barrier systems


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

General characteristics

  • Structure: Made of AISI 304/316L stainless steel with sanitary finishes, offering durability and corrosion resistance. Custom ergonomic design with mock-up review to optimize personnel operations.
  • Dimensions: Adaptable to customer needs, from compact units to large-scale systems.
  • Panels: hinged or fixed panels in acrylic, tempered or laminated glass for optimum visibility of the process.
  • MK® Gloves and GIT (Glove Integrity Test) equipment: Ergonomic ports, designed to guarantee the integrity of assembly with the glove and integrity test equipment with validated recipes for each type of glove. Glove extenders for good exposure during the biodecontamination process.
  • Lamiar air flow: Unidirectional downward flow at 0.45 m/s ± 20%, ensuring ISO 5 conditions according to ISO 14644-1 or Class A according to GMP, indoors.
  • Air treatment: Passive (connected to the room HVAC) or active (with HEPA filters and fans) systems.
  • Filtration: HEPA H14 or ULPA U15 filters to remove particles and microorganisms.
  • Control and Monitoring: Control and monitoring system for all system parameters, including alarms, electronic records and compliance with CFR21 Part 11 and GAMP5.
  • Lighting: Integrated energy-efficient LED lighting for optimal visibility.
  • Transfer Systems (optional):
    • SAS material pass-through: Double-door transfer systems with integrated biodecontamination for aseptic material introduction and removal.
    • RTP (Rapid Transfer Ports): Fast transfer ports for efficient material handling.
  • VH₂O₂ System (optional): Solidfog® cold mist fogging technology, with dose, pressure and injection flow control. Easily validated system that complies with EN 17272.
  • Advanced Customization:
    • Integration with environmental monitoring systems, CIP equipment and advanced control systems.
    • ULPA filtration, air recirculation and full automation options.
    • Safety accessories, customized configurations and ergonomic attachments to optimize performance and operator comfort.

Frequently Asked Questions about Kirhtech RABS - Netsteril

Sobre Kirhtech y NetSteril

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.

  • User Manual
  • CE Certified
  • Functional Design Specifications (FDS)
  • Hardware and Software Specifications
  • Factory Qualification and Acceptance and Installation Test Reports
  • Maintenance Plan
  • Warranty and regulatory compliance documentation

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