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HOF product range Technologically leading Finding innovative solutions – Going new ways HOF quality is the sum of many success factors Innovative refrigeration technologies HOF products Freeze drying systems Vial and bulk systems laboratory systems Loading and unloading systems Automatic loading and unloading systems HOF VTS Vial transfer system HOF SIRIUS robot-assisted loading and unloading system Sealing machine Freeze-Thaw Units HOF FTU Pharma HOF FTU Plasma Special solutions HOF waterbath & debottling system HOF services Qualification Process development Design and concept studies Maintenance services Training courses LYOPOOL Premium existing plants HOF service 24-hour availability over 60,000 spare parts HOF at a glance 4 5 6 8 9 11 12 14 16 18 20 22 24 26 26 27 9 12 20 24 3

HOF‘s products can be described with three words that are important in the everyday life of pharmacy and bio- technology: future-proof, powerful and practical. HOF has been using robotic systems since 2006. For example, in the extraction of bulk products or in fully automatic frame handling for individualised storage. HOF also uses state- of-the-art robot technology in the system with waterbath & debottling system. HOF systems are individually tailored to their respective tasks and special production requirements. For systems built for research or for product and process development, HOF guarantees that the process parameters are trans- ferable to the production systems. This provides production reliability. Furthermore: each plant is optimally fitted into the structural design conditions. HOF always helps – in a quick and reliable way and with considerable knowledge Are you currently in a planning phase? Do you need tech- nical support with your concept? Our consultants and engineers are there to help you in word and deed. Technological leadership Technologies are only good to the extent that they are suitable for solving challenges. Therefore, at HOF, it is not the technology that determines the product, but the pro- duct properties that determine the technology. In order to work successfully on this path, three preconditions always have to be met: Firstly, there must be a need to develop new technical solu- tions – technology must never be an end in itself. Creativity, knowledge and lots of experience Secondly, this process requires new approaches, new materials or new components. Thirdly, that requires peo- ple who implement these new technical possibilities in practice with motivation and know-how. HOF has accepted this role for more than 30 years, as a specialist market leader, as a technological leader. But how has HOF managed to maintain this pioneering role for such a long time? It is quite simply, it’s the company‘s DNA. The founder Hans-Georg Hof and the highly qualified emplo- yees with their technological expertise are responsible for this success. HOF freeze drying systems: from practice for practice HOF Sonderanlagenbau GmbH is the leading specialist for manufacturing high-quality, future-proof freeze drying systems, loading and unloading systems and freezing and thawing equipment. The plants are characterised by their innovative character and many new developments are pa- tented. Advantages at a glance Individual tailored State-of-the-art technology Reliable results High flexibility Space-saving systems Highest efficiency 4

Finding innovative solutions – treading new paths Brand essence: Innovative strength For more than three decades, HOF has been standing for the development of forward-looking technologies – both nationally and internationally. The company has a self-imposed requirement which is a forward-looking planning and developing. HOF‘s employees don’t focus per se on the technological innovations, but on the changing customer- specific requirements. Pioneer – today and tomorrow Brilliant innovative strength Beeing in the vanguard in the freeze-drying sector is and remains a main objective of HOF‘s employees. Innovative charging systems, a flexible shelf adjustment, the use of liquid nitrogen and natural refrigerants as well as inte- grated trendsetting measuring system control, such as NIR and mass spectrometers, HOF Syncho- Freeze or vacu- um insulation, are just a few examples of the willingness to always take new approaches. Over the recent decades, an extensive pool of knowledge and know-how could arise, fed by the latest research and science findings. There are in total many factors which make HOF a leader in technology today. It has also con- tributed that HOF has been awarded with the TOP 100 seal of the most innovative companies in Germany, several times in a row since 2016. Creativity, knowledge and a lot of experience Listening, thinking and acting in a team-oriented manner – these skills are the basis for a successful cooperation and are also a key to the innovations developed at HOF, such as the Cyro-Blizzard. With these technologies using ambient air as a refrigerant, the current requirements for freeze- drying and blast freezing are transcended. Advantages at a glance Over 30 years of expertise Innovative pioneer in research and development Technologically leading Future-proof freeze drying systems 5

