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premium pharma solutions Freeze Drying Systems | Loading and Unloading Systems | Freeze-Thaw Units | Waterbath and Debottling Systems | Service edition 2025 HOF FTU Pharma – reliable, efficient and innovative HOF Freeze-Thaw Solutions An interview with Fabian Plaum, Sales Manager, about the wide range of applications and technological features of HOF Freeze-Thaw solutions PAGE 4 - 5 HOF Massanalyzer Quality monitoring of pharmaceutical freeze-drying systems – fulfils all criteria of Annex 1 of the EU GMP Guide PAGE 10 - 11 Versatility in product applications HOF Pharma Blast Freezer – Flexible solution for bag and bottle systems Precise freezing, environmentally friendly with air
HOF – editorial Ladies and gentlemen, 2024 was a year full of innovations and significant progress for HOF. Our commitment to the pharmaceutical and an bio- technology industry has motivated us to continuously develop our product range and to align ourselves even closer to the needs of our customers. The past year was also characterized by a strengthening of the F-Gases Regulation, which have encouraged us to intensify the development and engineering of our environmental-friendly refrigeration technologies HOF CAR6 and HOF CryoBlizzard – another example of our commitment to sustainability. One highlight in 2024 was the further development of our Freeze-Thaw Units (FTUs). These systems stand for precision and maximum product safety in order to process biopharma- ceutical products reliably. With state-of-the-art refrigeration technology, they combine efficiency, flexibility and sustainabil- ity – crucial factors in today’s production. Our performance at ACHEMA 2024 was another highlight, where we demonstrated with solutions such as the SIRIUS 2.0 that HOF is the reliable partner for excellent technology and comprehensive services. This show has once again confirmed that our innovative strength and customer proximity are the basis of our success. In addition to the FTUs, we are looking forward to extending our product portfolio at the beginning of this year with our newly developed HOF Pharma Blast Freezer, a flexible solution that can efficiently process both bag and bottle systems. This expansion of our portfolio demonstrates our endeavour to provide innovative and adaptable production solutions. I hope you enjoy reading this edition of the HOFinsight and we invite you to find out more about our innovative solutions and developments. We have also taken automation to a new level. The usage of the IO-Link technology in our control systems illustrates how much we are committed to optimized process control and in- creased operating efficiency. Kind regards Dr. Alexander HOF (CEO) Further development HOF Freeze-Thaw Units Product novelty HOF Pharma Blast Freezer State-of-the-art measuring system HOF Massanalyzer 2
HOF – Freeze-Thaw Units HOF Freeze-Thaw Units: Reliability, performance and innovation Wide range of applications for various biopharmaceutical products The versatility of HOF FTUs is also reflected in their appli- cation possibilities: From monoclonal antibodies to mRNA and vaccines through to cell and gene therapy products – the systems ensure the safe processing of a wide range of pharmaceutical and biotechnological products. Each product application has specific requirements, which are ideally sup- ported by the high flexibility and adaptability of the FTUs. Today‘s Freeze-Thaw Unit design: modern and reliable HOF Freeze-Thaw Units (FTUs): Innovation and reliability for the highest requirements The HOF Freeze-Thaw Units (FTUs) are reliable and powerful freezing and thawing units that have been continuously de- veloped and optimized since the 1990s. Originally designed for the rapid freezing of blood plasma, the FTUs have become indispensable in the pharmaceutical and biotechnological in- dustry. With comprehensive technological know-how, HOF supports customers worldwide in meeting their ambitious re- quirements while exploiting innovation potential. Controlled processes for safe and efficient production Technological excellence for highest product requirements In the pharmaceutical and biotechnology industry, it is crucial that temperature-sensitive products are frozen and thawed quickly, reliably and homogenously. The HOF FTUs offer opti- mum solutions for this and ensure that the quality of sensitive products is ensured at all time thanks to precisely controlled processes. Due to the adjustable freezing and thawing rates, individually defined for the specific requirements and proper- ties of each product, uniform and controlled process control is ensured. Through continuous further development in all technologi- cal areas HOF ensures that its freezing and thawing solutions always meet the latest technical standards and fulfill the highest product requirements. With innovative solutions and future-proofed design, HOF successfully supports its custom- ers in realizing their goals. In the following interview, Fabian Plaum, Sales Manager at HOF, provides deeper insights into the wide range of application possibilities and the special technological features of the HOF Freeze-Thaw Solutions. 3
