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Validation
HVAC (Heating, Ventilation, Air Conditioning) System Validation
      + HEPA Filter Leakage Test
The test according to “IEST-RP-CC034: HEPA And ULPA Filter Leak Tests” standard which is performed after the montage of HEPA filters by using photometer and aerosol generator (with PAO poly-alpha olefin liquid) to control whether there is leakage on filter surface, gasket and cabinet within acceptance criteria defined in the standard. When there is no change in the system, this test must be performed at least once a year based on the critically of processes in which HEPA filters are used. This test is also defined as Integrity or DOP test. (HEPA Filter - High Efficiency Particulate Air Filter)
      + Airflow Volume Measurement And Calculation Of Air Change Rate
The test is performed to control whether the quality and quantity of airflow in the clean room is in conformity with the air cleanliness class defined in “IEST-RP-CC006: Testing Clean Rooms” and “ISO 14644-3: Clean Rooms And Associated Controlled Environments - Part 3: Test Methods” standards by measurement of airflow volumes with balometer and calculating air change rate.
      + Differential Pressure Measurement
The test is performed to control whether the pressure differences, made to prevent contamination, between the clean room and adjacent areas are in conformity with the acceptance criteria defined in “IEST-RP-CC006: Testing Clean Rooms” and “ISO 14644-3: Clean Rooms And Associated Controlled Environments - Part 3: Test Methods” standards by measurement of pressures with manometer.
      + Temperature And Humidity Measurement
The test is performed to control whether the temperature and relative humidity in the clean room are within the acceptance criteria required by process/the standards or within the set value to prevent microbial contamination in clean rooms according to “IEST-RP-CC006: Testing Clean Rooms” and “ISO 14644-3: Clean Rooms And Associated Controlled Environments - Part 3: Test Methods” standards by measurement of temperature and relative humidity with temperature-humidity meter.
      + Decontamination - Recycle Test
The test is performed to determine the time for clean-up of air in the clean room during the clean room particle rate decreases from lower air cleanliness class to it’s own defined air cleanliness class defined in “IEST-RP-CC006: Testing Clean Rooms” and “ISO 14644-3: Clean Rooms And Associated Controlled Environments - Part 3: Test Methods” standards with a particle counter and a smoke generator.
      + Particle Count And Clean Room Classification
The test is performed to control whether the particle rate in the clean room is in conformity with the air cleanliness class acceptance criteria defined in “ISO 14644-1: Clean Rooms & Association Controlled Environment Part 1 Classification Of Air Cleanliness” with a particle counter.

Upon request, HVAC System of clean rooms, operating rooms, intensive care units and laboratories are reviewed up to validation acceptance criteria and pre-assessment reports are prepared.

LAF (Laminar Air Flow) Cabinet Validation
      + HEPA Filter Leakage Test
The test according to “IEST-RP-CC034: HEPA And ULPA Filter Leak Tests” standard which is performed after the montage of HEPA filters by using photometer and aerosol generator (with PAO poly-alpha olefin liquid) to control whether there is leakage on filter surface, gasket and cabinet within acceptance criteria defined in the standard. When there is no change in the system, this test must be performed at least once a year based on the critically of processes in which HEPA filters are used. This test is also defined as Integrity or DOP test. (HEPA Filter - High Efficiency Particulate Air Filter)
      + Airflow Velocity Measurement
The test is performed to control whether the quantity and laminarity of airflow in the cabinet is in conformity with the acceptance criteria defined in “IEST-RP-CC006: Testing Clean Rooms” and “ISO 14644-3: Clean Rooms And Associated Controlled Environments - Part 3: Test Methods” standards with velometer/anemometer.
      + Particle Count
The test is performed to control whether the particle rate in the cabinet is in conformity with the acceptance criteria defined in “ISO 14644-1: Clean Rooms & Association Controlled Environment Part 1 Classification Of Air Cleanliness” with a particle counter.
      + Airflow Direction Characteristics
The test is performed to control whether the airflow directions in the cabinet is in conformity with the acceptance criteria defined in “IEST-RP-CC006: Testing Clean Rooms” and “ISO 14644-3: Clean Rooms And Associated Controlled Environments - Part 3: Test Methods” standards with a smoke generator and a video camera recorder.

Drying Oven, Incubator, Cold Room, Refrigerator, Stability Cabinet Heat Distribution Test
The test is performed to control whether the temperature and relative humidity in the equipment are within the set value and to see the deviations in these values with simulations such as door open and power cut by mapping of heat distributions in different points in the equipment with thermal validator.
Sterilizator (Autoclave, Dry Air Oven, Tunnel) Validation
It is a combination of tests which are performed according to “TS EN 285: Sterilization – Steam Sterilizers – Large Sterilizers”, TS EN 13060: Small Sterilizers” and “PDA Technical Report No.1 Steam Sterilization”, “Technical Report No.3 Validation of Dry Heat Processes Used for Sterilization and Depyrogenation” and “HTM2010: Health Technical Memorandum” standards by mapping of heat distributions in different points in the equipment with thermal validator, by calculation of lethality and temperature in the material, by working parallel with BI’s (Biological Indicator) and (Endotoxin Challange Vial) ECV’s to control whether the qualifications of equipments are in conformity with acceptance criteria defined in the standards.
Water Systems Validation (WPU/WFI)
The tests are conducted by customer, validation protocols and report are prepared by I.C.C.E Turkey to control whether the WPU/WFI systems are in conformity with related pharmacopeia standards and meet the authority’s requests.
Hot/Cold Closed Water Loop Validation
It is a combination of tests of heat distribution mapping with thermal validator in WPU/WFI circulations and sterilization of these systems, calculation of lethality, working parallel with BI’s (Biological Indicator) to control whether the qualifications of water loops are in conformity with acceptance criteria defined in the standards.
Lyophilizer Validation
This validation is performed to control whether the lyophilizer works in conformity with process properties by series of tests such as heat distribution, control of sterilization properties, control of shelf temperature homogeneity, define of heating - cooling rates & evacuation - leak rates with thermal validator.
 
   
NEWS
FAQ
+  What is Validation?
+  What is a Protocol?
+  What is Installation Qualification?
+  What is Operational Qualification?
+  What is Design Qualification?
+  What is Prospective Validation?
+  What is a Clean Area/Room?
+  What is fumigation?
>> more...
     
     
 
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