The entry into force of Annex 1 of GMP standards has had a disruptive impact on the way sterile medicines are produced. Now, and explicitly, the regulation requires the use of barrier technologies to reduce the risks of contamination.

As a consequence, the implementation of RABS and/or aseptic Isolators is required to comply with regulations. The contamination control strategy may also involve the use of more effective, robust and easy-to-validate disinfection systems, such as VH₂O₂ fully automatic systems, as well as ensuring the integrity of elements in direct or indirect contact with the product by using gloves, Alpha ports/Beta containers, etc.

Kirhtech-Netsteril Solutions to Comply with Annex 1

In order to respond to the growing demand for these solutions, and after several years of collaboration in similar projects, Kirhtech and Netsteril have reached an agreement for the development of a line of barrier systems, including aseptic isolators, RABS and VH₂O₂ biodecontamination equipment.

The launch of Kirhtech-Netsteril’s barrier systems represents the arrival of a high-tech product Made in Spain, fully adapted to the needs of the customer and with a comprehensive and local service that covers from engineering to installation and maintenance.

Kirhtech is the specialized brand from Iguña for the containment and protection equipment, a benchmark in cleanrooms 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.

Netsteril is a company specialized in the supply, service and distribution of solutions for aseptic processes, such as VH₂O₂ bio-decontamination systems from Solidfog and glove integrity testing from MK.

As they are two companies specialized in such critical disciplines, their collaboration agreement is highly strategic and synergistic for the development of RABS, isolators and VH₂O₂ biodecontamination transfer hatches.