HOF – interview Interview with Fabian Plaum, Sales Manager, on the subject of the HOF Freeze-Thaw Units HOF is known for its innovative strength in the industry. What pioneering technologies are used in the FTUs? We rely on innovative refrigeration technologies, including the use of natural refrigerants such as liquid nitrogen, hydrocar- bons and air. With our latest development the HOF FTU Air- Line, we use only air as a refrigerant and take our FTUs to the next level in the aspect of sustainability. Beside this our sys- tems are equipped with the HOF Freeze-Viewer Professional, a visualization system that offers comprehensive process control and GMP-compliant batch documentation. Fabian Plaum (Sales Manager) Mr. Plaum, what role do the Freeze-Thaw Units (FTUs) from HOF play in modern pharmaceutical production? The HOF FTUs are essential for the safe and efficient process- ing of temperature-sensitive biopharmaceutical products. Thanks to high, but controlled freezing and thawing rates, product-specific requirements can be met while maintaining consistent product quality. HOF FTU Air-Line And how do the FTUs adapt to different production requirements? Our FTUs are extremely flexible and can work with different bag systems.They are able to process up to 300 litres of prod- uct per batch and can be adapted to customized installation requirements, including integration into cleanrooms up to class C. Can you tell us more about the range of applications for the FTUs? Which product types can be processed with them? Our Freeze-Thaw Units are designed for a wide range of bio- technological and pharmaceutical products. They ensure precise and controlled processes in order to guarantee the quality and efficacy of sensitive products. Due to their versatility our FTUs are indispensable in modern biopharmaceutical production. HOF Freeze-Thaw Unit Pharma with ©Entegris Life Science Aramus Bags HOF Freeze-Thaw Unit Pharma with ©Sartorius AG FFTp Bags 4
HOF – interview Innovative refrigeration technology for sustainable production Sustainability is an important item. How does HOF ensure that the FTUs comply with current environmental standards? Thanks to the use of environmental-friendly refrigerants and energy-efficient technologies, our FTUs meet the latest envi- ronmental regulations. We offer solutions that combine sus- tainability, performance and future-proofness. For example, during the development of the HOF FTU Ar-Line we made sure that the same performance criteria as for the existing synthetic systems are met, so that these systems can be easily retrofitted into existing production capacities. How does HOF integrate the FTUs into existing production lines? What makes this process particularly efficient? We work closely with our customers to develop customized solutions that can be seamlessly integrated into existing pro- cesses. Our FTUs are designed in a way for a flexible adaption to various production environments. And finally, how does HOF support its customers after the FTUs have been installed? What services can they expect? In addition to manufacturing, we offer comprehensive project support, ranging from system planning and commissioning through to training and annual maintenance. Our 24-hour emergency service combined with an extensive stock of spare parts ensures minimum downtimes. 5
HOF – technology Detailed illustration of the HOF Freeze-Thaw Units Optimum control and precision – The HOF Freeze-Thaw Units in detail The HOF Freeze-Thaw Units (FTUs) are specially designed for the controlled freezing and thawing of biopharmaceutical products. With their wide temperature range from +40 °C to -90 °C, the FTUs offer maximum flexibility and precision for customer processes. The devices are able to process a wide range of bag systems with a maximum load of 300 liters of product per batch. Thanks to this versatility, they are optimally tailored to the high demands of the pharmaceutical industry. Temperature regulation and process control Loading process of the HOF FTU Pharma with bag systems The FTUs from HOF ensure precise control of the freezing and thawing processes, which is necessary to ensure the quality of the products. The adjustable freezing and thaw- ing rates can be individually adapted to the specific require- ments of each batch. This flexibility allows for freezing and thawing with maximum speed or for controlled rate pro- cesses consisting out of various temperature control steps. A homogenous and controlled heat transfer is ensured – a decisive factor in maintaining consistent product quality. Integrated solutions for cleanrooms and production lines The FTUs from HOF are designed so that they can be seamless- ly integrated into cleanrooms up to class C. This flexible design facilitates installation and ensures space-saving operation in a wide variety of production environments. In addition, the mo- dular design of the systems enables integration into existing production lines, making them ideal for integration into exis- ting processes. Whether standard installation or a customized solution – the FTUs adapt to the specific requirements of our customers. Sterile room integration of HOF FTUs 6
