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Clincal ImageMicrobiology Services

Microbiological Testing is time consuming enough; 14 days for sterility or 28 days for antimicrobial effectiveness testing. Our in-house Microbiology Laboratory efficiently conducts these lengthy tests within our development process. Our clients don’t experience the delays common when coordinating microbiological testing with outside laboratories.

Bio-Concept performs all compendia microbiology tests to support product development and regulatory submissions.

Endotoxin (LAL) Testing

Method development
Bacterial Endotoxin Testing, USP <85>
Endosafe Kinetic Turbidimetric system gel-clot method

Bioburden Testing

Microbial Enumeration by USP <61> and <62>

Microbial Identification

Vitek 2 Compact Microbial Identification System

Antimicrobial Agent Screening

Dose Range Studies
Neutralization Efficacy (AET validation)
Antimicrobial Effectiveness Testing,
USP <51>

Sterility Testing

Dedicated Class A Sterility Suite
Sterility Validation
(Bacteriostasis / Fungistasis)
Sterility Testing, USP <71>

With In-House Microbiology Testing available, Bio-Concept coordinates Sample Preparation and Testing so no precious Development Time is lost.

Capabilities

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