Engineering services for product development, specialist planning and GMP equipment qualification in pharma and medical technology
IBL Gesellschaft für Ingenieurdienstleistungen mbH
HeppenheimNew on Amplifa
Company Profile
Since 1996, IBL GmbH has combined engineering sciences with the specific requirements of medical and pharmaceutical technology. The company based in Heppenheim offers product and technology development in the fields of medical devices, drug delivery systems, process and cleanroom technology. Its service portfolio includes specialist planning for pharmaceutical process and medical technology with project design, URS, requirement specifications and functional specifications, as well as equipment qualification according to current GMP standards including FMEA risk analyses and qualification documentation in all phases (DQ, IQ, OQ, PQ). In addition to design and development with 3D printing prototyping, IBL supports the manufacture of developed assemblies with a partner network from parts production to assembly. Its experience ranges from one-off pieces to large-scale production; development and design are also offered in further technology fields such as optomechanics and consumer products.
- Site
- Heppenheim
- Processes
- Product and technology development (precision engineering, medical devices, test rigs), Specialist planning for pharmaceutical process and medical technology (project design, URS,, Equipment qualification according to GMP standards (DQ, IQ, OQ, PQ, FMEA risk analyses,, Design and development with 3D printing prototyping, Manufacturing support and assembly (supplier support from parts production to assembly), Development and implementation of cleanroom environments for the production of injection-molded, Testing equipment development for the production of medical devices / test facilities, Equipment qualification according to GMP (risk analyses/FMEA, DQ/IQ/OQ/PQ, traceability matrix)
- Materials
- Plastics, 3D printing prototyping, Plastic 2K injection molding
- Certificates
- GMP qualification (DQ/IQ/OQ/PQ)
- Founded
- 1996
- Employees
- 6 (team according
- Industries
- Pharmaceutical industry, Medical technology, Medical devices, Consumer products, Optomechanics
- 01
Product and technology development
- 02
Design with 3D printing prototyping
- 03
Specialist planning (URS, requirement specification, functional specification)
- 04
Manufacturing support and supplier sourcing
- 05
Assembly support
- 06
Commissioning (FAT/SAT)
- 07
GMP equipment qualification (DQ/IQ/OQ/PQ)
Materials and Processes
3D printing prototyping
Cost-effective production of individual parts to accelerate the development process.
Plastic 2K injection molding
Used in the development of a micro-optics module.
Plastics
Material for prototypes and assemblies in medical device development.
Locations
Heppenheim
DEHeadquarters / Office
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Product and technology development (precision engineering, medical devices, test rigs)Engineering | – | – | – | – | – |
| Specialist planning for pharmaceutical process and medical technology (project design, URS,Engineering | – | – | – | – | – |
| Equipment qualification according to GMP standards (DQ, IQ, OQ, PQ, FMEA risk analyses,Testing | – | – | – | – | – |
| Design and development with 3D printing prototypingEngineering | – | – | – | – | Plastics |
| Manufacturing support and assembly (supplier support from parts production to assembly)Assembly | – | – | – | – | – |
| Development and implementation of cleanroom environments for the production of injection-moldedEngineering | – | – | – | – | – |
| Testing equipment development for the production of medical devices / test facilitiesTesting | – | – | – | – | – |
Additional services
Quality and GMP Qualification
For customers from the pharmaceutical industry, planning, qualification and validation are carried out according to current GMP standards, including FMEA risk analyses and test plans in the DQ, IQ, OQ and PQ phases. The traceability matrix is created and maintained.
| Evidence | Heppenheim |
|---|---|
| GMP qualification (DQ/IQ/OQ/PQ) |
History
- 1996
Founding of IBL GmbH – combining engineering sciences with the specific requirements of medical and pharmaceutical technology