Pharma

The integrated leadership 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
• 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 assurance in the production process is implemented in several stages, including:

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

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 IT process management. They also have expertise in the area of relevant regulations, recommendations and standards (GAMP 5, 21CFR11, ISA S88.01).