HOF quality is the sum of many success factors HOF’s plants are often characterized by their innovative character and many new developments are patented. The plants and systems are designed and precisely implemented in line with customers’ individual requirements. HOF‘s products can be described by three success factors that are important in the daily routine of pharmacy and biotechnology: future-proof, high-performance and practical. consulting A team of experienced employees provides you with individual advice from the outset and accompanies all processes until the plant is successfully in use. You can rely on employees who are specially and continuously trained by HOF for this task. They all have well-founded training as engineers, natural scientists, technicians, service fitters or skilled workers. 24-hour service – 7 days a week Comprehensive service is very important to us. That’s why we don’t let anyone else work on our plants: we transport, install and commission your system and even qualify it too. This minimises interfaces and eliminates problems. HOF plants are a key component in the pharmaceutical production process. This is why our employees are available 24 hours a day and are immediately ready to go in emergencies. Your HOF team from service and production knows every detail of your plant and can help without delay. innovation Future-proof, high-performance and practical – these are the crucial parameters that HOF systems can be measured by. HOF is known for creative products that are precisely developed in line with customers’ requirements using the latest technologies. With our individual solutions and pioneering design, we successfully support our customers in achieving their goals. Focus on Individually designed, planned state-of-the-art technology At HOF, it is not the technology that determines the product, but the product properties that determine the technology. We rely on state-of-the-art technologies in our plants and systems to achieve the best results for our customers as reliably and effectively as possible. You can rely on that! 6

And the spare parts? No problem! Our own warehouse with more than 60,000 items ensures that the essential spare parts for all plants are available at all times, thus keeping downtimes as short as possible. Contact our emergency service on + 49 6462 9169-0 for immediate support. competence The knowledge, skills and experience of our employees form the foundation of our work. Thorough, comprehensive training and constant transfer of knowledge are an important investment in the future. They help to safeguard our extensive expertise and identify with our very own products. And: this also gives you the knowledge that you have made the right choice for your everyday production operations. Focus on your product Individually designed, planned and manufactured – with state-of-the-art technology quality With every HOF system, the goal is only achieved when the result fully meets your requirements – not 99 percent, but 100 percent. Following the company philosophy, „on-time quality for demanding customers“, quality is the highest standard for HOF. This applies to all areas, from conception to service – you can rely on it. manufacturing Our leading position is a constant commitment to excellent performance, continuously high quality and foresight for the development of pioneering technologies. All HOF systems are fully manufactured and tested by our employees at our production site. This allows us to ensure maximum quality. 7

Innovative refrigeration technologies Pioneering alternatives to conventional compression refrigeration HOF has a long-standing commitment to the issues of environmental protection, climate protection and greenhouse gases. We consequently offer our plants based on conventional refrigeration technology as well as a whole range of refrigeration technologies that are based on the use of natural refrigerants. Instead of refrigerants with a high impact on the climate, such as R404A/R507A, these plants use hydrocarbons (ethane/propene), liquid nitrogen or – as in the case of our innovative HOF CryoBlizzard cold air machine – air as a refrigerant. Air as a refrigerant Nitrogen as refrigerant Using air for cooling offers several advantages. Firstly, air is available everywhere at GWP0, is safe to use and does not promote climate change in any way. On the other hand, temperatures below -80 °C can be easily achieved with cold air machines, for example with the HOF CryoBlizzard. Legal regulations with regard to the F-Gas Ordinance are therefore not applicable. Our plants with liquid nitrogen as refrigerant offer im- mediate cooling performance because the -196 °C cold nitrogen is supplied directly from nitrogen tanks from outdoor installation. In addition, these systems are easy to commission and future-proof because they are not affected by new legal regulations. They also impress with low maintenance costs while offering a high level of tem- perature flexibility. Advantages at a glance: Natural refrigerant (GWP 0) Uses ambientair “Scale Up” via central cooling Future-proof and not affected by regulations Low maintenance effort High temperature flexibility Low noise emission Almost no requirements for machine room installation (pressure consideration/refrigerant) Very low training requirements and good safety aspect for employees and site Compression refrigeration Refrigerants such as R452A, R404A, R410A or R507A are used in conventional refrigeration systems, which we offer with two-stage compressors for refrigaeration in the freeze drying process if requested by the customer. As known and well-tried refrigerants, these have the advantage of being non-flammable and non-toxic. They also require little space and have low investment costs. With respect tot he F-Gas Regulation, however, some legal regulations have to be taken into account. Advantages at a glance: No special requirements concerning the material Tried, tested and optimized technology since 1988 Refrigerant of safety class A1 Low space requirement Advantages at a glance: Natural refrigerant (GWP 0) Simple process Proven since 1994 Future-proof and not affected by regulations Low noise emission Low maintenance costs Hydrocarbons as refrigerants Our two-stage CAR6 cascade system allows us to achieve low temperatures with natural refrigerants. The refrige- rants used are the hydrocarbons ethane and propene, which allow a very high level of efficiency to be achieved with maximum flexibility. The cascade systems ensure safe operation of a plant, which is also future-proof. Advantages at a glance: Very low GWP ≤6 High efficiency Years of experience since 2007 Future-proof and not affected by regulations Modular design Reliability You can find more detailed information on the subject of refrigeration technologies on our website: www.hof-sonderanlagen.de/en/hof-products/ freeze-drying-systems/ We will also be happy to send you our brochure. 8

