Micro-Media XL Series Depth Filter Media, formulated with cellulose, wet strength resin and Celpure® diatomite, an ultra-pure form of Diatomaceous Earth manufactured only by Advanced Minerals Corporation, is specifically designed for use in critical applications. DE can now meet the high quality standards dictated by 21CFR211.160 (b). Traditional “food-grade” forms of DE rarely meet USP-NF standards.
Most filter media manufacturers currently use DE formed to “food-grade” quality standards, NOT pharmaceutical component quality standards, which allows for problems with respect to compendial standards, purity, manufacturing and process control and packaging.
Because the majority of diatomite producers send more than 90% of their products into industrial and food-grade applications, “food-grade” DE is produced to commodity-type standards and economics, which means product specification testing is performed as little as every 10,000 kg of production volume. Unchecked variations in diatomite result in significant process deviation such as filtrate color, pH and impurity profiles.
ErtelAlsop Micro-Media filter sheets are composed of cellulose pulp, Celpure® Diatomaceous Earth and wet strength resin, which causes the media to exhibit a net positive charge zeta potential. This allows for the highly efficient removal of particles smaller than the filter’s nominal rating. The Micro-Clear™ carbon impregnated line of media can also be manufactured using Celpure® diatomite.
The table below is for reference only.
The most accurate way to optimize your process is through laboratory scale testing. Samples of Micro-Media® XL are available at no charge. Authorized ErtelAlsop representatives are equipped to run trials on-site, or product samples may be sent directly to ErtelAlsop for testing with prior approval.
Product testing is always available either at your facility or at our in-house laboratory*.
* In-house testing is subject to approval by CLEAR Solutions.
For in-plant testing and scale-up procedures, ErtelAlsop offers a variety of lab filters for rent. A portion of rental fees can be applied to the purchase of your full production filter.
The use of Celpure® Diatomaceous Earth in the manufacture of ErtelAlsop XL Series Media provides superior quality and lower extractable levels when compared to standard “food grade” DE as well as increased particle retention and product throughput.
Diatomite filter aids were originally developed for the beverage industry, when the beverage and pharmaceutical industries used similar quality standards. As a direct result, both industries relied extensively upon standard “food grade” diatomite. Even the advent of pharmaceutical GMPs did little to alter this practice.
Quality standards for this “food grade” DE were often not in keeping with the critical standards of the pharmaceutical industry. In particular, problems surfaced with regard to compendial standards, purity, manufacturing and process control and packaging.
|Calcium Ca||Below detectable limit||1050|
|Aluminum Al||Below detectable limit||1682|
|Antimony Sb||Below detectable limit||12|
In tests done by an independent facility on ErtelAlsop XL Series Media against four other grades, XL Series Media consistently outperformed its competitors. Test results follow, including run data, typical extractables and LAL data.
One batch of dirty serum was used as a challenge against 15 samples of depth filter media from 5 different manufacturers. Measurements were taken for optical density of the unfiltered sera and then of actual filtrate after the 5 minute challenge.
XL Grade M-953 test results are shown below.*
|Filter Manufacturer||Volume in 5 Minutes||O.D. of Filtrate|
|Competitor 1||29 ml||0.042|
|ErtelAlsop Grade M-593||141 ml||0.036|
|Competitor 2||16 ml||0.048|
|Competitor 3||27 ml||0.039|
|Competitor 4||85 ml||0.046|
*For complete details of the testing, contact ErtelAlsop to request the applifact entitled Filtration of Human and Animal Sera.
|Aluminum (PPB)||Calcium (PPB)||Iron (PPB)||Magnesium (PPB)|
|EU/ML||Test Procedure||Test Method||Test Date|
|<0.06||Cape Cod 5L/ft2 Rise||Gel Clot||12/01|