Zeta Freeze & ThawSystems. Sophisticated solutions for the biopharmaceutical industry.

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1 Zeta Freeze & ThawSystems Sophisticated solutions for the biopharmaceutical industry

2 Zeta FreezeSystem Low-temperature storage and transport of liquid pharmaceutical products & solutions Zeta FreezeSystem is the answer to the problem of bridging distances and times for temperature-critical products and solutions in the pharmaceutical sector. The products are deep-frozen in a controlled manner in order to ensure that they can be kept for long periods. Once they have been frozen, the products can be stored and/or transported safely. In order to bridge long distances, the frozen products can be transported by land, sea or air. The FreezeContainer is dimensioned to fit into an LD3 air-freight container. Long periods of time can be bridged by storing the Freeze- Container in a cold-storage room or by connecting it to a cooling station in order to keep it at the desired temperature for a long period. When the product is needed, it is thawed in a controlled manner up to a specific maximum temperature. After this, the product can be cooled in the FreezeContainer until it is actually required for further production steps. Zeta FreezeSystem The product range of the Zeta FreezeSystem includes the following components: FreezeController The cooling and heating unit for controlled freezing, storing and thawing of products in the FreezeContainer, with a heating and cooling capacity of up to 12kW. FreezeContainer Stainless-steel container for freezing, transporting and thawing the products. Available with volumes of 50 to 300 litres. Zeta FreezeContainer Storage and thawing systems For the storage and thawing of the deep-frozen products and solutions, Zeta offers complete systems for the simultaneous execution of the process steps with several FreezeContainer. 2 Evolution of Technology

3 Zeta FreezeController Zeta offers a high-performance, sophisticated solution for the loss-free freezing of products. The FreezeController, developed in cooperation with a renowned, worldwide active manufacturer of cooling units. The primary task of the FreezeController is the controlled freezing, storing and thawing of liquid pharmaceutical products and solutions in a FreezeContainer. But it also offers further functions which are indispensable for companies in the GMP sector, such as Storage Blow-out (blowing out of the heat-transfer fluid) SIP Zeta FreezeContainer Main components of the FreezeController The Zeta FreezeController consists of the following main components: Refrigerating machine (water-cooled) Circulation pump Storage tank for the heat-transfer fluid Automation system The process steps of the FreezeController include the filling and draining of the double jacket and of the cooling element. This ensures that the heat-transfer fluid is returned to the FreezeController when the FreezeContainer is disconnected. Temperaturemapping freezing process 3

4 Zeta FreezeController Armoured hoses with leak-free special couplings are provided for the rapid connection and disconnection of the FreezeContainer. Insulating sleeves are supplied with the FreezeController to prevent the couplings from freezing. Zeta FreezeController Automation: The automation system is based on a Siemens S7 controller with Siemens WinCC visualisation. The use of standard components permits problem-free integration into a higher-level control system. The controller of the FreezeController permits centralised creation and management of users and recipes. Thanks to the standardised interfaces, data can easily be recorded in a higher-level data acquisition system. In order to ensure the security of your data, the controller complies with CFR 21 Part 11. Leak-free quick coupling Cover seal 4 Evolution of Technology

5 Zeta FreezeContainer Optimum process integration and trouble-free validation With the Zeta FreezeContainer, you can transport your products safely all over the world, which means that you can make use of the available production and filling capacities in many different locations. The product is deep-frozen in the FreezeContainer with the aid of the Zeta FreezeController. The FreezeContainer can then be transported by land in a refrigerated truck, by sea in a refrigerated cell or by air in an LD3 Envirotainer (with controlled temperature) Zeta FreezeContainer Design: The Zeta FreezeContainer is designed for the safe freezing, storage and thawing of liquid products and of solutions between 50 and 300 litres which can be frozen to temperatures below -20 C (down to -40 C) within a short time. The containers are designed to withstand temperatures between -80 C and 150 C. Customer wishes with regard to the material quality and the finish of the FreezeContainer can be taken into account. The containers are available in accordance with various container design standards such as DIN or ASME. Zeta FreezeContainer 5