Vial and bulk systems Variety in top quality HOF – Freeze Drying Systems Advantages at a glance Individual plant engineering Flexible equipment variants Flexible refrigeration systems e.g. using natural refrigerants Requirement-oriented vacuum systems User-oriented unloading systems Individual solutions Tailor-made, reliable and easy to operate HOF is the specialist for individual solutions. That is why freeze drying systems are tailored individually and precisely to the task at hand and to the specific production require- ments. And: This allows us to ideally adapt each system to the structural conditions on site. In this area, HOF offers a wider range of freeze drying systems, with regard to system size, model variants and optional equipment. The portfolio ranges from small pilot systems with a footprint from 2.5 m² to systems with a footprint of 75 m². Keeping an overview with HOF software The specially developed software from HOF makes the pro- cess control of HOF systems particularly user-friendly. All functions are always visible at a glance and any irregularities are identified immediately. An optional remote control function provides reliability in production, because the cause is analysed precisely straight away in case of a malfunction. Our own products also include a visualisation system for creating product-specific temperature profiles, system visua- lisations and batch-based documentation of processes. Operation of the freeze dryers in the sterile area 9

HOF – Freeze Drying Systems Vial and bulk systems – variety in top quality Equipment General Vertical design Horizontal design Modular technical units which can be installed according to the building situation The systems can be equipped with different cleaning and sterilizing units for aseptic processing areas and with systems for decontamination of the system periphery. System design for drying products with organic solvents Systems for process monitoring and process analysis Different systems are available for unloading. These are selected according to individual requirements. The same options are available for vial and bulk production systems. Door concepts Single door Double doors (facing as a reach-through system) Slot door especially for automatic loading and unloading systems Slot door integrated into swivel doors Refrigeration systems Two-stage refrigeration sets with synthetic refrigerants Cascade refrigeration sets with natural refrigerants LN2 refrigeration via heat exchangers for the installation areas and the ice condenser LN2 refrigeration as direct evaporation for the ice condenser For vacuum systems, HOF offers different variants for different requirements: Oil-sealed rotary vane pumps with or without Roots-type blower Glandless pumps with Roots-type blower Screw compressors with or without Roots-type blower Upstream or downstream exhaust gas filtration Also in bulk production, HOF as a specialist for individual solutions, meets the different requirements in providing equipment such as: Systems with fixed shelves for loading with trays Systems with hydraulically height-adjustable shelves for easer tray handling Systems with tilting shelves for cascade filling, with the shelves designed as product pans The CIP/SIP process can be used here to reload the system with products without opening the chamber door. Opened slot door as interface to the loading and unloading system Process piping of the freeze-dryer HOF freeze dryer LYO PRO with closed swivel door 10

