Shanghai Chengsi standard test method for microbial grade tester for porous packaging materials

Porous packaging materials microbial grade tester implementation standards: ASTM F 1608 standard test method for microbiological grade of porous packaging materials is the same as YY/T 0681.
10YY/T 0681.
10 "Sterile medical device packaging test method Part 10: Breathable packaging material microbial barrier classification test"; The significance and application of this test chamber method is used to quantitatively determine the microbial barrier properties
of breathable materials under the conditions specified in the test.
The data obtained in this trial were used to evaluate the relative ability
of a particular breathable material to maintain the sterile state of the package contents relative to another breathable material.
This test method cannot give the performance
of a given material in a particular aseptic packaging application.
The maintenance of sterility in a particular packaging application depends on a number of factors, including but not limited to: a) the bacterial challenges (number and type of microorganisms) encountered by the packaging during transport and use; Note, this may be affected by shipping methods, expected shelf life, geographical location and storage conditions
.
b) the design of the packaging; Note: Includes the bonding between materials with or without the properties of the second and third layers of packaging and the device inside the
package.
C) The rate and volume of air exchange that the breathable material undergoes during transport and shelf life: Note: Transport, disposal, climatic or mechanical disturbances (such as door closure and heating, ventilation and air conditioning systems) can cause changes in the amount and pressure of free air in the package, resulting in air exchange
.
d) The microstructure of a permeable material under different airflow conditions affects its relative ability to
adsorb and/or permeate microorganisms.
Technical features: high-performance sampling pump, strong load capacity, stable flow; Microbial aerosol generator, good atomization effect; Rotameter, clear display, easy to control; Transparent test chamber for easy observation of spray and diffusion effect; Membrane and sample holder, easy to clip and receive; Spraying, sampling, self-cleaning can be controlled individually, easy to
operate.
Breathable packaging material microbial barrier test system: 1) output flow range: 5L-30L/min; 2) Flow control range: 1L-5L/min; 3) Aerosol chamber: acrylic plate; 4) Test group: 6 groups of controlled tests; 5) Sample collector: 6; 6) Sample flow: 2.
8L/min; 7) Dimensions: 900 (L)×580 (W)× 880 (H)mm (size can be customized) Test chamber ready due to the production of bacterial buds holding aerosol during the use of the instrument Test chamber should be installed and used in a biosafety cabinet.
1 The upper part of the box should be placed on the substrate.
2 The multiplex pipe is connected to the upper port of the six flow meters with a hose with an inner diameter of 6.
5 mm, and the multiplex pipe is connected to the vacuum source with the filter.
3 The inner diameter is 6.
5 mm The hose connects the bottom end of each sample flow meter to the connection port of each filter unit4 Connect the sprayer to the T-part with a rubber tube
.
The T-profile consists of a PVC tee with an inner diameter of 13 mm and a three-segment inner diameter of 6 mm and a length of approx.
7.
The vertical end of the 5 cm PVC tube consisting of the .
5.
T type is connected to the trap bottle by a rubber stopper with a 6.
5 mm inner diameter hole The second end of the trap bottle is used to capture the unsuspended droplets generated by the sprayer 6 The second end of the T-shaped part passes through the inner diameter of 13 mm and is about 3 mm long.
The 8 cm rubber tube is connected to the front port of the box7, the third end of the profile is connected to the nozzle end of the sprayer by a rubber tube with an inner diameter of 13 mm and a length of about 16 cm8, the inlet of the sprayer is connected to the upper mouth of the calibrated flow meter 5 Lmin ~ 30 L/min by a rubber tube with an inner diameter of 5 mm9, the lower port of the sprayer is connected to the filter air source 10, the pipe with an inner diameter of 13 mm is connected to the exhaust port on the box, and then connected to the air filter and the vacuum source in turn11, and the over-condemnion device is prepared 12, Each non-sterile sterilizable filter device is wrapped with a sterilized wrapping material 13, and the filter device is sterilized according to the manufacturer's regulations.
Pre-sterilized filtration units do not need to be sterilized Note: This test should be performed by trained personnel in a microbiology laboratory and should therefore have equipment and supplies for routine microbiological operations such as standard plate counting, pressure steam sterilizers
, etc.