If manufacturers want to score points in terms of quality and flexibility, they have to ask how they can take advantage of both concepts. Vetter has answered this question with the development of an integrated cleanroom concept: V-CRT® (Vetter Cleanroom Technology).
V-CRT® makes it possible to achieve safety and quality standards that come close to the performance of isolators while still offering the flexibility advantages of RABS.
This innovative concept is based on the central idea of fully automated decontamination of the entire cleanroom, including RABS, using hydrogen peroxide (H2O2). V-CRT® is a two-barrier system that minimizes the risk of contamination and offers a number of advantages over existing concepts:
Rapid decontamination enables efficient product changeover
H2O2 decontamination of the entire cleanroom prior to each batch minimizes the risk of microbial contamination
Continuous online monitoring of multiple variables helps ensure the effectiveness of the decontamination process
The containment approach follows the concept of the closed system since the RABS doors are no longer opened following H2O2 decontamination.
After innovation is before innovation
The introduction of V-CRT® was an important milestone in the technological development of aseptic production at Vetter. However, innovation is not an end in itself and is why we are continuously developing V-CRT®.
A port system which is integrated in the second installation step, the so-called “liquid path,” will make it possible in the future to dispense with transfers of materials from grade B to grade A. In addition, in the future an H2O2 decontamination airlock between the grade-B and C areas will allow contamination-free transfer of non-autoclavable materials into the cleanroom.
Vetter’s goal is to offer reliable aseptic production with high quality. This purpose of this effort is to provide support for our customers in meeting the requirements of the changing biopharmaceutical market.
Vetter has been relying on RABS technology for decades. With the development of V-CRT®, we have succeeded in catching up with the isolator in terms of quality while at the same time, maintaining the usual flexibility. V-CRT® is currently available in three cleanrooms at Vetter. The intent is to implement the innovative technology in all cleanrooms.