Process systems, agitator vessels and media distribution systems for sterile GMP production in pharma and biotechnology.
JENTEC GmbH Ingenieurbüro & Maschinenbau
New on Amplifa
Company
JENTEC GmbH is an engineering office and mechanical engineering company focused on process systems for pharmaceutical production. With over 35 years of experience as a family-run business, it combines engineering expertise with in-house manufacturing and delivers systems for sterile and aseptic processes – from planning through design and manufacturing to installation, commissioning and maintenance. The portfolio includes process systems, agitator vessels with up to 2,500 liters of working volume with optional heating and cooling, media distribution systems for pure media such as WFI, PW, HPW, clean steam, compressed air and nitrogen, validatable CIP/SIP cleaning systems, handling devices as well as automation solutions with control, visualization and GMP-compliant logging. Projects are accompanied by DQ, IQ and OQ, including documentation and FAT/SAT. Customers come from pharmaceuticals, biotechnology, fine chemicals, cosmetics and the food industry. The quality management system is certified to DIN ISO 9001.
- Processes
- DQ Engineering (Design Qualification) / design & planning, Manufacturing (IQ - Installation Qualification), Product tests & prototypes / OQ documentation (Operation Qualification), Installation & commissioning incl. FAT/SAT support, Service & maintenance (ongoing operation), Process systems (planning, design and implementation for GMP production areas), Agitator vessels (stirring, mixing, temperature control, optional heating/cooling), Media distribution systems (pure media WFI, PW, HPW, clean steam, compressed air, nitrogen)
- Materials
- Stainless steel, GMP-compliant design
- Certificates
- ISO 9001
- Industries
- Pharmaceutical industry, Biotechnology, Fine chemicals, Cosmetics, Food industry
- 01
Design & Planning (DQ)
- 02
Manufacturing (IQ)
- 03
Product tests & prototypes (OQ documentation)
- 04
Installation & commissioning incl. FAT/SAT support
- 05
Service & maintenance
Materials & Processes
Stainless steel
Material for agitator vessels and media distribution systems in hygienic-sterile process applications.
GMP-compliant design
Process-safe implementation of systems for GMP production areas.
Systems & Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| DQ Engineering (Design Qualification) / design & planningEngineering | – | – | – | – | – |
| Manufacturing (IQ - Installation Qualification)Assembly | – | – | – | – | – |
| Product tests & prototypes / OQ documentation (Operation Qualification)Testing | – | – | – | – | – |
| Installation & commissioning incl. FAT/SAT supportAssembly | – | – | – | – | – |
| Service & maintenance (ongoing operation)Assembly | – | – | – | – | – |
| Process systems (planning, design and implementation for GMP production areas)Engineering | – | – | – | – | – |
| Agitator vessels (stirring, mixing, temperature control, optional heating/cooling)Casting | – | – | – | Working volume up to 2,500 liters | Edelstahl |
| Media distribution systems (pure media WFI, PW, HPW, clean steam, compressed air, nitrogen)Joining | – | – | – | – | Edelstahl |
| CIP/SIP cleaning systems (validatable cleaning and sterilization systems)Engineering | – | – | – | – | – |
| Handling devices (mobile or stationary versions)Assembly | – | – | – | – | – |
| Automation (control, visualization, interfaces, process data handling,Engineering | – | – | – | – | – |
Additional services
Quality
The quality management system is certified to DIN ISO 9001. Projects are executed with DQ, IQ and OQ documentation as well as FAT/SAT support in accordance with GMP requirements.
| Evidence | Company |
|---|---|
| ISO 9001 |
History
Family-run business with over 35 years of experience in engineering services and mechanical engineering for pharmaceutical production.