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GLOBAL GOLD PARTICLE TEST SYSTEM MARKET
INTRODUCTION
Filters undergo a post-use integrity test known as the gold particle test (GPT) to ensure that there is no change in the distribution of pore sizes following virus filtration.
An in-line visual spectrometer measures the absorbance of the permeate fraction after diluted integrity test solution is pushed through the filter. Without the need for offline analysis, the control unit calculates the gold particle LRV on its own and generates a pass/fail filter result. There are significant time savings.
Biologic drug-substance manufacturing processes are cleansed of endogenous and/or adventitious viruses using nanofilters (1). For cellulose filters, the gold particle test (GPT) is used in addition to postuse leakage testing as part of postuse integrity testing.
GLOBAL GOLD PARTICLE TEST SYSTEM MARKET SIZE AND FORECAST
The Global Gold Particle Test System market accounted for $XX Billion in 2022 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2023 to 2030.
NEW PRODUCT LAUNCH
For Planova N series filters, Asahi Kasei Bioprocess has developed a second generation AGPTS-II (Ashai Kasei Gold Testing System) to simplify and automate the post-use gold particle test.
The AGPTS-II is available in single-filter and multi-filter configurations and can complete the test in less than 25 minutes. One Planova 1.0 or 4.0 m2 15N, 20N, or 35N filter at a time can be tested with the gold particle test using the compact, validated Single-Filter AGPTS-II. It is made up of two parts: a feed unit and a control unit.
Multiple Planova filters can be tested simultaneously automatically by Multi-Filter AGPTS-II. They are ideal for processes that use three or more Planova filters in a batch or for facilities that use more than one hundred Planova filters annually. They are available in five-, six-, and ten-filter configurations.
First, the test article is filtered through with a proprietary gold-colloid solution that is matched to the type of filter (for example, 20N).
Spectrophotometric absorbance readings of the integrity-test solution, such as a 1:10 dilution of Asahi Gold Particle solution AGP-HA20 to test Planova 20N, and the correct filtrate sample (minimum volume collected for measuring absorbance) can be used to calculate the gold-particle removal rate as a logarithmic reduction value (LRV). This filter’s pore-size distribution can be assessed.
COMPANY PROFILE
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