B I O P R O C E S S E Q U I P M E N T

Transcription

1 BIOPROCESS EQUIPMENT

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3 Bionet has more than fi fteen years of experience in process design and in the construction of bespoken equipment for the pharmaceutical, food and biotechnology industries. Backed by this experience, Bionet has developed a complete range of laboratory, pilot and industrial equipment for bioprocesses. Our equipment is innovative, with state of the art solutions and technologies, and with a design focused on reliability and easy maintenance.

4 PAGE 10 PAGE 12 PAGE 14 PAGE 16 F1 F2 F3 FS Autoclavable bench scale Bioreactors/ Fermentors Pilot scale SIP Bioreactors/Fermentors Pilot and small industrial production Bioreactors/Fermentors Large volume industrial Bioreactors/Fermentors

5 INDEX PAGE 18 PAGE 22 PAGE 24 PAGE 26 M CIP ROSA + SOFTWARE ACCESORIES Cross-Flow Filtration Systems from lab to industry Cleaning-In-Place Systems ROSA+ Advanced Software for control and automation of Bioprocesses Accesories and spare parts for Bioreactors and Filtration Units

6 THE COMPANY We are an independent company, founded in 1999, dedicated with passion and professionalism to bioprocess engineering. We offer state-of-the-art technology, with a practical approach and tailored to the particular needs of your project and company. We understand the project as a whole, thanks to the experience accumulated in multiple projects and an international team that comes from a variety of activities (R&D, engineering, production, maintenance, quality control ). Therefore we can help not only providing equipment but also developing processes, designing and building complete plants and training your operation and maintenance personnel.

7 THE COMPANY 7 Bionet is a specialist in bioprocesses engineering. We provide equipment (Bioreactors, Cross-Flow Filtration Systems and Cleaning-In-Place Systems) and advanced technical services. Our clients are industries and R&D organizations which work with bioprocesses in the chemical, food and pharmaceutical sectors. QUALITY We have a commissioning and FATs (Factory Acceptance Test) area that allows us to deliver tested and ready-tostart equipment, according to a Plug & Play concept. This reduces risk, shortens periods of commissioning of equipment and is useful to train future users. In Bionet, quality is part of our core culture and we work under a certifi ed quality management system, based on ISO 9001:2008. We work in a full documented engineering environment and provide our equipment with IQ (Installation Qualifi cation), OQ (Operation Qualifi cation) and PQ (Performance Qualifi cation). On demand, the design and qualifi cation may be executed according to cgmp standards.

8 8 BIOPROCESS EQUIPMENT Bionet has developed a complete range of Bioprocess Equipment including series of Bioreactors / Fermentors, Cross-Flow Filtration Systems and Cleaning-in-Place Systems (CIPs). Each of these series includes models throughout the range of use. From small R&D equipment, both in laboratory and pilot plant, to industrial scale equipment. These different units share a design philosophy we believe makes our current technological proposal unique. The designs incorporate the latest mechanical, instrumentation and control technology, being at the forefront of the industry. Bionet units are an up-to-date solution that will offer many years of service.

9 BIOPROCESS EQUIPMENT Since its initial conception (QbD), Bionet units have been designed to ensure availability and simplify maintenance and operation. For this purpose, the units include not proprietary components from leading vendors. This ensures manufacturing excellence, and allows quick and easy access to consumables and spare parts, allowing working with local suppliers. Furthermore, our equipment shares proven engineering solutions common to all models in a serie and also shared between different series. This reduces the need for maintenance and simplifi es your procurement tasks. All bioreactors and fi ltration units are available for both, cell culture and microorganisms (bacteria, yeasts and fungi) and in cgmp version. The 3D design is open and orderly, facilitating access to all system components and the supply of utilities to the equipment interfaces.

10 F1 F1 models are autoclavable bench-scale Bioreactors designed to meet the R&D requirements in biotechnological and biopharmaceutical processes.

