Blood plasma fractionation

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.

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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