option for turning off the control of the critical parameters
- 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. setpoints, alarm limits, tolerances, 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.
Data Logging and Audit Trail Designed to Satisfy 21 CFR Part 11
Data logging is a key requirement for BMS/EMS 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. setpoint changes)
- User notes
- Electronic Signatures
Eurotherm’s BMS/EMS systems 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 SQL 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/EMS system comprises 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/EMS system offers provisions for electronically copying data for archive and export facility to common packages (e.g. Excel, Word, PDF, 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
Alarms and Events Reporting
An important feature of the BMS/EMS system 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
The system can be configured to provide other alarms including;
- Sensor break
- Equipment failures
- Network failure
- Maintenance and calibration alarm
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 setpoint 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/EMS alarm system include:
- Audible alarm notification
- Notification of alarm conditions to designated users on a designated telephone number
- Local printing of alarms and events
Easy to Use, Comprehensive Reporting
Review and Reporting
The BMS/EMS system 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 Excel™, Word™
- Quick report generation with standard templates
Easy to Operate at every Level
Security Manager 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
Maintenance and Calibration
Maintenance is an essential part of any BMS/EMS system. Maintenance information on various elements of the system (e.g. last calibration date, calibration due date, last maintenance date, maintenance due date) is shown on multiple displays throughout the system. The system can provide warnings if calibration/maintenance dates for individual equipment are approaching and/or exceeded.
Access permission can be given to individual users to select maintenance modes for the following:
- Equipment (e.g. pumps, motors, valves)
Maintenance mode can also be selected for a given area e.g. a room or a zone of the plant. While in maintenance mode the individual equipment or area will be clearly identified on the display using colour and text. The system can be set to suppress alarms and stop logging parameters for associated equipment at this time.
Selection and the de-selection of the maintenance mode will be logged as an event in the audit trail.
Easy to use calibration tools are included in the system for use during maintenance mode. Selection and de-selection of the calibration mode is logged in the audit trail.
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 the delivery of the messages
- Easy to configure tools
- Login facilities and security patterns
- Redundancy options
Remote users, including off-site, can access plant information via a secure web portal.
- Remote real-time data visualisation
- Multi language facilities
- Support for multiple windows
- Integrated information from diverse data sources
Services need to be provided from the beginning of the project, though the project development and commissioning, and for the lifetime of the system.
Eurotherm 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
A key requirement for BMS/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. 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.
Validation documentation needs to be provided through the e cycle of the BMS/EMS system. Eurotherm 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
Mean Kinetic Temperature (MKT)
Measurement and recording of temperatures is vital to the storage of perishable goods, but there is more than one way to record an average. The ICH defines the mean kinetic temperature as being “A single derived temperature that, if maintained over a defined period of time, affords the same thermal challenge to a drug substance or drug product as would be experienced over a range of both higher and lower temperatures for an equivalent defined period”.
MKT expresses the cumulative thermal stress experienced by a product at varying temperatures during storage and distribution. It differs from other means (such as a simple numerical average or arithmetic mean) in that higher temperatures are given greater weight in computing the average, recognising the accelerated rate of thermal degradation of materials at higher temperatures.
Eurotherm minimizes the implementation and operation cost of providing MKT data by making all of the above methods as integral part of our solution with:
- A choice of stability testing period (hourly / daily /weekly)
- A choice of sampling frequency (from 1 minute to 1 hour)
- Option to remove individual probes from the calculation (e.g. during a calibration process)
- Corrective action in case stability is out of specification
- Secure and low cost custom reporting