API 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
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API Processing Isolators

The production of Active and Highly Potent Active Pharmaceutical Ingredients (API and HPAPI) has become a booming industry. The safe handling of bulk chemicals and very potent medicinal compounds need a carefully controlled environment with complete barrier isolation. ISOVAX ensures this containment with customized isolators tailored to the process needs; manufactured with precision and accuracy in your cleanrooms.

Negative pressure isolators that combine verified containment limits of less than 1 µg/m3 with ergonomic and maintenance efficiency can be designed and manufactured by us.

Common Features:-

  • Automated/ manual loading system
  • Laminar or Turbulent Airflow
  • N2 blanketing provision
  • CIP/ washable
  • Integrated/ Standalone VPHP.
  • All the isolators can be provided with Half suites/Full suites/air-fed helmets, dust masks.
  • HEPA filtration at inlet and outlet exhausts (with 99.997% efficiency).
  • Interlocked air-locks, doors, and visors
  • Breach/ Pressure change alarm
  • Digital or analogue pressure controller
  • PLC/HMI operation with 21CFR part 11 compliance
  • Designed as per operator convenience.
  • Clear visibility during operation and cleaning.
  • Pre-filters with (70% efficiency)

Isolators for Dispensing and Weighing

Dispensing Isolators are used to dispense material from various containers such as bags and drums into intermediate packaging or to charge directly into process equipment.
  • Two chambers
  • Side Chamber – inlet material
  • Central Chamber – Dispensing activities
  • Integrated weight scales with flush mounting
  • Material lifting arrangement provided for easy loading

Reactor Charging Isolator

There are various processes while handling the reactors with a potent API process; whether is the addition of a potent liquid or potent powder. There are SS reactors and Glass-Lined Reactors depending on the product’s nature.

ISOVAX provides containment operation with optimal protection and minimal risk.

    • Product sampling at high temperatures.
    • Addition of APIs or raw materials under operator protection.

Isolator for Sampling

  • In-process tests should be performed on the sampled material. The quality control dept. will be responsible for the testing.
  • Quality control personnel test samples to ensure conformity to requirements within permissible limits.
  • These tests are only used to fine-tune process parameters within a certain operating range.

ANFD Isolator

The ANFD (Agitated Nutsche Filter with Drying) is a closed system that uses filtration under pressure or vacuum to separate solid and liquid.

  • Enables the twin function of filtration and drying.
  • Split Butterfly valve for the discharge
  • Fixed or movable designs
  • Effective product removal with operator safety.
  • Liquid and dry powder sampling under a contained environment.
  • ISOLATOR is designed to have ANFD as an Integral part and vice versa for retrofitting.
  • Inert atmosphere can be maintained while product discharge too.

RCVD/DCVD discharge and scrapping

RCVD (Rota Cone Vacuum Dryer) is used to dry the heat-sensitive substances under vacuum at low temperatures.

  • ISOVAX provides a containment solution for the RCVD discharge with a Split butterfly valve.
  • Also, for the charging/scrapping, a glove box can be provided to assist product output.
VTD Isolator Isovax

ISOLATOR WITH VTD

  • Vacuum drying is a mass transfer operation that removes moisture from a substance, typically a wet solid, by creating a vacuum. Drying is an essential unit operation in chemical processing industries such as food processing, pharmacology, agriculture, and textiles to remove moisture.
  • ISOVAX builds customized Isolators with reference to the VTD and vice versa for retrofitting integration.

Isolator for Milling and Sifting

Milling is used to reduce the particle size of the product while sifting is used to segregate the particles.

  • Dust potential is very high at this stage.
  • Turbulent airflow is maintained inside the ISOVAX isolator
  • Inert atmosphere is maintained with N2 purging
  • The mill is designed in accordance with the Isolator and vice versa for retrofitting.

Milling can be achieved through the following as well:

  • Jet Mill
  • Cone mill
  • Micronizer
  • Pin Mill
  • Multi-mill