MACK PHARMATECH PVT.LTD. Sinnar, Nashik, Maharashtra

For Confirmatory studies, samples should be exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours / square meter to allow direct comparison to be made between drug substance & drug product.MACK PHARMATECH’s Stability Chambers are designed specifically to meet ICH & FDA requirements for Photostability testing. Near UV & visible light testing is performed simultaneously according to ICH Q1B option 2.Optional Features :GSM TECHNOLOGYHOOTER SYSTEM    FEATURES: » UV lights get switched off automatically once the door is opened. » You can test the samples on Fluorescent light or U .V lights separately as well as simultaneously. » Uniform light distribution & high intensity levels allow quick response for forced degradation testing and confirmatory studies. » Lights automatically shut off after a specified exposure level or time duration.   21 CFR PART-11 Compliance Log data, Event data, Audit Trail data, E-Records &E-signatures, Graphical analysis & Data acquisition.    

Specially designed Chambers for Low Humidity conditions such as 25°C & 40%RH, 40°C & 25%RH, 30°C & 35%RH.   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”     Features: ConstructionInner Working Chamber is fabricated of “Stainless Steel” (matt 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 DoorSingle 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).IlluminationInner working chamber is provided with a fluorescent tube for illuminating the chamber to view & inspect samples visuallyLeveling 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).TraysHeavy 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 ComplianceLog data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis& Data acquisition.     Optional Features: STAND BY REFRIGERATION SYSTEMSTAND BY STEAM GENERATOR SYSTEMSCANNERGSM TECHNOLOGYHOOTER SYSTEMEXTRA TRAY  

• The gap between inner & outer walls of chamber is filled with high grade mineral glasswool of thickness 4”, which ensures maximum thermal efficiency. • Bullet feets are specially designed for long life under heavy load with built in screwing adjustment. • Heating system: High efficiency, low watt density S.S. tubular air heaters are used with ceramic core. The combination of airflow, instrument response and fast reacting heaters provides very accurate and straight line control of temperature. These heaters have a long life and are very reliable with no down time. • A high efficiency air circulation system is an integral part of chamber construction. This direct drive design has an extended shaft electric motor coupled to aluminum centrifugal blower wheel. This horizontal airflow across the chamber working space provides an even and accurate temperature gradient. • Printer Interface Facility for data printing directly at desired print intervals. • Electronic Timer provided which will cut off the supply after testing period with audio video alarm.

Features:Eco Friendly PUF Insulation has thickness of 80mm. Projected door prevents condensation & allows product view. Inner & outer doors are sealed around the entire perimeter by silicone sponge rubber gasket.Bullet feet with in-built screwing adjustment are specially designed for long life under heavy load.Heavy Duty refrigeration system, maintenance free, with hermetically sealed refrigeration compressors and reliable refrigeration to minimize noise and vibration.   Optional Features: • GSM TECHNOLOGY• HOOTER SYSTEM • Extra Tray  

Temperature Range : UPTO - 40 °C