OSD - 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
522
page-template-default,page,page-id-522,wp-custom-logo,bridge-core-2.9.8,qodef-qi--no-touch,qi-addons-for-elementor-1.6.9,qode-page-transition-enabled,ajax_fade,page_not_loaded,,qode-title-hidden,qode_grid_1400,side_menu_slide_from_right,footer_responsive_adv,transparent_content,qode_disabled_responsive_button_padding_change,qode-theme-ver-28.2,qode-theme-bridge | shared by wptry.org,wpb-js-composer js-comp-ver-6.7.0,vc_responsive,elementor-default,elementor-kit-10,elementor-page elementor-page-522

ISOLATORS FOR OSD LINE

To protect operators, the production and handling of HPAPI or dangerous products (in gas or powder form) necessitate complete product isolation from the environment. Within the isolator’s closed volume, a negative pressure regime is maintained. Turbulent flow is commonly used.

Containment concerns are becoming increasingly significant in the manufacturing of solid dosage forms.

More than half of all novel chemical entities (NCEs) are classed as powerful (OEL 10 µg/m3), indicating that active pharmaceutical ingredients (APIs) are becoming increasingly effective.

The activity starts with the complete closed-loop system; dispensing & weighing, granules are formed, the bulk is dried, the product is sent for milling and sifting, and blending, then to the tablet compression and blister packing.

Operator access to isolator inside via glove ports or half-suit configuration. Containment levels from 10µg/m3 to 0,01µg/m3 are available, with different manufacturing solutions and configurations.

COMMON FEATURES:

  • Interlocked air-locks, doors, and visors
  • Breach/ Pressure change alarm
  • Digital or analogue pressure controller
  • PLC/HMI operation with 21 CFR part 11 compliance
  • Designed as per operator convenience.
  • Clear visibility during operation and cleaning.
  • Pre-filters with (70% efficiency)
  • HEPA filtration at inlet and outlet exhausts (with 99,997% efficiency).
  • BIBO Filtration Unit
  • Automated/ manual loading system
  • Laminar or Turbulent Airflow
  • N2 blanketing provision
  • CIP/ washable (WIP wash in place)
  • Integrated/ Standalone VPHP.
  • All the isolators can be provided with Half suites/Full suites/air-fed helmets, dust masks.
1.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
2.Granulation
  • The complete granulation line can be inside the isolator; Capacity range up to 10kg
  • Operator safety ensured.
  • Ease of operation
  • For capacity over 10kg, we provide a contained granulation line
  • Product transfer through VTS, creating a closed loop.
3.Milling

Milling is a procedure that can produce fine dust particles; this is a problem that needs to be thoroughly studied and investigated in order to maintain correct levels of containment, ergonomy, and process accuracy.

As a result, deciding whether or not to combine a mill with an isolator is a critical technical decision.

Even if the process room itself does not comply with ATEX, housing the mill inside an isolator can meet ATEX criteria inside the isolator.

The mill is integrated with the Isolator with the help of a body flange. The physical division of the cone mill head by the technical area left outside the isolator is made possible by this mounting flange and the specific layout of the cone mill.

4.Tablet compression
  • Compression is the most difficult part of the tablet manufacturing process when dealing with highly potent substances, due to the intricate geometry of tablet presses.
  • The machine is ideal for direct compression because it provides total separation between the processing and mechanical areas, reducing the number of surfaces in touch with the product.
  • In all scenarios – production, end of batch, maintenance, emergency, blackout – sealed doors and negative pressure inside the processing area ensure the safety of both operators and the environment.
  • Thanks to fixed spray nozzles, turret rotation, and proprietary solutions, the system can achieve OEB 5 in all of the above scenarios.
  • A completely automated cleaning cycle can be carried out at the end of WIP for Health & Safety decontamination.
  • To begin the cleaning cycle, the operator just needs to remove the size pieces and attach the cleaning devices.
5.Tablet coating

The high-sealing coating equipment is mostly used for coating API high-active ingredients on tablets. 

  • The rigorous isolation system protects operators, materials, and the environment while also allowing several coating processes to be completed.
  • The intake air handling unit feeds clean hot air to the tablet bed under negative pressure, according to established processes and process parameters, to dry the tablets or pills. 
  • The hot air from the outlet air handling unit is discharged at the bottom of the layer of tablets or pills, causing the coating media sprayed on the tablets or pills to quickly form a solid, dense, flat, and smooth film, completing the coating operation.
  • Glove ports and RTPs (Rapid Transport Ports) provide access to the isolated area, allowing the operator to work in the protected area without being contaminated. 
  • The number of glove ports and RTPs needed can be determined according to the operations’ needs.
6.IPQC

IPQC isolator is used for testing tablets or capsules in the production area for QC (Quality Control) analysis and approval.

  • High Potent tablets are dusty
  • High Potent Capsules can break open or leak
  • Highly Potent API powder must be checked

Structure:

  • Airlock to introduce bags of products
  • L-shape to maximize the length of the working chamber gives ample room for all instruments:
  • Analytical balance
  • Moisture analyzer
  • Weight variation system
  • Hardness tester
  • Friability tester
  • Automatic disintegration tester
7.Blister packing

The operator may correct any tablet process line packaging irregularities in a safe, hygienic, and totally contained environment using these high integrity barrier isolators, which are an intrinsic part of the tablet blister packaging machine.