11 BIOREACTORS / F1 11 The system is user friendly, flexible, and incorporates the latest technology of the sector with a high-quality service. F1 units are the right tool for initiating and developing your microbial and cell culture processes in stirred reactors. > Available in fi ve models (F1-1, F1-3, F1-5, F1-8 and F1-10) with working volumes from 0,7 to 10 liters. All five are compatible with the same control unit (FCU) and agitator motor. > Product-contact surfaces made entirely of stainless steel A316L, borosilicate and jacketed for optimum temperature control steel. > Noiseless servo top-mounted agitator with broad speed range ( rpm). Available with Rusthon or marine impellers. > 3-4 addition pumps, 1 with variable speed for fed-batch or continuous fermentation. > Controlled parameters: ph, dissolved O 2, temperature and level (foam). Other parameters (OD, exhaust gas...) can be easily added on demand even after the equipment delivery and commissioning. > Gas supply, temperature control, monitoring and additions are all integrated in Bionet FCU through an industrial PLC (Siemens) and a 12 HMI Panel PC, with ROSA+ control software installed. > Ethernet port with LAN and VPN communication. > cgmp version bioreactors and manufacturing under ASME-BPE standards available on demand. It includes CFR version of ROSA+ SW.

12 F2 Bionet F2 models include Steam-In-Place (SIP) Bioreactors made of stainless steel, incorporating the latest technology and practical conception.

13 BIOREACTORS / F2 13 A modular system designed and constructed under the highest quality standards, equipped for a simple operation that will be easily integrated into your facilities. F2 Bioreactors are used for both R&D and industrial production due to its high level of automation, control and flexibility on a robust and reliable design and construction. > Two models (F2-15 and F2-30) with max working volumes of 15 and 30 liters, respectively, and possibility to work with volumes between 6 and 30 liters. > Vessel and product-contact surfaces made of stainless steel A316L. > 15+ ports for instrumentation, addition, and outgassing. > Sterilisable (SIP) harvest valve. > Noiseless, maintenance free, 1,1kW top-mounted agitator, brushless servomotor, speed range of rpm. Available with Rusthon or marine impellers. > Ethernet port with LAN and VPN communication. > Controlled parameters: ph, dissolved O 2, temperature and level (foam). Other parameters (OD, exhaust gas...) can be easily added on demand, even after the equipment delivery and commissioning. > 3-4 addition pumps, 1 with variable speed for fed-batch or continuous fermentation. > Monitoring and additions integrated in Bionet s FCU through an industrial PLC (Siemens) and a 12 HMI Panel PC, with ROSA+ control software installed. > cgmp version bioreactors and manufacturing under ASME-BPE standards available on demand. It includes CFR version of ROSA+ SW. > Available in self-sterilisation version with integrated steam supply.

14 F3 Bionet F3 models are a unique concept for those seeking for a Steam-In-Place (SIP) Bioreactor/ Fermentor of industrial scale and conception, with the quality of a standardized product but with the flexibility of a local vendor. > Available in five models (F3-50, F3-100, F3-200, F3-300 and F3-500) with working volumes from 50 to 500 liters, and possibility to work with volumes between 30 and 500 liters. > Vessel and product contact surfaces made of stainless steel A316L. > 20+ ports for instrumentation, addition, and outgassing. > Sterilisable (SIP) harvest valve. > Bottom agitation system from 2,2 kw to 5,5 kw, servo or electrical motor with gear reduction motor. Available with Rusthon or marine impellers. > 3-4 addition pumps, 1 with variable speed for fed-batch or continuous fermentation. > Controlled parameters: ph, dissolved O 2, temperature and level (foam). Other parameters (OD, exhaust gas ) may be easily added on demand, even after the equipment is delivered and working. > Ethernet port with LAN and VPN communication. > Monitoring and additions integrated in Bionet S FCU through an industrial PLC (Siemens) and a 12 HMI Panel PC, with ROSA+ control software installed. cgmp version and other multiple options and accessories available on demand. > cgmp version bioreactors and manufacturing under ASME-BPE standards available on demand. It includes CFR version of ROSA+ SW.

15 BIOREACTORS / F3 15 A system with state-of-the-art technology meant to be the reference in industrial fermentation and cell culture. As all our products it comes with practical conception and the premium Bionet quality service.

16 FS Bioreactors entirely built at the workshop, with a self-supporting frame and assembled and fully tested prior to shipment to the customer. After the FATs (Factory Acceptance Test), the bioreactors are stripped out to be assembled in its fi nal location. It is a unique plug and play concept for large bioreactors. A safe and quick alternative to reduce risks in projects which, until now, were performed as unique with the limitations and risks that entails. > Available in three models (FS-1000, FS-2000, and FS-3000) with working volumes from 1000 to 3000 liters, and possibility to work with volumes between 150 and 3000 liters. > Larger volume bioreactors available on demand. > Vessel and product-contact surfaces made of stainless steel A316L. > 25+ ports for instrumentation, addition and outgassing. > Sterilisable (SIP) harvest valve. > Bottom agitation system from 5,4 kw to 7 kw, servo or electrical motor with gear reducer. Available with Rushton or marine impellers and higher power input.

