Planning, construction and qualification of cleanrooms, ventilation and air-conditioning technology as well as stainless steel cleanroom equipment
Alpha Ionstatex GmbH
Offenbach an der Queich (Interpark 7, 76877)New on Amplifa
About Alpha Ionstatex
Alpha Ionstatex GmbH is a cleanroom and ventilation technology company founded in 2001 and headquartered in Offenbach an der Queich (Rhineland-Palatinate). Its range of services covers the entire value chain: consulting and planning in accordance with HOAI, project design and realisation of complete cleanrooms to DIN EN ISO 14644 and GMP, room ventilation and air-conditioning technology, heat and cold generation, control cabinet and MSR technology as well as qualification (DQ, IQ, OQ, PQ), acceptance measurements and maintenance. In-house product developments include the Clean Air Module (CAM) with air filtration and ionisation, the ionisation module IAM and modular protective enclosures in cleanroom quality. In addition, the company manufactures cleanroom furniture and equipment made of stainless steel in various grades, with or without perforated surfaces, including cabinets, shelving, transport trolleys and flowboxes. Customers include companies and institutes from the pharmaceutical, biopharmaceutical, medical technology, microelectronics, food and research sectors. According to its own statements, more than 21,400 m² of cleanroom systems have been realised in 312 projects to date.
- Site
- Offenbach an der Queich
- Processes
- Cleanroom project design and realisation (complete systems to ISO 14644, GMP-compliant), Cleanroom installation and assembly (walls, window elements, doors, high-speed doors,, Modular protective enclosures in cleanroom quality, Ventilation technology / air-conditioning technology (central air handling units, supply, outdoor, Heat and cold generation (chillers, free cooling, recooler units, piping systems,, Control cabinet construction and measurement and control technology (central controllers with, Fire alarm and fire protection systems (smoke detectors, connection to fire alarm control panel,, Cleanroom equipment and furniture made of stainless steel (cabinets, dispensers, seating benches,
- Materials
- Stainless steel (various grades, with/without perforated surfaces), Stainless steel (various grades), Clean Air Module (CAM), Ionisation Module (IAM), Room Ventilation and Air-Conditioning Technology
- Certificates
- ISO 9001:2015
- Founded
- 2001
- Industries
- Pharmaceuticals, Biopharmaceuticals, Medical technology, Microelectronics, Food industry, Research institutions
- 01
Consulting, feasibility studies and planning in accordance with HOAI
- 02
Cleanroom project design according to ISO 14644 / GMP
- 03
Manufacture of in-house modules and stainless steel equipment
- 04
Installation and assembly (walls, ceilings, HVAC, heat/cold, MSR)
- 05
Qualification (DQ, IQ, OQ, PQ) and acceptance measurements
- 06
Maintenance, monitoring and training
Materials and Processes
Stainless steel (various grades)
For cleanroom furniture and equipment, with or without perforated surfaces, resistant to aggressive chemicals.
Clean Air Module (CAM)
In-house developed multifunctional module for air filtration with additional ionisation.
Ionisation Module (IAM)
Ionisers reduce damage to electrical components and extend their service life.
Room Ventilation and Air-Conditioning Technology
Central air handling units, HEPA/ULPA filters, filter-fan units and plenum solutions for defined cleanroom classes.
Sites
Offenbach an der Queich
DEHeadquarters with planning, manufacturing and assembly
- Materials
- Stainless steel
- CAM – Clean Air Module (in-house development)
- IAM – Ionisation Module (in-house development)
- Filter-fan units / ceiling air distribution (plenum)
- Control cabinet construction
- Workshop for stainless steel cleanroom furniture
Products and Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Cleanroom project design and realisation (complete systems to ISO 14644, GMP-compliant)Engineering | – | – | – | – | Stainless steel |
| Cleanroom installation and assembly (walls, window elements, doors, high-speed doors,Assembly | – | – | – | – | – |
| Modular protective enclosures in cleanroom qualityAssembly | – | – | – | – | – |
| Ventilation technology / air-conditioning technology (central air handling units, supply, outdoorSurface | – | – | – | – | – |
| Heat and cold generation (chillers, free cooling, recooler units, piping systems,Surface | – | – | – | – | – |
| Control cabinet construction and measurement and control technology (central controllers withAssembly | – | – | – | – | – |
| Fire alarm and fire protection systems (smoke detectors, connection to fire alarm control panel,Assembly | – | – | – | – | – |
| Cleanroom equipment and furniture made of stainless steel (cabinets, dispensers, seating benches,Assembly | – | – | – | – | Stainless steel |
| Qualification and acceptance measurements (DQ, IQ, OQ, PQ support, acceptance measurements,Testing | – | – | – | – | – |
| Feasibility studies with risk analysis (FMEA), energy concepts, personnel training, planningEngineering | – | – | – | – | – |
| Maintenance, commissioning, monitoring and control via software (control and monitoring)Testing | – | – | – | – | – |
5 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Cleanroom module (air filtration with ionisation) | Alpha Ionstatex (in-house development) CAM – Clean Air Module | – | – | – | Offenbach, Germany |
| Ionisation module | Alpha Ionstatex (in-house development) IAM | – | – | – | Offenbach, Germany |
| Filter-fan units / ceiling air distribution (plenum) | – | – | – | – | – |
| Air-conditioning units for halls and offices | – | – | – | – | – |
| Cleanroom furniture/manufactured products (cabinets, shelving, transport trolleys, flowboxes etc.) | Alpha Ionstatex | – | – | – | Offenbach, Germany |
Additional services
Quality and Certification
Projects are qualified in accordance with DIN EN ISO 14644, the EU GMP guideline and FDA requirements; the company supports DQ, IQ, OQ and PQ and performs acceptance measurements as well as RE qualifications. The management system is certified to ISO 9001:2015.
| Evidence | Offenbach an der Queich |
|---|---|
| ISO 9001:2015 |
History
- 2001
Foundation of Alpha Ionstatex GmbH; over 20 years of experience in the cleanroom and ventilation technology sector
- 2023
Initial certification to ISO 9001:2015 by PIAQ Deutschland GmbH on 27.11.2023 (certificate DE23_ALP0110)