The cytostatic safety cabinet BERNER FlowSafe® C-[MaxPro]³ has been specially designed fo the production of aseptic parenteral preparations. The modern work equipment focuses on three basic properties for optimal and risk-free working conditions: Personal, product and cross contamination protection. These protective properties have been tested in an elaborate PET- test method (Performance envelope testing) - with exceptional results:
BERNER FlowSafe® has the largest proven performance envelope on the market! Tested and accredited by the TÜV NORD CERT, Germany.
Connection to an integral clean room monitoring system (GRM)
and more
BERNER FlowSafe® cytostatic safety cabinets were developed, tested and produced in Germany - Quality »Made in Germany«! The revolutionary 3-filter system, innovative detailed solutions and exceptional ergonomic properties provide the highest standards in terms of comfort and safety.
Certified and controlled quality management system according to DIN EN ISO 9001:2000. Testing, certification and control by the named body.
TÜV Management Service GmbH
Unternehmensgruppe
TÜV Süddeutschland
Ridlerstraße 65
D-80339 München
Germany
GS-mark
Test and safety mark according to the German appliance and product safety law. Testing, certification and control by the accredited test house.
TÜV NORD CERT GmbH & Co. KG
Große Bahnstraße 31
D-22525 Hamburg
Germany
CE-mark
EC directive conformity mark signifies the adherence to the basic safety and health requirements of the relevant EC directive(s).
TÜV Cleancert Zeichen
GMP-gerechte Dokumentation und Prüfung gem. EG GMP-Leitfaden Anhang 15. Wird z.Zt. exemplarisch durch TÜV SÜD Cleancert geprüft und zertifiziert.
The TÜV personal certification »technical qualification verification for service technicians of microbiological safety cabinets and cytostatic safety cabinets« consists of a one-week intensive training course with subsequent theoretical and practical examinations. Personal certification is attained after successful completion of the examinations together with regular proof of calibrated measuring tools.
Testing, certification and control by the accredited test house.
TÜV NORD CERT GmbH & Co. KG
Große Bahnstraße 31
D-22525 Hamburg
Germany