FUNCTION MODULES ANALYSIS CONTROL MODULE ARCHITECTURE MODULE DESCRIPTION PROCESS LEVEL

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1 FUNCTION MODULES ANALYSIS CONTROL MODULE ARCHITECTURE MODULE DESCRIPTION PROCESS LEVEL CRYO.TAS has been developed specifically as a scalable system. One of the most important parts within the function modules is the analysis module. Analysis devices with connection to superordinate analysis control (PLC). Test gases with residual pressure monitoring. Gas connection modules for automatic gas direction switching with quick-flushing device. This module contains a comprehensive object library of common analysis devices and functions. All devices are administrated from the graphical user interface (GUI) of the system. The specification of individual user roles permits differentiation of user rights for every individual device. For example, the device group for medical gases can be excluded from normal operation and only released to qualified experts. Comprehensive, freely parameterizable functions permit a variety of different evaluations of the analysis system. The fully automated monitoring and documentation of all results ensure maximum process safety in quality control. All integrated functions meet all requirements of GMP and GAMP and are thus the basis for their system validation. CONTROL LEVEL Analysis control (PLC) with comprehensive function component libraries for many different test equipment types. Routing of all required test and action orders between the management and process levels. MANAGEMENT LEVEL Placement of measuring and calibration orders. Recording and evaluation of all incoming data and archiving them.

2 BENEFITS Automatic validation or adjustment of the devices; possibility to choose if time/date controlled or on demand Automatic locking of devices at defective evaluation of the validation or adjustment results Recording and evaluation of the cell drifts Automatic locking of products in the storage tanks at OOS results (Out of Specification) Specification of different evaluation methods for normal gases and medical gases Assignment of the user rights to user roles Monitoring of all test gases for residual gas pressure and validity Administration of the test gas specifications Automated communication-capable gas connection with manual and automatic functions Remote monitoring of all devices Message dispatch at device or product locks (add-on: messaging system) Automated generation of the certificates Choose if by document printing or by dispatch Entire system from a single source; no Device parameterization from the administrative user interface Free choice between normal evaluation or evaluation with error analysis TECHNICAL DATA USAGE AREA Operation possible as a single module or in combination with other modules Suitable for all gases with quality monitoring in storage and delivery ANALYSIS DEVICES Module libraries available for: Continuous devices with and without calibration function Gas chromatographs Mass spectrometers GAS CONNECTION Bus-capable connection module for 19" installation for up to 12 measuring points with quick flushing Integrated measuring gas conditioning SETUP Complete setup as cabinet systems or turn-key in containers interfaces for the orderer

3 EXCERPT FROM THE ANALYSIS OPERATING LEVEL DESCRIPTION The operating level offers comprehensive, role-related device operations: DEVICE CLASSES Analysis devices Test gases Product sources (storage tanks) Measuring points There are different registers for assignments or function definitions for every object in a device class. TABS Parameters: Specification of device parameters such as flushing times, measuring times, measuring ranges and device units Receipt of the measuring results and other data from a device Messages: Alarms and events of a device Calibration results: History of all validations and adjustments of a device Test gas bottles: Assignment of the present test gases to an analysis device OPERATING ELEMENTS Start calibration Manual request for a calibration cycle Reset device Deletion of all pending orders for a device Data:

4 ANALYSIS FUNCTIONS FUNCTIONS TEST EQUIPMENT MONITORING Free time- and date-controlled definition of orders. You can choose between the following functions: Validation Cyclic inspection of the devices with test gases. If the deviation exceeds the specified threshold, the test equipment is locked for use. Adjustment Automatic adjustment after validation runs is possible. Then further validation is performed and if the thresholds are complied with, the test equipment is automatically released for use again. Alternatively, cyclic adjustment is available as well. TEST GAS MONITORING All test gases used (zero gases, area gas- es, carrier gases and other service gases) are mapped in the system with their entire specification. If, for example, a test gas has exceeded its expiration date, all analysis devices using this test gas are locked. As a consequence of device locking, all products that need this analysis device in their specification also are no longer available. QUALITY MONITORING STORAGE TANKS Analysis points of storage tanks, pipelines or other product sources are cyclically monitored. The periods can be chosen freely. All product specifications assigned to the product source are inspected during monitoring. Non-compliant products are automatically locked and will no longer be available for loading. For special products, such as medical gases, the cyclic monitoring can also be replaced by execution of batch analyses. Af-

5 ter successful inspection of such products, a batch number is generated and a batch certificate is created. This may be sent to authorized offices for further release. EVALUATION OF ANALYSIS RESULTS The system offers various evaluation options for evaluation of the analysis results : All settings can be made individually per analysis point in any combination. Furthermore, you can specify different evaluation types for standard products and medical products. Evaluation with error analysis The overall error of a measuring circuit is considered for evaluation of the measured results, and the product specifications to be reviewed are increased by this error. Thus, you as the operator can be certain to comply with a product specification at all times. The function can be activated or deactivated individuality for every analysis point. A valid analysis (standard evaluation) If this evaluation type is activated for an analysis measuring point, only one valid measuring cycle is required for product inspection at a product measurement. N out of M valid analyses In this analysis type, N successful measurements out of M measuring attempts are required for positive evaluation of a product analysis. One followed by N One invalid analysis attempt requires N valid subsequent attempts. Parameter set of an analysis point

6 CRYO.TAS MODULE COMBINATION MODULE COMBINATIONS BASIC SINGE FACTORY LINE This standard license contains system basic functions and a freely selectable function module. Example: System with analysis control. This includes the entire function scope of the test equipment monitoring and product quality monitoring in the storage tanks and the loaded products. Generation of all certificates Application: Ideal execution for smaller sites. Can be validated for medical products. SMALL STANDARD EDITION System basic functions and two other available function modules. Example: Analysis control with weighing. With this additional module, the system is able to record and balance the loaded and produced quantities. sites. Can be validated for medical products. MEDIUM EDITION This license contains three functional modules. Example: Load control, analysis control and weighing Application: For medium-sized sites or for sites with pending modernization of the loading points. STANDARD EDITION Full development license for a single factory with all function modules without connection to a central system. ENTERPRISE EDITION Full development for organizations with several factories. Central master data reconciliation across all factories. Application: Ideal execution for smaller

7 CRYO.TAS THE OVERALL CONCEPT Tank-Management Product availability monitoring Lock and unlock of products Batch creation Special functions for medical and food-products Calculation of loaded quantities Analysis Automated gas path switching Test equipment and calibration gas monitoring Auto-calibration Locking and unlocking of test equipment Connectivity to a wide range of sample point types (e.g. pipeline) Entrance Implementation of any number of entrance control columns Permission control/monitoring Loading Loading and safety instructions Permission control/monitoring Force-presence-monitoring Quality assurance/analysis Blending functionality Off-loading Special functions for medical products Control of all field devices SCALE.TAS Usage of any number of weigh bridges Free usage of entry or exit weigh bridge, or both Creation of loading/transportation documents Quota control INFORMATION Simply contact: Would you like more information about the CRYO.TAS system? On the Internet you always get the latest information, or contact us directly. We are always ready to show you the performance of the system in a live presentation. IWB Alte Toelzerstr Egling/OT Deining Germany Tel: +49 (0) Fax:+49 (0) Contact: info@iwb-engineering.de

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