HOF – technology User-friendliness and versatility of the FTUs User-friendliness and digital process monitoring Compact design and easy integration With the HOF Freeze-Viewer Professional, HOF offers a power- ful software for process visualisation and control. This software enables GMP-compliant process documentation and supports 21 CFR part 11 standards, that meet the high requirements of the pharmaceutical production. Via network connections and the usage of digital interfaces, processes can be controlled, monitored and documented. The intuitive operation and var- ious monitoring options offer security and reliable control of all process parameters. The compact design of the FTUs integrates all process-relevant and electrical components within the system, saving valuable space in the production environment. For specific installation requirements, such as split installations, the machines can also be configured in a way that the technical components of system are placed in a separate technical room. This flexible configuration supports efficient space utilisation and facilitates maintenance. Integrated HMI for simplified operator handling Splitted machinery design of the HOF FTUs FFTp Bag ©Sartorius AG Maximum flexibility thanks to innovative technology The Freeze-Thaw Units offer the option of processing a variety of bag systems. This allows the systems to be used for for var- ious biopharmaceutical products and thus cover a wide range of applications. Regardless of bag size, the entire product is processed homogenously, which ensures consistent freezing and thawing results. The systems are designed in such a way that they fulfill the requirements for temperature stability and process reliability, while offering at the same time high process capacities. RoSS Shell ©SingleUse Support GmbH Aramus Bag with Plate Freezer Shell Entegris Life Science Inc. Aramus Bag ©Entegris Life Science Inc. 7
HOF – product novelty The HOF Pharma Blast Freezer – innovation meets flexibility With the development of the HOF Pharma Blast Freezer, HOF is expanding its product portfolio with a solution that effec- tively allows for the freezing and thawing of bag and bottle systems. This flexibility makes the HOF Pharma Blast Freezer the ideal choice for manufacturers who process a wide range of biopharmaceutical products. At the beginning of 2025, HOF will set new standards with its first own system. The HOF Pharma Blast Freezer combines years of research and devel- opment, to offer our customers a high-performance and fu- ture-proof solution. Flexible temperature settings and processing capacity The HOF Pharma Blast Freezer has been specially developed for use in demanding production environments. With temper- ature ranges from +40 °C to -110 °C, it enables flexible use that is tailored to the needs of a wide range of biopharmaceu- tical products. The possibility of handling different ranges of batch sizes, from small batches up to entire pallets, makes it the ideal choice for customers that require flexibility in their production cycles. Hygienic design and easy handling The HOF Pharma Blast Freezer is made of high-quality stain- less steel which fulfills the hygienic requirements of the phar- maceutical industry. The compact design and the intuitively operated panel ensure user-friendly operation and smooth integration into existing production lines. Thanks to its flex- ible design, the HOF Pharma Blast Freezer can be installed in non-classified rooms as well as in sterile areas to ensure maxi- mum safety and quality. HOF Pharma Blast Freezer with product 8 FFT Bag ©Sartorius AG Nalgene Bottle ©ThermoFisher Scientific Aramus Bag in Blast Freezer Shell ©Entegris Life Science Inc. With the development of the HOF Pharma Blast Freezer HOF will be launching a system at the beginning of this year that can effectively freeze and thaw both bag and bottle systems. Sustainability and innovative refrigeration technology In order to fulfill the current environmental requirements HOF relies on the environmentally friendly refrigerant air (R729). This refrigerant fulfills the F-Gases Regulations and ensures cooling capacity without the need for additional safety meas- ures. The sustainable technology enables energy-efficient pro- cess cooling and helps to minimize the environmental impact of the production process.
