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Sterilization

Sterilization

Validation of Terminal Sterilization of
Medical Devices

We have broad and profound expertise in validation and management of the following sterilization technologies:


- Ethylene Oxide
- Radiation
- Steam 

...

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Inhouse Sterilization

In-house Sterilization

In-house sterilization for new and existing plants

We can actively support you regarding (re-)validations and optimizations for your existing in-house sterilization facility or if you want to design, install and validate a complete in-house sterilization facility. 

Reprocessing

Reprocessing

Reprocessing

We can support you regarding reprocessing validation of reusable medical devices. 


-    Manual and/or Automatic Cleaning
-    Manual or Automatic Disinfection
-    Sterilization
-    Drying after Sterilization

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QA/RA

QA / RA

Sterilization Process related with Quality Management and Regulatory Affairs

We support you in all sterilization process related quality management and regulatory affairs topics as e.g. in creation of form-sheets and SOPs or the sterilization part of you technical files (STED or DHF) and communication with the authorities and notified bodies.

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Recruiting

Recruiting

Recruiting of
Sterilization Experts

We are Recruiting Sterilization Experts for projects or permanent positions using our networks and our technical know-how for the selection of personnel.

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SBS

Packaging

Sterile Barrier Systems (Packaging)

- Process validations (IQ, OQ, PQ)
- Packaging Design
- Packaging Design Testing
- ISO 11607-1&2
- Packaging Equipment

 

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Micobiology

Microbiology

Microbiology

We have broad experience and contacts to experts and laboratories to establish your internal processes, laboratory methods, studies and routine monitoring for all your Micro-biological Requirements

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