WALK- IN STABILITY / HUMIDITY CHAMBER

Technical Specifications :

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 / NMT 25%RH

Models	Cap. in liters	Internal size in mm	External size in mm	Rack Qty.	Tray Qty.	Tray size in mm	Connected laods
AO/WSC-400	4000	2000WX1000DX2000H	2160WX1630DX2200H	2	10	730WX625DX30H	4.0 KW
AO/WSC-600	6000	2000WX1500DX2000H	2160WX2130DX2200H	4	20	600WX625DX30H	4.25 KW
AO/WSC-800	8000	2000WX2000DX2000H	2160WX2630DX2200H	4	20	850WX625DX30H	4.25 KW
AO/WSC-1000	10000	2000WX2500DX2000H	2160WX2630DX2200H	6	30	720WX625DX30H	4.25 KW
AO/WSC-1200	12000	2000WX3000DX2000H	2160WX2630DX2200H	6	30	885WX625DX30H	4.25 KW
AO/WSC-1600	16000	2000WX4000DX2000H	2160WX4630DX2200H	8	40	905WX625DX30H	5.5 KW
AO/WSC-2000	20000	2000WX4000DX2500H	2160WX4630DX2700H	8	48	905WX625DX30H	6.0 KW
AO/WSC-2500	25000	2300WX4500DX2500H	2460WX5130DX2700H	10	60	815WX750DX30H	6.0 KW
AO/WSC-3000	30000	4000WX3000DX2500H	4160WX3630DX2700H	12	72	885WX625DX30H	9.0 KW
AO/WSC-4000	40000	4000WX4000DX2500H	4160WX4630DX2700H	16	96	905WX625DX30H	9.0 KW
AO/WSC-5000	50000	4500WX4500DX2500H	4660WX5130DX2700H	20	120	815WX725DX30H	12.75 KW

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

* Custom built Chambers are available in any dimensions and capacities

Standard Chamber Features & Provisions:

• Construction: PCGI/SS304/SS316 Tongue & Groove type panels of 80 mm thick with PUF density of 40Kg/m3

Sample Storage:

• Racks: Heavy duty SS304 Frame secured strongly to chamber walls for strength.
• Trays: Perforated types (CNC punched). Strengthened with support rails to prevent deformations.

Door : PUF Insulated door with full view double layered Toughened Glass, mounted with imported hinges & locks. Door frame is secured with silicone             rubber gasket on entire perimeter to ensure air tight, leak tight chamber.

Door Operation : Passcode protected door operation - 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.
• Chiller System / Compressor system uniquely & specifically designed for “Walk In Stability/Humidity Chambers”

Humidity Control: S S Reservoirs- steam kettles forms Humidification system.

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 .

Human Safety: “Person Trap” button provided inside the chamber, which triggers Audio Visual alarm. The button enables the trapped person to come out even if the door is physically locked from outside

Emergency Stop: button provided from outside.

• 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 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), PICS, MHRA, Health Canada, TGA, WHO, ANVISA, ISPE & 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 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.
• 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”