Modern laboratory systems Optimal system engineering HOF – Freeze Drying Systems Flexible fields of application Individual equipment variants The qualitative high-class and customized HOF’s laboratory systems are used by a number of well-known companies and scientific facilities for research purposes and for product and process development. Highly efficient product results HOF offers advanced systems in both compact and split de- signs with shelf area between 0,2 m² and approx. 2.5 m². Control, visualization and technical operation correspon- ding to that of a production system. This way, the transfer of the determined process parameters onto the production system is guaranteed and this is the basic requirement for a safe production. Each HOF laboratory systems consists of a fully functioning basic unit. Individual equipment vari- ants for customised solutions are also available, providing the required flexibility for the task at hand. Technical specifications Total footprint: 0.22 m2 – 2.5 m2 Number of shelf sets: 3+1 – 7+1 Dimensions of shelf sets (mm): 250/300; 420/470; 600/600 Hydraulic adjustment of the shelves Operating voltage: 400 V/50 Hz Cooling from +20 °C to -40 °C ≤ 40 min Heating from -40 °C to +20 °C ≤ 60 min Temperature range from -55 °C – +80 °C (optionally down to -60 °C) Advantages at a glance Tailor-made plant engineering Individual equipment variants Modern compact or split design Optimal control and technical operation Evacuation time from 1000 mbar – 0.1 mbar ≤ 30 min End vacuum: 5 μbar Leak rate: < 0.1 mbar*l/s Ice capacity: 4 – 40 kg Temperature minimum condenser: ≤ -70 °C (optionally ≤ -75 °C) Control: Siemens PLC S7-300 User interface: HOF Freeze Viewer Professional 11

HOF – Loading and unloading systems Automatic loading and unloading systems Safe and patented Versatile and individual High performance and reliability The safe, optimum and integrated transport of pharmaceu- tical products and primary packing is the core property of the loading and unloading systems from HOF. Customer-specific adaptations The large number of models for loading freeze dryers ranges from models for technical centres to production sizes. And: It allows individual adaptation to any layout. The new design was specifically adapted to customer-specific requirements. High performance and reliability are the crucial factors here. The range covers manual, semi-automatic and fully automatic systems. Special packaging materials such as 2-chamber vials or 2 chamber syringes can be transported with ease. We hold patents worldwide for these techno- logies. Short installation and test times The loading and unloading systems are installed and tested at our own production facility together with freeze dryers or in front of a suitable dummy frame. The clear advantage is the reduced installation and test period at the customer site. Existing freeze dryers can be retrofitted with the innovative loading and unloading systems from HOF to meet future requirements. Depending on the requirements, loading and unloading systems can be designed for insulator or RABS technology. Advantages at a glance Flexibility Process reliability Processing of different product shapes and product sizes 12 Automatic suction of bulk product with robot system

Bulk systems Automatic Robot with filling lance Robot with suction device Product separator Semi-automatic Filling car with dosing system Filling car without dosing system Manual Manual Lances for filling process Lances to the filling process Product separator Vial systems Frames/Magazines Storage Manual transfer carts to GT Semiautomatic loading and unloading Automatic loading and unloading Frameless row by row Loading and unloading row by row Loading row by row Unloading row by row Unloading multi-segments Charging for wagon systems Frameless plate by plate Loading and unloading wagon system Loading wagon system Unloading wagon system HOF VTS integrated in isolator Maximum flexibility through robot-based loading and unloading Unloading and separation on an unloading wagon with attached flanging machine Row by row loading with loading rates of up to 400 vials/min (2R) 13

HOF – Loading and unloading systems HOF VTS Vial transfer system The system meets the highest customer demands HOF VTS – pure innovation Sets new standards in design, technology and functionality Flexible control technology and intuitive operator guidance In the future, control technology of the loading and un- loading systems will focus on the new possibilities offered by Siemens as part of the TIA Portal (Totally Integrated Automation Portal). Advantages at a glance Can be adapted to all freeze-dryer sizes Short set-up times Easy and fast cleaning Intuitive operational guidance The demand for high-quality loading and unloading systems for freeze-drying systems in the pharmaceutical and biotech- nological industry is increasing and, with it, the technological requirements. HOF fulfils this need - with the right innova- tive answers and the expansion of reliable and high-quality production. Therefore, new developments have been continuously implemented in the field of loading and unloading systems in the past. The new HOF smartVTS meets the highest customer demands and is a good example of HOF’s knowledge, creativity and innovative power. Reliable, functional and easy cleaning processes Reliability and fast detection of individual objects all the way to hygienic design are crucial for HOF plant sensor technology. Reduced changeover times Changeover times with varying vial sizes will be signifi- cantly reduced in the future with the HOF VTS series through a simplified functional design of the format parts. 14 Multi-segment unloading for a maximal output during unloading

