Product Specification Sheet Zeta LabFreeze and PilotFreeze For improving scale-up and design of new industrial freezing and thawing processes The Zeta LabFreeze unit is a small volume controlled freeze unit that provides a profound base to develop mechanistic understanding and modelling of the freezing process. It establishes the foundation for the controlled scaling of freezing processes for the PilotFreeze and the customized industrial freezer units. Benefits The PilotFreeze system with 700 ml is the smallest freezing unit, built according to industrial standard. It uses the same construction materials and incorporates the same freezing and thawing technology. It is also the central scaling tool for all customized industrial freezing scales. Product stability studies The LabFreeze and the PilotFreeze system allow multiple experiments since the frozen product can be removed without thawing. Process improvement The LabFreeze and PilotFreeze systems can generate a wide temperature range and fully automated temperature profiles. Enhanced process know-how and mechanistic understanding of scaling support the requirements of QbD. The LabFreeze system allows multiple experimental studies while using very little product due to minimal working volumes of 200 ml and reproducible conditions. Controlled freezing processes and accurately defined boundary conditions provide excellent reproducibility for freezing, thawing and storage. Process control Various temperature probes at different positions, the measurement of pH in a frozen state and the optional implementation of a PAT probe for monitoring proteins and excipients during the process are available for the specific process control system. Scalability The LabFreeze system with 200 ml is the smallest system within the scaled Zeta Freeze System series. It identifies the essential parameters of the freezing process. 200 ml – LabFreeze Abbreviated validation Automated freeze control unit Automated control of temperature target values and actual temperature values achieves reproducible and highly accurate tempering. Trending for the temperature of the freeze controller. Softkeys for several temperature profile functions. Optional integration of a process temperature probe into the freeze control unit for an advanced temperature profile with a delta T. 700 ml – PilotFreeze Key Values LabFreeze PilotFreeze Working volume 200 ml 700 ml Gross volume 300 ml 1140 ml Material 316L, EPDM, sight cover 1.4435, EPDM Dimension 300 x 570 x 177 mm 200 x 173 x 450 mm Temperature range -45°C – 90°C -70°C – 130°C Ports 7 temperature sensors 3 ports for movable temperature sensors 12 ports for sampling 1 port for movable pH sensor 1 port for additional PAT probe Freeze Controller Pump connection M24x1,5AG M24x1,5AG Max media flow 55 l/min 55 l/min Max media pressure 0.9 bar 0.9 bar Weight (net) 56 kg 90 kg Dimension 425 x 270 x 636 mm 425 x 400 x 720 mm Electrical connection 230 V, 50Hz, 230 V, 50Hz Thermal fluid Silicone oil Silicone oil Digital RS232 and RS485 for connecting PC, SPS or PLS Ethernet, USB (host and device), RS232 Analogue Input: 1 times 0/4-20mA or 010V Input: ECS ONE Interface Output: POKO ONE Output: 3 times 0/4-20mA or 010V Temperature accuracy 0.01K 0.01K Temperature probe internal/external Pt100 Pt100 at 0°C at -20°C at -40°C at -60°C at -75°C 0.7 kW 0.4 kW 0.06 kW 0.65 kW 0.6 kW 0.6 kW 0.3 kW 0.06 kW Noise level pressure 62 dB(A) 62 dB(A) Cooling power Zeta Biopharma GmbH, Zetaplatz 1, 8501 Lieboch/Graz Phone +43 3136 / 90 10 - 0, Email: [email protected] www.zeta.com
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