Articles

Qualification

SAMA provides the service of qualifying Buildings, equipments, machines, instruments, and utilities to check its compliance to company specifications, manufacturer specifications, and international standards. Qualification studies as IQ, OQ, and PQ is conducted by a qualified and trained staff using certified and traceable instruments in a defined plan according to study priority, customer requirements, and study period of time

         

   I.   The performed qualification studies includes the following:

  

·               Dry heat oven

·               Autoclave including heat distribution and heat penetration studies

·               Air Handling unit and fan coil units 

·               Fan coil units        

·               Chiller         

·               Cooling tower

·               Heat Exchanger

·               Exhaust Fan

·               Boiler

·               Compressor

·               Water Treatment Unit

·               Furnace including heat distribution study

·               Dry Oven including heat distribution study

·               Vacuum Oven including heat distribution study

·               Incubator including heat distribution study

·               Water Bath

·               Stability Chamber/Room including heat distribution study

·               Dissolution Tester

·               Disintegration Tester

·               Freezer /Refrigerator including heat distribution study

·               Centrifuge

·               Hardness Tester using customer kit

·               Torque Meter using customer kit

·               Tap Density Tester

·               Friability Tester

·               HPLC, GC, GC/MS

·               Filling Lines: Tablet Compression, Capsule filling, Tube filling,

Bottle liquid Filling, Powder Filling …etc

·               Preparation lines: Granulation, Grinding, Milling, Sieving,

liquid preparation, cream preparation …etc

·               Packaging Line machines: cartoning, Printing, coding, embossing, …etc

The results of qualification studies shall be reported as a protocol

SAMA also performs Qualification tests for building, instrument, equipment and utilities (HVAC, PW, WTU, compressed air, steam generation, etc):

·               Light Intensity measurements

·               Noise intensity measurements

·               Differential Pressure between adjacent areas

·               Temperature measurements

·               Humidity measurements

·               Particle count measuring as per 209E and other standards

·               Air velocity measurements

·               Number of Air changes (ACH) measurements

·               Air balancing for HVAC networks

·               Vibration test measurement

·               DOP (Filter integrity testing)

·               Heat distribution study (empty/loaded)

·               Heat penetration study (different load sizes)

·               Pump Flow rate measurements

·               Motor Speed (RPM) measurements

·               Air Volume measurements for grills and networks