Technical specifications Construction Cleaning Forming widths up to 1,520 mm Fixed side guides on the individual positioning plates, transfer plane and buffer surface All stainless steel components in contact with the packing device are provided with an FDA-compliant coating to minimize friction. HOF VTS can be used both in the RABS and in the isolator Mechanical connection between the individual panels and the transfer level to ensure a clean transition between components Unloading unit inside the freeze dryer (ejection unit’s CIP and SIP, no additional space required in the equipment room behind the freeze dryer) Bellows optionally made of PTFE or stainless steel Format-independent horizontal vial ejection Format-independent horizontal vial recognition Small format parts for easy handling Short changeover times through the use of universal format parts Easy sensor replacement without reorientation All format parts can be mounted or adjusted without tools Process Row by row loading after single-lane feeding of the vials by upstream machines May be discharged as single row or multi-row Vial neck guides at critical points to improve vial stability at high levels of performance Automatically-swiveling hexagonal stopper for transporting vials Correction value entry for hexagonal stopper for vial tolerances Band body as open construction for improved H2O2 decontamination is possible Hygienic design sensors with resistance to H2O2 and all common cleaning agents HOF WIP cleaning system (Wash-in-Place) for example toxic applications Material selection is based on common cleaning agents for highest possible resistance Control system All drives are provided as servomotors with integrated absolute encoders Operation of the loading/unloading system and freeze dryer through a control panel Input table for precise positioning and identification of sample vials Operating modes: Production, Cleaning, Service, Sensor test PAT Technology Automatic exchange of normal plugs against prepared plugs with wireless temperature sensors at a freely selectable position on the positioning plate Automatic removal of vials with wireless temperature sensors before transferring vials to the crimper Detection of prepared vials via camera system Fully automated stopper handling via robot system (clean room-suitable, H2O2-resistant) Freely adjustable system output of 20 – 100% Verification of row length before transferring on the buffer surface Structured and clear visualisation for optimal plant operation Automatic placement of product temperature sensors 15

HOF – Loading and unloading systems HOF SIRIUS robot-assisted loading and unloading system future-proof, powerful and practical-oriented The requirements in the field of automatic loading and unloading of a freeze dryer are growing rapidly. Pharma- ceutical products and primary packaging material must be transported safely, optimally and in an integrated way. Based on these requirements, HOF, as the professional market leader, has developed an innovative robot-assisted loading and unloading system. The HOF SIRIUS new development convinces with its innovative technological character and is a sophisticated high-tech loading and unloading system. Very gentle product transport system SIRUS transports vials without glass-to-glass contact from the upstream machine to the freeze dryer. In the freeze dryer, a homogeneous, hexagonal vial pack is set up and placed on the shelves of the freeze dryer, independent of vial tolerances. By transporting the vials in format-specific nests mounted on individual electromagnetically driven movers, the possi- bility of fallen vials on their way from the upstream machine to the freeze dryer is eliminated. State-of-the-art robot technology ensures a maximum flexibility in the pharmaceutical sector A specially newly developed transport system ensures gentle product transport as well as the traceability of each individual vial during the loading process.The two 6-axis robots from Stäubli in the Stericlean version and the electromagnetic XTS-Hygienic from Beckhof ensure maxi- mum flexibility in the pharmaceutical sector. The system can be integrated into both a RABS and an isolator. All components meet the hygienic requirements demanded in the pharmaceutical environment and are resistant to H2O2. Advantages at a glance Flexibility – can be adapted to all freeze-dryer sizes State-of-the-art robot technology Short set-up times Easy and fast cleaning Intuitive operational guidance 16

