AW Celite NF Media is a High Purity, Direct Replacement
for Conventional (Food Grade) Celite Diatomite Filter Aids
AW Celite NF media is the best choice where a high purity,
USP-NF Grade direct replacement is needed for conventional
Food grade Celite filter aids. Other than the addition of
an acid washing step, the AW Celite manufacturing process
is similar to that of conventional Celite filter aids. This
similarity produces a media that will minimize differences
in filtration processes that previously used Food grades.
Studies show that after replacing Food
Grade Celite filter aids with AW Celite NF media, extractable
impurities are significantly reduced (Table 1).
Extractables
Expressed as mg/kg of Filter Aid
|
| |
Celite
Standard
Super-Cel®
(Food grade) |
AW
Celite Standard
Super-Cel® NF
(High Purity grade) |
| Al |
84.1 |
0.4 |
| Ca |
52.5 |
nd |
| Mg |
50.5 |
7.4 |
| Fe |
20.0 |
1.4 |
| Zn |
10.5 |
nd |
| Cu |
0.8 |
0.6 |
| Sb |
0.6 |
0.01 |
| Mn |
0.7 |
0.1 |
| Cr |
0.2 |
0.1 |
| *(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.
AW Celite NF media was developed as
a pharmaceutical grade CGMP alternative to Food Grade Celite.
AW Celite NF 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 AW Celite
NF and Food grades of diatomite see Filter Aid in CGMP Parenteral
Pharmaceutical Processing: A Regulatory Perspective and
Replacing Food Grade Celite® Media with AW Celite NF
Media in CGMP Pharmaceutical Processes.
For information on our production facility
that serves the pharmaceutical industry, see High
Purity Filter Media.
Intended Use of AW Celite® Media
AW Celite NF media is intended for solid-liquid separation
in conjunction with a pressure filtration system. AW Celite
NF media is available in a wide range of permeabilities.
The least-permeable AW Celite NF Grades can remove submicron
solids in filtration applications (Table 2).
Permeability
and Particle Size Retention |
| High
Purity Grade |
Permeability
(Darcy) |
Solids
Removed (micron)* |
| AW
Celite Filter Cel® NF |
0.10 |
0.5 |
| AW
Celite® 521 NF |
0.30 |
1.2 |
| AW
Standard Super-Cel® NF |
0.30 |
1.2 |
| AW
Celite® 512 NF |
0.40 |
1.5 |
| AW
Hyflo Super-Cel® NF |
1.0 |
2.0 |
| AW
Celite® 503 NF |
1.6 |
3.0 |
| AW
Celite® 535 NF |
3.0 |
3.5 |
| AW
Celite® 545 NF |
4.0 |
4.5 |
Table 1.
*Data is provided for comparison purposes only. Depending
on the compressibility of the solids, the values may range
by more than an order of magnitude.
Packaging
Products- High
Purity Filtration, Sorbents,
Gas-Liquid Chromatography, Sample
Request
Support- Application
Notes, MSDS,
Data
Requests, Glossary
Home . Contact
Us . Site Map
. Terms of Use . Privacy Policy
|
