Freeze Thaw or Cyclic Temperature stress tests are designed on the knowledge of the product so as to mimic likely storage conditions. The period of cycle is mostly considered 24 hours since the diurnal rhythm on earth is 24 hours.
Additionally, the distribution environment can vary greatly, especially when a drug product is shipped between various climatic zones. Seasonal changes, mode of transportation, and the number of drop-off points are also variables that should be considered within the pharmaceutical supply chain. Drug products requiring controlled-temperature storage conditions must be distributed in a manner that ensures that the product quality will not be adversely affected. With the exception of short transit times within the same climatic zone, it is virtually impossible to validate a shipping method against all environmental conditions.
Therefore, distribution stability studies are designed to generate additional data to complement preformulation development and routine (ICH) Q1A(R2).
NEWTRONIC Freeze Thaw Chambers control a broad temperature range of -20°C to 60°C thereby offering the flexibility to simulate a broad range of conditions. The min temperature, max temperature & cyclic time are all user-settlable thereby allowing the user to program a specific profile for their studies. Automatic cycling between the setpoints enables rapid simulation of conditions & the need to replicate freezing and thawing during product testing.
|Temperature Range||-20°C to 50°C|
|Double walled with 80mm PUF insulated modular panels with easy on-site assembly||System is made up of split type condenser unit in well-ventilated area to avoid throw of hot air in the room|
|SS 304 Interior & Exterior either SS 304 or Powder Coated G.I.||Stand by humidity system|
|Stainless Steel Trays||Complete Operations driven through PLC with data logging capacity of upto 1000 readings & email facility|
|Full length Inner glass door||High speed Ethernet based communication|
|Illuminated working area||All operations through a single 4" Color Touch Screen|
|U-shaped SS tubular heaters||High-quality German Make temperature humidity sensor with 4-20mA output|
|Forced air circulation for uniform temperature||Safety devices: Low & High temperature cut-off settable thermostats & high humidity cut-off device|
|Non Condensing steam injection type humidity system with standby heater & auto switch overs||Audio/Visual alarms for deviations|
|CFC free cooling system consisting of hermetically sealed compressor coupled with evaporation coil & condenser||Complete with DQ, IQ, OQ, PQ & Operations & Maintenance Manual|
|ICDAS - A Common Software suitable for 20 nos. Newtronic make equipments||Door Access system|
|Remote alarm system suitable for 4 nos. Newtronic make equipments||Mobile Alert system|
|Exterior &Interior is of stainless steel (SS 304)||Capacity||Internal Size||External Size||Tray Qty.||Tray Size||Approx. Weight kg|
|Cuft.||Litres||HxWxD (mm)||HxWxD (mm)||mm||Equip||Ship|
|NLFT7SI||7||200||1625 x 765 x 895||1350x630x945||3||430x460||150||225|
|NLFT11SI||11||300||1200x500x500||1880 x 765 x 945||4||430x460||200||275|
|NLFT16SI||16||430||1200x600x600||1950 x 1015 x 1090||4||560x560||250||325|
|NLFT21SI||21||600||1200x700x700||1950 x 1015 x 1170||4||660x660||275||350|
|NLFT28SI||28||800||1200x800x800||1950 x 1065 x 1310||4||760x760||300||400|
|NLFT34SI||34||1000||1425x800x840||2210 x 1065 x 1320||5||760x800||325||425|