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Micro Media XL Series Filter Media

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Micro-Media XL Series Filter Media

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.

Composition


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.

Applications


  • Botanical Extracts
  • Blood Fractions
  • Sera
  • Large Volume Parenterals
  • Small Volume Parenterals
  • Distilled Beverages
  • High Fructose Corn Syrup
  • Flavors & Fragrances
  • Cosmetics

Micro-Media® XL Grades


The table below is for reference only.

GradeRetention
M-05315 μm
M-10310 μm
M-4035.0 μm
M-4532.5 μm
M-5031.0 μm
M-503T0.8 μm
M-7030.45 μm
M-8530.3 μm
M-9530.25 μm

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


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.

Pilot Testing – Rentals


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.

Extractable Data


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.

CelpureStandard DE
Calcium CaBelow detectable limit1050
Aluminum AlBelow detectable limit1682
Magnesium Mg1241010
Iron Fe56400
Zinc Zn90210
Antimony SbBelow detectable limit12
Copper Cu1216
Maganese Mn414

ErtelAlsop vs. Competitors


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.

Testing Procedure


  • Original Serum E, Lot No. S4103, O.D. 710 nm=1.340
  • Membrane Size: 3.5-inch diameter
  • Filtration Time: 5 minutes
  • Pressure: 10 psi

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.*

Table III-FinePore Size Comparison (0.25 micron nominal)


Filter ManufacturerVolume in 5 MinutesO.D. of Filtrate
Competitor 129 ml0.042
ErtelAlsop Grade M-593141 ml0.036
Competitor 216 ml 0.048
Competitor 327 ml0.039
Competitor 485 ml0.046

*For complete details of the testing, contact ErtelAlsop to request the applifact entitled Filtration of Human and Animal Sera.

Water for Injection Extractable Test/Oxford Labs


Aluminum (PPB)Calcium (PPB)Iron (PPB)Magnesium (PPB)
<10200<525

LAL Testing/Associates of Cape Cod


EU/MLTest ProcedureTest MethodTest Date
<0.06Cape Cod 5L/ft2 RiseGel Clot12/01

Spec Sheets