News
Current developments at our company

Actual - 24.03.2021- Modernization of the radiation system

Today we would like to inform you about the further progress and the current schedule for the modernization of our irradiation system and also explicitly point out the associated downtime during which we cannot carry out any irradiation for you.

Our plans have now become so concrete that we will start expanding the previous conveyor technology on 28th of July 2021. We will be able to complete the installation and commissioning of the hot cell, including the necessary qualification measures, by September 12, 2021 if no unforeseen incidents occur.

In order to be able to optimally schedule your orders, close coordination with our production planning department is mandatory for all deliveries by the end of June at the latest. Processing of deliveries that have not been notified in advance and confirmed by us can then no longer be guaranteed. This also applies to deliveries in the first 2-3 weeks after our conversion.

For goods that are to be irradiated before our modernization, Friday, July 23rd, 2021 is the last possible delivery date. Deliveries that reach us at the beginning of week 30 may no longer be irradiated and may even have to be sent back, as BBF only has limited storage options.

We have meanwhile expanded our irradiation capacities through various measures such as additional work shifts so that we can cover your expected additional requirements for stockpiling. This additional capacity is now available, but can only be fully used if you send us your additional irradiation requirements as of now and evenly spread over the next 5 months. We would therefore like to ask you vividly to start building up your inventory immediately and to use the currently available irradiation capacities; a complete stockpiling at a later date cannot be guaranteed.

Thank you for your support so far and your understanding for the renovation work that is still to be done. We will continue to keep you up to date on the progress of the modernization measures via our homepage. Please don’t hesitate to contact us in case of any questions.

 

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Actual - 22.07.2020 - Modernization of the radiation system and the dosimetry 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.

Thereby the prerequisites for the implementation of the measures have now been reached and our partner, Framatome GmbH, has been commissioned with the realization.

Due to the complexity of the project, we are currently unable to present a specific schedule for the further course of the work. However, we are working on creating this in the next few weeks.

First, the system and the control system must now be built and programmed. After approval of the Factory Acceptance Test, the system will then be set up at BBF and initially subjected to a test operation / Simulation.

Only then will the final installation and commissioning take place in the hot cell. Together with the necessary qualification measures, we currently expect a downtime of approx. 4 weeks.

When creating the schedule for the further course of the project, we will plan for a lead time of approx. 12 months and will inform you in due time. During this lead time, we will expand our irradiation capacity through organizational measures and additional work shifts. Thus we would like to put you in a position to build up a sufficient inventory by expanding your production in order to be able to bridge the downtime.

We would also like to point out that we have commissioned DEKRA as our certification body to carry out an audit of the modernized irradiation system, including the associated qualification documentation.

As already stated in our letter dated January 22, 2018, we still assume that the effects of modernizing the plant on the established lose windows are neglectable. However, we will only be certain about this as a result of the qualification measurements (OQ) to be carried out.

The basis will furthermore be the standard cycle with a dose window of 25 to 45 kGy. In case of deviating lose windows in particular, there may be a higher risk that a new product-specific validation (lose distribution measurement) and, as a result, an increase in the maximum acceptable irradiation lose may become necessary.

We would also like to point out that we will start introducing a new dosimetry system in the next few months, probably in the second quarter of 2020. The proposed alanine dosimeters offer a number of advantages over the Red Perspex dosimeters, e.g. an even higher measuring accuracy.

After a certain (not yet defined) transition period, we will probably be able to offer Red Perspex dosimeters in special cases only.

We are also in the process of implementing a new process software for our radiation service. In this context, we will analyze the existing product-specific radiation processes. We will contact you in the coming weeks and months to clarify the necessary details and to coordinate the specifications with you.

Without an adequate process specification, which must be explicitly named in your order in the future, we will no longer be able to carry out your irradiation orders.

Finally, we would like to point out that we are currently planning to reload cobalt in May 2020 - not least to ensure the necessary irradiation capacity that we need to

build up your inventory. We will inform you in due time about the time of the one­ week system shutdown.

We will keep you up to date on the progress of the addressed projects and the plant modernization on our homepage, especially about duration and dates of plant downtimes.

We hope that this will provide sufficient planning security for you and thank you by now for your understanding and support in the work ahead and any restrictions and changes that may be associated with it for you. We are also happy to provide you with detailed information personally.

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28./29./01.2020 - BBF successfully certified again!

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

You can view and download our current certificates here.

Actual - 27.01.2020 - Modernization of the radiation system and the dosimetry 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.

Thereby the prerequisites for the implementation of the measures have now been reached and our partner, Framatome GmbH, has been commissioned with the realization.

Due to the complexity of the project, we are currently unable to present a specific schedule for the further course of the work. However, we are working on creating this in the next few weeks.

First, the system and the control system must now be built and programmed. After approval of the Factory Acceptance Test, the system will then be set up at BBF and initially subjected to a test operation / Simulation.

