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Stability Chamber
Product Details:
Stability 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
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)
TECHNICAL SPECIFICATION | |||
Temperature Range | 20°C to 60°C | ||
Humidity Range | 40% RH to 85% RH | ||
ICH Test Condition | 25°C/60% RH | 30°C/65% RH | |
Accuracy | ± 0.2°C | ± 2% RH | |
Uniformity | ± 1°C | ± 3% RH | |
Controller System | PLC BASED CONTROL SYSTEM (Make: Allen Bradley) |