Clean Room Measurements

MICROBIOLOGIC MEASUREMENT VALIDATION FOR CLEAN ROOM (CLEANING VALIDATION)

Cleaning validation must be carried out in accordance with GMP rules in certain periods during the year depending on use areas and conditions of Clean room. All equipment, personnel and cleaning process used in cleaning process after such validation must be validated.

  • Controlling cleaning processes and cleaning agents and making correct choices in this respect;
  • Preparing cleaning validation protocol;
  • Preparing validation plan and determining critical points of sampling with Risk assessment approach;
  • Determining the critical personnel from whom sample will be taken;
  • Product selection for worst-case;
  • Taking samples, testing the samples and reporting relevant results.

VALIDATION OF ETHYLENE OXIDE STERILIZATION

Validation of Ethylene oxide sterilization process for the medical devices released to the market after being sterilized with ethylene oxide is mandatory in accordance with EN ISO 1135 standard. Sterilization validation processes must be validated in terms of physical and microbiological aspects in accordance with EN ISO 1135 standard.

  • Defining product and request of the company on appropriateness of sterilization of the materials used in raw material and product with ethylene oxide;
  • Preparing all reports in Turkish-English in line with the customer request;
  • Preparing validation protocol and starting the works in accordance with this protocol;
  • Completing physical validation parameters and reporting temperature and humidity distributions through data-loggers;
  • Completing microbiologic validation cycles;
  • Determining process investigation tools representing the most difficult conditions and drawing distribution plans in the load
  • Determining the numbers of Biological Indicators in accordance with EN ISO 1135 and drawing distribution plans in the load;
  • Carrying out package performance tests after 2 consecutive full cycles;
  • Preparing and submitting a validation report containing all results.

CLEANROOM PERFORMANCE VALIDATION

Performance validation works of production areas, surgeries, intensive care units, electric-electronic materials production areas described as clean room must be carried out in accordance with the relevant standards.

  • Measuring air flow rate, air change rate, air flow
  • Particle counting and room classification
  • Measuring pressure differences
  • Measuring sound levels
  • Measuring lighting
  • Temperature and humidity measuring
  • HEPA and ULPA filter equipment impermeability test
  • Decontamination/recovery test
  • Air flow visuality test

PACKAGING VALIDATION

Medical devices must be released to the market after they are sterilized or such devices must be released to the market after being packaged in a non-sterile manner. Conformity of the packaging materials used in packing medical devices with EN ISO 11607-2 and EN 868 standards must be tested.

  • Defining product and request by the producer company on material appropriateness of packaging materials;
  • Preparing all reports in Turkish-English in line with the customer request;
  • Preparing validation protocol and starting the works in accordance with this protocol;
  • Determining and reporting critical process parameters of packaging. Process parameters:
    • Process before and after sterilization
    • Process after accelerated ageing test
    • Process after drop test
    • Process after transport adaptation
  • Carrying out and reporting the tests during the whole process of packaging, tests to be carried out;
    • Physical control of package external view
    • Package impermeability test
    • Package adhesion control
    • Package adhesion resistance test
  • Preparing and submitting a validation report containing all results.

PERFORMANCE EVALUATION OF BIO-SAFETY CABIN

Performance validation of bio-safety cabins must be carried out in certain periods depending on the frequency of their use.

  • Particle counting test
  • Air flow rate
  • Air flow direction visuality test
  • Operation test of alarm functions
  • Performance classification and verification of bio-safety cabins
  • Reporting the relevant measurements

Since the duration of the services change according to the characteristics of the parameters to be measured, please, be informed about the service period.

SZUTEST > Laboratory Services > Clean Room Measurements