DATASHEET COMPACT CRYOGENIC-GASES TERMINAL AUTOMATION SYSTEM SYSTEM DESCRIPTION SYSTEM ACHITECTURE

Transcription

1 COMPACT DATASHEET CRYOGENIC-GASES TERMINAL AUTOMATION SYSTEM SYSTEM DESCRIPTION CRYO.TAS COMPACT and CRYO.TAS COM- PACT MED have been specially designed for simple entry to the automated analysis of cryogenic air gas products. A prefabricated solution for the gas producing industry, which can be expanded with greater functionality like all CRYO.TAS solutions. After the fully equipped cabinets have been assembled, only hauling for the analysis pipe needs to be completed. Naturally, IWB offers full validation. Automation systems play a significant role in the storage and redelivery of high quality gas products via filling systems. By relying on CRYO.TAS COMPACT solutions, you will avoid risks in your dayto-day business. In addition, you will increase productivity and security, while reducing time and cost expenditure. The highly-developed quality management combined with the integrated change logging and latest standard of gas-analyzer systems enables the generation of 3.1 and 3.2 certificates. In addition, integrated archiving stores every single operation plus analytical and calibration related data. CRYO.TAS COMPACT MED is naturally fully compliant with phar- maceutical regulations according to GMP and GAMP 4 as well as all the requirements for the validation of medical and food production. CRYO.TAS COMPACT can be expanded at any time with all the available modules and add-on features and is the ideal start to comprehensive management and monitoring of your products. CRYO.TAS COMPACT MED is a turnkey solution for medical gases. This system includes all the necessary components and is immediately ready for operation after set-up. SYSTEM ACHITECTURE CRYO.TAS applies a system architecture using the latest technologies. An integrated WEB-Server opens the system, enables operation and control independent of the operating system platform used. The system coordinates the entire quality monitoring of the products. RFID identification systems for users and vehicles are the standard for this system.

2 BENFITS High process security Efficiency due to full automation OS-independent operation Continuous quality monitoring Batch formation for medical, or other special products Analysis system in accordance with pharmacopoeia Can be validated Multilingual Auto created quality certificates Administration at one glance CRYO.TAS COMPACT MODULE OVERVIEW Expandable with all the available system modules and add-on features at any given moment CRYO.TAS COMPACT FUNCTIONS PRODUCT MANAGEMENT Administration of product specifications Free definition of approval steps concerning medical or special products Cyclic tank control Blocking of products with specification deviations Client product assignment Dual control principle for medical products TEST EQUIPMENT MANAGEMENT Automated, cyclical calibration of test equipment Automated, cyclical validation of inspection equipment (add-on) Automated device locking of test equipment in the event of deviation from calibration/ validation Evaluation of all data with error analysis Validity check of test gases Residual gas pressure monitoring of test gas (optional) Notification of upcoming bottle change Detection of equipment drifts

3 TANK MANAGEMENT Cyclic tank control, batch analysis Batch tank, continuous tanks Supervision of tank clearance Product availability monitoring Batch formation and clearances INSPECTIONS Operating and safety instructions (ADR) Individual authorization control Driver/truck/rail tank carriage identification with location recognition Definition of recurrences of erroneous analyses Recording of OOS results Role management (logistics, quality control, operator, QP) SCALABILITY Expandable with all the available CRYO.TAS modules Scalable license model MASTER DATA MANAGEMENT Company database (clients, forwarders, competitors) Individual generation of time-controlled authorizations (e.g. ADR, permission for loading regarding medical or food products etc.) Customer database (tanks, products) Free definition of release steps for special products Automatic transmission during approval processes to authorized personnel (QP) Personnel database Parameter database (process data, event alerts) Product database Storage tank database Vehicle database Device management RFID Transponder Management REPORT DRAFTING Inspection certificates (e.g. 3.1 and 3.2 acc. EN10204; Pharmacopoeia; FDA) Batch reports and tank certificates, protocol of substances, production protocol and test report, finished medicinal product Operational details Calibrating data Daily, weekly and monthly reports Enable register for tanks and vehicles Logbooks Audit trail Free user reports and export features transmission SYSTEM MANAGEMENT System SQL Back-Up Data synchronization and adjustment across all locations if connected to the central system (add-on) Remote diagnosis of all system components Alarm indication system and incident reporting (add-on) VALIDATION Monitoring of the general obligations of the loader according to 9 GGVSE, ADR and RSE 2005 Monitoring function in accordance with GMP guidelines, medication order appendix 6 Electronic approval of pharmaceutical products (add-on) Incorporated electronic dual control principle Execution of analyses in accordance with the methods of the pharmacopoeia Optional with validation service Analysis points

4 CRYO.TAS COMPACT ARCHITECTURE CRYO.TAS COMPACT (MED) TECHNICAL DATA RANGE OF APPLICATION LAR / LIN / LOX / KrXe / CO2 / H2 Medical Gases Vehicle and tank analysis COMPUTER SYSTEM Compact Server MS SQL-Server with Report Server ID-SYSTEM Standard design with RFID 13,56 MHz, Transponder acc. ISO-14443A COMMUNICATION SYSTEM Administrator level: TCP/IP Ethernet SAP/ERP and scheduling systems ANALYSIS SYSTEM Standardized analyser cabinets per product group All devices used for analytics are in compliance with pharmacopoeia. Together with our partners we provide you with a wide range of analysis systems. Fully installed as a cabinet construction system or as complete analyzer containers with implemented system infrastructure Interfaces: OPC-Server/Client Process-oriented level: Profibus or Fieldbus INTERFACE CONTROL Depending on existing setup. Operates with all standard interfaces

5 CRYO.TAS THE SCALABLE OVERALL SYSTEM Tank management Product monitoring Product approval and blocking Batch formation Special features for medical and food-products Calculation of amounts produced System analytics Automated gas switching Test equipment and calibration gas monitoring Automated calibration Blocking and clearance of test equipment Linkage to different analysis points (e.g. pipeline) Facility access control system Integration of any number of access terminals Authorization checks Loading stations Loading instructions according to ADR Authorization checks Monitoring of compulsory presence Quality control/analysis Blending function Unloading Special features for medicinal products Regulation of all actuators/pumps Weighing Usage of any number of weighbridges Free allocation of usage as entrance, exit scales or both Drafting of cargo documents and certificates Contingencies 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