Sterile clean workshop verification test equipment
Sterile clean pharmaceutical cleanroom verification test equipment
The verification and testing activities of different equipment/instruments have different degrees of complexity and require different testing instruments. According to the types of testing instruments used in sterile clean workshops, they can generally be divided into air purification system testing instruments, clean utility system testing instruments, Equipment testing instruments.
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Text label: sterile clean pharmaceutical cleanroom testing, clean pharmaceutical cleanroom testing equipment
Aseptic Cleanroom Validation Test Equipment
The verification and testing activities of different equipment/instruments have different degrees of complexity and require different testing instruments. According to the types of testing instruments used in sterile clean workshops, they can generally be divided into air purification system testing instruments, clean utility system testing instruments, Equipment testing instruments.
Let's first understand the testing equipment of air purification system: The air purification system in a broad sense mainly includes: clean air conditioning system, isolator, ultra-clean workbench, biological safety cabinet, laminar flow hood, transfer window and other facilities and equipment. Different air purification system test items are different, the common key test items are as follows.
Air volume/number of air changes: Verification usually uses an air volume hood to measure the air volume of each air outlet, and obtains the number of air changes in the room by calculating the total air volume and volume of the room.
One-way flow wind speed test: Verification is usually carried out using an anemometer to confirm that the one-way flow system is evenly supplying air in its working area, and the wind speed meets the requirements. The wind speed is generally required to be 0.36~0.54m/s (guidance value), and a lower wind speed can be used in a closed isolation operator or glove box.
Differential pressure test: Verification usually uses a differential pressure gauge to measure the differential pressure of different rooms to confirm the differential pressure of different rooms or different levels in the clean area. The differential pressure test should be carried out after passing the air volume test. The pressure difference between clean area and non-clean area and between clean areas of different levels should not be less than 10Pa. If necessary, an appropriate differential pressure gradient should also be maintained between different functional areas (operating rooms) of the same cleanliness level.
HEPA filter leak test: Verify that a certain concentration of aerosol smoke is usually generated upstream of the HEPA filter using an aerosol generator
, use a photometer to scan and detect downstream of the high-efficiency filter to confirm whether the high-efficiency filter itself and the installation frame have leaks.
Airflow and smoke flow pattern test: To verify that a smoke generator or water mist generator is usually used to generate a certain concentration of smoke or fog, and the air flow pattern is confirmed by video recording to meet the design requirements, and the smoke flow pattern under laminar flow cannot appear turbulent or turbulent. backflow.
Temperature and Humidity Test: Verification is usually carried out with a thermo-hygrometer to confirm that the temperature and humidity of the tested area are maintained within the control limits. The temperature and humidity test should be carried out after the air volume and pressure difference are adjusted.
Self-cleaning time test: The verification is usually carried out with a particle counter, and the self-cleaning ability of the space is evaluated by the particle concentration change rate or the self-cleaning time of 100:1. Usually, aerosol is used to increase the initial concentration of particles in the space to 100% of the target clean concentration. times or higher.
Suspended particle concentration test: The verification is usually carried out with a particle counter, and a portable dust particle counter with a short sampling tube should be used to avoid the sedimentation of suspended particles ≥5.0μm in the long sampling tube of the remote sampling system. In a unidirectional flow system, an isokinetic sampling head should be used. The test state is divided into static test and dynamic test. Zhongjing Global Purification can provide supporting services such as consultation, planning, design, construction, installation and transformation of clean workshops and sterile workshops.
Sedimentation microorganism test: collect the microorganisms in the air in the sedimentation dish through the principle of natural sedimentation, and after cultivation under suitable temperature and humidity conditions, count the number of microorganisms in the sedimentation dish to evaluate the cleanliness of the clean area. The exposure time of a single settling disc can be less than 4h, and multiple settling discs can be used for continuous monitoring and cumulative counting at the same location. The test state is divided into static test and dynamic test.
Planktonic microorganism test: Validation usually uses plankton sampler to test, and the test status is divided into static test and dynamic test.
Surface Microbial Test: The test method usually adopts cotton swab method or contact dish method, and the test state is divided into static test and dynamic test.
Testing instrument for clean utility system: Clean utility system generally includes purified water system, water for injection system, pure steam system, clean gas (such as compressed air or nitrogen). Common verification test items are as follows.
Purified water pretreatment system-SDI test (to test the pollution index of the water produced by the multi-media filter of the purified water preparation system); test); purified water pretreatment system - residual chlorine content test (test the residual chlorine content of the water produced by the activated carbon filter of the purified water preparation system); pure steam quality test (pure steam quality includes three indicators: non-condensable gas , dryness, superheat); pure steam condensed water sampling (sampling after pure steam condenses to check whether the indicators of the condensed water meet the standards of water for injection); clean gas dew point/water content test (the dry state of the gas can be controlled Growth of microorganisms, confirm that the dew point/water content meets the requirements); clean gas oil content test (oil is an impurity for products, and the oil content of clean gas should be strictly controlled); clean gas suspended particle test (confirm the system's filtering effect on particles .Confirm that the distribution system will not pollute the clean gas); clean gas planktonic bacteria test (confirm the effect of the sterilizing filter, confirm that the system is not contaminated by microorganisms).
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