Mack Pharmatech Pvt. ltd. Nashik, Maharashtra

Technical Specification Temperature Range: 20°C - 60 °C Humidity Range: 40%RH - 95%RH Accuracy: +0.2 °C +2.0 % RH Uniformity: +1.0 °C +3.0 % RH Test suitable for: 25°C & 60%RH, 30°C & 65%RH, 40°C & 75%RH, 30°C & 75%RH Specially designed chambers for Low Humidity conditions, such as 25°C & 40%RH, 40°C & 25%RH, 30°C & 35%RH. Optional Features GSM TECHNOLOGY HOOTER SYSTEM EXTRA TRAY

• Temperature20°C - 50°C

Photostability Chambers are designed specifically to meet ICH & FDA requirements for Photostability testing. Near UV & visible light testing is Approved Approved performed simultaneously according to ICH Q1B option 2.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.

• Power SupplySingle Phase, 230V 50Hz
• Accuracy+ 0.2 °C
• Temperature Range20°C - 50°C

Photostability chamber 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. 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.

Chamber Interior is fabricated of stainless steel with dull finish & exterior is of stainless steel G.I. Powder coated. The inner working chamber is water & vapour tight high-grade stainless steel. All seams are arc-welded & passivated for strength& durability.

• Temperature20°C - 60 °C

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.Inner 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.