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Kirhtech-NetSteril’s RABS (Restricted Access Barrier Systems) provide a controlled and aseptic production environment essential in the pharmaceutical and biotech industry.
By combining physical barriers with high efficiency laminar airflow, these systems minimize the risk of microbial contamination, ensuring the integrity and quality of the processes being carried out and the products handled inside.
At Kirhtech, we develop our RABS in collaboration with Netsteril, specialists in the supply and distribution of aseptic process solutions, VH2O2 bio-decontamination services and systems, and glove integrity testing and transfer systems (RTP and beta-containers).
Steel Construction
Stainless steel AISI 304/316L
Working ports
with gloves
Panels and doors
of access
Control systems
Filtration system
HEPA/ULPA
Kirhtech is a brand specialized in the development of containment and protection equipment for classified spaces. Created by Iguña, a company with more than 20 years of experience in the cleanroom sector, Kirhtech benefits from Iguña’s extensive know-how and facilities to manufacture advanced and tailor-made solutions for the pharmaceutical and biotech sectors, among others.
Netsteril is a company specialized in the supply and distribution of solutions for aseptic processes, such as VH2O2 Solidfog™ bio-decontamination systems and services and MK™ brand glove integrity testing and lifecycle management systems.
After several years collaborating on one-off projects and in view of the growing demand for barrier systems arising from the requirements of the new GMP Annex 1, Kirhtech and NetSteril have established a partnership to jointly develop isolators, RABs and SAS Pass boxes with H₂O₂ biodescontamination systems by H₂O₂.
This strategic alliance combines Kirhtech’s expertise in the manufacture of containment equipment with NetSteril’s specialization in bio-decontamination, to respond efficiently and competitively to each customer’s specific requirements in the implementation of barrier technologies.
The design and manufacturing process of the RABS (Restricted Access Barrier Systems) at Kirhtech-NetSteril is characterized by a comprehensive approach that guarantees the satisfaction of the customer’s specific needs.
From the initial requirements definition phase to the final delivery and after-sales support, each stage is carried out with meticulousness and attention to detail:
Phase 1: Definition of Requirements
During the initial consultation with the customer, specific project requirements are gathered, including dimensions, materials and applicable regulations. A detailed analysis is performed to determine the required technical characteristics and to ensure compatibility with industry standards.
Phase 2: Design and Planning
A preliminary design is developed based on the collected requirements, which is presented to the client for review and approval. Subsequently, a final design and mockup creation phase is carried out to ensure the ergonomics and functionality of the RABS.
Phase 3: Design Validation
The final design is subjected to validation testing to ensure that it meets all established functional and regulatory specifications.
Phase 4: Manufacturing
Once the design is validated, the manufacturing process begins using high quality materials and following strict production standards.
Phase 5: Factory Acceptance Testing (FAT)
Extensive factory acceptance tests are performed to verify full system functionality, with the active participation of the customer to ensure customer satisfaction.
Phase 6: Installation, Start-up and Training
The isolator is shipped and installed at the customer’s facility, and acceptance tests are performed on site to ensure proper operation in the real environment. End-user training is also provided.
Phase 7: After-sales support
Ongoing support, including maintenance contracts and technical assistance, is provided to ensure optimum performance of the isolator throughout its service life.
Venus 55-B
Pol. Ind. Can Parellada
08228 Terrassa (Barcelona)
Tel. +34 93 784 28 25
Mail. info@kirhtech.net
© Iguña Pharmaceutical Technologies, S.L. | All rights reserved.
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