Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Food Ingredients Functions
Features & Benefits
- Labeling Claims
- Food Ingredients Features
- Benefits
Celpure® has many benefits compared to standard DE grades for the pharmaceutical industry.
- FDA registered plant
- GMP process and change control systems in place
- Very good filtration properties
- A broad range of filter aids for each application
- Full regulatory support
- Characteristics
- Diatomaceous earth (DE) is used in many processes (e.g. cell removal, plasma fractionation) as a filter aid for alluvial filtration. DE is fossilized remains of diatoms. Diatoms are hard-shelled algae. Two different types are known: salt (marine) water and fresh water diatoms. Salt water DE is less homogeneous and consists of various types of algae skeletons which leads to different characteristics compared to fresh water DE which normally consists of only one type of algae skeletons. DE is also present in filter sheet. Depending on the retention rate are more or less DE added.
- The patented Celpure® manufacturing process is a major advance in filter aid technology. This process produces media that surpasses conventional diatomite filter aids in purity, performance, regulatory support, and finished product consistency.
Applications & Uses
Properties
- Physical Properties
| Value | Units | Test Method / Conditions | |
| Permeability | 150-300 | mDarcy | — |
| Solids Removed (Depending on the compressibility of the solids, the values may vary by more than an order of magnitude) | 0.45-0.6 | µm | — |
| Surface Area | 3-4 | m2/g | — |
Regulatory & Compliance
- Certifications & Compliance
Technical Details & Test Data
- Comparison Of Food Grade And Pharmaceutical Grade Filter Aid
Food grade Celpure® Production facilities Food grade materials are produced under minimal control for
material integrityCelpure® products are manufactured in a dedicated FDA
registered facilityQuality control (QC) Release criteria based on filtration properties
QC every 10‘000 kgVery tight specification
QC every 100 kgPurity / Typical SiO₂ content 86 %–93 % 96 %–98 % Extractables Not controlled Consistently lower extractable substances
Packaging Paper bags, labeled as “Not intended for use in Pharma GMP
manufacturing”Packed in DuPont Tyvek bags offering protection against
physical damage and moisture penetrationRegulatory support No Full regulatory support documentation and service
Purification steps None, only one selection Extensively, multiple purification procedures during manufactu-ring
Density Standard Lowest density - Extractables
Extractable analysis by ICP-MS except for Fe (colorimetric complex with 1,10-phenanthroline). Extractables expressed as mg/kg of filter aid extracted from 2-g samples incubated in 100-mL solutions. Solution: 10 mg/mL albumin, 50 mM sodium acetate, pH 4.3. Incubation: 4 h, 160 rpm, 50 °C.
Extractable Celite Standard Super-Cel®
(Food grade)Celpure® C300
(High purity grade)Al₂O₃ 84.1 nd* Ca 52.5 nd* MgO 50.5 6.2 Fe₂O₃ 20 2.8 Zn 10.5 nd* Cu 0.8 0.6 Sb 0.6 nd* Mn 0.7 0.2 Cr 0.2 nd* *not detectable
- Material (source advanced minerals)
Material % SiO₂ 98.65 Al₂O₃ 0.6 Fe₂O₃ 0.27 Na₂O 0.14 K₂O 0.1 MgO 0.08 CaO 0.08 TiO₂ 0.03 P₂O₅ 0.03 MnO₂ nd* SO₃ nd* Cl nd* Total 99.98 *not detectable
Packaging & Availability
- Availability
- 0.03kg, 0.3kg, 1kg, 15kg.
- Available from 30 g can to 15 kg Tyvek bags.