For Exceptional Purity in Pharmaceutical Applications and Low Protein Binding
The Bio-series of depth filter sheets from 颇尔 was specially developed for the strict requirements of the biotech and pharmaceutical industries.Manufactured from highly purified natural and modified cellulose fibers, Bio-series depth filter sheets have significantly reduced levels of ash and heavy metal extractables.These extractables are usually contributed by inorganic material typically found in most depth filter sheets such as diatomaceous earth (DE), perlite, and glass fibers.
Bio-series depth filter sheets are available in three different retention ratings ranging from bio-burden reduction to coarse filtration.
When filtering ion sensitive products such as parenteral solutions, therapeutic proteins, dialysis solutions as well as protein-based diagnostics, a considerably better filtrate quality is reached with Bio-series depth filter sheets.
The use of selected cellulose fibers and their arrangement results in a very low protein adsorption in the filter matrix and excellent rinsing behavior after filtration.
|High bioburden reduction||BIO 10||Cell harvest, clarifying filtration of fermenter broth (cell separation), clarifying filtration of TFF permeate, clarifying filtration of cell cultures, filtration of CHO cells, protection for chromatography columns and membrane processes, protection for sterile filter membranes, filtration of pharmaceuticals and biopharmaceuticals, filtration of therapeutical protein, vaccines, diagnostics and blood products, therapeutical DNA, filtration of nutrients.|
|Bioburden reduction||BIO 20||
Cell harvest, clarifying filtration of centrifugation supernatant, filtration of biopharmaceuticals, filtration of therapeutical protein, vaccines, diagnostics and blood products, plasma fractionation (fine filtration), filtration of nutrients, protection for
chromatography columns and membrane processes, protection for sterile filter membranes.
Rel Protein Loss
The tests are performed according to the methods of the Technical / Analytical Work Group within the European Depth Filtration Association or in accordance with in-house test methods.
Weight per Area
Extractable Ions Soluble in 0.025m H2SO4 (mg/m2)
Ca Fe Al
|BIO 10||1400||<1||<0.5 ppm(1) <0.1 ppm(1) <0.05 ppm(1)|
|BIO 20||1400||<1||<0.5 ppm(1) <0.1 ppm(1) <0.05 ppm(1)|
The Bio-series depth filter sheets are in accordance with the U.S. Pharmacopeia (USP) Plastics Class VI and also meets the specifications of total extractables as per 21 Code of Federal Regulations (CFR), Part 177.2260 e, f, g, h, i, j, k for depth filters with resin.
The figures quoted in the diagrams and tables should be regarded as guidelines.
The following certificates and documentation are available:
- Technical Data sheets
- Certificate of Analysis available on request
- EU Safety Data Sheet
- Brochures etc.
Important Note :-Use of this product in a manner other than in accordance with 颇尔’s current recommendations may lead to injury or loss.颇尔 cannot accept liability for such injury or loss.
Because of developments in technology, these data and/or procedures are subject to continual review and update.