MICROBIOLOGY LABORATORY SERVICES
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FDA REGISTERED
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17025 ACCREDITED
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CUSTOMER MAIL-IN SAMPLES ACCEPTED
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PROVIDE ONSITE FIELD SAMPLING SUPORT
Microbiology Lab Capabilities
Our Microbiology Laboratory Testing Services were designed to offer our customers a wide range of options for handling their routine and on-demand project requirements. As part of our microbiology testing services, we process CUSTOMER MAIL-IN samples and provide routine onsite FIELD SAMPLING services.
Quantus, Inc. has one of the largest LifeSciences environmental monitoring field service teams in the area.
Our Team consists of (1) Environmental Monitoring Department Manager, (1) Microbiology Lab Manager, (3) Microbiologists, and (6) Dedicated EM Field Technicians.
Environmental Monitoring Sample Analysis
Maintaining a state of microbial control and understanding sources of contamination is a crucial part of our customer’s processes. Our core microbiology laboratory services include incubation, enumeration, and identification of recovered microbial growth in compliance with the most current guidelines of the pharmaceutical industry.
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USP <797>
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USP <1116>
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USP <825>
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ISO 14698
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EU ANNEX 1
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EN 17141
Environmental monitoring media is assessed for sterility and capability of supporting growth for each sample submission. learn more
Microbial Organism Identification
Microorganisms identification to the species level is a key task of our microbiology testing laboratory. We have invested in the most advanced system in the marketplace to provide our customers with reliable and fast organism identification services. Our MALDI Biotyper uses a molecular-based mass spectrometric identification method that enables faster and more efficient analysis than conventional assays or sequencing.
MEDIA FILL ANALYSIS
Aseptic processing operations should be validated using a microbiological growth medium in place of the product. This process simulation, also known as a media fill, is used to measure the aseptic skill of your compounding personnel/manufacturing personnel.
The Quantus Microbiology Laboratory has the ability to analyze media fill samples in compliance with USP <797> and FDA guidelines. Additionally, our lab is able to perform growth promotion testing utilizing compendial organisms to confirm media suitability.
USP <55> Biological Indicator Testing
The Quantus Microbiology Laboratory can test and perform qualitative analysis of biological indicators in compliance with USP <55>. Incubation and analysis is based on the carrier organism and manufacturer instructions.
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Qualitative BI analysis – Positive / Negative
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Ampoules and self-contained BI’s
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Direct transfer of BI carriers to liquid growth medium
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Strips, Discs, and Ribbons