17 BIOREACTORS / FS 17 The FS Bionet models are thought to fill a market gap so far unresolved: medium and large volume Fermentors which being competitive with local suppliers, provide the great advantages of carefully engineered equipment and mass-manufactured. > Controlled parameters: ph, dissolved O 2, temperature and tevel (foam). Other parameters (OD, exhaust gas ) may be easily added on demand, even after the equipment is delivered and working. > Ethernet port with LAN and VPN communication. > All monitoring and additions integrated in Bionet S FCU through an industrial PLC (Siemens) and a 12 HMI Panel PC, with ROSA+ control software installed. Available in cgmp version and other multiple options and accessories. > cgmp bioreactors and manufacturing under ASME-BPE standards available on demand. It includes CFR version of ROSA+ SW.

18 18 CROSS-FLOW FILTRATION Cross-Flow Filtration is a widespread technology in industrial separation, clarification and concentration processes. At Bionet we strive to understand your technology, production and regulation needs, to design and build the optimal solution for your cross-flow filtration processes. We offer a fl exible relationship, adapted to your needs, including process development, process engineering, production, equipment, turnkey projects and training. Our goal is to partner with you to provide you with a production capacity according to your needs and status of your project. Production and process development

19 CROSS-FLOW FILTRATION The design of cross-fl ow fi ltration processes, and equipment that run them, is a complex process that requires knowledge and experience, in addition to the necessary technological capabilities. Bionet has a department dedicated to process development, composed of highly qualifi ed staff that has extensive experience working in many projects of high complexity. Reach the optimal solution requires a methodical process that may include different tests, such as: > Screening of the most suitable membrane technology (ceramic vs organic, fl at, tubular or HF membranes...) and cut-offs for your fi ltration process. > To optimize working conditions. > Physical/chemical conditioning of the products to be fi ltered to enable the process and optimize yields. > Study of multi-stage processes. > Development and validation of cleaning processes. Our laboratory and pilot plant is equipped with several fi ltration units to perform tests with different membrane technologies and from multiple vendors. We can work from small batches (2-3 liters) up to hundreds of liters. All this work reduces project risks ensuring that the equipment you are buying responds to a process execution tested and validated. We can produce commercial or validation batches in our pilot plant so you can advance your technical and commercial development.

20 Bionet has developed de M and R series, a complete range of pilot and industrial scale Cross-Flow Filtration systems. Our models cover all fi ltration levels (microfi ltration, ultrafi ltration, nanofi ltration and reverse osmosis). In addition, most market leaders available technologies (fl at ceramic tubular, hollow fi ber, spiral...) can be integrated.

21 CROSS-FLOW FILTRATION / SERIES M-R 21 > Bionet owns Backpulse systems, for cleaning enhancement and/or for delaying fouling episodes. > Alternative pump technologies depending on the medium rheology. > All units are available in several sizes and from pilot units, with working volumes between 30 and 100 liters (M50, R50), to units for small and medium industrial production (M500 and R500) and customized industrial units to fi lter thousands of liters per hour (MR and RS). > All models may be fully automated with process and control instrumentation through ROSA+ SW. Software implemented in 12 Touch Panel PCs. > ATEX compliant version for organic solvent fi ltrationextraction processes available. > Based on standard capacity most units can incorporate further membranes units to increase fi ltration surface. > All models may incorporate temperature control through temperature exchange jackets or heat exchangers integrated in the filtration circuit. > cgmp versions of all models and manufacturing under ASME-BPE standards available on demand. It includes CFR version of ROSA+ SW. BIONET offers, as a service, cross-fl ow fi ltration process development. Our laboratory and pilot plant house the right-scale equipment to select and optimize processes with all technologies we install. This reduces project risks ensuring that the unit we deliver responds to a process performance already tested and validated.

22 22 CLEANING IN PLACE Bionet CIP (Cleaning-In-Place) systems are engineered to guarantee an effective and efficient cleaning of your lines, vessels, reactors and process units. They are designed based on proven engineering solutions (process, equipment and control SW) and we adapt them to specific project and client needs.

