Scope of Application

【Operating Instructions】

YY/T 0929.3-2023 "Pharmaceutical Filters for Infusion - Part 3: Liquid Bacteria Retention Test Method for Pharmaceutical Filters with a Nominal Pore Size of 0.22μm"YY/T 1551.2-2017 "Air Filters for Infusion and Transfusion Devices - Part 2: Liquid Bacteria Retention Test Method"

【Technical Parameters】

1. Challenge Pressure System

1.1 Three-channel pressure control system: independently controlled and independently detects 

output pressure;1.2 Pressure Control Range: 10~400kPa;1.3 Pressure Display Accuracy: ±0.5% F.S. 

(Full Scale);1.4 At least 3 units of 1-gallon pressure vessels, used for containing challenge bacterial 

solution, wetting solution, and cleaning alcohol respectively;1.5 Pressure control mode: optional direct

 pressurization or gradual pressurization; the amplitude and frequency of gradual pressurization are configurable;

2. Sample Challenge System

2.1 Sample Challenge Assemblies: At least 12 sets of sample challenge assemblies, compatible with clamping

 samples of different sizes;2.2 Test Piping: Entire piping system can be autoclaved (high-temperature sterilizable);

2.3 At least 6 channels of adjustable all-metal flow control valves;

3. Test Environment

3.1 Biosafety Cabinet: Complies with the requirements of YY 0569-2011 "Class II Biosafety Cabinets";3.2 Average 

Downward Air Velocity: 0.33±0.025m/s;3.3 Average Inlet Air Velocity: 0.53±0.025m/s;

【Configuration List】

1．Stainless steel pressure vessels (1-gallon): 3 units;

2．Aluminum busbar: 1 piece;

3．Test chambers: 12 units;

4．Air pipe: 3 meters;

5．Test chamber brackets: 2 pieces;

6．Air compressor: 1 unit;

7．Ultraviolet (UV) lamp tube: 1 piece;

8．Test chamber brackets: 2 pieces; (Note: Duplicate item retained as per original list; suggest verifying if it's a typo in the source text)

9．Biosafety cabinet: 1 unit.