Continued on next page 296 Steam Sterilizers webcode WWQMA004 1 Horizontal Pass-through and Floor-standing Autoclaves, Systec H series, Systec STANDARD FEATURES for Systec H series / Systec H series 2D • Integrated steam generator with AutoFill for automatic supply of demineralised water • Housing and carrying structure made of corrosion-resistant stainless steel (AISI 304) • Pressure vessel made of pharmaceutical stainless steel (AISI 316) • All fittings and valves in the supply lines (frommedia connection to sterilisation chamber) for demineralised water, steam or compressed air are made of stainless steel. All pipelines made of FDA-certified PTFE. • Annular door locking system for extended security • Flexible PT-100 temperature sensor for monitoring the temperature in the sterilisation chamber or in a reference vessel • Temperature and pressure range up to 140°C/4 bar • Additional PT-100 sensor in the condensate outlet for temperature control at the coldest place in the autoclav • Water-cooled steam exhaust, thermostatically controlled, to protect the autoclave from heat • Extended HMI and PLC with touchscreen control • Optimised HMI for faster navigation/adjustment of processes & settings • Newly developed software for the entire autoclave system (PLC) reduces the total process time by up to 25% • Up to 100 sterilisation programmes can be added, disabled, or adapted by the operator in every detail • Secure access control for adjustment of programmes and parameters • Timer for time-controlled start of sterilisation processes • F0 value can be calculated individually for all liquid programmes • Individual activation of temperature holding function for liquids after end of programme • Special programme for waste sterilisation for fractional heating for more efficient release of air from waste bags (in the absence of the optional vacuum system) • Individual entry of batch information before start of process • Thanks to the extended internal memory, documentation files can be saved for at least 10 years • Via the USB connection, documentation files can be downloaded from the autoclav to a USB flash drive. • All documentation data can be collected directly from the autoclav in PDF and/or CSV file format (MS Excel). Reading the documentation data does not require installation of any proprietary software on a PC. • Complete backup of the autoclav control on a USB stick, including all individual settings • Ethernet interface for connecting the autoclav to a computer network • Time synchronisation with time servers. Internet connection required. • Remote service function. Requires Internet connection and authorisation by the operating company • Systec can adjust all the settings in-house and save them to a configuration file on a USB flash drive for easy and convenient implementation of new configurations by the customer. OPTIONAL FUNCTIONS • Extended temperature and pressure range of up to 150 °C/5 bar • Optionally, up to 5 additional flexible PT-100 temperature sensors are available, each of which can be configured individually. • Extended user control – up to 100 users and groups can be generated. All users or groups can use the same program list, or a single program list with individual programmes and settings. • Personalised electronic certificates for electronic transfer of documentation files • Save to folder: automatic data transfer (via FTP/SFTP) from documentation data. When 21 CFR Part 11 is ordered, AuditTrail data is saved to predefined files on a network drive (server, PC, or other network-based memory devices) FDA 21 CFR Part 11 package (onboard) • All documentation data can be downloaded via a USB flashdrive in PDF and/or CSV file format (MS Excel). The PDF and the CSV files have an electronic signature related to the autoclav which generated the files; it indicates whether the data is valid (i.e. no manipulation). Any manipulation will render the files immediately invalid, which is directly indicated in the respective electronic signature. • Extended user control – up to 100 users and groups can be generated. All users or groups can use the same program list, or a single program list with individual programmes and settings. Furthermore, every user can be assigned roles (e.g. user, operator, supervisor, administrator, etc.). • Includes the AuditTrail for following up and recording all measures, adjustments and alarms sorted by date, time, and user • Comprises up to five fields for electronic signing of the PDF and/or CSV files on a PC (or other device) capable of executing a PDF or CSV viewer and processing electronic signatures OTHER OPTIONS • FAT / SAT, IQ, OQ and PQ (validation) with extensive GMP-/GLP-compliant documentation available on request • Special programmes such as steam/air mix, pharmacopoeia programmes (1) Test programm,e for hydrolytic resistence of glassware (European Pharmacopoeia chapter 3.2.1) and United States Pharmacopoeia (USP <660>) 2) Pursuant to chapter 3.2.9 of the European Pharmacopoeia and USP <381>, for testing rubber caps for pharmaceutical jars etc.) and material test programmes are available on request • Customer-specific process evaluation, design and development are available on request Safety, Cleaning, Hygiene Sterilization
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