Context
The entry into force of Annex 1 of the GMP standards has had a disruptive impact on the way sterile drugs are produced. Now, and explicitly, the standard requires the use of barrier technologies between the person and the product to reduce the risk of contamination. As a consequence, the use of RABS and/or isolators is required to meet these requirements. The required contamination control also implies the use of more efficient and easier to validate disinfection systems, such as automatic systems with VH2O2, as well as ensuring the integrity of the elements in direct or indirect contact with the product, such as gloves, Alpha ports/Beta containers, etc.
Collaboration
In order to respond to the growing demand for these solutions, and after several years of collaboration on specific projects, Kirhtech and Netsteril have reached a collaboration agreement for the development of a line of barrier systems, including Isolators for aseptic processes, RABS and SAS for biodecontamination by vaporized hydrogen peroxide.
The market launch of the new Kirhtech and Netsteril equipment represents the arrival on the national market of a high-tech product, fully adapted to the customer’s needs and with a comprehensive and proximity service ranging from engineering to installation and maintenance.
Kirhtech
Kirhtech is the brand specialized in the manufacture of containment and protection equipment of Iguña, a reference in clean rooms with more than 20 years of experience in the sector. Kirhtech has a multidisciplinary team with proven know-how in engineering, mechanics, automation, installation and maintenance of equipment for classified spaces.
www.kirhtech.net
info@kirhtech.net
+34 93 784 28 25
Netsteril
Netsteril is a company specialized in the supply and distribution of aseptic process solutions, such as VH2O2 Solidfog™ bio-decontamination systems and services and MK™ brand glove integrity testing and lifecycle management systems.
www.netsteril.com
info@netsteril.com
+34 935 554 063
