Quality management

Professional qualifications

Strokovna usposobljenost

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).

Qualifications

kvalifikacije, brinox

Qualifications are carried out in accordance with the good practice guidelines and documented evidence that the manufactured equipment, the facility or the process system is suitable/ready for the intended use and fulfils the user requirements.

The activities of the department refer to the implementation of IQ/OQ tests in the scope of FAT and SAT tests as well as the calibrations and user training after completion of SAT testing.

Quality control

kontrola kakovosti, brinox

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.

Certificates

certifikati, brinox

Brinox d.o.o. maintains an integrated management system certified by TÜV SÜD, which includes the requirements of international standards

  • ISO 9001
  • ISO 14001
  • ISO 45001
  • ISO 27001

The integrated management system includes the requirements of guidelines of good practice (cGxP, ISPE).
Brinox products are designed and produced in line with the requirements for factory production control following these standards:

  • EN ISO 3834-2
  • EN 1090-1
  • EN 12732 (A through D)
  • ASME Section VIII, Division 1
  • ASME BPE 2000
  • EN 1090-1
  • AWS D 18.1 and AWS D 18.2

Brinox has obtained certificates for the production of pressure equipment according to:

  • ASME Certificate Type U
  • AD 2000-Merkblatt HP0 / EN 13445-4 / and EN ISO 3834-2
  • PED 2014/68/EU

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
     
References
Aerie Pharmaceuticals
Zoetis
Merck
Novartis
Leo Pharma
Pharmathen
Mlekarna Celeia
Bionorica
GlaxoSmithKline
Zott
Pharmstandard
Johnson & Johnson
Lactosan
Pfizer
Sandoz
Pomurske mlekarne
Žito
Sarajevksa pivara
Alkermes
Lactalis
Sotex
Mlekarna Planika
Takeda
Capsugel
CSL Behring
Lonza
Lek
Grupacija Imlek
Mlekarna Škofja Loka
Galderma
Heineken pivovarna Laško
Frutarom Etol
Fresenius Kabi
Teva
Meggle
Dottikon
Alvogen
Krka
Alcon
PepsiCo
Nektar Natura
Coca-Cola HBC
Heineken pivovarna Union
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