We are providing cost effective, precise but robust Equipment’s using a unique combination of analytical capabilities, instrumentation and technical expertise with 21 CFR Part 11 Compliance as per requirement.
We at Nexgen Scientific and its associates or channel partners strive to provide solutions in a timely manner with adamant commitment to quality, reliability and with utmost Efficiency.
Equipment Range: Includes Humidity chamber , Walk–In–Humidity Chamber , Photostability Chamber , B.O.D. Incubator and Bacteriological Incubator , Cold Chamber (2 °C to 8 °C) , Deep Freezer (Up to -40 °C) , Hot Air Oven , Biosafety cabinets, Verticle LAF / Horizontal LAF / R LAF units, Horizontal and Verticle Autoclave, Seed Germinator , Vacuum Oven, Muffle Furnace , Dynamic Passbox, etc.
Humidity chamber |
Technical Specification
Temperature Range:20°C - 60 °C
Humidity Range: 40%RH - 95%RH
Accuracy: +0.2 °C / +2.0 % RH
Uniformity: +1.0 °C / +3.0 % RH
Test suitable for: 25°C & 60%RH, 30°C & 65%RH,
40°C & 75%RH, 30°C & 75%RH
Specially designed chambers for Low Humidity conditions
such as 25°C & 40%RH,
40°C & 25%RH , 30°C & 35%RH.
Variants: 200 ltrs to 3000 Ltrs
21 CFR PART-11 Compliance
Log data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis& Data acquisition.
Optional Features
STAND BY REFRIGERATION SYSTEM
STAND BY STEAM GENERATOR SYSTEM
SCANNER
GSM TECHNOLOGY
HOOTER SYSTEM
EXTRA TRAY
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Walk-In-Humidity Chamber |
Technical Specification
Temperature Range: 20°C - 60 °C
Humidity Range: 40%RH - 95%RH
Accuracy: +0.2 °C / +2.0 % RH
Uniformity: +1.0 °C / +3.0 % RH
Test suitable for: 25°C & 60%RH, 30°C & 65%RH,
40°C & 75%RH, 30°C & 75%RH
Specially designed chambers for Low Humidity conditions,
such as 25°C & 40%RH,
40°C & 25%RH, 30°C & 35%RH.
Variants : 6000 to 18000 Ltrs
Optional Features
GSM TECHNOLOGY
HOOTER SYSTEM
EXTRA TRAY
Scanner
For Validation purpose Temp / Humidity multipoint Scanner can be provided with printer & PC interface facility.
21 CFR PART-11 Compliance
Log data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis& Data acquisition.
Stand by Refrigeration & Humidity System
Two steam generators and two water reserve tanks are provided. In case of any system failure or breakdown the stand by system is switched over automatically without disturbing the test condition.
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Photostability Chamber |
Technical Specification
Temperature Range: 20°C - 50°C
Accuracy: + 0.2 °C
Uniformity: + 1.0°C
Variants : 200 to 400 Ltrs
For confirmatory studies, samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours / square meter to allow direct comparison
to be made between drug substance & drug product.
Our Photostability Chambers are designed specifically to meet ICH & FDA requirements for Photostability testing.
Optional Features
GSM TECHNOLOGY
HOOTER SYSTEM
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BOD Incubator |
Technical Specification
Temperature Range: 10° C to 60 °C
Accuracy: + 0.2 °C
Uniformity: + 1.0 °C
Variants : 200 ltrs to 3000 Ltrs
Features
21 CFR PART-11 Compliance
Log data, Event data, Audit Trail data, E-Records &
E-signatures, Graphical analysis & Data acquisition.
Optional Features
SCANNER
GSM TECHNOLOGY
HOOTER SYSTEM
EXTRA TRAY
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Bacteriological Incubator |
Technical Specification
Temperature Range: 10° C above ambient to 60 °C
Accuracy: + 0.5 °C
Uniformity: + 1.0 °C
Variants : 200 to 300 ltrs
Features
21 CFR PART-11 Compliance
Log data, Event data, Audit Trail data, E-Records &
E-signatures, Graphical analysis & Data acquisition.
Optional Features
SCANNER
GSM TECHNOLOGY
HOOTER SYSTEM
EXTRA TRAY
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Cold Chambers |
Technical Specification
Temperature Range: 2° C to 8 °C
Accuracy: +1.5 °C
Uniformity: +2.0 °C
Variants : 200 to 3000 Ltrs
Features
21 CFR PART-11 Compliance
Log data, Event data, Audit Trail data, E-Records &
E-signatures, Graphical analysis & Data acquisition.
Optional Features
SCANNER
GSM TECHNOLOGY
HOOTER SYSTEM
EXTRA TRAY
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Deep Freezer |
Technical Specification
Temperature Range: UPTO - 40 °C
Accuracy: + 3 °C
Uniformity: + 3 °C
Variants : 275 and 575 Ltrs
Features
Eco Friendly PUF Insulation has thickness of 80mm. Projected door prevents condensation & allows product view. Inner & outer doors are sealed around the entire perimeter by silicone sponge rubber gasket.
Bullet feet with in-built screwing adjustment are specially designed for long life under heavy load.
Heavy Duty refrigeration system, maintenance free, with hermetically sealed refrigeration compressors and reliable refrigeration to minimize noise and vibration.
21 CFR PART-11 Compliance
Log data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis & Data acquisition.
Optional Features
GSM TECHNOLOGY
HOOTER SYSTEM
EXTRA TRAY
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Hot Air Oven |
Technical Specification
Temperature Range: 10 °C Above ambient to 250 °C
Accuracy: ± 1°C
The gap between inner & outer walls of chamber is filled with high grade mineral glasswool of thickness 4”, which ensures maximum thermal efficiency.
