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Code: #22307
Supplier: Pharma Test Apparatebau AG
The Pharma Test media addition station PTWS 820-MA together with the PTWS 820D tablet dissolution testing instrument can be used to perform the automated media half change for delayed release dosage forms. The operation is performing according to the requirements from USP <711>, EP <2.9.3> and CP <931> for delayed release dosage forms (in CP, enteric coated dosage forms). The test will start with 750ml of 0.1N HCl. After 2 hours, 250ml of concentrated, pre-heated buffer solution will be dosed quickly into the dissolution vessels. The pH will change to 6.8 and the dosage form should then start to dissolve.
Parameter
Specification
Number Vessels
8
Standard Vessels
250 milliliter USP/EP Borosilicate glass vessel, each individually coded
Vessel Covers
Ultra-low evaporation design (< 0.7% within 24h)
Heating System
Pump for water circulation and 1500W heater for fast heating up (230/240V units only)
Heater Range
25-45°C
Heater Accuracy
± 0.2°C inside the water bath
Water Circulation
Water circulated from external heating system through special diffuser inside the water bath
Vibration Elimination
External heating system, spring loaded pump assembly
Instrument Dimensions
Bath: approx. 60cm x 25cm x 64cm (width x depth x height) Heater: approx. 26cm x 37cm x 21cm (width x depth x height)
Net Weight
Approx. 12kg waterbath, 5kg heater
Certification
All components certified to USP / EP requirements
CE / EMC Certification
All CE / EMC Certification provided
Validation
All IQ & OQ documents included
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