Containment Solutions(Isolators)

Containment Solutions(Isolators)

Isolation technology has shown tremendous potential due to various technological development such as transfer, filtration, granulation, ventilation systems etc.
Isolator means a physical barrier between a process and its operator. An isolator is closed system whose size and features vary according to the type of application. Within this environment simple and complex operations can be carried out, either manually or automatically. These operations can be conducted in controlled atmospheres, at particle or microbiological levels. Control system, quality of air and type of gases used inside the isolator are the important things for the successful implementation of an isolation system.
Isolator Applications Requirements for Containment Processing

  • Generally operated under negative pressure to ensure maximum operator safety.
  • Negative pressure isolator is basically used for powder handling process and highly dispersible products
  • Well designed capacity of motor and blower as per sufficient airflow requirement.
  • They must not exchange air with the surrounding environment (except through a HEPA filter)
  • Equipped with nitrogen supply if required
  • Negative pressure of -100 Pa
  • Pneumatically controlled interlocked isolator door after start of operation
  • Visual display indicates permanent status of the isolator
  • Radii in the isolator chamber >15 mm
  • Tightness test before each process
  • Push –push” system for exhaust air filters
  • Integrated Rapid Transfer Ports (RTP) for loading and discharging without compromising the surrounding environment.
  • Negative isolator is used for Sampling, Dispensing, Quality checking, Product charging, Filtration, Drying, Milling, Sieving, Blending, Solution Preparation, Weighing and R&D .

Isolator Applications Requirements for Aseptic Processing

  • Generally operated under positive pressure to ensure maximum product safety.
  • Positive pressure isolator is basically used for Sterile Operation.
  • Exhaust system will be based on recirculation basis.
  • Well Designed capacity of motor and blower as per sufficient airflow requirement.
  • They must not exchange air with the surrounding environment except when that air passes though a HEPA filter.
  • Typically classified as ISO 5 (Class 100, Grade A)
  • In cases of applications with hazardous bacteria, subsequent biological decontamination can be carried out by means of gaseous hydrogen peroxide (H2O2) or UV radiation.
  • Positive isolator is used for sterile transfer, filtration, sterility testing, loading and unloading of vials into lyophilizers and compact filling lines.

Isolator Integrity Leak-Testing
Four level classification system of hourly leak rate

OEL (OPERATOR EXPOSAL LIMITS) CATEGORIES:
OEL LIMITS: Products are classified according to hazards levels that correspond to these five OEL levels as shown in the chart below :

Categories Hazard Description
OEL 1 Harmful, and / or low pharmacological activity
OEL 2 Harmful, and / or moderate pharmacological activity
OEL 3 Moderately toxic and / or high pharmacological activity
OEL 4 Toxic and / or very high pharmacological activity
OEL 5 Extremely Toxic and / or extremely high pharmacological activity

 


Isolator for Sampling and Dispensing

  • Negative Pressure with respect to atmosphere.
  • Sampling chamber: 1250 L × 650/550 W × 800 H mm
  • Dispensing chamber : 900 L × 750/550 W × 800 H mm.
  • Turbulent Air Flow
  • Push-push type safe changeable HEPA filters
  • Digital pressure controller to maintain a constant pressure.
  • Fully PLC controlled
  • Fully washable.
  • Integrated Weighing Scale
  • Continuous liner port
  • Drum loading chamber or drum loader.

Reactor charging Isolator

  • Negative Pressure with respect to atmosphere.
  • Chamber Size: 1250 L × 650/550 W × 800 H mm
  • Turbulent Air Flow
  • Digital pressure controller to maintain a constant pressure.
  • Push-push type safe changeable HEPA filters
  • Fully PLC controlled
  • Fully washable.
  • Reactor charging port with flange end.

Agitated Nutsche filter pressure dryer(ANFD) Isolator

  • Negative Pressure with respect to atmosphere.
  • Chamber Size: 1250 L × 650/550 W × 800 H mm
  • Turbulent Air Flow under nitrogen atmosphere
  • Push-push type safe changeable HEPA filters
  • O2 monitoring
  • Digital pressure controller to maintain a constant pressure.
  • Fully PLC controlled
  • Fully washable.
  • Hinged type flange for ANFD docking.

