Clean Room Equipments
Pass Box
Static Pass Box

In pharmaceuticals manufacturing facilities it is essential to minimise man / material movement and to avoid cross contamination between different classified areas to achieve desired classification & to maintain integrity of products & processes.

passthru™ is designed to allow material transfer without much personnel movement. It also aids controlling ingress of particulate contaminants into clean rooms & between different classified areas.

passthru™ is available in powder coated Mild Steel, SS 304 / SS 316/ SS 316L or a combination of both.

General Specifications

  • Double Walled Construction
  • Doors with double walled flush glass view panels
  • SS Handles & SS hinges
  • Internal covings for easy cleaning
  • Electro-magnetic Interlocking
  • Door Release Switch on either side
  • Indicator on either side

 

Standard Models

Model Work Area Dimension (L x W x H)
PT-18-18-18 450 x 450 x 450 mm
PT-24-24-24 610 x 610 x 610 mm

 

passthru™ is with a variety of standard dimensions.
Also our passthru™ can be custom engineered to any size.

 

Operating Conditions
POWER SUPPLY : 230V AC 1-Ø 50HZ

 

Options and Accessories
A wide range of configurations to suit any application :

  • Mechanical Interlocking
  • Provision for ventilation with perforated grills
  • U. V. Light with Hour Meter with interlocking arrangement to put-off U.V. Light if either door opens
  • Three wall construction in case of floor mounting
  • Floor mounted construction with three side wall structure & Door Drop Seal
  • Support stand to mount the pass box
  • Flange for sealing the gap between the pass box and the clean room wall

 

Dynamic Pass Box

steripass™ is designed to allow material transfer through controlled environment without much personnel movement. It also aids controlling ingress of particulate contaminants into clean room & between different classified areas.

steripass™ is available in powder coated Mild Steel, SS 304 / SS 316/ SS 316L or a combination of both.

General Specifications

  • Two Stage filtration
    • EU6 – Prefilter (95% down to 5 micron)
    • EU14 - HEPA Filter – Supply (99.999% down to 0.3 micron)
  • Statically & Dynamically balanced Motor-blower with suspension arrangement to reduce noise level
  • Doors with double walled flush glass view panels
  • SS Handles & SS hinges
  • Internal covings for easy cleaning
  • Electro-magnetic Interlocking
  • Indicator on either side
  • Door Release Switch on either side
  • Differential Pressure Gauge : 1 No.
  • On / Off Switch for Motor
  • DOP Test Port

 

Standard Models

Model Work Area Dimension (L x W x H)
PT-18-18-18 450 x 450 x 450 mm
PT-24-24-24 610 x 610 x 610 mm

 

steripass™ is with a variety of standard dimensions.
Also our steripass™ can be custom engineered to any size.

 

Operating Conditions

A wide range of configurations to suit any application :

  • Mechanical Interlocking
  • U. V. Light with Hour Meter with interlocking arrangement to put-off U.V. Light if either door opens
  • Floor mounted contruction with three side wall structure & Door Drop Seal
  • Support Stand to mount the pass box
  • Flange for sealing the gap between the pass box and the cleanroom wall

 

Laminar Flows

Vertical Laminar Air Flow Unit

vertiflo™ is designed for offering highest product protection for samples and processes by providing ISO Class 5 particle free work area. vertiflo™ offers proven protection for the samples and processes. The work area is continuously supplied with positive pressure HEPA filtered Vertical air flow. Vertical unidirectional airflow prevents contamination from operator and environment to workarea. The laminarity of the flow prevents cross contamination between the items handled in the working space.

vertiflo™ is suitable for the handling of non hazardous products sensitive to dust and/or to contamination wherever operator protection is not required.
vertiflo™ is available in powder coated Mild Steel, SS 304 / 316 / 316L or a combination of both.

Standard Models

Model Hepa Filter Area (L x W) Work Area Dimension (L x W x H)
CSVF-48-24 1220 x 610 MM 1320 x 760 x 685 MM
CSVF-36-24 915 x 610 MM 1015 x 760 x 685 MM

 

vertiflo™ is with a variety of standard dimensions. Also our booths can be custom engineered to any size.

