SMART LYO. High quality, affordable freeze drying: the smart choice. engineering for a better world

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1 SMART LYO High quality, affordable freeze drying: the smart choice engineering for a better world

2 GEA Group is a global specialist in solid and liquid dose technology. Combining trusted technology with an ongoing programme of innovation and price/performance leadership, GEA has a long history of expertise and an unparalleled depth of experience in the fields of batch and continuous granulation, drying, pelletizing and coating, contained materials handling, tablet compression, pharmaceutical freeze drying, fermentation and liquid formulation, separation, homogenization and cell disruption. With manufacturing and technology centres all over the world, GEA provides the services that the pharmaceutical industry needs, including technical know-how, test facilities for product development and process evaluation, project management, market-leading equipment, customer service and support. Working closely with its customers to develop new products, reduce time to market and enhance clinical effectiveness, GEA s scope of supply ranges from R&D-scale and standalone production equipment to the installation of completely integrated production lines and continuous processing technology. GEA is your single-source supplier of robust, flexible and cost-effective pharmaceutical manufacturing solutions that maximise operational reliability and productivity. 2

3 High quality, affordable freeze dryers GEA a world leader in freeze drying offers SMART LYO, a range of high quality, technologically advanced and competitively priced pharmaceutical freeze dryers. Standardised and Customised Based on proven, standardised modules, SMART LYO pharmaceutical freeze dryers are designed according to the specific size and technology requirements of each customer. As a result, SMART LYO products are not only cost-effective, they also facilitate planning, validation and documentation, and significantly reduce delivery times. There s no need to compromise with SMART LYO : every customer gets the plant they need, customised to suit their existing facility and production requirements, exactly when they need it. Made in China, Designed in Germany German engineering and project management, combined with GEAcontrolled supply chains, make the SMART LYO freeze dryer a top quality product (the Quality Management System has been ISO 9001-certified since 1997). GEA s committed team of engineers and specialists all work to ensure that the freeze dryers are of a consistently high standard. It is this dedication and attention to detail that results in reliable, trouble-free pharmaceutical production and entire lifecycle economy. SMART LYO SL 20 Integration of two SMART LYO SL 200-D Freeze Dryers with ALUS 3

4 Smart features Affordable Standardised modules are more cost-efficient to produce and more reliable than bespoke systems, resulting in lower purchase and maintenance costs for the customer. Using prefabricated units also reduces delivery and validation times, providing a clear commercial advantage by significantly reducing time-to-market. Reliable Building on GEA s reputation as a reliable supplier of equipment designed to minimise product loss for more than 50 years, SMART LYO freeze dryers are no exception. Extensively tested and engineered with proven process technology and the expertise of the GEA team, each plant offers trouble-free operation, smooth production and minimum downtime. And, should a problem occur, the Global Service Network is ever ready to spring into action and dispatch spare parts or a service engineer to your door. SMART LYO SL 150-D Technology SMART LYO freeze dryers can be supplied with filling systems, isolators and inspection services to provide a fully integrated production facility, sourced from a single supplier. Each component meets the highest possible technical requirements and the strict standards of the global licensing authorities, as well as complying with all current good manufacturing practices (cgmps). 4

5 the smart choice SMART LYO freeze dryers are available in shelf sizes of m² with a condenser capacity of up to 800 kg. Features the entire system is constructed on a single- floor plant frame for fast, simple commissioning; the system includes a compact chamber/condenser unit, all system modules (hydraulics, venting system, vacuum) and options such as CIP/SIP the refrigeration unit can be installed remotely from the plant frame, on a different floor if necessary, enabling the installation to be adapted to fit the customer s infrastructure the electrical cabinet can be positioned in the freeze dryer plant or centrally in a control room frame mounting allows SMART LYO freeze dryers to be installed in the existing building architecture (the machinery room and the sterile area); installation and assembly is, therefore, very simple, only requiring the plant to be connected to the unit frame and the switch cabinet the GEA Global Service Network provides rapid worldwide access to original spare parts and a comprehensive repair service that minimises downtime and keeps costs under control. SMART LYO SL 150-D Also available are comprehensive documentation that explains both the operation and maintenance of the freeze dryer a CIP system to clean the chamber and condenser a SIP system to steam sterilise the plant, including all the necessary re-cooling of the freeze drying chamber, including the door (constructed as a jacket for effective and rapid re-cooling of the plant following steam sterilisation) factory acceptance tests to demonstrate installation conformance and key performance specifications a standardised IQ/OQ package that allows rapid validation. SMART LYO SL 200-D with ALUS 5