HOF – product novelty Advantages at a glance Maximum process reliability: Precise control to ensure product quality, regardless of the system size. Flexibility: Suitable for processing a wide variety of bag and bottle systems. Sustainability: Usage of the environmental-friendly refrigerant air (R729) and energy-efficient technologies. Ease of use: Simple integration into existing processes and intuitive operation. Compact design: Space-saving construction and flexible installation possibilities. Innovative technology: State-of-the-art refrigeration technology and digital process monitoring for optimum production conditions. Service+: Our Service+ ensures smooth operation – from commissioning to maintenance, including 24-hour emergency service. “Our Freezing and Thawing Solutions are indispensable when it comes to the safe and efficient processing of temperature-sensitive biopharmaceutical products. With controlled freezing and thawing processes, we ensure that the product quality is maintained at all times.“ Fabian Plaum (Sales Manager) Take a look at two videos: HOF FTU with Sartorius FFTp Bags www.hof-sonderanlagen.de > Communication + media > downloads HOF FTU with Entegris Aramus Bags www.hof-sonderanlagen.de > Communication + media > downloads More information about HOF Freeze-Thaw Units can be found on our website: www.hof-sonderanlagen.de > Communication + medien > downloads 9
HOF – technology The HOF Massanalyzer – Multifunctional measuring system for more safety in everyday production Quality monitoring of pharmaceutical Freeze-Drying plants – fulfills all criteria of Annex 1 of the EU GMP guidelines Mass spectrometers are being used more and more frequently in the pharmaceutical industry, as they increase production safety and continuous monitoring of the production environ- ment. The HOF Massanalyzer fulfills the criteria of the Annex 1 of the EU GMP guidelines and offers the necessary safety for simple and efficient quality monitoring. This state-of-the- art mass spectrometer ensures seamless control, guaranteeing product safety at the highest level. HOF Massanalyzer – safe handling and high accuracy An indispensable tool for production When using the HOF Massanalyzer, our customers benefit from early detection of potential contamination by silicone oil. This early detection minimizes risks for the entire production process. The HOF Massanalyzer also enables precise moisture monitoring, which increases the efficiency of the Freeze-Dry- ing process through optimized drying times. Last but not least, effective leakage testing is an important component to ensure the integrity of the system. Innovation and flexibility combined The HOF Massanalyzer is available in three versions: mobile, smart and integrated. Each of these versions can be flexible integrated into existing Freeze-Drying systems, without inter- rupting the production flow. This versatility makes it an ideal partner for different production requirements. Optimum detection of silicone oil Precise monitoring of moisture Effective leakage testing HOF Massanalyzer – highly precise, absolutely reliable and flexible 10
HOF – technology Functions, service and benefits Fast and efficient integration Our Massanalyzer variants offer maximum flexibility. Whether as a mobile solution, for simple transport between different production sites, or as a version permanently integrated into the system – the HOF Massanalyzer adapts to the individual requirements of our customers and guarantees seamless inte- gration into existing processes. Maximum technological precision and regulatory safety The HOF Massanalyzer not only improves process reliability, but also supports continuous compliance with regulatory re- quirements. Our customers appreciate the combination of high-precision technology, reliable service and HOF‘s exper- tise, which we bring to each of our solutions. Service at the highest level With our proven ring exchange system, we minimise down- times. The assemblies to be serviced are simply exchanged on site and sent to HOF for comprehensive inspection and repair. This efficient approach ensures that production can continue without long downtimes and that the devices are always in optimum condition. HOF Massanalyzer – stationary version with own software “The HOF Massanalyzer is the optimal measuring “The HOF Massanalyzer is the optimal measuring instrument for monitoring the quality of instrument for monitoring the quality of pharmaceutical Freeze-Drying processes due pharmaceutical Freeze-Drying processes due to its safe handling and high accuracy.