Consecutive meaning following closely with no gap or following one after another without interruption. The number of batches to be taken under validation depends upon the risk involved in the manufacturing Critical process parameters & critical Quality Attribute so depends upon that manufacturer have to choose the number of batches to be validated. If we will consider less than two batches then the data will not be sufficient for evaluation of and to prove reproducibility of data between batch to batch variation & if we consider more than three batches it can increase the time & cost of manufacturer which usually not preferred. Generally if we will require quality in the First batch, then it is accidental (co-incidental), Second batch quality is regular & third batch quality is Validation or Confirmation. Statistical evaluation cannot be done by considering two points, because two points always draw a straight line so minimum three points requir...
Centrifugation uses gravity and centrifugal force to separate particles heavier than the liquid medium . Centrifuges spin the material at high rotation speeds and separate the particulate from the liquid.
The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements. list of instruments calibration in pharma industry: Thermo-Hygrometer Weight Box (E2 Class and coarser) Temperature controller / Indicator Autoclave Mapping Micro pipettes ORP Meter Temperature Mapping Weighing balance Data Loggers Humidity Mapping Glass wares Safety Valve Incubator Hydrometer Magnahilic Gauge Oven Measuring scale Manometer Glass thermometer Caliper Pressure gauges Thermocouples / Temperature Sensor Wobble meter Compound gauges Muffle Furnace Dial gauge Pressure recorder Anemometer Lux Meter Hot-Wire anemometer Temperature recorder Temperature transmitter Pressure Transmitter Humidity transmitter Test sieve Dial Gauge
Comments
Post a Comment