23 CLEANING IN PLACE Our CIP units are designed to work integrated with both Bionet equipment or other manufacturer equipment and processes. With this equipment you will have the security and confi dence of a complete and traceable cleaning for all your systems. In addition, you will be able to easily confi gure different operation recipes to adress process changes or new requirements. > Models to clean process vessels from 30 to 50,000 litres of volume, plus piping and ancillary equipment. > Portable or stationary design. > One-tank (Wash & Rinse) or multi-tank version for shorter process cycle. Single tank versions imply reduced capital costs, limited footprint and are easy to transport. Multi-tank versions save water and chemicals, reducing operating costs, environmental impact and cleaning cycle time. > All systems performance can be qualifi ed through a Ribofl avin Test. > Bionet specialized staff, in addition to supplying equipment, can provide support to design and optimize your cleaning recipes. > All models may be fully automated with process and control instrumentation through ROSA+ SW. Software implemented in 12 Touch Panel PCs. > cgmp versions of all CIP models and manufacturing under ASME-BPE standards available on demand. It includes CFR version of ROSA+ SW.

24 24 ROSA + SOFTWARE ROSA+ is the advanced SW solution created by Bionet to automate Bioprocess equipment and complete Bioprocess lines. The core module is designed for fermentation and cell culture process control, and it is installed in all Bionet F Series. It is a powerful tool that incorporates all the necessary functions for integrated process control, process qualification and validation, and data analysis and data management. ROSA+ is installed as standard in each Bionet FCU (Fermentor Control Unit). The FCU is the unit where all the operations (utility supply, process and automation control) are centralized and has been designed to be compatible with each particular model of the F series. ROSA+ also offers fi ltration and CIP automation modules, guaranteeing an optimal integration of all processes under single software. All software modules are available in 21CFR Part11 compliant version. ROSA + may be installed in multi-language version. The application allows users to work on different languages for every work session.

25 ROSA + SOFTWARE ROSA+ main features include: > 7 screen modes: > Process synoptics. > System alarms. > Process tendency curves. > Loading and programming of recipes. > Instruments and pumps calibration. > Controls and control programming. > Batch reports. > 3 types of data logging: > Alarms and messages of the system. > Process data. > Audit trail, regarding the change of status of process variables. > 2 user levels (operator and administrator). > VPN connection via ethernet port. > MODBUS communication to process hardware (instruments, pumps, etc).

26 ACCESSORIES Bionet is not limited to the supply of complete equipment but also provides accessories, spare parts and consumables for Bioreactors / Fermentors and Filtration Plants. Accessories and spare parts meet the established international standards and are available in different sizes and micron ratings to ensure proper adjustment to the scale and equipment considered. Fermentation Accessories integrated in bioreactors/ fermentors, such as: > Sterile sampling and addition devices. > Foam level probes. Sliding probe for the establishment of different level maximums. > Manual aseptic addition accessories (septums, septum needles ). > Automatic aseptic dosing accessories (double-dosing nozzles, dosing bottles, ) and peristaltic pumps. > Aeration and agitation; impellers, baffles, spargers, massflow controllers. > Contention accessories (0,22 μm fi lters, fi lter housings ). > Safety accessories (burst discs, overpressure relief valves ). > Probes; temperature, ph, do 2 or turbidity. > Steam line accessories: Steam contention valves and steam tramps. > Aseptic fi ttings: nuts and screws, lids, caps and plugs, adaptors, connections

27 ACCESSORIES 27 Cross-flow Filtration Common cross-fl ow fi ltration systems accessories: > Different technology membranes (ceramic, hollow fiber, spiral...) and characteristics (pore size, filtration area...) to encompass all levels of filtration (microfiltration, ultrafiltration, nanofiltration and reverse osmosis). Besides all the parts required for installation. > Harvest and concentration tanks of different volumes. > Recirculation pumps (peristaltic, centrifugal, lobe ) CIP CIP units accessories and related peripherals, such as; chemical dosing pumps, chemical storage tanks... General Accessories Common accessories to different Bionet units, such as: > Different type of aseptic valves (ball valves, diaphragm valves, butterfl y valves, needle valves...) manual or pneumatic. Different ends (clamp, threaded, welded ). > Water recirculation valves for jacketed tanks. > Indicators (tank level, load cells, temperature, pressure gauges, fl owmeters ). > Different type (clamp, fl ange, threaded ) and different shape (grooves, elbows, crosses, reducers, hose nipples, tube adaptors, end caps, fi ttings ). > Consumables made of different materials such as; hoses, aseptic tubes, o-rings, gaskets, seals...

28 Bionet Engineering Parque Tecnológico Fuente Álamo Fuente Álamo (Murcia) Spain Tel.: / Fax: sales@bionet.com