Engineering, automation, plant construction and GMP qualification for pharmaceutical, chemical, food and cosmetics industries.
Lehmann Engineering GmbH
OsthofenNew on Amplifa
About Lehmann Engineering
Lehmann Engineering GmbH is a privately owned engineering office based in Osthofen with more than 25 years of experience in the business areas of electrical engineering, automation, plant construction as well as GMP qualification and validation. The company plans and realizes demanding projects, from concept, basic and detailed planning through project coordination and specification drafting to commissioning and GMP-compliant qualification (DQ, IQ, OQ, PQ, FAT, SAT). In the field of automation, the service spectrum includes control programming (Step7, TIA, Safety), visualization and SCADA (WinCC), recipe systems (PM-Control), batch record systems (PM-Quality) as well as network and IT technology. Upon request, Lehmann Engineering GmbH acts as general contractor and manages projects for the new construction, conversion and expansion of production plants. The company primarily works for the pharmaceutical and cosmetics industry, the chemical industry as well as the food and feed industry, also in Ex and non-Ex areas of tank farms. As a Siemens Solution Partner and partner of P³ PHARMA PROJECT PILOTS GmbH, computer validation according to GAMP 5 and maintenance of the validated state are also offered.
- Site
- Osthofen
- Processes
- Engineering (concept, basic and detailed planning, specification drafting), Automation (PLC programming, visualization/SCADA, commissioning), GMP qualification (DQ, IQ, OQ, PQ, FAT, SAT, risk assessment/FMEA), Plant construction (new construction, conversion, expansion of plants, general contractor), Project coordination, Planning & realization of electrical engineering, Planning & realization of instrumentation and control technology (field instrumentation, field, Network and IT technology (copper-based, fiber-optic-based, highly available)
- Materials
- Engineering, Automation, GMP qualification, Network and IT technology
- Certificates
- GMP / GAMP 5, FMEA according to DIN EN 60812, Documentation according to Machinery Directive 2006/42/EC
- Industries
- Pharmaceuticals, Cosmetics, Chemicals, Food, Feed, Media supply
- 01
Concept and feasibility planning
- 02
Basic and detailed planning / specifications
- 03
Project coordination and supplier management
- 04
Plant construction (new construction, conversion, expansion)
- 05
Automation (PLC, SCADA, commissioning)
- 06
GMP qualification and validation
- 07
Remote maintenance and training
Services and Systems
Engineering
Concept, basic and detailed planning of electrical engineering, instrumentation and control technology and automation technology, including specification drafting and 2D & 3D CAD drawings.
Automation
Control programming (Step7, TIA, Safety) as well as SCADA visualization with WinCC/TIA and recipe and batch record systems.
GMP qualification
DQ, IQ, OQ, PQ, FAT, SAT, risk assessment according to FMEA and computer validation according to GAMP 5.
Network and IT technology
Planning and realization of copper- and fiber-optic-based as well as highly available network infrastructures.
Locations
Osthofen
DEHead office / engineering office
- Test systems for PLC programs and visualizations
- Virtualized IT systems
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Engineering (concept, basic and detailed planning, specification drafting)Engineering | – | – | – | – | – |
| Automation (PLC programming, visualization/SCADA, commissioning)Engineering | – | – | – | – | – |
| GMP qualification (DQ, IQ, OQ, PQ, FAT, SAT, risk assessment/FMEA)Testing | – | – | – | – | – |
| Plant construction (new construction, conversion, expansion of plants, general contractor)Assembly | – | – | – | – | – |
| Project coordinationEngineering | – | – | – | – | – |
| Planning & realization of electrical engineeringEngineering | – | – | – | – | – |
| Planning & realization of instrumentation and control technology (field instrumentation, fieldEngineering | – | – | – | – | – |
| Network and IT technology (copper-based, fiber-optic-based, highly available)Engineering | – | – | – | – | – |
| Computer validation and GAMP 5 categorizationTesting | – | – | – | – | – |
Additional services
Reference customers
Quality and GMP
Qualification is carried out systematically according to the V-model with risk assessments according to FMEA (DIN EN 60812), a four-eyes principle with the customer, a traceability matrix derived from the specifications and computer validation according to GAMP 5. Programs and visualizations are tested prior to commissioning in extensive in-house tests.
| Evidence | Osthofen |
|---|---|
| GMP / GAMP 5 | |
| FMEA according to DIN EN 60812 | |
| Documentation according to Machinery Directive 2006/42/EC |
Experience
More than 25 years of experience in engineering, automation, plant construction and GMP qualification (company statement)
Projects including a filling and packaging line with an investment volume of €60 million, purified water distribution, fiber-optic network and an AI-controlled 7-component inline mixer