MICROBIOLOGY LABORATORY
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17025 ACCREDITED
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CUSTOMER MAIL-IN SAMPLES ACCEPTED
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PROVIDE ONSITE FIELD SAMPLING SUPORT
Environmental Monitoring Sample Analysis
Maintaining a state of microbial control and understanding sources of contamination is a crucial part of our customer’s processes. The Quantus Microbiology Laboratory’s core service is 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.
Microbial Organism Identification
Microorganisms identification to the species level is a key task of our microbiology lab. We have invested in the most advanced system in the market place 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
17025 Accreditation
ISO 17025 is the main international standard for general requirements for the competence of testing and calibration laboratories. This standard is applicable to all or any laboratory regardless of the size or the scope of testing and most laboratories must hold this accreditation in order to be deemed technically competent. Accreditation formally recognizes the organization implements a quality management system, employs/trains a technically competent team, and produces results you can trust.