Liofilchem microbiology products Biopharma applications

Biological indicators

The USP (United States Pharmacopoeia), EP (European Pharmacopoeia) and DAB (Deutsches Arzneibuch) regulations recommend the use of bioindicators during the sterilization processes of drugs, medicines in vials, culture media, medical instruments and other devices. Liofilchem provides a wide range of biological indicators for the steam, ethylene oxide, dry heat, hydrogen peroxide and irradiation sterilization processes, available in ampoules, self-contained, strip, suspension and coupon formats in several materials such as glass, aluminum, poliflex, steel, PVC. Liofilchem manufactures its Biological Indicators in strictly controlled environment to fulfill the requisites indicated in USP and EP and in accordance with the ISO 11138 and EN 866 regulations.

Learn more about our Biological Indicators product range

Quanti-CultiControl Quantitative freeze-dried microorganisms

The Quanti-CultiControl are lyophilized, quantitative microorganism preparations to be used in industrial laboratories for Quality Control purposes. Processed as directed, these preparations provide a challenge of <100 CFU per 0.1 mL, which is a concentration usually suitable for several pharmaceutical applications, including growth promotion testing of culture media to be employed in sterility testing. These microorganism preparations are derived from the American Type Culture Collection (ATCC®). The Quanti-CultiControl are suitable for the Growth Promotion Test recommended by the international Pharmacopoeiae, without need of intermediate dilution steps, since each rehydrated suspension generates less than 100 UFC for 0.1 mL inoculum. Each suspension (1 mL) allows 10 inocula. Download the product technical sheet Download the photographic test procedure The derived from ATCC Licensed Derivative Emblem, the derived from ATCC Licensed Derivative word mark and the derived from ATCC catalog marks are trademarks of derived from ATCC. Liofilchem® s.r.l. is licensed to use these trademarks and to sell products derived from derived from ATCC® cultures. Look for the derived from ATCC Licensed Derivative® Emblem for products derived from derived from ATCC® cultures.

Liofilchem srl  Headquarters, Manufacturing Site, International distribution Zona Industriale, 64026 Roseto degli Abruzzi (TE) Italy Tel +39 0858930745 Liofilchem, Inc. US Distribution Center 465 Waverley Oaks Rd. Suite 317 Waltham, MA 02452 United States Tel +1 781-902-0312

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