Cleaning, cleanroom assembly, sterile packaging, validation and sterilization of medical devices from a single source.
Eurofins STERIPAC GmbH
Calw-Altburg (DE)New on Amplifa
About Eurofins Steripac
Eurofins Steripac GmbH is a specialized full-service provider for the industrial processing, packaging and sterilization of medical devices, headquartered in Calw-Altburg, Baden-Württemberg. The company is part of the Eurofins Group (Eurofins Sterile Packaging, Medical Device Services) and already supports customers during the development phase with consulting and development services. Its service portfolio includes the cleaning of medical devices, cleanroom assembly, packaging design and contract packaging of sterile barrier systems including the 3dpac system, as well as labeling and the procurement of plastic packaging materials. Sterilization is performed in an in-house EO sterilization facility or by externally accredited providers for gamma and EO sterilization. In addition, validations and documentation according to ISO 11607, packaging and transport testing, shelf-life studies, laboratory testing and regulatory consulting (MDR, ISO 13485, ISO 11607) are offered. With this one-stop-shop approach, manufacturers are supported in bringing safe, compliant medical devices to market.
- Site
- Calw-Altburg
- Processes
- Cleaning of medical devices, Assembly (in cleanroom), Contract packaging / packaging of medical devices (sterile barrier systems), EO sterilization (in-house facility), Gamma sterilization (external, accredited service providers), External EO sterilization (accredited service providers), 3dpac System (packaging solution), Procurement management
- Materials
- Plastics (packaging materials), 3dpac System, Ethylene Oxide Sterilization (in-house), Gamma Sterilization (external), Packaging Validation
- Certificates
- EN ISO 13485:2016 incl. AC:2018 + A11:2021, ISO 13485 (Accreditation), ISO 9001 (Accreditation), FDA Registration (USA), MHLW Registration (Japan), ISO 13485, ISO 9001, FDA Registration
- Industries
- Medical Technology / Medical Devices
- 01
Packaging Design & Procurement Management
- 02
Cleaning
- 03
Assembly (Cleanroom)
- 04
Contract Packaging / Labeling
- 05
Validation & Laboratory Testing
- 06
Sterilization (in-house EO / external EO & Gamma)
- 07
Documentation & Regulatory Support
Packaging Materials & Processes
3dpac System
Packaging solution for medical devices as a sterile barrier system.
Ethylene Oxide Sterilization (in-house)
Sterilization of medical devices on the company's own EO facility at the Calw-Altburg site.
Gamma Sterilization (external)
Outsourcing of sterilization to accredited external service providers.
Packaging Validation
Validation of sterile barrier systems according to ISO 11607 including documentation.
Locations
Calw-Altburg
DELaboratory: cleaning, assembly, packaging, sterilization
- Materials
- Plastic packaging materials
- EO sterilization facility
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Cleaning of medical devicesAssembly | – | – | – | – | – |
| Assembly (in cleanroom)Assembly | – | – | – | – | – |
| Contract packaging / packaging of medical devices (sterile barrier systems)Assembly | – | – | – | – | – |
| EO sterilization (in-house facility)Heat Treatment | – | – | – | – | – |
| Gamma sterilization (external, accredited service providers)Heat Treatment | – | – | – | – | – |
| External EO sterilization (accredited service providers)Heat Treatment | – | – | – | – | – |
| 3dpac System (packaging solution)Plastics | – | – | – | – | – |
| Procurement managementEngineering | – | – | – | – | – |
| Validations & documentation (packaging validation, sterilization validation, ISO 11607)Testing | – | – | – | – | – |
| Packaging design & manufacturingPlastics | – | – | – | – | – |
| LabelingAssembly | – | – | – | – | – |
| Laboratory testing / packaging tests, transport testing, shelf-life studiesTesting | – | – | – | – | – |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| EO sterilization facility | – | – | – | – | Calw-Altburg |
Additional services
Quality & Certifications
Quality assurance is carried out on the basis of accredited management systems (ISO 13485 and ISO 9001), including a testing laboratory, transport testing and shelf-life studies. Registrations with the FDA (USA) and the MHLW (Japan) enable supply to the respective markets.
| Evidence | Calw-Altburg |
|---|---|
| ISO 13485 | |
| ISO 9001 | |
| FDA Registration | |
| MHLW Registration (Japan) |
History
Eurofins STERIPAC is part of the Eurofins Group (Eurofins Sterile Packaging, Medical Device Services).