Biopharma
Certificates

Brinox d.o.o. maintains an integrated leadership system certified by TÜV SÜD, which includes the requirements of international standards ISO 9001, ISO 14001, OHSAS 18001.

The integrated leadership system includes the requirements of guidelines of good practice (cGxP, ISPE).

Brinox products are designed and produced according to the requirements for factory production control following these standards:

  • EN ISO 3834-2
  • ASME BPE 2000
  • 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

Welding procedures are certified according to the standard ISO 15614-1.

The quality and functionality of our products are also confirmed by acknowledged certification bodies:

  • Praevena AG
  • EHEDG
  • ATEX
Quality control

Our goal are high-quality products and satisfied clients; therefore, quality control is an important part of our production process, especially as our products are highly specific.

Quality assurance in the production process is implemented in several stages, including:

  • input control,
  • intermediate controls in the production process, and
  • a final product control.
Professional qualification

In our production we involve contractors with the best qualifications with welding certificates according to ISO 9606, for welding operators according to ISO 14732 and for providers of non-destructive testing according to ISO 9712.

The designers and constructors of process systems and equipment use 3D modelling applications and are experts for the sizing of process equipment using classical methods and FEM analysis. They are qualified for the preparation of technical documentation for the production of general equipment and pressure equipment according to various directives and the regulations PED 2014/68/EU, ASME VIII-1, AS 1210.

The process automation team consists of engineers with several years of experience in process management who are expert in various software tools and process management IT technologies. They also have expertise in the area of relevant regulations, recommendations and standards (GAMP 5, 21CFR11, ISA S88.01).

References
GlaxoSmithKline
Lonza
CSL Behring
Sandoz
Novartis
Legal notice

All downloaded materials remain property of Brinox d.o.o. and can be used solely for non-commercial uses. Brinox d.o.o. endeavors to always provide accurate information but is not responsible for the content within the downloads which is provided for informational and promotional purposes only.