6 Smart options: Model SL 10 to SL 80 Features Model SL SL 10-D - 80D No SIP SIP Chamber Rectangular Chamber Pressureless Material 316 L Ports 3d Door Full Size Door Automatic Locking Condenser Rectangular Single Skid Rear CIP o CIP Chamber + Condenser o SIP PED ASME o GB-150 o Chamber Re-cooling after SIP Hydraulic Lift/Lower + Stoppering Shelf Package Bellow Refrigeration Piston Compressors Vacuum Oil Sealed Vacuum Pump Model SL SL 10-D - 80D No SIP SIP Pressure Regulation On/Off Flow Controller o o Process Sensors Pirani MKS o o Venting System + Filter Sterilisable Ports for I-Test Second Venting Media o o Control System and Documentation VIPA (Siemens Compatible) Siemens o o SCADA WinCC Recorder o o GAMP o o Audit Trail 21 CFR Part 11 FAT/SAT IQ/OQ Documents and Tests o o Material Certificates o o Welding Documentation o o Technology LYOPLUS o o ControLyo o o included o option not available 6

7 Smart types and sizes: Model SL 10 to SL 80 Types and sizes Model Units SL 10 SL 20 SL 40 SL 60 SL 80 Shelves Shelf Area m 2 0.6/ / / /3.3 4,2 / 5 No. of Vials (Ø 16 mm) Quantity No. of Vials (Ø 22 mm) Quantity No. of Vials (Ø 30 mm) Quantity No. of Shelves Quantity 4/ / / / /6 + 1 Shelf Size mm 460 x x x x x 914 Clearance mm 120/90 120/90 120/ / /110 Shelf Temperature C Condenser Condenser Capacity kg/24h Condenser Temperature C Unit Dimensions Length (B) mm Width (A) mm Height mm Weights Unit t Technical information Model Units SL 10 SL 20 SL 40 SL 60 SL 80 Utilities Pure Steam barg C CIP Water barg C m Cooling Water C <25 <25 <25 <25 <25 m 3 /h (peak) Electrical Power Supply kw

8 Smart options: Model SL 100 to SL 800 Features Model SL SL 100-D D No SIP SIP Chamber Rectangular Chamber Pressureless Material 316 L Ports 3d Door Full Size Door Automatic Locking Pizza Door (Constant Loading Level) o o Door in Door o o Condenser Rectangular Rear Side o o Bellow CIP o CIP Chamber + Condenser o Recirculation o o Second Cleaning Media o o SIP PED ASME o GB-150 Chamber Recooling after SIP Hydraulic Lift/Lower + Stoppering Shelf Package Without Rails With Rails and Fully Collapsible o o Bellow Interface for ALUS o o Refrigeration Piston Compressors Screw Compressors o o Model SL SL 100-D D No SIP SIP Vacuum Oil Sealed Vacuum Pumps + Blower Redundancy (Second Pump Set) o o Dry Pumps + Blower o o Pressure Regulation On/Off Flow Controller Process Sensors Pirani MKS o o Venting System + Filter Sterilisable Ports for I-Test Second Venting Media Second Venting Filter o Automatic WIT Test o Control System and Documentation VIPA (Siemens Compatible) Siemens o o SCADA WinCC Recorder o o GAMP o o Audit Trail 21 CFR Part 11 FAT/SAT IQ/OQ Documents and Tests o o Material Certificates o o Welding Documentation o o Technology ALUS o o LYOPLUS o o ControLyo o o included o option not available 8

9 Smart types and sizes: Model SL 100 to SL 800 Types and sizes Model Units SL 100 SL 200 SL 300 SL 400 SL 600 SL 800 Shelves Shelf Area m No. of Vials (Ø 16mm) Quantity No. of Vials (Ø 22mm) Quantity No. of Vials (Ø 30mm) Quantity No. of Shelves Quantity Shelf Size mm 914 x x x x x x 1803 Clearance mm Shelf Temperature C Condenser Condenser Capacity kg/24h Condenser Temperature C Unit Dimensions Length (B) mm Width (A mm Depending on Layout Height mm Weights Unit t Technical information Model Units SL 100 SL 200 SL 300 SL 400 SL 600 SL 800 Utilities Pure Steam barg C CIP Water barg C m Cooling Water C <25 <25 <25 <25 <25 <25 m 3 /h (peak) Electrical Power Supply kw

