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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).
AISI 316L Stainless Steel Construction
Touch screen
Work ports with gloves
Inflatable access door with interlock
Biodescontamination
by VH2O2
Filtration system
HEPA/ULPA
Chamber of Labor:
Lamiar air flow system with air filtration:
Biodescontamination System:
Control and Supervision Systems:
Transfer of materials:
Gloves and glove testing
Dimensions:
Materials:
Integrated LED lighting:
Electrical Voltage:
Regulatory Compliance:
Real Time Monitoring:
H₂O₂ Monitoring and Particle Counting:
Accessories and tooling:
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:
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.
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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