Only then will the final installation and commissioning take place in the hot cell. Together with the necessary qualification measures, we currently expect a downtime of approx. 4 weeks.

When creating the schedule for the further course of the project, we will plan for a lead time of approx. 12 months and will inform you in due time. During this lead time, we will expand our irradiation capacity through organizational measures and additional work shifts. Thus we would like to put you in a position to build up a sufficient inventory by expanding your production in order to be able to bridge the downtime.

We would also like to point out that we have commissioned DEKRA as our certification body to carry out an audit of the modernized irradiation system, including the associated qualification documentation.

As already stated in our letter dated January 22, 2018, we still assume that the effects of modernizing the plant on the established lose windows are neglectable. However, we will only be certain about this as a result of the qualification measurements (OQ) to be carried out.

The basis will furthermore be the standard cycle with a dose window of 25 to 45 kGy. In case of deviating lose windows in particular, there may be a higher risk that a new product-specific validation (lose distribution measurement) and, as a result, an increase in the maximum acceptable irradiation lose may become necessary.

We would also like to point out that we will start introducing a new dosimetry system in the next few months, probably in the second quarter of 2020. The proposed alanine dosimeters offer a number of advantages over the Red Perspex dosimeters, e.g. an even higher measuring accuracy.

After a certain (not yet defined) transition period, we will probably be able to offer Red Perspex dosimeters in special cases only.

We are also in the process of implementing a new process software for our radiation service. In this context, we will analyze the existing product-specific radiation processes. We will contact you in the coming weeks and months to clarify the necessary details and to coordinate the specifications with you.

Without an adequate process specification, which must be explicitly named in your order in the future, we will no longer be able to carry out your irradiation orders.

Finally, we would like to point out that we are currently planning to reload cobalt in May 2020 - not least to ensure the necessary irradiation capacity that we need to

build up your inventory. We will inform you in due time about the time of the one­ week system shutdown.

We will keep you up to date on the progress of the addressed projects and the plant modernization on our homepage, especially about duration and dates of plant downtimes.

We hope that this will provide sufficient planning security for you and thank you by now for your understanding and support in the work ahead and any restrictions and changes that may be associated with it for you. We are also happy to provide you with detailed information personally.

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01.08.2019 - New shareholder and managing director

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.


As a new shareholder and managing director we welcome Ms. Edda Kemmer to BBF Sterilisationsservice GmbH. Ms. Kemmer has already provided the company with her commercial expertise in the past. We look forward - together with her - to further expand BBF Sterilisationsservice GmbH as an excellent service provider and wish her success.

10.04.2019 - We will attend the new T4M!

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

Our booth is located in hall 9 number C38.

In addition, we will give a lecture on radiation sterilization on 07.05.2019 at 14:00 o´clock on Stage Blue with the following title: "Radiation sterilization, which microbiological validation methods are available and which are in trend."

01.03.2019 - Article about us appeared in the DeviceMed!

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.

We give our customers the necessary advice and assistance.

Click here for our article!

21.02.2019 - Joining Expert Table CleanMed

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. Core areas and groups that have been formed are: further development of the previous guideline "SME Guidelines for Standardized Cleaning of Surgical Instruments" from 2017, as well as the standardization of particle measurement and quantification according to suitable standards. We attended the meeting of the Expert Tables on 19th Feb 2019 and contributed our expertise in particle quantification. If you would like information about the current state of knowledge regarding particle measurement or are interested in the test, please contact us. Our contact persons are there for you!

11.01.2019 - We are at the IMRP19 in Strasbourg!

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

The IMRP19 (International Meeting on radiation processing) will be taking place in Strasbourg from 01 - 05 April 2019. International companies will meet in the congress and exhibition centre to discuss the latest developments in science and business on the subject of radiation processes.

We will be represented on site with our booth (number 5) and look forward to your visit!

 

 

IMRP19

 

Click on the picture to download further information about this congress as PDF.

IMR19  Einladung

21.12.2018 - We are at the T4M in Stuttgart!

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

We are excited about the new exhibition and look forward to your visit!

You will find us in hall 9, booth C39.

 

 

 

 

17.09.2018 - BBF successfully accredited again!

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.

The accreditation covers an extensive spectrum of tests in the fields of biological, microbiological-hygienic and physical testing of medical devices and their packaging as well as in the fields of pharmaceutical and active substance microbiology, pharmaceutical technology and environmental monitoring.

New additions to the accredited catalogue of services include testing for bacterial endotoxins using the recombinant Factor C test (EndoZyme, EndoLISA) and testing for particle contamination by light blockade of medical devices and pharmaceuticals. (Contact person: Dr Christopher Rösch, Tel.: 07151 – 94570-21)

So that we may be able to offer you a demand-oriented and comprehensive range of qualified testing services for medical devices and pharmaceuticals in the future, we will continue to strive to constantly expand our range of services.

You can view and download our current accreditation certificates here.