Mack Pharmatech Pvt Ltd Malegaon, Nashik, Maharashtra

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.

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 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. Optional Features GSM TECHNOLOGY HOOTER 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. Optional Features GSM TECHNOLOGY HOOTER SYSTEM EXTRA TRAY

Accuracy : +0.2 °C / +2.0 % RH

• 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.

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 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.

Design Qualification (DQ) Defines the functional and operational requirement and specification of the instrument and details the conscious decisions in the selection of the supplier. Installation Qualification (IQ) Confirms that all the equipment was installed to specifications. All of the model and serial numbers are documented. Operational Qualification OQ) Verification of operator controls, alarms, software, stand by system & chamber temperature mapping and verification that chamber stays within the humidity tolerances. Performance Qualification (PQ) Confirms that the chambers are meeting the operating set points at stipulated product load. The temperature and humidity accuracy is also confirmed. Calibration & Validation Calibration Calibration is the comparison of an instrument to a known standard. Our equipments are calibrated with multipoint calibrator, which is certified by ERTL (Indian Government Agency) traceable to NABL India and NPL (National Physical Laboratory), Delhi – one that has paperwork showing it compares correctly to a chain of standards going back to a master standard.   Validation Validation of equipment means preparing an authentic report of performance of the equipment,  which establishes the fundamental documentary proof of proper working of the equipment within the specified limits of its performance accuracy and repeatability.

Features 21 CFR PART-11 Compliance Log data, Event data, Audit Trail data, E-Records & E-signatures, Graphical analysis & Data acquisition. Optional Features SCANNER GSM TECHNOLOGY HOOTER SYSTEM EXTRA TRAY