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MICROBIOLOGY LABORATORY

  • FDA REGISTERED

  • 17025 ACCREDITED

  • Customer Mail-in Samples Accepted

  • Provide Onsite Field Sampling Support

QLIMS The Future of LIMSystems

THE MOST ADVANCED SAMPLE TRACKING, WORKFLOW MANAGEMENT, and QUALITY CONTROL

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The Ultimate Sample Tracker

Providing visibility of both Quantus Field Samples and Customer Mail-in Samples

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Lab Workflows

Templated Lab Workflows ensures testing is always completed in conformance with unique customer testing requirements

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Online Reporting & Trending

Advanced reporting and trending web application includes:

  • notifications

  • report downloads

  • trending

  • @mention us

  • in-app communication

QLIMS Ensures Sample Integrity

QLIMS powerful user features:

  • Sample Tracking & Progress Status

  • Templated Lab Workflows

  • Automated Scheduling

  • Early & Late Incubation Alert

  • Integrated QA Review Algorithms

CUSTOMER DASHBOARD APP provides:

  • Chain of Custody (CoC) Generator

  • Free Shipping Label

  • Action & Alert Notices

  • Trending & Online Report Download

  • @mention rapid internal communication tools

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. 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.

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Environmental Monitoring Sample Analysis

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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.

  • USP <797>

  • USP <1116>

  • USP <825>

  • ISO 14698

  • EU ANNEX 1

  • 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

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MEDIA FILL ANALYSIS

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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.

  • Qualitative BI analysis – Positive / Negative

  • Ampoules and self-contained BI’s

  • Direct transfer of BI carriers to liquid growth medium

  • Strips, Discs, and Ribbons

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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.

MORE INFORMATION
COMING SOON