Powerful loading and unloading system Technologically versatile and individual Unloading of the freeze dryer is done according to the row by row principle. This means that the individual vials can also be traced back to the downstream machine. Thanks to the innovative interaction of a high-tech transport system and modern robot technology, HOF is able to meet the high requirements of aseptic loading and unloading of a freeze dryer in the smallest possible space. Depending on the size of the freeze dryer, this system can be easily scaled up to meet our customers’ requirements. The capacity can be scaled depending on the size of the freeze dryer and the packaging material, up to 400 vials/min for loading and 400 vials/min for unloading. SIRIUS can therefore cover the loading and unloading pro- cesses of the freeze dryer in the small-scale sector as well as in large production plants. SIRIUS is a modular system that can be adapted to any layout. It can be supplied with vials from one side and also conveys the dried product back in this direction to the downstream machine. Alternatively, the product can be transported out on the opposite side after freeze-drying. Pass-through- conveying in the case of liquid filling is also possible. By eliminating conveyor belts, glass-to-glass contact, and the accumulation of vials on conveyor belts, SIRIUS signifi- cantly reduces particle generation. SIRIUS is also adaptable to already known applications, such as automatic stopper placement with temperature sensors, and is a system that combines all previously known vial handling possibilities with the latest technology, increasing process reliability and reducing manual operations. Integration in RABS and isolator possible Minimal space requirement with high loading and unloading performance Precise grasping of objects by a format-specific gripper system Safe vial transport without conveyor belts 17

HOF – Freeze-Thaw Units HOF FTU Pharma Exact processes and own software Customer-specific development and manufacturing Adjustable freezing with full control and own software Adjustable freezing speed and full control over the free- zing process are among the top specifications for freezing systems from HOF. The total fill quantity is frozen evenly and independently of the bag size. Each product bag has the same freezing conditions at all times and the same shape at the end. This means that barcodes can be read by machine on the flat surface, for example of a plasma bag. Reliable documentation of tem- perature and time is a matter of course. HOF freezers are energy efficient using indirect cooling and do not consume any energy when the machine is stopped. Large doors ensure a fast loading and unloading. The inner area of the unit is made of stainless steel and is easy to clean. Safe control of all parameters Reliable process control is indispensable when freezing and thawing pharmaceutical and biotechnological products. The same applies to the adjustable freezing and thawing speed. Here, with the individual Freeze-Thaw Units (FTUs), HOF meets all the requirements of professional users from the industry. The FTUs are each developed and manufactured accordingto customer-specific requirements. Products that have to be fed into bag systems can be transported into the plant either manually or by means of a semi-automatic loading aid developed by HOF. Custom requirements – individual plant sizes Two types are offered in order to respond flexibly to on-site installation possibilities. The compact design accommodates all process-relevant and electrotechnical components inside the device. On the other hand, there is the possibility of split-construction to lower the sound pressure level directly on the device. Here, the refrigeration components outside the unit are mounted on a separate machine frame. Reliable cooling, reliable heating Product tempering takes place within the FTU via a plate system. The control panels are designed to freeze the entire load evenly and regardless of bag size. 20

For temperature control, silicone oil is cooled by a separate cooling system or heated by the built-in electric heater. The design of the integrated refrigeration system is speci- fied according to customer requirements. It is possible to choose a compressor system with a partially halogenated hydrofluorocarbon of type R452A, a compressor system with natural refrigerants (ethane/propene), a system with liquid nitrogen or our innovative cold air machine HOF Cryo-Blizzard (refrigerant air). Service is a matter of course HOF’s FTUs always comply with state-of-the-art technology and meet high safety standards. Apart from production, HOF stands for comprehensive project support. At the same time, the entire project – from plant planning and production at HOF to commissioning – is entirely mana- ged on-site by a project team. HOF is also available during transport and during introduction of training courses and the annual service and maintenance units. Included in the scope of delivery: the “HOF Freeze Viewer Professional” For process control, the FTUs are equipped with a visuali- zation system, the “HOF Freeze Viewer Professional”. This system complies with FDA requirements according to 21 CFR, Part 11. With this software, specially developed by HOF, all process-relevant data such as batch reports and tempe- rature profiles can be printed out in the form of a process report or sent to a superordinate system. The respective programs for the individual products can be generated individually by the customer. Advantages at a glance State-of-the-art technology Highest safety standards Energy-saving and with indirect cooling Product contact area is easy to clean Compatible with many commercially available single-use bag systems Front view of HOF Freeze-Thaw Unit Pharma with closed door Front view of HOF Freeze-Thaw Unit Pharma with door open HOF Freeze-Thaw Unit Pharma with exemplary loading HOF Freeze-Thaw Unit Pharma with exemplary loading 21

