Stand Alone Humidity Chamber

Stand Alone Humidity Chamber

Stability Chambers also known as Humidity chambers are a type of environmental test chambers 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.

Category:

Description

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 define 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 the safety of users and equipment by providing multiple “Safety Features” in the form of Audio Visual Alarms ensuring trouble free performance & extended life of the 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”

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 Operating Conditions:

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

Low Humidity Equipment Operating Conditions:

  • 25°C/40%RH
  • 30°C/35%RH
  • 40°C/NMT25%RH

Models

Cap. in
litres

Internal size in mm

External size in mm on

Tray
Qty.

Tray Size in mm

Connected Load
AO/SC-15

150

500Wx400Dx750H

625Wx1050Dx1350H

2

405Wx400Dx30H

2.25 KW

AO/SC-25

250

700Wx400D×900H

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

825Wx1250Dx1800H

3

605Wx600Dx30H

2.25 KW

AO/SC-80

800

700Wx800Dx1450H

825Wx1450Dx2050H

4

605Wx800Dx30H

2.25 KW

AO/SC-100

1000

830Wx830Dx1450H

955Wx1480Dx2050H

4

735Wx830Dx30H

2.25 KW

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

Standard Chamber Features & Provisions:

Construction: Dynamically Designed PUF filled Double walled, Inner Tank & outer body with PCGI/SS 304/SS 316 with PUF Density of 40Kg/m³

Sample Storage: Trays: Perforated types (CNC punched). Strengthened with support rails to prevent deformations.

Door: PUF Insulated External door mounted with imported hinges & locks, Inner glass doors with latches. Door frame is secured with a silicone rubber gasket on the entire perimeter to ensure an air tight, leak tight chamber.

Door Operation: Passcode protected door access – from software & HMI.

Control System:

  • Ergonomically designed Control Panel.
  • Ferrule printed wiring.
  • Advanced PLC Program with built in processor-based Auto Tuning.
  • 4.3″ HMI Color LCD Display.
  • Built in Redundancy & Safety.
  • Advanced High Accuracy “Transmitter based sensors” with output of 4-20 mA.

Temperature Control:

  • Efficient, Reliable, Time tested & Trustworthy Refrigeration Design.
  • Built in redundancy with PLC based Auto Change Over during power outage or component failure viz: Compressor, Humidification system
  • PLC Controlled “U” Shaped SS Air Heater Banks.

Humidity Control: S S Reservoirs- steam kettles form a Humidification system.

Optional Backup System: PLC based Auto Change Over Backup system for Refrigeration & Humidification.

Safety: Dedicated Thermostats for all key points: Chamber High Temperature, Steam Kettle Element, Utility High Temperature.

PLC Safety Cut Off for Temperature & Humidity: High, Higher & Low, Lower safety cut off.

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