News
Current developments at our company

News

As many already know, we went into linear operation after the renovation of the sterilization system. This mode is largely analogous to the circulation in the old system.

For better capacity, however, it is very important for us to go into circular operation. For your clarification, the goods are, for example, guided along the existing conveyor system at four times the speed but in 4 rounds. So 4 rounds that apply a dose of 6.25 kGy to the goods can apply a total of 25 kGy total dose to the goods, as well as one round with 25 kGy in linear mode. This results in a certain flexibility, since goods with a lower total dose required can be irradiated, e.g. with 3 rounds, without having to run the system empty.

Due to the technical requirements that have to be implemented for the linear mode, we have decided not to introduce the linear mode before the second half of 2023.

Dear customers,

our renovation work is finished. We have resumed gamma-ray sterilization since September 13th, 2021.

Please note the following: Please send orders for irradiation to the following email: bestellungen-steri@steriXpert.de

Your goods can only be sent for irradiation after we have received a confirmation from us with the corresponding delivery date.

Remember to provide the delivery note or order as well as your goods with the article number / process number assigned by us!

Dear customers,

our renovation measures are coming to an end and our qualification work has largely been completed.

We are therefore confident that we will be able to resume irradiation operations from September 13th, 2021. Please note the following:

Send orders for irradiation to the following email: bestellungen-steri@steriXpert.de Your goods can only be sent for irradiation after receiving a confirmation from us with the corresponding delivery date.

Remember to provide the delivery note or order as well as your goods with the article number / process number assigned by us!

 

Recently, the factory acceptance test of an advanced transport
system for BBF Sterilisationsservice GmbH’s sterilization facility in Kernen, Germany was completed successfully. The self-conveyor
transport system ensures medical products to be sterilized move carefully in containers through the
irradiation process. The system is based on walking-beam technology and represents the first time that
technology will be used in the process of sterilizing medical products and pharmaceuticals. More

Due to the renovation of the "hot cell", we have closed the radiation sterilization facility.

It is not possible to deliver irradiation material before September 13th, 2021.

We will keep you up to date on the current status.

All other departments such as our microbiological test laboratory and packaging are still there for you!

WE'RE RECONSTRUCTING !!! DELIVERY STOP !!!

Deliveries of goods are only possible after prior notice!

Goods that have not been announced or have been reconfirmed by BBF will be rejected until further notice.

In cooperation with the company Framatome, our new system has now been completed. Here is a video of how it works on YouTube.

Our White Paper about the current rational dose distribution (as of 2021) is available now ...

We would like to inform you about the further progress and the current schedule for the modernization of our irradiation system ...

Two years ago we informed you about the planned modernization of our irradiation site.

In the meantime, the extensive planning work has been completed and we have received nuclear approval for the planned measures.

The annual Dekra audit for the ISO-9001 and ISO-13485 certificates was successfully undertaken in January 2020.

Two years ago we informed you about the planned modernization of our irradiation site.

In the meantime, the extensive planning work has been completed and we have received nuclear approval for the planned measures.

After more than 20 years as Head of Sterilization and subsequently as Managing Partner of BBF Sterilisationsservice GmbH, Dr. Mario Bernkopf on 31.07.2019 in his well-deserved retirement. We thank Dr. Bernkopf at this point for his great commitment and successful cooperation and wish him all the best.

We will attend the new T4M exhibition in Stuttgart from 07th to 09th May 2019.

Our booth is located in hall 9 number C38.

Article about us appeared in the DeviceMed!

There is a new article about our work in particle measurement on medical devices. The particle measurement is becoming more and more the focus of the Notified Bodies, but evaluating the results and setting the acceptance criteria is not easy.

Joining and our 1st meeting at Expert Table CleanMed!

We joined the Expert Table CleanMed. The task of the working group is to define, establish and continuously update the guideline for cleanliness for medical devices.

We will be attending the IMRP19 in Strasbourg from 1 - 5 April 2019!

We were just informed, that the company Framatome GmbH will held a lecture at the IMRP on the upcoming modernization of our sterilization plant! The following link leads you to the abstract of the lecture https://cm.imrp-iia.com/mobis/lecture/110

We will be attending the T4M (Technology for Medical Devices) in Stuttgart from 07. - 09. May 2019!

Extended accreditation scope for medical devices and pharmaceuticals

As our testing laboratory has been accredited according to ISO 17025 for the testing of medical devices since 2013, we have now successfully completed the renewed audit with a significantly extended scope of accreditation. It should be stressed in particular that the scope now covers not only medical devices but also pharmaceuticals and active substances.


BBF Sterilisationsservice GmbH
Willy-Rüsch-Str. 10/1
71394 Kernen-Rommelshausen
+49 7151 94570 -0
+49 7151 94570 -12