HOF – Freeze-Thaw Units HOF FTU Plasma Exact processes and own software Customer-specific development and manufacturing Adjustable freezing with full control and own software Freezing processes are at the top of the performance description for HOF freezing and defrosting units. The entire filling quantity is frozen evenly and independently of the bag size. Each product bag has the same freezing conditions at any time and the same shape in the end. This means that barcodes can be read by machine on the flat surface, for example on a plasma bag. For a reliable documentation of temperature and time. systems for up to 120 of these bags. For individual adaptation Plants are divided into two different designs The compact design accommodates all process-relevant components within the device. On the other hand, there is the possibility of split-construction to lower the sound pressure level directly on the device. Here, the refrigeration components outside the unit are mounted on a separate machine frame. Absolutely reliable freezing and thawing HOF’s Freeze-Thaw Units guarantee quality-compliant sto- rage of blood plasma because the product bags are frozen within 45 minutes to at least -30 °C at the bag’s core. At the same time, up to 120 bags with a capacity of 400 ml can be processed. The frozen blood plasma can also be safely thawed again. Custom requirements – individual plant sizes Because our customers have different product capacities, two model types are available: On the one hand, systems for processing up to 60 of the 400 ml bags are manufactured and, on the other hand, 22 HOF Freeze-Thaw Unit Plasma in compact design

Advantage: uniform heights of the bag systems More than hardware and software The integrated pneumatic adjusting plate system com- presses the product bags for the freezing process, so that all processed product bags have the same height after freezing. The product bags also have flat surfaces on both sides: Barcodes can be machine-read and storage is greatly simplified. Transparent documentation The “HOF Freeze Viewer Professional” software, specially developed by HOF, is available for the documentation of process-relevant data. The device design for blood transfusion services is based on HOF’s state-of-the-art technology. Apart from production, we also offer, as part of the scope of supply, special packa- ging, transport and handling support, as well as annual service and maintenance units. Advantages at a glance Energy-saving and with indirect cooling Quality compliant storage of blood plasma Product contact area easy to clean Split design of a HOF Freeze-Thaw Unit Plasma Plasma bag inside the HOF Freeze-Thaw Unit Plasma after a freezing process Compact design of HOF Freeze-Thaw Unit Plasma Installation example of several HOF Freeze-Thaw Units Plasma 23

HOF – Special solutions HOF waterbath & debottling system Automated thawing with state-of-the-art robot technology The innovative HOF waterbath & debottling system was developed for automated, targeted defrosting of frozen plasma bottles, allowing the remaining frozen core and the surrounding liquid to be removed easily after cutting open the bottle. With this system, HOF is providing again a highly innovative equipment in terms of technology. At the same time, this solution proves to be very compact, reliable and safe. An intuitive, safe and ergonomic operation of the machine The operation of the HOF waterbath & debottling system is very intuitive due to the modern control technology. The ease of use is complemented by a high level of safety and by the ergonomic design of the machine operation. Another advantage of this HOF system is the possibility to fill the machine’s magazine with up to 16 plasma bottles simul- taneously. The transport of the bottles is fully automated. Suitable for pharmaceutical use and with perfect control The HOF waterbath & debottling system are designed to meet pharmaceutical requirements. A valid defrosting process of the human plasma and the pos- sibility to design the system for different temperature ranges of the plasma are applied. This includes, for example, the product temperature on delivery, the maximal resting time in the thawing bath and the precise water temperature con- trol. The perfect control of the system with the robot-assi- sted motion sequences also ensures maximum product yield. Automatic cleaning processes Using HOF waterbath & debottling system means a fully automatic cleaning of the water bath and a partially auto- matic cleaning of the debottling system. Other parts of the debottling system are specially designed for cleaning in a part washing machine. They can be removed without tools and be reassembled easily and repeatedly. 24 The HOF waterbath & debottling system is a technologically highly innovative solution. Compact, reliable, safe and with the latest robot technology. Advantages at a glance Compact design Fully automated transport State-of-the-art robot technology Highest safety standards Ergonomic design of machine operation Modern control technology and intuitive operator guidance Fully automated cleaning of the water bath Partially automated cleaning of the debottling system

