Isolators for sterile, controlled and containment environments

Isolation and containment solutions for critical applications in the pharmaceutical industry, hospitals and clinics, and laboratories and research institutes.

Isolators enable work to be carried out in sterile, controlled environments, helping to protect the product, the operator and the environment, as well as preventing the risk of contamination.

Available in different configurations depending on the application, they can be customised and bespoke-designed to suit specific processes, working protocols, sector requirements and the constraints of each facility.

Main sectors of application:

• Pharmaceutical industry: sterility testing, aseptic processes, production and handling of active pharmaceutical ingredients, transfer, formulation, filling and containment applications.
• Hospitals and clinics: preparation and reconstitution of medicines, cytotoxic agents and monoclonal antibodies, sterile preparations, parenteral nutrition and advanced therapy medicinal products.
• Laboratories and research institutes: medical research, microbiology, in vitro culture, handling of biological agents, gene and cell therapies, and other applications requiring controlled or containment conditions.

The features and configuration are tailored to each application and model:

• Ventilation systems with unidirectional, laminar or turbulent airflow.
• Operation under positive or negative pressure, depending on the application requirements.
• HEPA or ULPA filtration.
• Bio-decontamination systems using H₂O₂ (hydrogen peroxide) or PAA (peracetic acid).
• Safe RTP transfer systems.
• Various configurations and workstations.
• Option to integrate instrumentation, monitoring systems and auxiliary equipment.
• Materials and finishes tailored to the application’s requirements, including PMMA and 316L stainless steel, depending on the configuration.
• Recording and traceability of operational data, depending on the configuration.

Isolators can be configured to meet different requirements for sterility, containment and environmental control, including:

• Protection of the product against contamination risks.
• Protection of the operator whilst handling sensitive products or substances.
• Protection of the environment and containment of potentially hazardous agents.
• Control of environmental and working conditions.
• Aseptic processes and handling.
• Bio-decontamination.
• Safe transfer of materials, products and waste.

The configuration and operating parameters are determined according to the application and the specific requirements of each project.

Design and configuration of equipment in accordance with the requirements applicable to each application and sector, including, where applicable:

• GMP
• cGMP
• Applicable ISO standards.
• PIC/S.
• Requirements for cleanrooms and other controlled environments.

The applicable regulations and qualification criteria are determined on the basis of the project, application and installation environment.

A wide range of accessories and specialist equipment, configurable to suit the needs of each installation:

• Control, supervision and monitoring systems.
• RTP safe transfer systems.
• Glove and sleeve integrity testing systems.
• SAFECAN containers for the safe disposal of pharmaceutical waste, toxic products and sensitive waste.
• Isolation gloves and sleeves
• Microbiological air samplers.
• Bio-decontamination systems and equipment.
• Uninterruptible power supply (UPS) systems.
• Equipment and auxiliary components for handling and ergonomics.
• Specific accessories and consumables.

Please enquire about the configurations and accessories available for each application.