Our Services - 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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ISOLATOR VALIDATION​

ISOVAX conducts Validation tests for all solutions provided, in compliance with the appropriate standards and testing guidelines. All containment devices must be accompanied with the basic qualification package, which includes DQ, IQ, OQ, and PQ.

Here’s the list of all the validation tests covered by ISOVAX:

  • Leak Test
  • Blower Test
  • Drain test
  • Filter integrity test
  • Particle count
  • Lux Level
  • Acoustic Sound Test
  • PLC test
  • Breach Velocity Test
  • Vibration Test
  • Velocity Test
  • Biological Validation (sterile isolation)
  • Recovery test

Surrogate Monitoring Test

Isovax, through Surrogate testing, aims to providing significant performance data prior to installation, that assists you in determining whether the isolators are compliant to the appropriate standards and capable of sufficing your requirement.

Surrogate testing is the use of a substitutes or surrogate compound that replicate an Active Pharmaceutical Ingredient (API) in order to validate the efficiency of dust containment alternatives for hazardous materials handling.

The test conditions are intended to imitate workplace activities as precisely as possible without the cost or health risks associated with handling the actual API.

Containment Consultancy

Developing containment solutions for various products and dosage forms is just as important to us as optimizing processing ideas for highly active compounds according to their Operator Exposure Limits (OELs). From idea through execution and qualification, ISOVAX holds expertise in solids manufacturing and liquid pharmaceutical filling, as well as Formulations and API containment facilities. Our team has extensive experience in the planning and implementation of containment projects.

Retrofit/Integration

For an existing facility, Isovax can help you extend the life of valuable, otherwise obsolete equipment, reduce the overall project cost and timescale, and optimizing your containment processes according to the respective OEL levels for:

  • Existing Process Machinery in Isolators – Restricted Access Barrier systems
  • Personnel protection measures
  • Airlock and pressure cascades
  • Material Flow methodology
  • Decontamination measures

This guarantees that you comply with the most recent industry rules and that your people, products and business receive maximum protection.

Technology Transfer

At ISOVAX, we are confident in our ability to facilitate technology transfers across the Globe, for the following reasons.

  • Improve public health in your community and help people get access to medications.
  • Encourage the growth of industry.
  • Reduce the dependency on imports in any country.
  • Disseminate information and make it technologically viable.

ISOVAX Offers End-To-End Technology Transfer Solutions based on Various Collaboration, Licenses, and Supply Models. Each development setup is distinct, based on the project’s goals and a thorough examination of the available information. Following consultation with in-house experts and close collaboration with you, we provide tailor-made solutions for your specific expectations of the targeted transfer.

Cleanroom Validation

A good validation system greatly reduces the risk of regulatory non-compliance. ISOVAX is backed by an experienced team of specialists that provide cleanroom validation services all around the world leveraging calibrated advanced equipment. The reports created are in the right forms, giving the customer a clear picture of any non-compliances, if any, with worldwide acceptable standards.

Our Clean room Validation Tests include:

  • Air flow pattern
  • Air flow velocity and changes                per hour
  • Filter leak test
  • Particle count
  • Viable monitoring
  • Filter integrity test
  • Fresh air determination
  • Temperature and humidity                      uniformity test
  • Recovery
  • Pressure difference
  • HEPA Integrity Test
  • Differential Pressure Tests
  • Blow Down Clean up and Recovery
  • Light Intensity
  • Noise
  • Temperature and RH Mapping

OEB validation

OEB (Occupational Exposure Band) is a mechanism used to precisely assign chemicals into “categories” or “bands” based on their adverse health outcomes and potency considerations. It also aligns chemicals in groupings based on OEL (Occupational Exposure Limit) in order to establish safe handling guidelines.

QUALITY WORK

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MANAGING PROJECTS

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GETTING MATERIAL

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INTERIOR DESIGN

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46

Projects

480

Employees

120

Sites

200

Clients

53

Firms

800

Days

  • Basic Plan
  • $46
    • Mobile optimized
    • Powerful Metrics
    • Free Custom Domain
    • Annual Purchase
Best price
  • Standard Plan
  • $66
    • Mobile optimized
    • Powerful Metrics
    • Free Custom Domain
    • Annual Purchase
  • Pro Plan
  • $86
    • Mobile optimized
    • Powerful Metrics
    • Free Custom Domain
    • Annual Purchase