Services
Industrial standards and guidelines

We follow these industrial standards and guidelines:

  • validation of the GAMP5 computer system,
  • FDA 21CFR11 requirements for e-signatures and e-records,
  • process modelling based on ISA S88.01.
Tools

We use established universal tools:

  • PLC level: Siemens, others upon request,
  • SCADA: GE iFix, Siemens WinCC, others upon request,
  • production informatics level: MS SQL and Reporting server, MS .NET, GE Historian,
  • with the open concept we are able to integrate the solution into the customer’s environment.
The automation system ensures
  • The advanced SCADA visualisation allows to control all elements of a process (valves/motors, sensors).
  • The use of the ISA S88.01 recipe system ensures a high level of automation and at the same time makes the process highly adaptable and allows good use of the process equipment.
  • The modular hierarchic leadership system concept ensures the execution of the process in various procedure levels (stages, operations, unit procedures, procedures) and consequently the process optimisation and a faster introduction of new products.
  • The user independently creates recipes based on the provided templates which protects their know-how and product.
  • The recipe approval work process is based on e-signatures.
  • The unit procedures run entirely on the PLC-level which ensures reliable operation and fast changeovers between individual steps.
  • The recipe and process execution data, historic data and the Audit Trail provide an extensive database for electronic reporting.
  • The FDA 21CFR11 support is based on Windows protection.
  • The implementation of interfaces to other systems at the PLC level (supply of clean media, safety systems, etc.) and at the information level (MES, KPI).
     
References
Žito
Pharmstandard
Sarajevksa pivara
Meggle
Sandoz
Fresenius Kabi
Takeda
Johnson & Johnson
Zoetis
Lactalis
Mlekarna Celeia
Aerie Pharmaceuticals
Nektar Natura
GlaxoSmithKline
Leo Pharma
Pfizer
PepsiCo
Alkermes
Alvogen
Dottikon
Pomurske mlekarne
Zott
Lactosan
Galderma
Frutarom Etol
Lek
Novartis
Teva
Alcon
Merck
CSL Behring
Mlekarna Planika
Mlekarna Škofja Loka
Capsugel
Heineken pivovarna Union
Lonza
Coca-Cola HBC
Krka
Grupacija Imlek
Sotex
Bionorica
Heineken pivovarna Laško
Pharmathen
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.