Planning, construction and maintenance of validated cleanroom monitoring systems for pharmaceuticals, medical technology and research.
vali.sys ag
Bubikon (CH) · Cairo (EG)New on Amplifa
About us
vali.sys ag is a Swiss company based in Bubikon (ZH) that has specialized since 2003 in certified and validated monitoring systems for cleanrooms in GMP and ISO environments. The offering covers the planning and construction of turnkey monitoring systems, real-time monitoring of temperature, humidity, pressure, air velocity and particle concentration with alarms around the clock, as well as the calibration of environmental sensors on site or in its own calibration laboratory with SCS- or DKD-traceable reference devices. Further services include system qualification according to GMP (FAT, IQ, OQ, PQ), maintenance, mapping of temperature and humidity distributions as well as SCADA applications. As the official distributor of Lighthouse Worldwide Solutions in Switzerland, vali.sys also sells particle counters for continuous cleanroom monitoring, mobile measurements and liquid analyses. The systems and processes meet FDA and EU GMP requirements as well as ISO 14644. With more than 300 installed systems, over 5000 installed sensors and customers in more than 25 countries, the company serves Pharma & Biotech, Medical Technology & Hospitals, Research & Chemistry as well as Food & Cosmetics. In addition to around 30 employees at its headquarters, vali.sys employs a subsidiary in Cairo (vali.sys – swiss engineering services) with around 40 employees.
- Site
- Bubikon
- Processes
- Sensor calibration (environmental sensors, on site or in calibration laboratory, SCS/DKD-traceable), Planning & construction of turnkey monitoring systems, System qualification (FAT, IQ, OQ, PQ according to GMP), Maintenance of monitoring systems, Mapping (temperature and humidity distribution in rooms, climate chambers, transport containers), Cleanroom monitoring, Sensor calibration (SCS/DKD-traceable), System qualification (IQ/OQ/PQ, FAT)
- Materials
- SCADA applications / monitoring systems, Particle counters (Lighthouse), Environmental sensors (temperature, humidity, pressure, air velocity, particles)
- Certificates
- ISO 9001:2015, Swiss Label, SCS/DKD-traceable calibration
- Founded
- 2003
- Employees
- 70
- Industries
- Pharma & Biotech, Medical Technology & Hospitals, Research & Chemistry, Food & Cosmetics
- 01
Consulting and project engineering
- 02
Planning & construction of the monitoring system
- 03
Installation and commissioning
- 04
System qualification (FAT, IQ, OQ, PQ)
- 05
24/7 real-time monitoring and SCADA
- 06
Calibration, maintenance and mapping
Services & Technology
SCADA applications / monitoring systems
Proprietary software for real-time data monitoring with alarms when limit values are exceeded.
Particle counters (Lighthouse)
Sales and integration of particle counters for cleanrooms, mobile measurements and liquid analyses.
Environmental sensors (temperature, humidity, pressure, air velocity, particles)
Sensors from partners such as Vaisala, Wago, E+E Elektronik, MSR, Tinytag and Novasina for continuous environmental monitoring.
Locations
Bubikon
CHHeadquarters, engineering, calibration laboratory, sales
- Materials
- Environmental sensors, particle counters
- Calibration laboratory (ISO 9001)
- Particle counters Solair 1100LD, ApexZ3/Z50, ApexP3/P5, HH2016, ApexR5/P5, Remote 1104LD, ScanAir Pro
- Airborne microbe sampler ActiveCount 100H
Cairo
EGSubsidiary vali.sys – swiss engineering services
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Testing | – | – | – | – | – |
| Sensor calibration (environmental sensors, on site or in calibration laboratory, SCS/DKD-traceable)Testing | – | – | – | – | – |
| Planning & construction of turnkey monitoring systemsEngineering | – | – | – | – | – |
| System qualification (FAT, IQ, OQ, PQ according to GMP)Testing | – | – | – | – | – |
| Maintenance of monitoring systemsTesting | – | – | – | – | – |
| Mapping (temperature and humidity distribution in rooms, climate chambers, transport containers)Testing | – | – | – | – | – |
10 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Particle counter | Lighthouse Worldwide Solutions Solair 1100LD | – | – | – | Bubikon, Switzerland |
| Particle counter | Lighthouse Worldwide Solutions ApexZ3 & Z50 | – | – | – | Bubikon, Switzerland |
| Particle counter | Lighthouse Worldwide Solutions ApexP3 & P5 | – | – | – | Bubikon, Switzerland |
| Particle counter | Lighthouse Worldwide Solutions Handheld HH2016 | – | – | – | Bubikon, Switzerland |
| Particle counter | Lighthouse Worldwide Solutions ApexR5 & P5 | – | – | – | Bubikon, Switzerland |
| Particle counter | Lighthouse Worldwide Solutions Remote 1104LD | – | – | – | Bubikon, Switzerland |
| Particle counter | Lighthouse Worldwide Solutions ScanAir & Pro | – | – | – | Bubikon, Switzerland |
| Bioaerosol sampler / active airborne microbe sampler | Lighthouse Worldwide Solutions ActiveCount 100H | – | – | – | Bubikon, Switzerland |
| SCADA applications / monitoring systems | vali.sys ag | – | – | – | Bubikon, Switzerland |
| Environmental sensors (temperature, humidity, pressure, air velocity, particles) | Vaisala, Wago, E+E Elektronik, MSR, Tinytag, Novasina | – | – | – | Bubikon, Switzerland |
Additional services
Quality
vali.sys ag has been certified to ISO 9001:2015 (SGS) since 2010 and is a member of Swiss Label. Calibrations are performed with reference devices calibrated by SCS- or DKD-accredited laboratories; all services are documented in compliance with standards and digitally signed.
| Evidence | Bubikon |
|---|---|
| ISO 9001:2015 | |
| Swiss Label | |
| SCS/DKD-traceable calibration |
History
- 2003
Foundation of vali.sys ag in Bubikon
- 2006
Thomas Christen hired as the first technician
- 2010
ISO 9001 certification by SGS (since 08.09.2010)
- 2015
Member of Swiss Label
- 2019
Thomas Christen takes over the company as owner