 

General Specifications

  • Two Stage filtration
    • EU6 – Prefilter (95% down to 5 micron)
    • EU14 - HEPA Filter (99.999% down to 0.3 micron) at supply position
  • Statically & Dynamically balanced Motor-blower with suspension arrangement to reduce noise level
  • SS work table with due reinforcement
  • Glass side panels
  • Fluorescent Lights with Milky White Diffuser
  • Differential Pressure Gauge : 1 No.
  • ON/OFF Switches
  • Clean Down Timer with Operation HOLD indicator
  • DOP Test Port
  • 5/15 Amp Switch Socket for external equipment

 

Operating Conditions
Air cleanliness : ISO Class 5 (ISO 14644-1:1999 (E))
Air Velocities :    0.45 ± 0.05 mps
Air Flow :             Horizontal
Noise Level :      Less than 67 dB
Vibration Level : Minimum
Light intensity :   > 300 lux
POWER SUPPLY : 230V AC 1-Ø 50HZ

 

Options and Accessories
A wide range of configurations to suit any containment application :

  • Front doors (hinged/pneumatic cylinder)
  • U. V. Light with Hour Meter
  • Air / Gas Cock
  • Night Mode Operation
  • Filter blocked alarms (audible and visible)
  • Velocity display with alarms (audible and visible)
  • Explosion proof electrics for Flame-proof applications

 

Horizontal Laminar Air Flow Unit

horiflo™ is designed for offering highest product protection by providing ISO Class 5 particle free work area for handling critical process. horiflo™ offers proven protection for the samples and processes. The work area is continuously supplied with positive pressure HEPA filtered horizontal air flow.

Horizontal unidirectional airflow speed prevents contamination from operator and environment to workarea. The laminarity of the flow prevents cross contamination between the items handled in the working space.

horiflo™ is suitable for the handling of non hazardous products sensitive to dust and/or to contamination such as injectable medicines, cell and tissue cultures, food sample preparation for sterility testing, sterile packaging and I.V. pharmacy preparations as well as micromechanics, optics, electronics. horiflo™ is available in powder coated Mild Steel, SS 304 / SS 316/ SS 316L or a combination of both.

 

General Specifications

  • Two Stage filtration
    • EU6 – Prefilter (95% down to 5 micron)
    • EU14 - HEPA Filter – Supply (99.999% down to 0.3 micron)
  • Statically & Dynamically balanced Motor-blower with suspension arrangement to reduce noise level
  • Doors with double walled flush glass view panels
  • SS Handles & SS hinges
  • Internal covings for easy cleaning
  • Electro-magnetic Interlocking
  • Indicator on either side
  • Door Release Switch on either side
  • Differential Pressure Gauge : 1 No.
  • On / Off Switch for Motor
  • DOP Test Port

 

Standard Models

Model Hepa Filter Area (L x W) Work Area Dimension (L x W x H)
HF-36-24-24 915 x 610 MM 915 x 610 x 610 MM
HF-48-24-24 1220 x 610 MM 1220 x 610 x 610 MM
HF-48-24-30 1220 x 760 MM 1220 x 610 x 760 MM
HF-48-30-30 1220 x 760 MM 1220 x 760 x 760 MM
HF-72-24-24 1830 x 610 MM 1830 x 610 x 610 MM

 

horiflo™ is with a variety of standard dimensions. Also our units can also be custom engineered to any size.

 

General Specifications
A wide range of configurations to suit any application :

  • Glass Side panels
  • Two Stage filtration
    • EU6 – Prefilters (95% down to 5 micron)
    • EU14 - HEPA Filter (99.999% down to 0.3 micron) at supply position
  • Statically & Dynamically balanced Motor-blower with suspension arrangement to reduce noise level
  • SS work table with due reinforcement
  • Fluorescent Lights with Milky White Diffuser
  • Differential Pressure Gauge : 1 No.
  • ON/OFF Switches
  • Clean Down Timer with Operation HOLD indicator
  • DOP Test Port
  • 5/15 Amp Switch Socket for external equipment

 

Operating Conditions
Air cleanliness : ISO Class 5 (ISO 14644-1:1999 (E))
Air Velocities : 0.45 ± 0.05 mps
Air Flow : Horizontal
Noise Level : Less than 67 dB
Vibration Level : Minimum
POWER SUPPLY : 230V AC 1-Ø 50HZ

 

Options and Accessories
A wide range of configurations to suit any containment application :

  • Front doors (hinged/pneumatic cylinder)
  • U. V. Light with Hour Meter
  • Air / Gas Cock
  • Night Mode Operation
  • Filter blocked alarms (audible and visible)
  • Velocity display with alarms (audible and visible)
  • Explosion proof electrics for Flame-proof applications

 

Bio safety cabinet

biosafe™ is designed to provide personnel, environmental and product protection. Air flow is drawn around the operator into the front grille of the cabinet, which provides personnel protection.

In addition, the downward laminar flow of HEPA-filtered air provides product protection by minimizing the chance of cross-contamination along the work surface of the cabinet. Because cabinet air passes through the exhaust HEPA filter, it is contaminant-free (environmental protection).