10 Technical Data General Technical Data for All Models System Requirement Data Chamber Surface Finish System Leak Rate (Applicable to the Total Freeze Condenser, Piping etc.) Ra 0.8µm mbar*l*s-1 Shelves Flatness in the Usable Area 1 mm/m Surface Finish on Top Side Ra 0.8µm Surface Finish on Bottom Side Ra 0.8µm / Ra = 1.0 to 1.6µm Shelf Cooling Rate from +20 to -40 C 60 minutes (no load) Shelf Heating Rate >1.5 K per minute (no load) Temperature Range <-55 C to +123 C Regulating Temperature Range During Drying -50 C to +60 C Condenser Nominal Ice Capacity > xyz kg in 24 hours at 0.4 mbar drying pressure Inner Surface Finish of the Condenser Ra 0.8µm Surface Finish of the Condenser Coils cold drawn Final Temperature (Measured at the Pipe Surface) -75 C Cooling Time from +20 to -40 C 40 minutes (no load) Defrosting of Ice minutes at maximum ice capacity Ratio Evaporator Area/Shelf Area 0.8 Vacuum Final Vacuum of the Vacuum Pump Set Final Vacuum of the Freeze Dryer Pump Time from 1000 to 0.1 mbar <0.005 mbar <0.01 mbar (cold condenser) 30 minutes (cold condenser) Sterile Piping and Valves Surface Finish Ra 0.5µm 10

11 Talk to us. We re here to answer your questions. From its earliest applications in the stabilisation of blood plasma in the 1940s, freeze drying has become a standard practice in the life science industries. Since that time, the freeze dryer or lyophiliser has evolved from a simple device for low temperature vacuum drying to an extremely sophisticated and integrated system that combines a number of processes to ensure that a product is consistently delivered to exacting technical and biological specifications, while complying with a number of economic, safety and environmental issues. With 60 years of experience in the engineering and manufacturing of freeze dryers, GEA has delivered more than 1000 installations and conducted thousands of freeze drying tests for the pharmaceutical and biotechnology industries, underlining the company s technological leadership and unparalleled expertise. GEA s thorough understanding of the freeze drying process enables them to supply a comprehensive range of products and services, comprising laboratory equipment, pilot plants for research and small-scale production batches, industrial size production freeze dryers as well as complete freeze dryer systems consisting of one or multiple modules plus ALUS (Automatic Loading and Unloading System), integrated isolators and CIP-skids. Offering a variety of both cost-effective standard and highly customised options, GEA s modular equipment extends from R&D to standalone production plants and high-capacity systems for bulk product applications. Plant configuration capacities extend from specialised solutions for highly potent products to two-storey units and fully integrated systems with multiple freeze dryers and loading systems (with or without the integration of your chosen filling system supplier). The design and manufacture of each module and system component is done in accordance with all cgmp, CE, GAMP and 21 CFR Part 11 guidelines, meeting the strictest requirements and regulatory standards around the world. Products include R&D: the SMART LYO SL range (shelf size m 2 ) is ideal for product development and optimisation, scale-up and small-scale production. Production: SMART LYO SL 100 SL 800 systems are constructed on a single-floor plant frame for fast, simple commissioning and include the compact chamber/condenser unit, all system modules (hydraulics, venting system, vacuum) and available options such as CIP, SIP and ALUS. Production: LYOVAC industrial freeze dryers (shelf size 8 55 m 2 ) for large-scale production plants are also available and can be built to customer specifications. 11

12 We live our values. Excellence Passion Integrity Responsibility GEA-versity GEA Group is a global engineering company with multi-billion euro sales and operations in more than 50 countries. Founded in 1881, the company is one of the largest providers of innovative equipment and process technology. GEA Group is listed in the STOXX Europe 600 index. GEA Pharma Systems GEA Lyophil GmbH Kalscheurener Straße 92, Hu rth, Germany Tel: +49 (0) pharma@gea.com gea.com GEA Group 2015 (Pharma). Specifications subject to change without notice. All trademarks recognised. All copyrights reserved. Under no circumstances should this document or any part of it be copied without written consent.