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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 FDA 21 CFR Part 11. Individual plant data can be configured to have one or a combination of the following alarms:
The system can be configured to provide other alarms including;
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 FDA 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:
Review and Reporting
The BMS/EMS system provides a comprehensive review and reporting system. The system offers two methods for collecting data:
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.
Security Manager
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.
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:
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.
Remote Alarm Notification
Nominated users can be quickly notified of alarm conditions via the telephone system.
The system offers:
Remote users, including off-site, can access plant information via a secure web portal.
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:
BMS/EMS
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 cycle of the BMS/EMS system. Eurotherm can offer a range of documentation services following ISPE GAMP5 guidelines and in accordance with customer requirements:
Calculation
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:
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