Micro-Media - Pharmaceutical P-Grade Filter Pads
The pharmaceutical and biotech markets require a high level of functional consistency from filtration products. To provide a higher level of confidence for these customers, ErtelAlsop drafted its Drug Master File and submitted it to the FDA Center for Drug Evaluation and Research. ErtelAlsop manufactures all filter pads to very high standards, and the Drug Master File provides the documentation to ensure consistency in manufacturing and raw materials. All filter pads manufactured by ErtelAlsop are fully lot traceable back to the raw material suppliers, and their suppliers, where applicable and are supplied with a "P" certificate. The low extractables, low LAL concentrations, and highly consistent manufacturing process, make ErtelAlsop filter pads the ideal choice for your critical application.
ErtelAlsop also offers a Validation Guide to assist in the validation of its filter pads in your process. The Validation Guide contains information regarding raw materials, extractables, and general information about the product. The combination of ErtelAlsop "P" grade filter pads and ErtelAlsop`s BioClean plate and frame filter press design, can help to simplify your depth filtration validation now more than ever.
The Right Choice for Critical Processing
Pharmaceutical Grade Micro-Media Series Depth Filter Media, formulated with cellulose, wet strength resin and diatomite and/or perlite is specifically designed for use in critical pharmaceutical and biotech applications. All components are listed in the CFR as generally recognized as safe for contact with food as dictated by 21CFR 176.170. Pharmaceutical Grade Micro-Media Series Depth Filter Media is manufactured in accordance with ErtelAlsop Drug Master File located at the United States Food and Drug Administration Center for Drug Evaluation and Research.
Composition
ErtelAlsop Micro-Media filter sheets are composed of cellulose pulp, Diatomaceous Earth and/or Perlite, or CelPure for the XL Series, and a wet strength resin, which charge modifies the media to exhibit a net positive charge referred to as Zeta Potential. This allows for the highly efficient removal of particles smaller than the filter’s nominal rating.
- Blood Fractions
- Sera
- Cell Culture Media
- Active Pharmaceutical Ingredients
- Large Volume Parenterals
- Small Volume Parenterals
Product testing is always available either at your facility, through our network of distributors, or at our in-house laboratory.
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.
The most accurate way to optimize your process is through laboratory scale testing. Samples of P-Grade Micro-Media, Micro-Media XL Series, or Micro-Clear Media 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.
Table to the left is for reference only.
- Contains Cellulose, Perlite, and DE
- Contains Cellulose, High Purity DE