【适用范围】

Used to determine the retention efficiency of pharmaceutical filter membranes (0.22μm/0.45μm) and final filters for injections, large-volume parenterals, biological products, etc., against standard bacterial strains such as Pseudomonas diminuta (ATCC 19146). It verifies compliance with the sterility process requirements specified in Chinese Pharmacopoeia Volume IV General Chapter 1105, USP <71>, and ISO 13408-2. Suitable for pharmaceutical enterprises, filter membrane manufacturers, and medical device quality inspection institutions.

【相关标准】

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.