Celpure Diatomite is a High Purity Filter Aid
The patented Celpure manufacturing process is a major advance
in filter aid technology. This process produces a media
that surpasses conventional diatomite filter aids in purity,
performance, regulatory support, and finished product consistency.
Celpure is the ideal choice when developing
new high purity processes with diatomite filter aid, and
is available in USP-NF Grade and Food Grade.
Studies show that after replacing conventional
diatomite filter aids with Celpure diatomite filter aids,
extractable impurities are significantly reduced (Table
1).
Extractables
Expressed as mg/kg of Filter Aid |
| |
Celite
Standard
Super-Cel®
(Food grade) |
Celpure®
300
(High Purity grade) |
| Al |
84.1 |
nd* |
| Ca |
52.5 |
nd |
| Mg |
50.5 |
6.2 |
| Fe |
20.0 |
2.8 |
| Zn |
10.5 |
nd |
| Cu |
0.8 |
0.6 |
| Sb |
0.6 |
nd |
| Mn |
0.7 |
0.2 |
| Cr |
0.2 |
nd |
| *(nd)
Below detectable limit |
Table 1. 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.
Our USP-NF Grade Celpure media was
developed as a pharmaceutical CGMP alternative to Food Grade
diatomite filter aids. Celpure media addresses the following
CGMP needs that are unmet with Food Grade diatomite filter
aids:
 Regulatory
Support
Compendial
standards
Purity
Manufacturing
and process control
Packaging
For more information on the differences between USP-NF Grade
Celpure and Food grades of diatomite see Diatomite Filter
Aid in CGMP Parenteral Pharmaceutical Processing: A Regulatory
Perspective.
For information on our production facility
that serves the pharmaceutical industry, see High
Purity Filter Media.
Intended Use of Celpure Media
Celpure media is intended for solid-liquid separation in
conjunction with a pressure filtration system. Celpure media
is available in a wide range of permeabilities. The least
permeable Celpure grades can remove submicron solids in
filtration applications (Table 2).
Permeability
and Particle Size Retention |
| Grade |
Permeability
(Darcy) |
Solids
Removed (micron)* |
| Celpure®
25 |
0.025 |
< 0.3 |
| Celpure®
65 |
0.065 |
<
0.3 |
| Celpure®
100 |
0.100 |
0.4 |
| Celpure®
300 |
0.300 |
0.5 |
| Celpure®
1000 |
1.000 |
1.5 |
Table 2.
*Data is provided for comparison purposes only. Depending
on the compressibility of the solids, the values may vary
by more than an order of magnitude.
Packaging
Products- High
Purity Filtration, Sorbents,
Gas-Liquid Chromatography, Sample
Request
Support- Application
Notes, MSDS - NAFTA,
Data
Requests, Glossary
Home . Contact
Us . Site Map
. Terms of Use . Privacy Policy
|
