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Claire® substitutes C-[MaxPro]

Claire® substitutes C-[MaxPro]

NOTICE OF CHANGE

Claire® substitutes C-[MaxPro]

As of now, the models Berner FlowSafe® C-[MaxPro]³-130, C-[MaxPro]³-160 and C-[MaxPro]³-190, as well as the compact safety cabinet C-[MaxPro]³-70, will not be sold any longer in Germany! As a valuable substitution, the newly developed models from the Claire® pro & pure-Series are available as tested and certified safety cabinets for cytostatics, according to DIN 12980:2017-05.

The models Berner FlowSafe® C-[MaxPro]³-70, C-[MaxPro]³-130 and C-[MaxPro]³-190 were originally developed as safety cabinets for cytostatics and have been certified according to the outdated standard DIN 12980:2005-06. Since October 2016, a new version with significant changes is in effect and, with the end of the period of transition on April 1, 2017, these models do no longer conform to the state of the art. Solely because of the substantial expenditure, a re-certification according to the actual DIN 12980:2017-05 for the safety cabinet models C-[MaxPro]³-70/130/190 is not intended.

Another fundamental reason is the actual change in progress to the new model lines Claire® pro & pure. Some models have already been tested and certified according to the requirements of the new DIN 12980. Furthermore, the technical concept focuses on the themes energy efficiency, environmental compatibility and sustainable technique.

  • The EC-ventilators, used in the Claire®-Series, correspond to the high requirements on the degree of efficiency of the European legal ordinance No.327/2011, which defines the environmental sustainability or eco-design requirements of fans with an electric input power between 125 W and 500 kW. Many types of fans with high energy-consumption will no longer be available and legal within the next years according to these regulations. The EC-fan-technology in Claire® safety cabinets leads to a reduction in power consumption between 67 and 80 % in comparison to the AC fans of the FlowSafe® [MaxPro]-generation, depending on the model size and the used settings.
  • In all Claire®-models LED light technique is exclusively applied. Here also with equal or better light intensity the use leads to approximately 80 % reduction of the power consumption in comparison to fluorescent lamps. Fluorescent lamps contain mercury-vapor. In this regard LED technology is also more ecofriendly and sustainable.

In Germany with the actual version of DIN 12980:2017-05 a new state of the art for safety cabinets for cytostatics is required. In the manufacturing of cytostatic preparations and the compounding of application-ready cytostatic- and other CMR-pharmaceuticals some decisive changes are to be taken into account. In placing on the market and in the acquisition of a new safety cabinet for cytostatics, primarily it is necessary to meet the following requirements:

  • Ergonomics: The new standard defines to offer a minimum legroom depth on the height of the knees of 300 mm and a foot room depth as a minimum of 635 mm. These ergonomic requirements are important means to prevent health disorders and medical conditions, caused by unnatural body postures during longer work activities in a sitting position.
  • Provocation points: During the type testing by the manufacture it is additionally required to investigate the personnel protection at the access opening (Chapter 18.3) and the product protection (Chapter 19.3) at three different, so-called provocation points by standardized microbiological test methods and with several repeats. Hereby the safe function must be verified with defined variations around the nominal set point airflow velocities of the cabinet. Because variation of airflow velocities may also occur through different effects during the normal operation, e.g. due to filter loading, the HVAC-system of the laboratory or wrong adjustments during service, this performance spectrum demonstrates a higher degree of personnel and product protection to the user.

As a conclusion, with the consequent combination of contemporary, energy-efficient technical components (EC-fans, LED-illumination and TFT-touch-display) and with the high performance range in safety, tested according to the requirements of newest standards, the certified Claire® pure & pro models determine the state of the art for safety cabinets for cytostatics and in general on a new level.

  • Claire® pro C-3-130 (Art. No. 200000) or Claire® pure C-3-130 (Art. No. 202000) as fully certified devices with GS mark (by TÜV-Nord),
  • Claire® pro C-3-190 (Art. No. 200002) as fully certified devices with GS mark (by TÜV-Nord)
  • Claire® pure C-3-190 (Art. No. 202002) as device in the final phase of certification and for which the GS mark (by TÜV-Nord) will be available,
  • Claire® pro C-3-160 (Art. No. 200001) as device, which is tested internally, according to the methods of DIN 12980, and which complies in its construction type completely to the fully certified models Claire® pro C-3-130 and Claire® pro C-3-190.

For the model Berner FlowSafe® C-[MaxPro]³-70 as the most compact safety cabinet for cytostatics with a width of only 70 cm, there is currently no direct substitute available. The market situation is here as follows:

  • For microbiological applications or for pharmaceutical applications requiring sterile work conditions (e.g. preparation of parenterals without CMR-properties), the identically constructed model B-[MaxPro]³-70 is still available.
  • A substitution, based on the Claire®-series is at present in the planning state. From where we stand a new model as a full replacement can be available mid of 2018 (Q2/Q3).

Our distributor and customers in foreign markets have to decide, if the sales of C-[MaxPro]³-models as safety cabinets for cytostatics is still permitted or acceptable in their sales area and the country’s legal situation. Strictly seen, the DIN 12980 is primarily a standard in Germany. On the other hand, the DIN 12980 has always been an orientation and reference to many national and international pharmaceutical standards. That is the reason, why we recommend the change to the corresponding Claire®-models strongly, because they clearly represent the contemporary state of the art. As an alternative to Claire® safety cabinets, the B-[MaxPro]³-models, certified according to EN 12469, are presumably still available until the end of 2017 for microbiological applications or for pharmaceutical applications requiring sterile work conditions (e.g. preparation of parenterals without CMR-properties). Again also for this field of use we clearly recommend the corresponding Claire®-models as advanced and sustainable safety cabinets.