www.brinox.eu
Blood plasma fractionation
Biopharmaceutical industry
Technology that delivers
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Photo: Marko Prezelj
Customised equipment for your processes Brinox offers smart solutions for the pharmaceutical and biopharmaceutical industry. With nearly 40 years of experience in process engineering, Brinox provides specially designed equipment to fit process demands in accordance with required standards. Our integrated and experienced team of over 100 engineers collaborates with each customer continually and in depth throughout the project in order to find the best possible solutions. Over 200 employees in production, assembly, documentation and qualification ensure that solutions come to life.
QUALITY, FLEXIBILITY and RELIABILITY are our key advantages. Years of experience and learning have accompanied our continuous growth.
Working under the same roof, we strive to provide the best possible service and support our customers every step of the way.
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Brinox experience in blood plasma fractionation
Ethanol concentration
Brinox manufactures customised systems for blood plasma fractionation. Our equipment enables customers to produce most abundant albumin and other blood proteins (immunoglobulin G, coagulants, and inhibitors), therapeutically important plasma proteins used for a wide range of therapeutic purposes.
Cryo Separation
Centrifugation
Fraction I + II
Filtration
Fraction III
Filtration
Fraction IV
Filtration
Fraction V
Filtration
Paste
Purification
Factor VIII, IX
Waste
Paste
Purification
Ig
Waste
Paste
Purification
Albumin
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We provide equipment for most key steps:
Buffer preparation, storage and distribution ... also from high-grade alloys for highly demanding buffers.
Ethanol storage and distribution … in accordance with ATEX guidelines for explosion protection.
Precipitation … closed systems which fit outside clean rooms in the technical area.
Purification … dosing precision for efficient purification. 8
Diafiltration / Ultrafiltration … custom-made units .
Mobile vessels … a variety designs with various options for numerous operations.
Utilities and Temperature Control units … consistently high quality of PW, WFI, pure steam, AIP, nitrogen.
CIP skid … ensures an optimal and repeatable cleaning effect, integrated CIP/SIP/DIP.
Washing Systems … for washing of parts or pallets in accordance with cGMP. 9
How we do it
Brinox employs an all-in-one approach, by paying close attention to the customer’s needs and requirements at the very start of the collaboration and continuing to do so right until the end. A highly qualified team of experts, masters of modern technologies and production processes, implement the required solutions without fail. Close client cooperation during the basic or conceptual project design leads to: ¬ ¬ ¬ ¬
selecting the appropriate technology, confirming the feasibility, improving the cost assessment (CAPEX), identifying potential risks.
Research & development Project management
Quality management
Sales and after-salesservice
Quality
Process design
Customer
Qualification and commissioning on site
Costs
Lead time
Installation on site
Factory acceptance at Brinox (FAT)
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Mechanical construction & pipelines
Automation and electrical planning
Production & assembly
Engineering
Our ingenuity brings appropriate complex solutions in line with all the client’s requirements. By working smart, we successfully reduce: ¬ ¬ ¬ ¬
any potential process risks, cGMP risks (current Good Manufacturing Practice), HSE risks (Health and Safety Engineering), GEP risks (Good Engineering Practice).
For design, we use Smart P&ID in correlation with ERP system and 3D modeling tools
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Production
Brinox work processes allows the utmost flexibility and adaptability to the ever-changing market requirements and standards. The equipment and machines ensure the highest production quality in line with all international standards: Our team of highly qualified installers and contracting engineers assembles process systems and units professionally on a global level, whether manufactured at Brinox or produced by other independent manufacturers. Brinox’ welders are certified for manual, orbital and robotic welding of all types of stainless steels from the group 8 (8.1 and 8.2) and high-grade alloys.
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Automation
Working closely with our customers, our Automation department provides a complete automation solution in line with the process system’s requirements. We use „open“ PLC+ SCADA approach with recognized and general-purpose tools:
Guidelines and standards: ¬ ISPE GAMP5, 21CFR Part 11, ISA S88.01
¬ Siemens S7 PLCs, GE iFix SCADA, Microsoft SQL server, .NET PDBM - A S88 Recipe & Report engine we developed ourselves:
Open solution enables further integration: ¬ to client environment, ¬ MES system interface, ¬ Pharma 4.0 emerging trends.
¬ Flexible recipes built from a library of automated operations, ¬ simple to use: users can create their own recipes, ¬ version controlled, E-signatures workflow, Preview/Print/Export, ¬ unit procedure downloaded & running completely on PLC, ¬ integrated EBR and Audit-Trail, ¬ SQL database safe data storage, 21CFR11.
Control systems Brinox
PDBM Recipes/Reports: • Recipe management • EB Reports • Audit-trail
Historian
SQL OPC interface Or Database telegrams
SCADA: • Visualization • Alarming • Security (21CFR11) • Historical trending • Recipe control
PLC: • Basic control • Unit supervision • Operations/phases • Recipe execution • Security (21CFR11)
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Client
MES
I/O signals
DI
DO
AI
AO
Remote IO cabinet(s) Profibus units
FQ
Valve blocks
Pumps
Quality manegment
Brinox recognises the importance of a good management system in order to provide high satisfaction to customers and other parties. Brinox employees are committed to adhering to the company policy, which is in line with: ¬ ¬ ¬ ¬
ISO 9001 (quality), ISO 14001 (environment), ISO 45001 (work health and safety), ISO 27001 (information security).
The integrated management system includes the requirements of good practice guidelines (cGxP, ISPE): ¬ EN ISO 3834-2, ¬ ASME BPE, ¬ AWS D 18.1, AWS D 18.2 and SIST EN 12732 A through D, ¬ EN 1090-1.
Brinox has obtained certificates for the production of pressure equipment according to: ¬ ASME Boiler and Pressure Vessel Code AD 2000-Merkblatt HP0 / EN 13445-4 /and EN ISO 3834-2, ¬ PED 2014/68/EU Module A2. The quality and functionality of our products are also confirmed by acknowledged certification bodies: ¬ TÜV SÜD, ¬ Praevena AG, ¬ EHEDG. Brinox FAT service ensure quality and compliance of process systems and equipment. Testing facilities are equiped with all media required to execute testing. We also enable remote FAT.
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BPH202204 - EN Photo: Shutterstock
Brinox d.o.o. Sora 21 SI-1215 Medvode, Slovenija T: +386 1 361 97 30 info@brinox.eu www.brinox.eu
Brinox Deutschland GmbH Maria-und-Georg-Dietrich Str. 2 77652 Offenburg Deutschland T: +49 (0) 781 970 678 10 info@brinox.de
Brinox Innovations AG Poststrasse 14 CH-6300 Zug Switzerland T: +41 41 727 81 50 info@brinox-innovations.ch
ООО «БРИНОКС РУС» Кутузовский пр-т 9/2, офис 98, 121248 Москва Российская Федерация T: +7 499 243 71 55 russia.office@brinox.eu