Engineering service provider for industrial automation, process control systems, functional safety and GxP qualification
1o1 GmbH
Vienna (Leystraße 159, Top 2.36, 1020) · Gänserndorf (Tannengasse 1, 2230)New on Amplifa
About 1o1 GmbH
1o1 GmbH is an engineering office based in Vienna, operating in Austria, specialising in industrial automation and process digitalisation. The company supports industrial enterprises from the feasibility study through basic and detailed engineering to commissioning of production plants. Its service portfolio includes project management, PLC programming (Siemens Step 7/TIA Portal, PCS7, Honeywell Experion), batch systems according to ISA-88, MES, virtualisation and functional safety (ATEX, SIL, SIF). A key focus is on GAMP and GxP services for the pharmaceutical and biotech industry, including CSV, DQ/IQ/OQ/PQ qualification, GMP risk assessment according to ALCOA as well as disaster recovery and business contingency concepts. Reference projects include hydrogen compressor and refuelling station plants for OMV, Shell and Linde Gas across Europe and Japan, biopharma projects for Boehringer Ingelheim and Roche Penzberg, as well as automation tasks at Klöckner Pentaplast, Borg Warner, Mahle/Aumann and Bayer Leverkusen.
- Site
- Vienna
- Processes
- Industrial automation solutions (design and implementation of automated production processes), Functional safety (hazard analysis, risk assessment, SIF calculation and design), Basic & detail planning/engineering, PLC programming, Commissioning, Batch systems (ISA-88), MES (manufacturing execution systems), Virtualisation (virtual machines)
- Materials
- Siemens PCS7 process control system, Siemens Step 7 / TIA Portal, Honeywell Experion R511, Fanuc robots, Siemens G120 drives (Advanced Safety)
- Certificates
- DIN EN ISO 9001 (TÜV certification, functional safety), ISO 9001
- Industries
- Pharma, Biotech, Food industry, Automotive, Energy/Hydrogen, Energy / Hydrogen
- 01
Project management and concept development
- 02
Basic and detailed engineering
- 03
PLC/PCS7/DCS programming (Step 7, TIA Portal, Honeywell Experion)
- 04
Functional safety (hazard analysis, SIF calculation)
- 05
Commissioning (IHT/FAT/SAT)
- 06
Validation and qualification (CSV, DQ/IQ/OQ/PQ according to GAMP 5)
Services and Systems
Siemens PCS7 process control system
Process control system for migration and programming (SFC, CFC, IHT), among others in the EGA02 project at Bayer Leverkusen with 140+ plants.
Siemens Step 7 / TIA Portal
PLC programming including failsafe/safety, used among others for hydrogen plants and servo production lines.
Honeywell Experion R511
DCS for biopharma projects with ISA-88 batch and GAMP 5, among others Boehringer Ingelheim G3 Vienna.
Fanuc robots
Robot control with safe zones in packaging and palletising plants, among others at Klöckner Pentaplast.
Siemens G120 drives (Advanced Safety)
Drive technology with machine safety implementation on Step 7 failsafe and WinCC Safety.
Locations
Vienna
ATHead office / office
Gänserndorf
ATLocation
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Industrial automation solutions (design and implementation of automated production processes)Engineering | – | – | – | – | – |
| Functional safety (hazard analysis, risk assessment, SIF calculation and design)Engineering | – | – | – | – | – |
| Engineering | – | – | – | – | – |
| Basic & detail planning/engineeringEngineering | – | – | – | – | – |
| PLC programmingEngineering | – | – | – | – | – |
| CommissioningEngineering | – | – | – | – | – |
| Batch systems (ISA-88)Engineering | – | – | – | – | – |
| MES (manufacturing execution systems)Engineering | – | – | – | – | – |
| Virtualisation (virtual machines)Engineering | – | – | – | – | – |
| CSV (computer system validation)Testing | – | – | – | – | – |
| DQ / IQ / OQ / PQ qualification (design, installation, operational, performance qualification)Testing | – | – | – | – | – |
| GMP risk assessment / ALCOA guidelinesTesting | – | – | – | – | – |
| Disaster recovery & business contingency conceptsEngineering | – | – | – | – | – |
| PCS7 programming (SFC, CFC, IHT, system migration)Engineering | – | – | – | – | – |
| Siemens Step 7 / TIA Portal programming (including failsafe/safety)Engineering | – | – | – | – | – |
| Honeywell Experion programming (S88 batch, GAMP 5)Engineering | – | – | – | – | – |
| IHT / FAT / SAT planning and executionTesting | – | – | – | – | – |
5 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Fanuc robots | Fanuc | 3 | – | – | Klöckner Pentaplast (project) |
| Servo production line | – | – | – | 2019 | Borg Warner / Mahle (projects) |
| Siemens G120 drives (Advanced Safety) | Siemens G120 | – | – | – | Klöckner Pentaplast (project) |
| PCS7 process control system | Siemens PCS7 | 2 | – | – | Bayer Leverkusen (project) |
| DCS Honeywell Experion | Honeywell Experion R511 | – | – | – | Boehringer Ingelheim (project) |
Additional services
Reference customers
Quality and Certification
1o1 GmbH is TÜV-certified according to DIN EN ISO 9001 and offers functional safety including hazard analysis, risk assessment as well as SIF calculations and designs for industrial process plants. Quality assurance is additionally provided through GAMP-5-compliant validation (CSV, DQ/IQ/OQ/PQ) and GMP risk assessments.
| Evidence | Vienna |
|---|---|
| ISO 9001 |
History
- 2014
Automation engineer for OMV/Shell/Linde Gas: hydrogen compressor and refuelling station plants, 20+ plants in Germany, England, Finland, Sweden and Japan (until 2017).
- 2017
Application design engineer at Boehringer Ingelheim, LSCC Biopharma Utility (until 2018).
- 2018
Automation engineer at CTS Klöckner Pentaplast: packaging line with palletising, Fanuc robots and machine safety (until 2019).
- 2019
Automation engineer at Borg Warner; from 04/2019 lead engineer Boehringer Ingelheim G3 Biopharma Downstream Vienna (until 12/2020).
- 2021
Projects Roche Penzberg (Liqmatic) and Mahle/Aumann; from 09/2021 project management Bayer Leverkusen EGA02 brownfield GMP utility (PA Solutions).