Service provider for cleaning, assembly, sterile packaging, validation and sterilization of medical devices in Birkenfeld.
Eurofins Inpac Medizintechnik GmbH
Neureutstraße 4, 75217 Birkenfeld · Gewerbestraße 34, 75217 BirkenfeldNew on Amplifa
About Eurofins Inpac Medizintechnik
Eurofins Inpac Medizintechnik GmbH is a specialized full-service partner for the industrial reprocessing, sterilization and packaging of medical devices. At its Birkenfeld site in Baden-Württemberg, the company offers an integrated range of services from a single source: cleaning of medical devices in ISO class 7 and 8 cleanrooms, cleanroom assembly, contract packaging, as well as the development and manufacture of validated sterile barrier systems including blister design and packaging design. Sterilization is carried out in an in-house EO (ethylene oxide) facility or at external accredited service providers for gamma and EO sterilization. In addition, the company performs sterilization and packaging validations (among others according to ISO 11607), transport testing, shelf-life studies, laboratory testing, labeling and technical documentation in accordance with the MDR, ISO 13485 and ISO 11607. Its customers come from medical technology, in particular surgical instruments, endoscopy, and hygiene and sterile goods supply. Already during the development phase, the team supports customers with consulting and development services so that safe, compliant and market-ready medical devices reach the market efficiently.
- Site
- Birkenfeld
- Processes
- Cleaning of medical devices, Assembly (in the cleanroom), Contract packaging / sterile packaging (sterile barrier systems), Packaging design & manufacture (blister design), EO sterilization (ethylene oxide, in-house facility), Gamma sterilization (external, accredited service providers), Sterilization validation, Packaging validation (among others according to ISO 11607)
- Materials
- Ethylene oxide sterilization, Gamma sterilization, 3dpac system
- Certificates
- EN ISO 13485:2016 incl. AC:2018 + A11:2021, FDA registration (USA), MHLW registration (Japan), EN ISO 13485
- Founded
- 2003
- Industries
- Medical technology, Surgical instruments, Endoscopy, Hygiene & sterile goods supply
- 01
Procurement management
- 02
Cleaning of medical devices
- 03
Cleanroom assembly
- 04
Packaging design & manufacture (blister design)
- 05
Contract packaging / sterile packaging
- 06
EO sterilization (in-house) or external gamma/EO sterilization
- 07
Sterilization and packaging validation
- 08
Laboratory testing, transport testing, shelf-life studies
- 09
Labeling & technical documentation
Services & Processes
Ethylene oxide sterilization
In-house EO sterilization facility for the sterilization of medical devices in Birkenfeld.
Gamma sterilization
Process is coordinated via external accredited service providers.
3dpac system
Proprietary system for sterile packaging solutions for medical devices.
Locations
Birkenfeld – Neureutstraße
DESite/Laboratory
- EO sterilization facility
Birkenfeld – Gewerbestraße
DESite
Capabilities
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Cleaning of medical devicesSurface | – | – | – | – | – |
| Assembly (in the cleanroom)Assembly | – | – | – | – | – |
| Contract packaging / sterile packaging (sterile barrier systems)Assembly | – | – | – | – | – |
| Packaging design & manufacture (blister design)Plastics | – | – | – | – | – |
| EO sterilization (ethylene oxide, in-house facility)Heat treatment | – | – | – | – | – |
| Gamma sterilization (external, accredited service providers)Heat treatment | – | – | – | – | – |
| Sterilization validationTesting | – | – | – | – | – |
| Packaging validation (among others according to ISO 11607)Testing | – | – | – | – | – |
| Laboratory testing / routine packaging testsTesting | – | – | – | – | – |
| Transport testingTesting | – | – | – | – | – |
| Shelf-life studiesTesting | – | – | – | – | – |
| 3dpac systemAssembly | – | – | – | – | – |
| Procurement managementEngineering | – | – | – | – | – |
| Labeling and technical documentation (MDR, ISO 13485, ISO 11607)Engineering | – | – | – | – | – |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| EO sterilization facility | – | – | – | – | Birkenfeld |
Additional services
Quality & Certifications
Quality assurance is carried out according to a certified management system in accordance with EN ISO 13485:2016 incl. AC:2018 + A11:2021 (Deutsche Akkreditierungsstelle GmbH). Validations, laboratory testing, transport testing and shelf-life studies ensure product safety and regulatory conformity in accordance with the MDR, ISO 13485 and ISO 11607.
| Evidence | Birkenfeld |
|---|---|
| EN ISO 13485 | |
| FDA registration (USA) | |
| MHLW registration (Japan) |
History
- 2003
Company founded