“ to its safe handling and high accuracy.“ Dr. Alexander Hof (CEO) More information about the HOF Massanalyzer can be found on our website: www.hof-sonderanlagen.de > Communication + medien > downloads Advantages at a glance Maximum product safety: Ensured by the precise monitoring and seamless control of the drying process. Optimized process control: Real-time measurement and analysis enable rapid reaction to changes in the production process. Compliance with EU GMP guidelines: Conformity with the requirements of Annex 1 of the EU GMP guidelines ensures the highest quality standards. User-friendliness: Simple integration into existing systems and intuitive operation facilitate the usage. Technological excellence: Use of an advanced mass spectrometer for precise analyses and reliable process monitoring. Reliable documentation: Seamless logging and availability of audit trails ensure comprehensive traceability. 11
HOF – technology HOF SIRIUS 2.0 – New standards in precision and efficiency Proven and successful technology Pharmaceutical products and primary packaging must be transported safely and efficient. HOF SIRIUS was specially de- veloped for this requirement and has proven itself a success- ful high-tech loading and unloading system for Freeze Dryers. Since its presentation at ACHEMA 2022, the robot-assisted HOF SIRIUS has been continuously developed and sets new standards through its technological progress. HOF SIRIUS – state-of-the-art robot technology ensures a maximum flexibility in the pharmaceutical sector HOF SIRIUS – future-proof, powerful and practical Flexibility - adaptable to all Lyo sizes State-of-the-art robot technology Short set-up times Easy and fast cleaning Intuitive operator guidance The HOF SIRIUS 2.0 not only ensures high technological performance, but also maximum flexibility and product safety in every production process. ““With the HOF SIRIUS, we are setting new standards in pharmaceutical production. Our combination of innovative technology and practical implementation ensures maximum product safety and efficiency.“ Peter Schneider (Sales Management) More information about HOF SIRIUS and a detailed product video can be found on our website. www.hof-sonderanlagen.de > HOF products > loading and unloading systems 12
HOF – technology Advantages at a glance 13 1. Maximum product protection thanks to an advanced transport system: The HOF SIRIUS transport system ensures safe transport of vials without glass-to-glass contact. The vials are prevented from falling over by format- specific nests. The integration of camera and laser technology enables precise identification of the front row of vials in the Freeze Dryer. The combination of two cameras and two lasers captures precise information number and position of the vials, even in difficult lighting conditions inside the Freeze Dryer and changing conditions in the process room. Both transparent as well as coloured glass vials can be reliably deteceted. 2. Reduces friction and particle generation: The HOF SIRIUS transport system has been further optimized to minimize friction and particle generation. Format parts with a base ensure that the bottom of the vial does not lay on a fixed guidance during the transport. This ensures gentle and safe movement. 3. High flexibility thanks to state-of-the-art robot technology: State-of-the-art 6-axis robot technology combined with the electromagnetic XTS-Hygienic system ensures maximum flexibility in the pharmaceutical sector and adapts easily to all Lyo sizes. 4. Efficient loading and unloading system for optimized process sequences: The system works on a row-by-row basis, which ensures precise traceability. It is scalable and can be flexible adapted to individual requirements. 5. Modular system for individual customization: The HOF SIRIUS has a modular design and can be customized to any layout. The absence of conveyor belts helps to reduce particle generation and optimise cleanliness. 6. Innovative drive technology to minimize friction: An innovative magnetic drive ensures friction-free movement of the vials and optimizes the entire transport process. 7. Long-term testing and continuous optimization: The HOF SIRIUS system has successfully completed test runs to determine system stability and product safety. Continuous optimization and on-going developments guarantee constant process safety and reliability.
