Stability Chamber

Stability Chamber 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

Stability Chamber

Stability Chamber

TECHNICAL SPECIFICATION
Temperature Range 20°C to 60°C  
Humidity Range 40% RH to 85% RH  
ICH Test Condition 25°C/60% RH
40°C/75% RH
30°C/65% RH
30°C/75% RH
Accuracy ± 0.2°C ± 2% RH
Uniformity ± 1°C ± 3% RH
Controller System PLC BASED CONTROL SYSTEM (Make: Allen Bradley)

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

Stand By Steam Generator System Stand By Steam Generator System

Stand By Steam Refrigeration System
Stand By Steam Refrigeration System

Control System Control System

Size
Model MK*-20H MK*-40H MK*-60H MK*-80H MK*-100H MK**-S100H
Capacity 200 Ltrs 400 Ltrs 600 Ltrs 800 Ltrs 1000 Ltrs 1000 Ltrs


Interior Dimension
Width in mm 600 700 700 700 800 800
Depth in mm 400 600 800 800 800 800
Height in mm 850 950 1100 1450 1600 1600


Exterior Dimension
Width in mm 760 860 860 860 960 960
Depth in mm 1030 1230 1430 1430 1430 1430
Height in mm 1450 1550 1700 2100 2210 2250


Trays
No of Trays 2 3 3 4 4 4
Type Perforated Type
Tray spacing Every 1/2" Adjustable


Power Supply
Power Supply Single Phase, 230V 50Hz
Warranty 12 Months

Other Sizes also available as on requirement.


MATERIAL OF CONSCTUCTION (MOC)
  INSIDE MATERIAL OUTSIDE MATERIAL INSIDE FINISH OUTSIDE FINISH
MK – 1 SS 304 G I Powder Coated Matt Finish G I Powder Coated
MK – 2 SS 304 SS 304 Matt Finish Matt Finish
MK – 3 SS 316 SS 304 Matt Finish Matt Finish


Note:
  • MK* :- MK1 / MK2 / MK3
  • MK**-S :- Split type Condensing Unit
A stability chamber, also known as a stability test chamber or environmental chamber, is a controlled environment used for testing and evaluating the stability of pharmaceuticals, food products, chemicals, and other substances under various environmental conditions. These chambers simulate and maintain specific temperature, humidity, and lighting conditions to assess the long-term stability and shelf life of products. Here is some information about stability chambers:

Components of a Stability Chamber:

Temperature Control:
Stability chambers feature precise temperature control systems to maintain a constant temperature throughout the testing period. They often have a wide temperature range to simulate different climate conditions.

Humidity Control:
Humidity control is crucial for assessing the impact of moisture on product stability. Chambers are equipped with humidity control systems to regulate relative humidity levels.

Lighting Systems:
Some stability chambers include lighting systems to simulate exposure to light, which is important for certain products that may be sensitive to light.

Airflow Systems:
Proper airflow is maintained to ensure uniform temperature and humidity distribution within the chamber. Air circulation prevents localized variations that could affect the stability testing.

Monitoring and Control Systems:
Advanced stability chambers are equipped with monitoring and control systems that allow real-time tracking of temperature, humidity, and other relevant parameters., Alarms are often included to alert users to deviations from set conditions.

Applications:
Pharmaceutical Industry:
Stability testing of drugs to ensure efficacy and safety over time., Regulatory compliance testing to meet pharmaceutical industry standards.

Food Industry:
Evaluating the shelf life and stability of food products., Testing the impact of environmental conditions on food quality.

Chemical Industry:
Assessing the stability of chemicals under various conditions., Regulatory compliance testing for chemical products.

Compliance and Standards:

ICH Guidelines:
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines for stability testing in the pharmaceutical industry.

Regulatory Requirements:
Stability testing is often a regulatory requirement for product approval in various industries.

Maintenance and Calibration:
Regular Calibration:
Stability chambers need to be regularly calibrated to ensure the accuracy of temperature and humidity control.

Maintenance Checks:
Routine maintenance checks are essential to identify and address any issues that may affect the performance of the chamber.

Conclusion:
Stability chambers play a crucial role in ensuring the quality and safety of products by providing valuable data on how they respond to different environmental conditions over time. These chambers contribute significantly to research and development processes, regulatory compliance, and quality assurance in various industries.

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