6 Zeta FreezeContainer Integration The FreezeContainer can be integrated easily into your existing processes, since they have colour-coded valve connections and there is no need to configure a software interface. After connection, the container can be filled, emptied, cleaned, sanitised or sterilised. Validation The Zeta FreezeContainer can be fully validated in accordance with the cgmp guidelines. This has already been proved in various projects and documented with, amongst other things, successful riboflavin tests. Cooling coil Test procedure: During execution of the project, and as part of several projects which have already been completed successfully, various tests were carried out with the containers. These included, for example: performance tests of the cooling capacity temperature mapping in the FreezeContainer differential-pressure measurements in the inlet and outlet lines for the heat-transfer fluid measurements of the flow rate of the heat-transfer fluid riboflavin test of the FreezeContainer pressure-maintenance tests at ambient temperature pressure-maintenance tests in the deep-frozen state measurement of the surface roughness delta-ferrite measurements endoscopic examination of the welded seams product extraction central pipe (determination of the residual quantity) The FreezeController and FreezeContainer are manufactured and documented in accordance with the current versions of GAMP (V model) and cgmp. With the documentation provided by Zeta, they can be integrated without problems into existing validation concepts. For the FreezeSystem, Zeta possesses standardised protocols and procedures for the execution of IQ, OQ, PQ, FAT and SAT. Optimisation During the development process, particular attention was paid to achieving the shortest possible process time. In order to reduce the freezing and thawing times, the FreezeContainer has a cooling coil integrated into the container and the thawing time can be reduced even further by the use of an external circulation pump or a shaker. CFD As part of the engineering process, the arrangement of the pipes inside the container was designed for an optimal heat transfer by simulating the freezing and thawing with the aid of computational fluid dynamics (CFD). 6 Evolution of Technology

7 Zeta storage and thawing systems Storage of the frozen products: Once a product has been frozen with the aid of the FreezeController, it can be stored almost indefinitely. This can be done in one of two ways: by storing the container in a deep-freeze storeroom or by connecting the container to a cooling station (coolant then flows continuously through the FreezeContainer ) Thawing the frozen products: Depending on the requirements, the frozen products can be thawed in one of two ways: by thawing individual containers with the aid of the FreezeController or Valve level by thawing several containers in parallel with the aid of the FreezeStation (thawing system) Regardless of whether the containers are thawed individually or in parallel, the process is reproducible. A temperature profile can be defined for the thawing process to ensure that thawing is always executed with the same parameters. After thawing, the containers are kept cool (for example, at 3 C) by the FreezeController or the FreezeStation, permitting storage of the product at a minimal activity until it is needed for the next production steps! Batch formula drafting 7

8 Zeta Holding GmbH As a technology supplier of the biotechnological and pharmaceutical industry, we design, manufacture and install customised solutions for renowned companies around the world. Biopharmaceutical systems Preparation and formulation systems CIP/SIP- and media systems Process equipment Sterile plant installation Automation solutions Agitation and mixing technology Freeze & thaw systems A-8501 Lieboch/Graz, Zetaplatz 1 Phone / Fax / office@zeta.com Zeta Biopharma GmbH A-8501 Lieboch/Graz, Zetaplatz 1 Phone / Fax / office@zeta.com A-1150 Wien, Graumanngasse 7/B4-2 Phone / Zeta Automation GmbH D Freising, Münchner Straße 8 Phone / Fax / info.automation@zeta.com CH-4147 Aesch, Bruggfeldweg 1 Phone / Zeta Alro AG CH-5102 Rupperswil, Suhrhardweg 6 Phone / Fax / office-schweiz@zeta.com Zeta Biopharma s.r.o. CZ Úvaly, Riegerova 12 Phone / Fax / office@zeta.com Zeta OOO RU Moscow Prospekt Mira, 104, Bld. 2, Office 30 Phone / russia@zeta.com