All Class II cabinets are designed for work involving microorganisms assigned to biosafety levels 1, 2 and 3. Class II cabinets provide the microbe-free work environment necessary for cell culture propagation, and also may be used for the formulation of nonvolatile antineoplastic or hemotherapeutic drugs. biosafe™ is available in powder coated Mild Steel, SS 304 / SS 316 / SS 316L or a combination of both.

 

Standard Models

Model Hepa Filter Area (L x W) Work Area Dimension (L x W x H)
BS-36-24-24 915 x 610 MM 915 x 610 x 610 MM
BS-48-24-24 1220 x 610 MM 1220 x 610 x 610 MM

 

biosafe™ is with a variety of standard dimensions. Also our units can be custom engineered to any size.

 

General Specifications

  • Two Stage filtration
    • EU6 - Intermediate Filter (95% down to 6 micron)
    • EU14 - HEPA Filter - Supply / Exhaust (99.999% down to 0.3 micron)
  • Statically & Dynamically balanced Motor-blower with suspension arrangement to reduce noise level
  • Double walled flushed Glass Side Panels
  • SS 304 work table with perforations at front & back which can be removed occasionally for cleaning purpose
  • 1-piece fully openable sliding toughened glass front door with counterweight arrangement
  • Sealed Fluorescent Lights with Milky White Diffuser
  • Differential Pressure Gauges : 2 Nos.
  • ON/OFF Switches for motor & Lights
  • Clean Down Timer with Operation HOLD indicator
  • Alarm triggers in case front door is raised more than 8” (i.e. safe clear opening during operation)
  • DOP Test Port
  • 5/15 Amp Switch Socket for external equipment
  • SS 304 stands with leveling lugs
  • SS 304 1 ft long elbow duct for exhaust

 

Operating Conditions
Air cleanliness : ISO Class 5 (ISO 14644-1:1999 (E))
Air Velocities : 0.45 ± 0.05 mps
Air Flow : Vertical - Recirculatory
Noise Level : Less than 67 dB
Vibration Level : Minimum
Light intensity : > 300 lux
POWER SUPPLY : 230V AC 1-Ø 50HZ / 415V AC 3-Ø 50HZ

 

Options and Accessories
A wide range of configurations to suit any containment application :

  • Night Mode Operation
  • Filter blocked alarms (audible and visible)
  • Velocity display with alarms (audible and visible)
  • Explosion proof electrics for Flame-proof applications
  • Once through System
  • Front doors with Glove arrangement
  • Transfer hatch for material movement
  • PLC based Control System
  • Safe change Bag in/Bag out arrangement for filters

 

Air Showers

sterijet™ is designed to supply Class 100 HEPA filtered air at high velocity to remove particulate matter from the person entering into the Clean Room.

 

General Specifications

  • Two Stage filtration
    • EU6 - Prefilter (95% down to 5 micron) for return air & fresh air intake
    • EU14 - HEPA Filter (99.999% down to 0.3 micron) at supply position
  • SS 304 doors with double walled flush glass view panels & door closer
  • Statically & Dynamically balanced Motor-blowers with suspension arrangement to reduce noise level for suction and booster
  • Differential Pressure Gauge : 1 No.
  • ON/OFF Switches
  • DOP Test Port
  • 5/15 Amp Switch Socket for external equipment
  • Control Systems – to ensure that both the doors cannot open at the same time & to ensure that both the doors will be locked during the time air flow is on.
  • Timer for setting Air Shower operation time (settable for 30 seconds to 5 minutes)
  • Emergency STOP
  • Straight Entry – Straight Exit / 90o Door Opening
  • Automatic as well as Manual Mode

 

Standard Models

Model Work Area Dimension (L x W x H)
SJ-001 700 x 850 x 2000 MM
SJ-002 700 x 1200 x 2000 MM

 

Operating Conditions
Air cleanliness : ISO Class 5 (ISO 14644-1:1999 (E))
Air Velocities : 18 - 20 mps
Vibration Level : Minimum
POWER SUPPLY : 415V AC 3-Ø 50HZ

 

Isolators

Isolation technology has shown tremendous potential due to various technological developments 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

Class Hourly Leak Rate
Rh
h-1
Pressure Integrity Test Methods
1 < 5 * 10-4 High Oxygen method, Pressure change method or Parjo method
2 <2.5 * 10-3 Medium Oxygen method, Pressure change method or Parjo method
3 <10-2 Low Oxygen method, Pressure change method or Constant Pressure method
4 <10-1   Constant Pressure method

 

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
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