Due to the demographic change, medical devices are becoming increasingly important.
The packaging of sterile medical devices ...
... serves to maintain the sterile condition from sterilisation to application of the product and is therefore critical for the product’s safety. The highest quality standards are required in their manufacture in order to guarantee their service life, reliability and safety for the user and thus not expose the patient to any unnecessary risk.
BBF Sterilisationsservice GmbH accompanies you in the development and validation of the
and takes over the production for you from the raw product to the sterile medical device that is ready for sale. A reliable quality management is the basis for our company and we are certified according to ISO 13485.
Process-related critical contaminations on medical devices can usually not be ruled out completely. Possible contamination by equipment, process media and personnel can endanger the safety of patients.
Suitable cleaning prior to final assembly and packaging in our state-of-the-art clean rooms ensures maximum safety and efficiency for the subsequent sterilisation process.
A wide variety of methods are available for cleaning and drying in our ISO class 8 clean room.
Based on the product properties, we work with our customers to develop suitable cleaning processes that meet the legal and normative requirements for a medical device.
We assemble your products according to your specifications in clean rooms of ISO class 7 or under ISO class 5 conditions using trained and qualified personnel.
Especially in connection with upstream cleaning processes and the possibility of subsequent thermal decontamination before final packaging, assembly in the clean rooms of BBF Sterilisationsservice GmbH offers maximum safety.
The primary purpose of packaging medical devices is to maintain sterility until the time of use.
Our experts will work with you to develop a packaging concept tailored to your products that not only aims to achieve an appealing design, but especially meets your product’s functional requirements. Our employees make use of their wealth of years of experience.
Packaging takes place in our ISO Class 7 clean rooms. In this way, we guarantee the hygienically perfect quality of the packaged products as the basis for a successful and valid sterilisation process.
With our versatile equipment we can offer a wide range of single or double packaging solutions. For example, these include:
- Pouch packages
- Blister packages
- Vacuum packages
- Protective gas packaging
- Protective packaging/folding boxes
- Shrink packages
In addition, we take over the subsequent sterilisation by means of gamma irradiation or arrange for other sterilisation processes to be carried out in close consultation with you, such as treatment with ethylene-oxide.
BBF Sterilisationsservice GmbH of course only uses calibrated and qualified equipment. All sealing processes are validated by us and are subject to regular in-process controls. The sterile barrier systems commonly used by us are all validated with regard to sterilisation compatibility and shelf life.
Your contact persons
Should you have any questions about our services, please do not hesitate to contact us.