Ultra-clean clean bench monitoring procedures and usage guidelines

Super clean clean bench monitoring procedures and instructions for use


Ultra-clean cleaning workbench monitoring procedures and usage guidelines [Ultra-clean workbench manufacturers, purification workbench, ultra-clean clean workbench] The principle of ultra-clean workbench is that in a specific space, indoor air is pre-filtered through the pre-filter. Pressed into the static pressure box by a small centrifugal fan, and then filtered by the air high-efficiency filter. The clean air flow from the air outlet surface of the air high-efficiency filter has a certain and uniform cross-section wind speed, which can exclude the original air in the working area. Dust particles and biological particles are carried away to form a sterile, high-clean working environment. The ultra-clean workbench is a widely used equipment in the microbiology testing laboratory, and monitoring procedures and instructions should be established. 1. Ultra-clean workbench monitoring procedures: The super-clean workbench should be developed with corresponding monitoring procedures. The main contents are: 1 Regularly monitor the microbiological quality of the inner surface of the ultra-clean workbench and the sterile isolation system and its internals. The air quality (particles and microorganisms) requires that the high-efficiency filter used should ensure that the rejection of particles larger than or equal to 0.3um is 99.97% or more. The flow rate of laminar air should be sufficient to carry the particles out of the work area. In general, the ideal laminar flow velocity should be controlled between 0.36 and 0.54 m/s on a plane (working area) 15 to 30 cm downstream from the filter; 2 the integrity of the high efficiency filter and the laminar flow rate should be It has been confirmed that the integrity (leak) inspection and filtration efficiency (performance) tests must be performed at the site of use after installation. Such tests must be carried out on a regular basis (usually at least once every six months); 3 routine management should be checked immediately if the equipment is found to be unstable, or the environmental monitoring results are abnormal, or the deviation of the microbiological test results is on the rise. And performance testing. This type of inspection is very important to avoid the potential contamination risks associated with aseptic processing. During aseptic work, the air quality in the operating area and the microbiological quality of the surface of the console should be monitored at the same time. In the experiment, a positive positive control test should be performed at the same time. 2. Ultra-clean workbench use guide: The main contents of the laminar flow purification workbench guide are: there should be relatively few people walking around, and the laminar flow purification workbench should be placed far away from the door, in order to make the equipment around The airflow in the environment is relatively stable, does not affect the operating area, and must not interfere with the laminar flow in the operating area. After the equipment is turned on, the operator should first check whether the reading of the differential pressure indicator is normal. Compared with the conventional pressure difference, the pressure difference is small or too large, indicating that the equipment is operating abnormally. It is necessary to investigate immediately and take necessary corrective measures. If a UV lamp is installed in the operating area, the UV lamp must be turned off before operation until all sterility has been completed. Prevent UV damage to the operator and damage to microorganisms that may be present in the sample. Operators can operate in laminar flow areas after wearing sterile latex gloves and sterile cuffs. After opening the workbench, disinfect the surface with a sterile disinfectant (70% sterile ethanol), wait at least 5 minutes before starting operation. All items placed in the workbench should be thoroughly sterilized and allowed to air dry before aseptic processing. All items in the work area should be tidy so as not to interfere with the direction of the airflow. The idle items in the ultra-clean workbench should be evacuated immediately and the airflow should not be blocked. Operators should be familiar with the design, operating principles, and airflow patterns of a laminar flow clean bench. The airflow in the normal laminar flow purification workbench is ultimately directed toward the operator to the surrounding environment. Therefore, such purification workbench should not be used to treat infectious, toxic or sensitive items. They are only suitable for general aseptic handling activities, such as assembly of sterile items, microbiological examination of conventional items, preparation of culture media, and the like. Although on the surface, the working flow of the vertical laminar flow purification workbench is not affected by any personnel and the surrounding environment, it is bound to cause potential pollution to the operator and the surrounding environment; the operation should avoid pollution to the surrounding environment and operators. When using a laminar flow table, it is important to ensure that the high efficiency filter is not blocked, thus ensuring that clean air is blown over and covers the entire work area. To prevent disruption of laminar flow, operators should avoid moving their hands and arms in or out of the laminar flow area as much as possible. Even if moving, care should be taken to keep all activities as possible downstream of the exposed area of ​​the sterile item (following the layer). Flow direction). The laboratory is equipped with a purification workbench, preferably a biological safety cabinet, dedicated to the treatment of conventional microbial strains, such as the identification of microorganisms, preparation and culture of biological indicators, preparation of standard strains for positive control or sensitivity testing of culture medium. , preservation and use. In the clean area, as far as conditions permit, try to make the laminar flow purification workbench always in operation. However, once restarted and restarted, the work area should be thoroughly disinfected and pre-run for at least 5 minutes before use. In addition, cleaning and disinfection measures should be taken on the work surface before and after each use. Detailed standard operating procedures should be developed for the operation, cleaning and disinfection, calibration and maintenance of various indoor laminar flow tables. Use and maintenance records for each laminar flow table, HTY aseptic isolation system. The contents of the usage record include: date and time of use, status before and after the instrument is used, cleaning or disinfection status, and the signature of the user; the maintenance record includes: description of the fault, maintenance status, and signature of the maintenance personnel and the person responsible for the equipment. A retrospective review of the equipment's cleaning or disinfection records and environmental monitoring records is performed periodically to assess the maintenance of the work area within the laminar flow table.


JC-1200 clean sampling car


The mobile clean sampling vehicle is a simple device that provides a partial purification working environment for raw material sampling. It has the advantages of low cost, simple trial, and movable, and is adopted by most GMP-certified units.


working principle


The mobile clean sampling vehicle uses a centrifugal fan system to draw in air through a medium-efficiency and high-efficiency filter, and the laminar flow hood is evenly outputted to deliver clean air to the work area, so that the working area can reach the required purification level with uninterrupted Power supply for easy sampling.


Structural features

The dust-proof and high-precision plate material is used as the frame, and the experimental area is made of stainless steel veneer, which has good sealing performance, beautiful appearance, firmness and durability.


Technical Parameters

model

JC-900

JC-1200

Cleanliness

Level 100 @≥0.5μm (US Federal 209E)

Number of colonies

<0.5 pcs/dish. (diameter 90mm culture plate)

noise

≤62dB(A)

average wind speed

0.25-0.6m/s

Vibration half-peak

≤0.5μm (X·Y·Z)

Illuminance

≥300LX

power supply

AC, single phase 220V/50HZ

Maximum power consumption

400W

800W

weight

160KG

300kg

Working size

730*650*950mm

1030*650*950mm

Dimensions

900*730*1950mm

1200*730*1950mm

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