barrier systems

for Aseptic Processes

Kirhtech-NetSteril Aseptic Process Isolators are closed systems custom designed to handle sterile or highly sensitive products, minimizing the risk of contamination.

These systems are designed to maintain a controlled controlled environment environment that is isolated from the external and operational environment by means of physical barriers.

The interior of the camera has Grade A (ISO 5) thanks to a laminar air flow for optimum process unidirectional laminar airflow for optimum process protection.

Isolators are essential to protect the product and the operator during critical processes in sectors such as pharmaceutical, biotechnology, chemical, hospitals and laboratories.

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

Aislador para procesos asépticos

AISI 316L Stainless Steel Construction

Touch screen

Work ports with gloves

Inflatable access door with interlock

by VH2O2

Filtration system

General characteristics

Chamber of Labor:

  • It constitutes the functional core of the isolator, being the space for aseptic manipulations.
  • Sanitary design and construction, manufactured in AISI 316L stainless steel for optimum corrosion resistance (consult other material options).
  • Fully custom-designed to meet the customer’s needs.

Lamiar air flow system with air filtration:

  • The unidirectional laminar air flow system guarantees the absence of suspended particles.
  • The isolators use high efficiency HEPA/ULPA filters to remove up to 99.999% of particles and microorganisms.
  • Guarantees a Class A (GMP) / ISO 5 (ISO14644-1) rated environment.
  • Continuous pressure control of the chamber.

Biodescontamination System:

  • Solidfog® cold mist vaporization technology is used, with dose, pressure and injection flow control.
  • The cycles performed with this technology require little time in the conditioning and aeration phases, offering fast, robust and effective decontamination.
  • Easily validated system that complies with EN17-272.

Control and Supervision Systems:

  • Advanced control interfaces with intuitive touch screens are included.
  • They allow efficient monitoring and control of all aspects of isolator operation.
  • Equipped with electronic record keeping systems to meet 21 CFR Part 11, Annex 11 and GAMP5 data integrity requirements.

Transfer of materials:

  • They allow the entry and exit of materials without compromising the sterile environment.
  • They can be done through access gates or SAS pass-through (open system) or through RTP ports and Beta-containers (closed systems).

Gloves and glove testing

  • The glove ports are designed to minimize the risk of breakage or accidental disengagement.
  • The number and location of the ports are determined by the process needs and the ergonomic requirements of the operators.
  • Ergonomically designed, lightweight, easy to use MK® glove integrity testers. Resistant to disinfectants and VH2O2.
  • We have the most advanced software on the market to automate the performance and reporting of glove integrity tests: RFID recognition, wireless data transmission, data integrity and auditing, etc.
  • Exclusive recipe development and validation (PQ) service for each glove type and pore size.


  • Fully customizable to adapt to different spaces and manufacturing processes.


  • Manufactured from AISI 316L stainless steel for maximum corrosion resistance (consult other material options).
  • Tempered glass doors with double glass design and inflatable gaskets for hermetic sealing.

Integrated LED lighting:

  • Provides optimum visibility in an efficient manner without altering the chamber temperature.
  • Colored illumination indicates the status of the decontamination cycle and alerts about H2O2 bottle change.

Electrical Voltage:

  • The equipment can be configured to meet local electrical standards, typically ranging from 115V to 400V.

Regulatory Compliance:

  • Kirhtech-NetSteril isolators for aseptic processes comply with ISO, GMP and FDA regulations for quality and safety standards.

Optional features

Real Time Monitoring:

  • Possibility of real-time monitoring by means of sensors and cameras, allowing precise control and continuous supervision of the processes inside the isolator.

H₂O₂ Monitoring and Particle Counting:

  • Possibility to monitor hydrogen peroxide levels (ppm of H₂O₂) for both operator safety and process monitoring purposes.
  • Implementation of viable and non-viable particle counting equipment for accurate assessment of the sterile environment.

Accessories and tooling:

  • Optional supply of supports, grids and ergonomic accessories that allow the isolator to be adapted to different operators and processes, thus optimizing comfort and efficiency during use.

Frequently Asked Questions about Isolators for Aseptic Processes

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 choice of an isolator over other barrier or containment systems in aseptic processes depends on several factors, including the nature of the process, sterility requirements, product handling and manufacturer’s preferences.

Here are some reasons why an isolator may be preferable in certain situations:

  • Tightness Level: The isolators offer a high level of tightness, creating a completely closed and sterile environment. This is especially important in processes that require extreme sterility, such as the manufacture of sterile drugs or the handling of sensitive cell cultures.
  • Design Flexibility: Isolators can be designed to suit a wide range of configurations and applications, making them versatile for different processes and manufacturing environments. They can be customized in terms of size, shape and additional features according to customer needs.
  • Product Handling: Isolators allow for more direct handling of the product within a controlled and sterile environment. This is particularly beneficial in processes where close interaction with the sensitive material is required, such as the preparation of cell cultures or the handling of active pharmaceutical ingredients.
  • Contamination Control: Isolators offer a high level of control over cross-contamination, both microbiological and environmental. By maintaining a sterile environment separate from the surrounding environment, isolators reduce the risk of contamination during product handling and processing.
  • Regulatory Compliance: In many industries, such as pharmaceuticals, isolators are recognized and accepted as an effective way to ensure sterility and product integrity. They comply with regulations and standards set by regulatory agencies such as the FDA and EMA, simplifying the approval process and ensuring regulatory compliance.

A typical example of the operation of an isolator used in aseptic tasks is described below, highlighting the key steps in the operation of these units. The final operation will depend on the nature of the process to be carried out:

Start of Operations and Preparation

Before starting any operation, a biodecontamination of the working chamber is performed using the hydrogen peroxide vaporization system (VHP) to ensure a sterile environment.

Introduction and extraction of materials

Materials required for the process are introduced and extracted through SAS transfer chambers or Rapid Transfer Ports (RTPs), designed to maintain the sterility of the environment when transferring materials to and from the isolator without compromising the aseptic barrier. Materials can also be introduced into the chamber through the door prior to the first biodecontamination cycle.

Product Handling

Inside the isolator, products are handled directly by integrated glove systems, allowing interaction with the material in a controlled and sterile environment.

4. Monitoring and Control

Operators continuously monitor internal conditions using touch-screen control systems, adjusting parameters such as temperature and humidity to maintain optimal conditions.

5. Filtration and Aeration Maintenance

The air filtration system, equipped with HEPA/ULPA filters, operates constantly to remove particles and maintain air quality within ISO 5 standards, ensuring a continuous aseptic environment.

6. Completion

At the end of the process, biodecontamination is not always necessary, but may be carried out depending on the nature of the product handled and the specific protocols of the process.

7. Waste Management

The waste generated is disposed of safely through closed systems designed to contain and handle these materials without exposing the external or internal environment to contaminants.

8. Documentation and Compliance

The entire operation is documented through the SCADA system, complying with current regulations, ensuring compliance and facilitating the review and audit of the processes.

The design and manufacturing process of isolators for aseptic processes at Kirhtech-NetSteril is characterized by a holistic 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 mock-up phase is carried out to ensure the ergonomics and functionality of the isolator.

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 and Commissioning

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.

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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