HOF – look back HOF infrastructure for FAT – flexibility and precision at the highest level HOF has a state-of-the-art infrastructure that covers almost 100% of the FAT (Factory Acceptance Test) requirements. With flexible set-up options that extend up to 15 metres in height and 11 ABUS large crane systems with capacities from 10t to 40t, HOF is able to cover a wide range of customer requirements and simulate the installation conditions at cus- tomer site. This outstanding infrastructure not only enables maximum flexibility, but also efficient process integration. Automated systems and central utility supply ensure smooth processes during the tests and significantly increase the efficiency. In addition HOF focuses on environmental awareness: The usage of renewable energy sources and resource-saving tech- nologies reduces the ecological footprint and and emphasis- es our commitment to sustainability. For our customers, this means that all requirements – from the energy and water sup- ply through to the provision of nitrogen and compressed air – are seamlessly covered. You can find more information on our website. www.hof-sonderanlagen.de > Knowledge + experience > development Stricter regulations for F-Gases: What this means for HOF customers With the new F-Gases Regulation, which came into force in March 2024 stricter requirements for the usage of fluorinated gases were introduced. These gases, which have a high glo- bal warming potential, were previously used in many industrial applications, including in pharmaceutical processes. The new rules aim the CO2 equivalents to be phased out by 2050. HOF has prepared for these changes already at an early stage and therefore already offers environmental-friendly alterna- tives to conventional refrigeration technologies. Our solutions rely on natural refrigerants such as hydrocarbons, liquid nitro- gen and air, which makes the use of highly climate-effective refrigerants unnecessary. The innovative HOF CryoBlizzard technology is one example of our approach to design future-proof refrigeration systems and promoting climate protection at the same time. HOF thus remains a reliable partner that is actively shaping the change in refrigeration technology. You can find more information on our website. www.hof-sonderanlagen.de > HOF NEWS 14
HOF – look back Efficient automation for our customers through digital connection with IO-Link Power supply PLC IO-Link master Profinet up to 100 m 24 VDC Further bus devices IO-Link up to 20 m Innovation and customer satisfaction are top priorities at HOF-Automation. With the integration of the automation standard IO-Link into our control software, we are setting new standards. This pioneering technology offers many ad- vantages for the pharmaceutical industry and increases both cost-effectiveness and efficiency. The first successful Factory Acceptance Test of production systems confirm the reliability of this solution. Freezing and Thawing processes and our innovative refrigeration techno- logies also benefit from the usage of this technoloy. IO-Link enables improved process monitoring, rapid fault diagnosis and optimized maintenance, giving our customers a real com- petitive advantage. Process sensors Positions sensors Identification systems Devices You can find more information on our website. www.hof-sonderanlagen.de > HOF NEWS ACHEMA 2024 – innovative, challenging and successful! ACHEMA 2024 was a complete suc- cess for HOF. With over 2,800 exhi- bitors and over 100,000 visitors the exhibition offered a platform for the exchange of innovative ideas and technologies. Under our new claim ‘HOF premium pharma solutions’, we presented our highlights, including the new gen- eration SIRIUS 2.0 system – a fu- ture-proof, high-performance loading and unloading system for Freeze- Dryers. Our commitment to environmen- tal-friendly solutions was also high- lighted, for example through the topic “HOF Freeze-Drying with natural re- frigerants – Innovations by Nature”. The positive outcome of the event showes that our focus on technologi- cal excellence and customized solu- tions is well noted and received. Many visitors, partners, including existing customers but also potential new cus- tomers took the opportunity to learn more about our latest developments and to discuss future projects. Once again, we would like to thank all visitors at ACHEMA 2024 and look forward to seeing you at the next ACHEMA from 14 to 18 June 2027 in Frankfurt am Main. 15
HOF – company Headquarters HOF Sonderanlagenbau GmbH Ludwig-Rinn-Str. 1–3 | 35102 Lohra | Germany phone + 49 6462 9169-0 | fax + 49 6462 9169-199 info@hof-sonderanlagen.de | www.hof-sonderanlagen.de Mornshausen site HOF Sonderanlagenbau GmbH Vor dem Langen Loh 2 | 35075 Gladenbach-Mornshausen | Germany phone + 49 6462 9169-0 | fax + 49 6462 9169-199 info@hof-sonderanlagen.de | www.hof-sonderanlagen.de Imprint publisher: HOF Sonderanlagenbau GmbH Ludwig-Rinn-Str. 1–3 | 35102 Lohra | Germany phone + 49 6462 9169-0 | fax + 49 6462 9169-199 | www.hof-sonderanlagen.de responsible under German press legislation: Alexander Hof, Stefan Becker concept, design, editorial support: exposé Marketing & Werbung, Marburg, Michael Grebe, contact: + 49 6421 484880 picture credits: Adobe Stock and HOF Sonderanlagenbau GmbH