Aseptic Transfer Systems

Biodescontamination VH₂O₂ SAS Pass boxes

Kirhtech-Netsteril material transfer SAS with vaporized hydrogen peroxide biodecontamination system (VH₂O₂) allow you to disinfect surfaces and transfer materials from a C or even D classified area directly to a B room, avoiding the risk of contamination.

The biodecontamination process is performed fully automatically, safely and through validated cycles at a logarithmic reduction of up to 6-log, ensuring the elimination of bacteria, viruses, fungi and spores.

It is the ideal solution for pharmaceutical, biotechnology, food, hospitals and research centers that require aseptic transfer of materials and equipment.

At Kirhtech, we develop our Biodecontamination SAS in collaboration with Netsteril, specialists in the supply and distribution of aseptic process solutions, VH2O2 bio-decontamination services and systems and glove integrity testing systems and transfer systems (RTP and beta-containers).

SAS de Biodescontaminacion por VH2O2

AISI 304/316L Stainless Steel Construction

Touch screen

Hornacina for
H₂O₂O₂ supply.

Inflatable access door with interlock

General characteristics

  • Construction: AISI 316L or AISI 304 stainless steel, mirror polished sanitary finish (Ra < 0.8 µm). Continuous and polished welds to avoid residue accumulation. Modular design for easy installation and maintenance.
  • Dimensions: Adaptable to the customer’s needs. Single or double chamber configuration (inlet and outlet) for a unidierectional material flow. Possibility of integrating automated transport systems.
  • Doors: Swing doors with inflatable silicone gasket and tempered glass visor. Electromechanical door locking system to ensure tightness during the decontamination cycle.
  • VH₂O₂ System: Solidfog® cold mist fogging technology, with dose, pressure and injection flow control. Easily validated system that complies with EN 17-272.
  • Fast Cycles: The cycles performed with this technology require little time in the conditioning and aeration phases, offering fast, robust and effective decontamination.
  • Filtration System: HEPA filters to retain particles and microorganisms during ventilation.
  • VH₂O₂ removal: high-flow forced ventilation system to remove residual VH₂O₂O₂ to the outside. Possibility of recirculation with catalytic filters to decompose VH₂O₂ into water and oxygen.
  • 21CFR Part 11 Control System: Color touch screen or panel PC, according to requirements. Intuitive and easy to use interface. Possibility of connection to building management systems (BMS). Remote monitoring system for diagnostics and technical support.
  • Safety: VH₂O₂ sensors to monitor concentration in real time. Door locking system. Visual and acoustic alarm system in case of failure or parameter deviation.
  • Validation and Documentation: Execution of IQ/OQ/PQ validation protocols. Preparation of validation reports and technical documentation.
  • Others: Energy-efficient LED lighting. Humidification system to optimize decontamination efficiency. Electrical voltage adaptable to local standards. Option of special finishes for aggressive environments.

Frequently asked questions about the SAS of Biodescontamination by VH₂O₂

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 for VH₂O₂O₂ Biodecontamination SAS at Kirhtech-NetSteril is characterized by a comprehensive approach that ensures that the customer’s specific needs are met.

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 phase is carried out and, if necessary, mockups are created to ensure the ergonomics and operational functionality of the SAS.

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 SAS is shipped and installed at the customer’s premises, and acceptance tests are carried out on site to ensure correct operation in the real environment. End-user training is also carried out.

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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