New product launch | Alipore® DHC PES Sterilizing-Grade Hydrophilic Filter
Alioth has launched a new range of full-specification Alipore® DHC Sterilizing-Grade Filters, utilizing advanced Polyethersulfone (PES) material. This further enriches the portfolio of sterile filtration products within the series, catering to the sterile filtration needs of various process fluids in the life sciences industry. The Alipore® DHC Filters are designed to assist pharmaceutical enterprises in increasing product yields, reducing the risk of clogging, and effectively managing filtration costs.
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Figure 1. Application Sites in Biopharmaceutical Production Processes (Taking Monoclonal Antibody Drugs as an Example)
When we select a filter, we need to consider whether its physical and chemical properties meet the needs of a particular process.
Physical Properties
The key to the physical properties of a filter is its ability to maintain structural and performance stability at temperature and pressure under specific process conditions. This depends not only on the material and design of the membrane, but also on the manufacturer's production process. Therefore, we can determine the operating parameters of the filter, such as the maximum operating differential pressure and the maximum withstand temperature, by reviewing the filter verification documents provided by the supplier. In addition, conducting an audit of the supplier is also an important step in ensuring the quality of the filter.
Chemical properties
Chemical compatibility is a key factor when selecting a filter, which determines whether the filter will deform, dissolve, precipitate, or change in strength when exposed to a particular liquid.
Alipore® DHC's polyethersulfone (PES) material and unique filter manufacturing process exhibit excellent pH tolerance, providing high filtration flux and loading, as well as reliable sterilization and pressure resistance.
Comparison of physical performance parameters of Alipore® DHC and mainstream brand filters
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Conclusion
In terms of high-temperature sterilization and working pressure characteristics, the Alipore® DHC series has a higher level of repeated sterilization and liquid pressure tolerance than the mainstream brands of sterilizing filters on the market, and has passed the rigorous filter process validation.
Case Study: Polyclonal Cell Fermentation Broth, Clarified for Column Protection Filtration
A load capacity test was conducted using a mixed broth (14.02 NTU) from CHO fermentation after depth clarification filtration. The test compared primary products from both foreign and domestic filter manufacturers in terms of filter membrane selection.
Method
Given the limited volume of available feed liquid, appropriate small-scale equipment was used for the filtration test.
Each test set used the same feed liquid and was filtered under constant pressure (Vmax) of 1.0 bar (14.5 psi), with the flow rate decay recorded.
The load capacity of each filter membrane was calculated based on the test data using a standard pore blocking model, and the load capacity (L/m²) at 90% flow rate decay (V90) was used for data comparison.
Results
In the feed liquid used for this test, the relative performance of the Alipore® DHC filter compared to other tested filters is shown in Figure 2 and Figure 3.
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Figure 2. Diagram of flux vs. throughput change
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Figure 3. Comparison chart of filter membrane filterability
Conclusion
In this fluid test, the Alipore® DHC series showed relatively high flow rate and high capacity compared to similar products on the market, which can achieve the optimization of process efficiency and economic benefits.
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Bacterial Retention：Meets ASTMF838 standards，>107 cfu/cm2 B.diminuta ( ATCC® 19146TM)
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Biological Safety：All the construction components of this filter comply with the requirements for biological safety of Class VI plastics in current USP <88>
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Cleanliness：Cleanliness meets the requirements for nonfiber releasing filter as specified in FDA 21 CFR211.72 and 210.3 (b) (5) (6), and the level of insoluble particles in rinsing liquid meets the requirements of USP <788>
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Endotoxin：The endotoxin level of cartridge rinsing liquid is <0.25 EU/mL as indicated by gel method, which complies with the requirements of USP <85>
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TOC / Conductivity：Filtrate of this filter , TOC＜0.5 mg/L, Conductivity＜1.3 μS/cm
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Indirect Food Additive：The primary construction components of this filter comply with the requirements for food contact materials as stipulated in EU 1935 /2004 / EC and FDA 21 CFR 177-182
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No Animal Origin: All structural components of the filter are not of animal origin
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