Humidity Chamber
Humidity Chamber
Humidity Chambers are used in performing “Stability Studies”. Stability studies provide an evidence on the changes in the quality of product with Time, under the influence of varied environmental factors: Temperature, Humidity.
Evaluation of product (API or Formulations) under recommended storage conditions, ( with appropriate tolerances) that test its “Thermal Stability” & if applicable, its sensitivity to moisture.
In simple words, Stability can be expressed as: “The capacity of a drug to remain within specifications established, to assure its Integrity, Strength, Quality & Purity”
Specially designed chambers for Low Humidity conditions such as
• 25°C & 40%RH
• 40°C & 25%RH
• 30°C & 35%RH
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TECHNICAL SPECIFICATION
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Temperature Range
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20°C to 60°C
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Humidity Range
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40% RH to 85% RH
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ICH Test Condition
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25°C/60% RH
40°C/75% RH
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30°C/65% RH
30°C/75% RH
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Accuracy
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± 0.2°C
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± 2% RH
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Uniformity
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± 1°C
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± 3% RH
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Controller System
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PLC BASED CONTROL SYSTEM (Make: Allen Bradley)
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Features
Construction
Chamber interior is fabricated of “Stainless Steel” with dull finish & Exterior is of G.I. Powder coated OR stainless steel: sSS304 or SS3016 according to the needs of client or user. The inner working chamber is water & vapour tight high-grade stainless steel. All seams are arc-welded & passivated for strength& durability.
Full View Glass Door
Single Door with a “Viewing Window” (of Toughened Glass) for easy inspection & viewing the samples without disturbing the set environmental conditions of the chamber (by opening the door).
Leveling Legs
“Bullet feet” ensures easy mobility during installation & cleaning. Bullet feet are specially designed for longer life under heavy load with built in screwing adjustment “for accurate horizontal levelling of the chamber.
Illumination
Inner working chamber is provided with a fluorescent tube for illuminating the chamber to view & inspect samples visually.
Trays
Heavy duty solid stainless steel duly electro polished perforated trays are provided, which are easy to clean, saves time & efforts while cleaning, & also height adjustable for convenience with the help of channels.(Height Adjustable every Half an inch).
21 CFR PART-11 Compliance
Log data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis& Data acquisition.
Standard Features:
- "CE APPROVED" EQUIPMENT
- ALLEN BRADLEY MAKE : PLC BASED CONTROL SYSTEM
- ALLEN BRADLEY MAKE : HMI : LED 4.3" TOUCH SCREEN DISPLAY
- PRINTING INTERFACE FACILITY
- PC COMMUNICATION VIA ETHERNET
- REFRIGERATION & HUMIDITY SYSTEM
- MASTER & STAND BY IMPORTED SENSORS
Optional Accessories:
- 21 CFR PART 11 COMPLIANCE SOFTWARE : DAAS - V 4.0
- SCANNER 4 + 4 (TEMP & RH) IMPORTED SENSORS
- STAND BY REFRIGERATION SYSTEM & STAND BY HUMIDITY SYSTEM
- EXTRA TRAY
- HOOTER SYSTEM ( Security Alarm System)
- GSM TECHNOLOGY ( SMS Alert System)
- PASSWORD PROTECTED DOOR ACCESS SYSTEM
