Containment Isolators
Description:

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 very according to the type of application. With in this environment simple and complex operation 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 those are importance things for the successful implementation of isolation system.




Isolator Applications Requirements for containment Processing

  • Generally operated under negative pressure to ensure max. Operator safely.
  • Negative pressure isolator is basically used for powder handling process and highly disperses products.
  • Well Designed capacity of motor and blower as per sufficient air flow requirement.
  • They must not exchange air with the surrounding environment (except through a HEPA filter)
  • Equipped with nitrogen supply if required
  • Negative pressure of-100Pa, Pneumatically controlled interlocked isolator door after start of operation.
  • Visual display indicates permanent status of the isolator.
  • Radii in the isolator chamber>15mm
  • 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
  • Negative isolator basically used for sampling, Dispensing, Quality checking, Product charging, Filtration, Drying, Milling, Sieving, Blending, Solution Preparation, Weighing and R& D purpose.

Isolator Integrity Leak-Testing
Four level Classification system of hourly leak rate
Class Hourly leak rate
Rh h-1
Pressure
integrity
Test methods
1 <5x104 High Oxygen method, pressure
change method or parjo
method
2 <2.5x102 Medium Oxygen method, pressure
change method or parjo
method
3 <104 Low Oxygen method, pressure
change method or
constant pressure Method
4 <103   constant pressure Method

OEL (OPERATOR EXPOSAL LIMITS) CATEGORIES:
OEL LIMITS: Products are classified according to hazards level that correspond to these five OEL level as shown in the chart below:
Categories Hazard Description  
OEL 1 Harmful, and/ or low pharmacological
activity
1000-
5000ug/m3
OEL 2 Harmful, and moderate
pharmacological activity
100-1000ug/m3
OEL 3 Moderately toxic and/ or high
pharmacological activity
10-100ug/m3
OEL 4 Toxic and/ or very high pharmacological
activity
1-1ug/m3
OEL 5 Extremely Toxic and /or extremely high
pharmacological activity
<1ug/m3

Isolator for sampling and Dispensing:
  • Negative pressure with respect to atmosphere.
  • Sampling Chamber: 1250Lx650/550WX800Hmm.
  • Dispensing chamber: 900Lx750/550WX800Hmm
  • 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: 1250Lx650/550WX900H 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 dryer (ANFD) Isolator:
  • Negative pressure with respect to atmosphere.
  • Chamber size: 1250Lx650/550WX900H 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.

Filtration Isolator:
  • Negative pressure with respect to atmosphere.
  • Chamber size: 1250Lx650/550WX900H mm.
  • Turbulent Air Flow
  • 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.
  • Chamber size: 1550Lx650/550WX900H 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.
  • Integrated with Nutsche filter and VTD

Granulation Isolator:
  • Negative pressure with respect to atmosphere
  • Chamber size: 1250Lx650/550WX1200H 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 with Weighing scale, Sifter,Multi mill and Blender.

Micronization Isolator:
  • Negative pressure with respect to atmosphere
  • Chamber size: 1250Lx650/550WX900H 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 with Micronizer (Airjet mill).

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.
  • Integrated with FBO, RCVD, ATD Isolators & also available

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 : AISI316L
Beta Canister : AISI316L/HDPE
Wash Gun
  • SS316/PTFE wash gun
  • Reach every corner of chamber
  • Flexible silicones/ SS braded hose pipe

Validation We provide following documentation
  • Functional Design Specification(FDS)
  • Design qualification(DQ)
  • Factory Acceptance Test(FAT)
  • nstallation 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