Test required for Clean rooms testing to demonstrate compliance with ISO-14644

 

TESTING

PART 1

DEMONSTARTION OF CONTINEOUS COMPLIANCE FOR CLEAN ROOMS 

PHYSICAL ENVIRONMENTAL MONITORING

1.  Physical Testing (General)

Compliance with air cleanliness (ISO Classes) requirements specified by the ISO14644 is verified by performing specified testing procedure and by providing specified documentation of the result and conditions of testing, as agreed upon by client and service supplier (the third party) and internal testing labs.  The reference test method for demonstration of compliance is as per ISO-14644-1, ISO 14644-2 & ISO 14644-3. An alternative method having comparable accuracy may be specified, although if no method is specified or agreed upon, the reference method shall be used.

For Clean rooms, clean zones & clean air devices existing at any company, following physical tests are included for demonstration of compliance.

1.1.     Airborne particle count

This test is performed to determine air cleanliness class (classification test).

Testing schedule for continued compliance to the reference test method and the maximum time intervals between such tests to prove continued compliance with the designated ISO class are given in standard.

Routine environmental monitoring shall be performed by respective department as per documented procedure, a record will be maintained.

When area is at rest monitoring shall be performed at least once a week while when there is Shutdown period then before resuming the production, area will be tested for air cleanliness as per documented procedure.

The sampling site as should be as per ISO-14644 

 

Sampling locations subject to increase or decrease as per contamination, layout, and historical record of the area.

1.2.   Airflow test

This test is performed to determine the supply airflow rate in a non-unidirectional cleanroom and the air velocity distribution in a unidirectional cleanroom. Typically, either airflow velocity or airflow rate testing will be performed, and results will be required in only one format: average velocity, average airflow rate or total airflow rate. Total airflow rate may, in turn, be used to determine the air exchange rate (air changes per hour) for a non-unidirectional installation. The air velocity will be determined in unidirectional cleanrooms. Test procedures for the airflow test are given in ISO 14644.

Company planned to perform these tests by third party on annual basis and records of these test are attached as an annexure with validation report. Third party will perform these test as per ISO-14644 and share calibration record with Client and client will maintain the record.

Some area required air changes per hour will be monitored and some areas required only air velocity distribution will be monitored.

1.3.    Air pressure difference test (Principle)

The purpose of this test is to verify the capability of the complete installation (HVAC) to maintain the specified pressure difference between the installation and its surroundings, and between separate spaces within the installation. This test is applicable in each of the three designated occupancy states and can also be repeated on a regular basis as part of a routine facility monitoring program as described in ISO 14644. The air pressure difference test should be performed after the installation has met the acceptance criteria for airflow velocity or volume, airflow uniformity and other applicable tests. 

Company planned to perform these tests by third party on annual basis and records of these test are attached  with validation report. Third party will perform these test as per ISO-14644 and share calibration record of instrument with client and client will maintain the record.

Company also perform these tests on daily basis in operation state and once in a day at rest state. If area is under shutdown period, before resuming the production, all gauges will be check, and record will be maintain.

1.4.   Installed filter system leakage tests

These tests are performed to confirm that the final high efficiency air filter system is properly installed by verifying the absence of bypass leakage in the installation, and that the filters are free of defects (small holes and other damages in the filter medium and frame seal) and leaks (bypass leaks in the filter frame and gasket seal, leaks in the filter bank framework). These tests do not check the efficiency of the system. These tests are performed by introducing an aerosol challenge upstream of the filters and scanning downstream of the filters and support frame or sampling in a downstream duct. 

Company should plan installed filter system leakage test shall carried out after 24 months by third party to show compliance.

Third party share/provide information regarding test apparatus, aerosol photometer, aerosol generator, aerosol source, calibration, and test record. Company will maintain the record and attach with  validation report.

1.5.    Airflow direction test and visualization

The purpose of this test is to confirm either the airflow direction or airflow pattern or both regarding the design and performance specifications. 

Company should plan to perform air visualization test inhouse OR by third party after 24 months by using both either fog direction visualization through aerosol generator/fog generator or tracer thread method. The photographs and videos should be kept as a record and attach with  validation report.

1.6.    Temperature and humidity uniformity tests

The purpose of these tests is to demonstrate the capability of the cleanroom air-handling system to maintain air temperature and moisture (expressed as relative humidity or dew point) levels within the control limits over the time specified by the company.

Company should plan to perform temperature and humidity uniformity test once a year by third party testing provider.

Company should require to plan temperature monitoring test will be performed in house as per written SOP and it will be part of routine testing for ISO-5, ISO-6, ISO-7, and ISO-8. Routine monitoring shall be performed by respective department on daily basis in operational state before start of production and record will be maintained. When area is at rest once in a day monitoring shall be performed. While when there is Shutdown period before resuming the production, area will be tested for temperature control as per documented procedure.

