Products

Stand Alone Stability / Humidity Chamber

Walk-in Stability / Humidity Chember

Technical Specification

Temperature Range : 20°C to 60°C Accuracy :< ± 0.2°C Uniformity :< ± 1.0°C*
          Rel. Humidity Range : 40%RH to 90%RH Accuracy :< ± 1.0% Uniformity :< ± 3.0%*

Standard equipment operatng conditons :

  • 25°C / 60%RH
  • 30°C / 65%RH
  • 40°C / 75%RH
  • 30°C / 75%RH

Low Humidity equipment operating conditions :

  • 25°C / 40%RH
  • 30°C / 35%RH
  • 40°C / 25%RH
 
Models  Cap. in liters Internal size in mm External size in mm  Tray Qty Tray size in mm  Connected laod
 AO/SC-15 150 500Wx400Dx750H 625Wx1050Dx1350H 2 405Wx400Dx30H 2.25 KW
AO/SC-25 250 700Wx400Dx900H 825Wx1050Dx1500H 2 605Wx400Dx30H 2.25 KW
AO/SC-40 400 700Wx500Dx1150H 825Wx1150Dx1750H 3 605Wx500Dx30H 2.25 KW
AO/SC-50 500 700Wx600Dx1200H 825Wx1250Dx1800H 3 605Wx600Dx30H 2.25 KW
AO/SC-60 600 700Wx600Dx1450H 825Wx1250Dx2050H 3 605Wx600Dx30H 2.25 KW
AO/SC-80 800 700Wx800Dx1450H 825Wx1450Dx2050H 4 605Wx800Dx30H 2.5 KW
AO/SC-100 1000 830Wx830Dx1450H 955Wx1480Dx2050H 4 735Wx830Dx30H 2.5 KW

* Measured with high accuracy data-log ger at sample storage area with standard Set Point

Standard Chamber Features & Provisions:

  1. Ergonomically designed Control Panel.
  2. Ferrule printed wiring.
  3. Advanced PLC Program with built in processor-based Auto Tuning.
  4. 4.3” HMI Color LED Display.
  5. Built in Redundancy & Safety.
  6. Advanced High Accuracy “Transmitter based sensors” with output of 4-20 mA.
  1. Efficient, Reliable, Time tested & Trustworthy Refrigeration Design.
  2. Built in redundancy with PLC based Auto Change Over during power outage &/or component failure viz: Compressor, Humidification system
  3. PLC Controlled “U” Shaped SS Air Heater Banks.

 

Stability Chambers also known as Humidity chambers are a type of environmental test chamber that are used to measure the effects of particular circumstances (Temperature & Humidity) on everything ranging from Pharmaceutical Drug substances, Formulations, Active Pharmaceutical Ingredients, biological materials, Chemicals, food and beverages, Cosmetics, Industrial materials, and even electrical components.

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature & humidity, establishes a retest period for the drug substance or a shelf life for the drug & establish product storage requirements and expiration dating.

In short, “Stability” is the ability of a pharmaceutical product to retain its chemical, physical, microbiological and biopharmaceutical properties within specified limits throughout its shelf-life.

Stability testing is of paramount and inseparable part when it comes to assessing the Assurance of Quality (QA)& Controlling the Quality (QC) of pharmaceutical Drug substance, formulations and products.

Testing stability of New Drugs, Formulations & Pharmaceutical Substances is one of the most important prerequisites in the licencing process those are defined by various Regulatory Authorities of the world like ICH (Guideline Q1AR2), US FDA (21 CFR Part 11),ISPE, PICS, MHRA, Health Canada, TGA, WHO, ANVISA & so on

These Regulatory Authorities defines and harmonize the various stability Test conditions that are to be performed in order to provide authentic & verified evidence of the stability of the formulations.

Data from these Stability studies enable recommendation & establishment of storage conditions, retest intervals and shelf lives: projected shelf life & expiration and most importantly for New Product Development

The shelf life of a product is commonly estimated using types of stability testing: Real-time, Intermediate, Long Term & Accelerated. 

In real-time stability testing, a product is stored at recommended storage conditions and monitored until it fails the specification.

In accelerated stability tests, a product is stored at elevated stress conditions of high temperature & humidity.

ALLYONE mastered & perfected the art & science of manufacturing Stability (Humidity) Chambers: an ability to maintain a stable temperature, and thus, maintain a stable value of relative humidity. We have a wide range of chambers for you to choose from as per your requirement: Standard & Customized.

Our Stability (Humidity) Chambers have a reputation to quickly achieve & maintain the defined setpoint to simulate the condition perfectly & flawlessly with extraordinary control on both Temperature & Humidity along with outstanding uniformity.

Our Stability (Humidity) Chambers are conceptualized, meticulously designed and are built by artisans & professionals which meets and encompasses all the statutory regulatory requirements laid by world’s leading Regulatory Authorities & can be used to perform Stability Studies defined by ICH Guideline Q1AR2 for Real, Intermediate, Long Term & Accelerated types.

We have gained mastery in designing Specially designed chambers for “Low Temperature-Low Humidity” & “High Temperature, Low Humidity” operating conditions as well.

ALLYONE Stability Chambers comes with a dynamic, User Friendly, Future ready, most advanced proprietary software “ALLYSOFT INTE GRO 2.0” compatible with US FDA 21 CFR Part 11 norms offering complete control & freedom in the hands of user so that the user can focus on the more important tasks on his/her hands!

“ALLYSOFT INTE GRO 2.0” software precisely orchestrates all the utilities of the machine to achieve the Set Point at the quickest and maintains the condition even in the most demanding conditions without compromising on performance. The software records the test data accurately at all times without missing a single bit of data.

Extra emphasis has been given on to the safety of users and equipment by providing multiple “Safety Features” in form of Audio Visual Alarms ensuring trouble free performance & extended life of machine.

ALLYONE Stability (Humidity) Chambers comes with the complete statutory Qualification & Validation Documentation part as laid down by cGMP Norms & ISPE recommendations which is of paramount importance in Pharmaceutical & Allied Industries: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) of the equipment, as well as Operational Qualification (OQ) & Performance Qualification (PQ) for the software “ALLYSOFT INTE GRO 2.0”

 

 

ALLYONE ENVIRONMENTAL TECHNOLOGIES INDIA PVT LTD

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