Granulation Isolator

  • Negative Pressure with respect to atmosphere.
  • Turbulent Air Flow
  • Push-push type safe changeable HEPA filters
  • Digital pressure controller to maintain a constant pressure.
  • Fully PLC controlled
  • Fully washable.
  • Integrated with Weighing scale, Sifter, RMG, FBD, Co-mill and Blender .

Filtration Isolator

  • Negative Pressure with respect to atmosphere.
  • Turbulent Air Flow under nitrogen atmosphere
  • Push-push type safe changeable HEPA filters
  • O2 monitoring
  • Digital pressure controller to maintain a constant pressure.
  • Fully PLC controlled
  • Fully washable.
  • Integrated with nutsche filter and mother liquor.

Filtration and drying Isolator

  • Negative Pressure with respect to atmosphere.
  • Turbulent Air Flow under nitrogen atmosphere
  • Push-push type safe changeable HEPA filters
  • O2 monitoring
  • Digital pressure controller to maintain a constant pressure.
  • Fully PLC controlled
  • Fully washable.
  • Integrated with nutsche filter and VTD 4-Tray

R & D Isolator

  • Negative Pressure with respect to atmosphere.
  • Turbulent Air Flow
  • Push-push type safe changeable HEPA filters
  • Fully PLC controlled
  • Digital pressure controller to maintain a constant pressure.
  • Fully washable.

Isolator For Aseptic Filling and Capping Machine

  • Positive Pressure with respect to atmosphere.
  • Unidirectional (laminar) Air Flow
  • Minipleat HEPA/ULPA filters
  • ISO 14644-1: class ISo 5
  • Fully PLC controlled
  • Temperature controller to maintain isolator ambient temperature.
  • Digital pressure controller to maintain a constant pressure.
  • Fully washable.
  • Bag in bag out filters replacing method
  • Integrated with VHP (vaporised hydrogen peroxide) as per requirement.

Sterility Testing Isolator

  • Positive Pressure with respect to atmosphere.
  • Unidirectional (laminar) Air Flow
  • Minipleat HEPA/ULPA filters
  • ISO 14644-1: class ISo 5
  • Fully PLC controlled
  • Digital pressure controller to maintain a constant pressure.
  • Integrated CIP (clean in place)
  • Bag in bag out filters replacing method
  • Integrated with VHP (vaporised hydrogen peroxide) as per requirement.

Lyophilizer Isolator

  • Positive Pressure with respect to atmosphere.
  • Unidirectional (laminar) Air Flow
  • Minipleat HEPA/ULPA filters
  • Fully PLC controlled
  • Digital pressure controller to maintain a constant pressure.
  • Integrated CIP (clean in place)
  • Bag in bag out filters replacing method
  • Integrated with VHP (vaporised hydrogen peroxide) as per requirement.
  • Provision for lyo loading.

Rapid Transfer Port (RTP)

  • Rapid transfer port used as the contamination free transfer of product into and out of an isolator.
  • RTP (Interlocked, rotate type) active Alpha port bolted to the chamber at suitable location and passive with Beta canister is movable.
  • MOC : AISI 316L
  • Beta Canister : AISI 316L / HDPE

Wash Gun

  • SS 316/ PTFE wash gun
  • Reach every corner of chamber
  • Flexible silicone/ SS braded hose pipe

Validation
We provide following documentation,

  • Functional Design Specification (FDS)
  • Design Qualification (DQ)
  • Factory Acceptance Test (FAT)
  • Installation Qualification (IQ)
  • Operation Qualification (OQ)
  • Calibration Certificates
  • MOC Certificates
  • Site Acceptance Test (SAT)
  • Operation and Maintenance Manual (OMM)

Documentation will cover the following Tests,

  • Finishing Check
  • Dimensional Check
  • Levelling Check
  • Drain ability Check
  • Electrical Components Check
  • Lighting Level Check
  • Utilities Check
  • Fan Control Check
  • Leak Tightness Test
  • Air Change Rate Test
  • Area Classification Check
  • Recovery Time Determination Test
  • Glove Breach Test
  • Noise Level Check
  • HEPA Filter Integrity Check
  • RTP Operation Test
  • Oxygen Reduction Check
  • Deviation Reports