1.7.    Humidity test (Principle)

The purpose of this test is to demonstrate the capability of the installation's air-handling system to maintain the air humidity level (expressed as relative humidity or dew point) within the control limits and over the time agreed between the customer and the supplier for the area being tested.

Company should plan that temperature and humidity uniformity test will be performed once a year by third party testing provider.

Company should plan that humidity monitoring test shall be performed in house and it will be the part of routine testing for ISO-5,  ISO-6, ISO-7, and ISO-8. Routine monitoring shall be performed by respective department on daily basis in operational state before start of production and record will be maintained. When area is at rest, once in a day monitoring will be performed while there is Shutdown period before resuming the production, area will be tested for humidity control as per documented procedure.

1.8.    Particle deposition test

The purpose of this test is to measure the quantity (number or mass) or the effects (light scatter or area coverage) of particles deposited upon surfaces at any orientation. 

 

Company should plan that particle deposition monitoring test shall be performed outsource/ in house annually at the time of validation or Qualification activity.

The test will be performed for measuring the quantity (Number) of particles deposited upon surfaces of media plates observed under microscope.

1.9.    Recovery test

The recovery test is performed to determine whether the installation can return to a specified cleanliness level within a finite time, after being exposed briefly to a source of airborne particulate challenge or after being shutdown overnight. This test is not recommended for unidirectional airflow installations. 

This test is not recommended for ISO Classes 8 and 9. 

Company should plan that recovery monitoring test shall be performed after 24 months by outsource/ in house. Particle counter results will be recorded, and then sufficient time provided to each area to resume required class cleanliness level and this time duration will be noted.

1.10.                Containment leak test

This test is performed to determine if there is intrusion of unfiltered air into the cleanroom or clean zone(s) from outside the cleanroom or clean zone enclosure(s) through joints, seams, doorways, and pressurized ceilings. 

Company should plan that installed filter system leakage test will be carried out after 24 months by third party to show compliance.

Company should plan to get third party services for containment leak test and third party will share/provide information regarding test procedure, test apparatus, aerosol source, calibration, and validation record if applicable. Company will maintain the record and attach it with validation report.

 

TESTING 

PART 2 

DEMONSTARTION OF CONTINUEOS COMPLIANCE 

MICROBIOLOGICAL ENVIRONMENTAL MONITORING

2.  Microbiological Testing (General)

Company should have formal system for biocontamination control established, implemented, and maintained within cleanroom and associated control environment as per ISO 14698. To achieve this goal company has to adopted air monitoring, surface monitoring, clean uniform testing, and operator finger testing. NHT also adopted hand and surface disinfection protocol to reduce microbial load.  For Clean rooms and clean zones existed at production facility following microbiological tests must be include for demonstration of compliance

2.1.   Air borne biocontamination.

Detection and monitoring of microbial contamination of a air in a risk zone is carried out by collecting viable particles with appropriate sampling devices. Air borne biocontamination will be determined by settle plate test. settle plates are exposed for specified time for the collection of air borne bioburden. plates are used to test the level of microbial contamination.

Microbiology Lab shall be performing air sampling on routine basis. It should be part of facility daily monitoring.  At the time of validation and Qualification air sampling test shell also be performed by  microbiology lab/dept. and result will be maintained.

2.2.      Biocontamination on surfaces (Principle) 

Collection of viable units may also be achieved by appropriate application of a swabbing technique. The use of sterile moistened swabs, sponges and wipes is particularly convenient for sampling large, non-absorbent, irregular, or recessed surfaces not accessible to contact devices.

Microbiology Lab shall perform surface sampling through swab (or contact plate if required) test on routine basis. It should be part of facility daily monitoring. At the time of validation and Qualification surface sampling test should also be perform.

2.3.   Determining biocontamination of textiles (Principle)

Detection and monitoring of microbial contamination of a textile in a risk zone is carried out by collecting viable particles with appropriate sampling devices, according to a sampling plan. Contact plates are used to test the level of microbial contamination on clothing of personal working in controlled environment. Contact plates are analyzed for total viable counts (referred to as colony forming units). 

Contact plate test is performed on all personal present/working in clean rooms (ISO-5, ISO-6, ISO-7 & ISO-8). Microbiology Lab performing personnel/operator garments sampling through contact plate (or swab if required) test on routine basis. It should be part of facility daily monitoring. At the time of validation and Qualification personnel gowns sampling test will also perform.  

2.4. Finger dab test of operators gloved finger (Sampling Procedure for Finger Dab Test)

Contact plates are used to test the level of microbial contamination on Gloved finger of personal working in controlled environment.  Contact plates are analyzed for total viable counts (referred to as colony forming units). Contact plate test is performed on all personal present in clean room (ISO-5, ISO-6, ISO-7 & ISO-8).

Microbiology Lab should take sample from operator finger through finger DAB test procedure on routine basis. It should be part of facility daily monitoring. At the time of validation and Qualification finger DAB test should also be performed microbiology lab.