Develops and manufactures GMP-compliant stainless steel HMI systems, workstations and trolley systems for cleanrooms and sterile production.

Systec & Solutions GmbH

Karlsruhe · Holbæk (DK) · Apex, NC (US) · Rayong (TH)New on Amplifa

Systec & Solutions GmbHLegal form

KarlsruheHeadquarters, development and production

4Sites (DE, DK, US, TH)

IP65 and higherIngress protection of the systems

Cleanroom hardware specialist

Systec & Solutions is a specialized manufacturer of complete hardware solutions for cleanrooms and GMP environments, headquartered in Karlsruhe. The company develops and produces HMI systems (TYDORA, WAVE, PILOT, CONTROL, MODI), mobile workstations and trolley systems, cleanroom tablets as well as Ex solutions for explosive atmospheres – Made in Germany, manufactured locally in the Karlsruhe technology region. The housings are made of stainless steel in a edge-free, enclosed design, predominantly with ingress protection IP65 and higher; glass keyboards can optionally be made shatterproof with laminated polyester films. The solutions are aimed at the pharmaceutical, food (in particular dairy processing) and cosmetics industries as well as the life science sector and meet GMP and HACCP requirements. Products and services are in use in more than 40 countries, including by virtually all leading pharmaceutical manufacturers. In addition to manufacturing, the company offers consulting, installation & qualification, maintenance, support and modernization with GMP-/FDA-compliant documentation as well as software for GMP-compliant labeling and real-time visualization.

Site: Karlsruhe
Processes: Assembly of HMI systems (manufacturing of cleanroom hardware, Made in Germany), Consulting/engineering of HMI solutions for cleanroom and GMP environments, Installation & qualification of HMI systems, Maintenance, support and modernization of HMI systems, Consulting, Installation & qualification, Maintenance, Support (remote and on site)
Materials: Stainless steel (housings of the HMI systems), Polyester film (laminated onto glass keyboards), Glass (glass keyboards), Stainless steel housings, Glass keyboards, Polyester film
Certificates: DIN EN ISO 9001:2015, ISO 9001
Industries: Pharmaceutical industry, Food industry, Cosmetics industry, Life sciences, Food industry (especially dairy processing)

01
Consulting and requirements analysis on site
02
Engineering of the HMI solution
03
Manufacturing and assembly of the hardware in Karlsruhe
04
Installation and documented qualification
05
Maintenance, support and modernization

Materials and construction

Edelstahl

Stainless steel housings

Edge-free, enclosed housing for cleanrooms, resistant to cleaning agents and disinfectants, predominantly IP65 and higher.

Glas

Glass keyboards

Shatterproof glass front, optionally with laminated polyester film to meet HACCP requirements.

PE-Folie

Polyester film

Laminated onto glass keyboards for use in the food industry.

Sites

Karlsruhe

Headquarters, development and production

Materials: Stainless steel, glass, polyester film

HMI systems (TYDORA, WAVE, PILOT, CONTROL, MODI)
Trolley systems (TROLLEY LIGHT, TROLLEY SLIM, TROLLEY COMPACT, TROLLEY MAXI, VENTUS)
Ex-HMI system PILOT EX
Cleanroom tablet (Surface Pro for Business 12th Edition)

Holbæk

Nordic Region branch (Systec & Solutions ApS)

Apex, NC

North Carolina branch (Systec & Solutions Inc.)

Rayong

APAC branch (Systec & Solutions Asia Ltd.)

HMI systems and workstations

**HMI system TYDORA**Stainless steel · pharmaceutical industry

**HMI system WAVE**Stainless steel · life sciences

**HMI system PILOT**Stainless steel · food industry

**HMI system CONTROL (flush-mounted)**Stainless steel · cleanroom

**IoT HMI system MODI**Stainless steel · pharmaceutical industry

**Cleanroom tablet (Surface Pro for Business 12th Edition)**Cleanroom · life sciences

**Ex-HMI solution PILOT EX**Stainless steel · explosive atmosphere

**TROLLEY LIGHT trapezoid**Mobile workstation · cleanroom

**TROLLEY SLIM**Mobile workstation · cleanroom

**TROLLEY COMPACT**Mobile workstation · cleanroom

**TROLLEY MAXI**Mobile workstation · cleanroom

**VENTUS grey-area workstation**Mobile workstation · grey area

Inside the production

LSL – Life Science Label in the cleanroom

Industries

Pharmaceutical industryFood industryCosmetics industryLife sciencesFood industry (especially dairy processing)

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Assembly of HMI systems (manufacturing of cleanroom hardware, Made in Germany)Assembly	–	–	–	–	Stainless steel
Consulting/engineering of HMI solutions for cleanroom and GMP environmentsEngineering	–	–	–	–	–
Installation & qualification of HMI systemsAssembly	–	–	–	–	–
Maintenance, support and modernization of HMI systemsTesting	–	–	–	–	–

4 Anlagen & Maschinen

Machine	Manufacturer / model	Quantity	Working area	Year built	Site
HMI systems (TYDORA, WAVE, PILOT, CONTROL, MODI)	Systec & Solutions	–	–	–	Karlsruhe
Mobile workstations / trolley systems (TROLLEY LIGHT, TROLLEY SLIM, TROLLEY COMPACT, TROLLEY MAXI,	Systec & Solutions	–	–	–	Karlsruhe
Ex-HMI system PILOT EX for explosive atmospheres	Systec & Solutions PILOT EX	–	–	–	Karlsruhe
Cleanroom tablet	Systec & Solutions / Microsoft Surface Pro for Business 12th Edition	–	–	–	Karlsruhe

Additional services

ConsultingInstallation & qualificationMaintenanceSupport (remote and on site)ModernizationAssembly solutionsGMP-/FDA-compliant documentationTesting and calibration3D product configuratorSoftware (VEYA / Stormbit, GMP-compliant labeling and real-time visualization)

Reference customers

Nearly all leading pharmaceutical manufacturers; Top-20 pharmaceutical companies use the products

Quality and certification

Systec & Solutions is certified according to DIN EN ISO 9001:2015. The systems meet GMP requirements, predominantly ingress protection IP65 and higher as well as HACCP requirements; service activities are documented in a fully audit-ready manner.

Evidence	Karlsruhe
ISO 9001