Specialised Isolators - Isovax Technologies
ISOVAX specializes in the containment of airborne particles often present when handling drug compounds in Pharma, Biotech and allied applications, and has a team that has years of experience in the supply of proven containment solutions
Containment, RABS, OEB, OEL, Isolators, Oncology, Hormone, VHP, API, OSD, Nitrile Gloves, Orings, Hypalon Gloves, Reactor Charging, Sterility, Leak Test, Surrogate Monitoring Test, Cleanroom, OEB Validation, Fume Hoods, Laminar Air flow, LAFs, Reverse Laminar Air Flow, RLAF, Biosafety Cabinet, Decontamination, Split Butterfly Valve, RTP, SBV, Rapid Transfer Port, Alpha Valve, Beta Valve, Walk In Isolator, Half Suit, cRABS, Closed Restricted Barrier access Barrier, Isolators , Positive Isolator , Negative Isolator, Positive and Negative Isolator , Personnel Protection, Product Protection , Occupational Exposure Level , OEL 5, OEL 4, Flexible Isolator, Rigid Isolator, Containment Solutions , Alpha Beta Port , RTP , Rapid Transfer Port, Liner , Oncology Project , hormone project , Cytotoxic projects, Steroids , Oncology API and Formulation Project, Oncology Tech Transfer , ORABS, CRABS , Restricted Access Barrier Systems , Sterility Isolator , Granulator Charging Isolator, Dry Isolator, Blending Isolator, Milling isolator, Dynamic Pass Box , Static Pass Through, Dispensing Booth , Sampling Booth, Ceiling Suspended Laminar Air Flow, LAF , Dedusting Booth, Air Shower , Misty Shower, Mist Showers , HLAF , Horizontal LAF , Bio Safety Cabinet , Garment Storage Cabinet, Clean Room Furniture, COB , Cross Over Bench, Pass Box, Pass through Hatch
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Specialized Isolators

ISOLATOR systems can be used for quality-critical, safety-critical, or combined applications.

Features

Automatic Leak Test: The isolators come with an automatic leak testing system that runs an independent leak test cycle for each chamber using ISO 10648-2 (5.2) (E) pressure change technique.

Isolators for Stem-cell/cell Culture/Live viruses

By eliminating any possibility of human contamination of cell cultures, the Cell Culture Isolator cGMP Class A/ISO 5 system provides users with a cell culture environment that is safer than settings in typical biosafety cabinets, clean booths, or regular cleanrooms. Integrated bio-decontamination system to allow 6-log bacterial reduction.

The Cell Culture Isolator is designed to execute cell and gene autologous therapeutic tasks such as the activation and transduction of non-infectious viruses, viral vectors, and other non-infectious viruses that could become infectious or overexpressed. With full integration of specific process equipment, such as incubator, digital microscope, centrifuge, and refrigerator.

The exhaust of the filters is connected with hot air to eliminate the viruses missed by the filters.

Isolators for Nuclear/Radiation/Radiopharma Applications

Radiopharmaceutical compounding isolators have a variety of features, capacities, and technical standards. Among them are:

  • Back, sides, bottom, and front of the work area are all covered in lead shielding.
  • Lead is contained between the unit’s internal and exterior stainless-steel panels, allowing it to comply with USP 797 without requiring extensive pharmacy ventilation upgrades (No need for ISO Class 8 cleanroom)
  • The isolator’s filtration system filters all supply and exhaust air from the work area and the antechamber to provide a completely enclosed and regulated environment.
  • Negative chamber Isolator.
Walk-In Isolator
  • In certain cases, processes building containment systems can be more of a barrier for operation and can limit the productivity of the system. Under these circumstances, a walk-in isolator is advisable to have ease of access, optimized efficiency of cost and energy.
  • Systems confirm leak test class 3 as per leak test classified in ISO 10648 – 2 standards. This system contains rigid multiple chambers having a dedicated environmental controlled system for each section.
  • A Bubble type pressure gradient system in the Airlock will serve as an entrance to the walk-in stability chamber, this shall ensure double protection from cross-contamination of external air entering into the main processing chamber.
  • Gowning activity will be carried out in this Airlock. The person will wear Safety hoods, Coveralls, Air fed suit, breathing accessories, etc., and then will enter the Air shower which shall lead them to the Main processing area which can be customized to suit the process.
  • The processing chamber, material entry and exit pass boxes, and packing chamber are constructed from single skin SS 316 L materials with sufficient coving radius and TIG welded to ensure a crack and crevice-free smooth inner surface.
  • The operator will then exit through a mist shower which is a self-contained modular chamber with toughened glass doors designed to deliver mist which shall ensure decontamination and dust potential reduction before the operator de-gowns and exits the walk-in isolator.
Flexible Isolator

Flexible isolators from ISOVAX are a simple-to-use flexible containment device that has shown to be exceptionally successful for handling active pharmaceutical components and other potentially hazardous compounds.

ISOVAX flexible isolators can be utilized at any stage of the manufacturing process when the operator needs access to the process while maintaining a high level of containment and GMP compliance.

 Applications

  • Contained filter change out
  • Inspection
  • Dispensing
  • Vessel charging
  • Dryer discharging
  • Contained sampling
  • Reactor charging
VHP Pass box

VHP Pass Box is a machine designed to perform the low-temperature superficial bio-decontamination of materials using vaporized hydrogen peroxide (VHP). We assure log 6 efficacy for bio  decontamination. It is used to bring goods into sterile areas that can’t be sterilized in an autoclave, such as heat-sensitive products like sterile Petri dishes; sterile materials for validation or cleaning activities, such as disinfectants; electronic particle meters; clothes, and so on. It’s also commonly used to disinfect day-to-day production materials that can’t be sterilized with steam, like rubber stopper bags and API aluminum containers.

Working:

The hydrogen peroxide is heated using a built-in VPHP generator, which converts it from liquid to vapor. This is blown into the chamber, generating a fatal environment that kills bacteria, viruses, and fungi. Each stage of the process is meticulously monitored, ensuring flawless performance over time.

Sterility Test Isolator

Sterility Test Isolator is a cGMP Class A/ISO 5 modular isolator system built exclusively for Sterility Testing, ensuring the safest working conditions possible during Quality Control Operations.

It’s a versatile piece of equipment that ensures the optimal working conditions for a variety of tasks, including sterility testing, aseptic dispensing and sampling, and aseptic product transfer.

Guaranteed Asepsis: Sterility Test Isolator ensures the highest air quality in the isolated environment thanks to: – an engineered filtration system consisting of High-Efficiency Particulate Air (HEPA H14) inlet, unidirectional downflow, return, and exhaust filters; – our integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for a very fast bio-decontamination cycle.

Isolator for Poultry Vaccine Manufacturing Process

There are several critical factors to consider when creating new poultry vaccinations. The cost of the finished product is likely the most important of these, since this will generally dictate the approach taken and uptake by the end-user.

 

To prevent and control contagious poultry diseases, poultry vaccinations are frequently used. Their usage in chicken production aims to prevent or reduce the emergence of clinical disease on the farm, hence enhancing output. Vaccines and immunisation programmes are generally controlled by the poultry industry and vary widely depending on numerous local circumstances (e.g., kind of production, local pattern of disease, expenses, and potential losses). For both the commercial and governmental sectors, the financial losses caused by the two epidemic diseases of poultry (avian influenza and Newcastle disease) have been substantial in the recent decade.