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CLEAN ROOM VALIDATION

CLEAN ROOM VALIDATION

Testing of HVAC Controlled Clean Room/Areas and LAF Cabins
As the national and international regulation and standards require, air quality measurement of several HVAC-controlled fields, particularly the health sector, is made periodically. In this context;

In Hospitals
Surgical rooms, Intensive Care Units, Newborn Units

In production:
The testing and reporting transactions of regions where air quality matters such as Medicine Production Plants, Medical Material, Electronic, Optic, Food, Cosmetic, Laboratories etc. are realized by our firm within the scope of our accredited services as a third party independent corporation.

Clean room tests made by UNIVERSAL Certification are fulfilled by reporting of the measurement and controls within a wide range according to ISO/EN14644 and FDA regulations along with customer criteria. The process of reporting having determined ISO Class according to the particle measurement values only implemented by non-accredited firms is not an adequate Validation Test.
Test procedures are performed according to the control parameters to be set in the following scope or according to customer needs in tests conducted by our firm, and Clean Area and LAF cabins are reported.

HEPA/ULPA Filter Impermeability Tests
• Particle Measurement/Clean Area Classification
• Humidity/Temperature Experiment
• Different Pressure Experiment
• Air Flow Measurement
• Air Cycling Factor
• Decontamination Experiment
• Air Flow Direction and Imaging
• Light and Noise Measurements
 

Temperature and Moisture Mapping with Datalogger or Data Collection Systems in Temperature and Humidity Controlled Rooms

FDA and cGMP regulations require uninterrupted recording of the temperature and humidity values of fields and equipment such as all storage stores, stoves-cold room, stability cabin and cold chain transportation vehicles used in the course of storage and shipment of product/raw materials for the medicine sector, and saving of all the data.
In this context, temperature/humidity mapping should be made to determine proper observation points in humidity and/or temperature controlled fields and equipment as well as worst case points before placement of observation sensors in concerned areas.

These mapping procedures should be repeated in revising implementations that involve changes such as repair and fixing to take place in the ventilation system or the field.
The devices to be used in temperature/humidity mapping should be compatible with 21CFRPart and have a measurement range and precision to meet customer requirements.

Determination of the measurement points and the number of points is made by our experienced field personnel in line with physical conditions and customer criteria, if any, before measurements, through analysis with customer authorities.

All data acquired as a result of the temperature and humidity studies shall be reported within the scope of TURKAK accreditation having been analyzed with MARKET and standard deviation values after subtraction of the period spent in various case scenarios applied.
 

GERİ

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