CALW-ALTBURG (Germany)
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Steripac GmbH
Steripac GmbH is a service provider of cleaning, assembly, packaging, and sterilisation services for the medical device industry. Having served customers in the medical device industry for 20+ years, Steripac has a strong footprint in the market. The company operates a 2,000m² facility in the southwest of Germany which includes ISO Class 7+8 cleanrooms. From there, its highly-skilled team members package millions of medical device products each year.
Contact UsDEKRA certificate for quality management, sector:
Service provider in the fields of cleaning, assembly and packaging of medical devices as well as the development and validation of sterile barrier systems.
International Certificates
Japanisches Gesundheitsministerium: Pharmaceutical Affairs Act, § 13-3
- Accreditation certificate of foreign drug manufacturer
- Accrediation cerificate of medical device manufacturer
FDA Registration
- Registration Number: 3009217531
Certified according to EN ISO 13485
Final product cleaning
- Vacuum extraction cleaning process with modified alcohols
- Cleaning and disinfection machines
- Ultrasonic cleaning
- Vacuum drying
- Drying cabinets
- Drying under laminar flow
- Reverse osmosis system for water treatment
Assembly under clean room conditions
- Optionally with subsequent functional or quality tests
Contract packaging
- Four-side sealed pouches
- Soft blister
- Hard blister
- GAG-PET / G-PET
- Portfolio of different packaging materials
- Innovative 3dpac packaging system
Sterilization as a service
- Gamma irradiation
- Sterilization by means of ethylene oxide
- Steam sterilization
- E-beam
Validation of the processes used
- Cleaning validation
- Packaging validation
- Sterilization validation
- Microbiological tests
- Mechanical stress tests
- Particulate testing
- Accelerated and real-time aging
steripac GmbH
Oberreichenbacher Straße 15-17
75365 Calw-Altburg (Germany)
+ 49 7051-58 88 0
E-Mail: info@steripac.com