Water bath Debottling system Typical clean room environment CNC Simple and centralised task to product – available from a manual task, a semi-automatic storage up to a fully automatic solution Connection and integration to higher-level process control systems or stand-alone operation Different bottle dimensions can be processed – various format sets and flexible system parameters are used for this purpose External cleaning and drying of the bottles prior to the transport to the cutting area Output range: max. 1,200 bottles / h Fully automated cleaning (CIP) with water and additives (brine) Additional cleaning/drying modules can be implemented for internal cleaning and drying of the thawed bottles prior to the cutting process. Suitable designs for the pharmaceutical industry. robot in SteriClean design Typical cleanroom environment C (according to EC GMP guidelines, Annex 1) Pharmaceutical suitable machine safety enclosure with automatic door locking system Cutting process optimally adapted to the product Automatic control of the emptying process Integrated interface for further processing of the cut bottles Modern control technology and intuitive user guidance Connection and integration to higher-level process control systems or stand-alone operation Different bottle dimensions can be processed – various format sets and flexible system parameters are used for this purpose Robots are equipped with multi-gripper tools Output range: max. 1,200 bottles / h Part-automated cleaning (CIP) with water and additives (brine) in place (WIP) for non-demountable parts Optimised system design for rotating parts – cleaning in washing machine Fully automated transport Fully automated debottling sytem – “gripping station” Human plasma thawing process State-of-the-art robot technology – compact, reliable and safe 25

Services Our services at your disposal Service As individual as our solutions Qualification We qualify your systems in a GxP-regulated environment. Our own qualification department creates the individual qualification and validation requirements for our systems. Only our own employees work on your system at HOF – even long after it has left our factory. HOF employees trans- port, install and commission your system and also qualify it. This minimises interfaces and excludes problems, saving time and costs. Process development 24-hour service The qualified HOF process development offers you im- portant benefits in safety. Thus HOF reliably supports you in all questions related to process control. Design and concept studies HOF is the specialist for individual solutions and ensures the ideal integration of freeze drying plants and systems in industry and research on the basis of customer-specific studies. Maintenance To ensure proper functioning, with little or ideally no downtime, HOF offers maintenance activities done by specialists who really know the machine to be serviced. Documented test runs are of course part of it. Training Target-oriented imparted knowledge, adapted to your com- pany and machine requirements. This is saving machine downtime and enables you to act quickly and indepen- dently. LYOPOOL Premium existing plants HOF’s existing plants are a recognised and safe investment due to their short-term availability and high quality. You can always reach one of our employees in emergencies at +49 6462 9169-0. 24 hours a day, 365 days a year. Why? Simply because we know that our systems are an im- portant part of the production process and that production reliability has to be ensured. Our emergency team from service and production know the system down to the last detail and can help immediately to keep downtimes as short as possible. The on-site warehouse with over 60,000 items ensures that the essential spare parts for all systems are always available without delay. Advantages at a glance 24-hour service Own spare parts warehouse with over 60,000 items Own qualification department Extensive process development Individual design and concept studies Maintenance know-how Technical training – successfully imparting knowledge Service on existing equipment For more information about HOF services please visit our Website: www.hof-sonderanlagen.de/en/hof-products/service 26

HOF at a glance 1988 Foundation 13,500 sqm production, warehouse and office area over 300 employees HOF products at a glance: Freeze drying systems Vial and bulk systems Laboratory systems Loading and unloading systems Automatic loading and unloading systems HOF VTS: Vial transfer system HOF SIRIUS robot-assisted loading and unloading system Sealing machine Freezing and thawing equipment Pharmaceutical industry biotechnology Blood donation services Special solutions HOF waterbath & debottling system HOF services: Qualification Process development Design and concept studies Maintenance services Training courses LYOPOOL Premium existing plants Service & spare parts: 24-hour availability over 60,000 spare parts in stock emergency service 27