The combination of airflow, instrument response and fast reacting heaters provides very accurate and straight line control of temperature. These heaters have a long life and are very reliable with no down time.
A high efficiency air circulation system is an integral part of chamber construction. This direct drive design has an extended shaft electric motor coupled to aluminum centrifugal blower wheel. This horizontal airflow across the chamber working space provides an even and accurate temperature gradient.
Printer Interface Facility for data printing directly at desired print intervals.
Electronic Timer provided which will cut off the supply after testing period with audio video alarm.
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Biosafety cabinets |
Technical Specification
Supply filter : EU-14 Grade at supply position with an efficiency rating better than 99.999% down to 0.3µ.
Exhaust
HEPA filter : EU-14 Grade at exhaust position with an efficiency rating better than 99.999% for 0.3µ.
Pre-filter : EU 6 grade, with an efficiency rating better than 95% down to 5µ.
Other Parts Includes
Motor Blower Assembly , Differential Pressure Gauge , Fluorescent light (250 Lux) ,
SS 304 work table , Front door , Door Opening Alarm , Exhaust Duct , Minimum Noise Level , Minimum Vibration Level .
Optional Features
Front door with gloves and glove port arrangement ,Transfer hatch for material movement , PLC based control system
U.V. Light with hour meter ,SS 304 cock for gas and air , Foldable polycarbonate front door ,Audio visual alarm indicating condition of HEPA filters ,Clean down timer with operation hold indicator , VFD based control systems , Photohelic guage / Digital pressure gauge to monitor of pressure drop across filter.
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Vertical / Horizontal LAF units / R LAF
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Technical Specification
Supply filter : EU-14 Grade at supply position with an efficiency rating better than 99.999% down to 0.3µ.
Pre-filter : EU 6 grade, with an efficiency rating better than 95% down to 5µ.
Other Parts Includes
Motor blower Assembly, Differential Pressure Gauge , Fluorescent light with milky white diffuser (250 Lux) ,
ON/OFF Switches ,Switch Socket ,Work Table , DOP Port , Minimum Noise Level , Minimum Vibration Level.
Optional Features
U.V. Light with hour meter , SS 304 cock for gas and air , Foldable polycarbonate front door ,Audio visual alarm indicating condition of HEPA filters , VFD based control systems , Photohelic guage / Digital pressure gauge to monitor of pressure drop across filter, Sodium vapor lamps.
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Horizontal and Vernicle Autoclave
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Technical Specification
Working pressure: 1.2 to 1.7 kg
Working temperature: 121°C to 134°C
Inner working chamber: Stainless steel 316 grade of 6mm thickness
Chamber flange: Stainless steel 304 grade of 10mm thickness
Steam jacket: MS Boiler / SS 304 of 10 mm thickness
Door: Thick Stainless Steel door of 15mm thick
For Double Door Option: Two thick SS doors of 15mm thickness, one opening in sterile area and the other opening in non sterile area
Outer cabinet : Stainless steel 304 grade of 1mm thick - mirror finish
Other fittings
Piping: Stainless steel 316 grade good quality seamless
Fittings: Stainless steel 316 grade with B.S.P thread
Insulation :Rock wool slabs 50mm thick
Gasket: Silicon joint less.
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Seed Germinator
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Technical Specification
Temperature Range: 5°C to50°C
Temperature Fluctuation: ±0.5°C
Temperature Uniformity: ±1°C
Temperature Precision: ±0.1°C
No. of Chambers : Single / Double Chamber
Temperature Controller: PID Controller
Relative Humidity Range: 10% RH to 95% RH
Humidity: Natural humidity with water inside
External Construction: Powder Coated 304 Grades Stainless Steel
Lighting: Fluorescent Lamps
Doors: Solid and Glass Doors w/ magnetic gasket
Insulation: PU Foam
Shelves: Painted Steel wire
Refrigerant: CFC-free refrigerant
Timer: Automatic
Alarm: Audio / Visual Alarm for temp & humidity deviations
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Vacuum Oven
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Technical Specification
Maximum Temperature: Standard 250°C Optional 300-400 °C
Temperature :Fluctuation + / - 1°C
Temperature :controller PID Controller or HMI Controller or PLC Based
Sensor type: PT100
Inner chamber: SS 304
Exterior: Powder coated galvanized steel
Insulation: Glass wool
Shelves: 1 or 2
Ports: Vacuum port, Inert gas port and Vent port
Safety Device: Over pressure limit / Over load breaker / Timer & Alarm, fuse
Vacuum Range: 10 mbar to 1100 mbar
Vacuum Control: Digital electronic vacuum control through solenoid valves
Vacuum pump: Standard or oil-free pump
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Muffle Furnace
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Technical Specification
Temperature Accuracy: +/- 1°C (+/- 1.8°F)
Temperature Controller: PID controller
Display: LED / LCD Display
External Chamber Construction: MS w/ Powder Coating / 304 Grade Stainless Steel (Optional)
Internal Chamber Construction: Ceramic Board & Grooved Refractory Chamber as per Temp. Requirement
Insulation: Ceramic wool insulation
Alarm: Audible & Visual type
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Static / Dynamic Pass box
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Technical Specification
HEPA Filter : EU-14 Grade at supply position with an efficiency rating better than 99.999% down to 0.3µ.
Pre-filter : EU 6 grade, with an efficiency rating better than 95% down to 5µ.
Other Parts include : Motor blower Assembly , Differential Pressure Gauge , Doors , Interlocking ( Electro-Magnetic), Door Indication , Door release switch on either side , SS coving , ON/OFF , DOP Port Minimum Vibration and noise level.
Optional Accessories :
U.V. Light with Hour Meter , Support stand for mounting of pass box , Floor mounted construction with three side wall structure & Door drop seal , Audio visual alarm indicating condition of HEPA filters
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