Microbiological QC Solutions
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Microbiological QC Solutions - 1

Microbiological QC Solutions Performance You Deserve, with the Compliance You Expect

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Microbiological QC Solutions - 2

Intelligent Tools for Microbiological Quality Control Working in pharmaceutical manufacturing quality control is a big responsibility, and you are understandably concerned for the patient’s wellbeing. We understand that ensuring safety and compliance for your sampling detection and microbiological processes is critical to you and your company. Our microbiological QC portfolio is designed to give you the best tools to meet the challenges you face every day, ensuring your results meet the required levels of safety and compliance. We offer intelligent solutions for unmet needs. USP <61>, <62>...

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Microbiological QC Solutions - 3

Microbial Enumeration Mycoplasma Detection Rapid Sterility Sterility Testing Sartorius Service Supporting Products Forceps-Free & Effortless Membrane Transfer Microsart® @filter & @media Do you want to transfer your membrane after the filtration without risking contamination to the agar media? Membrane filtration is the regulatory-preferred method for microbial enumeration testing. However, transferring the membrane filter to the microbiological medium is one of the most common sources of contamination and false-positive results. Your Benefits Touch-Free Membrane Transfer Microsart®...

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The New Gold Standard for Mycoplasma Detection Microsart® Mycoplasma qPCR Detection Kits Would you rather know in 3 hours or wait 28 days? Mycoplasma testing per USP <63> and EP 2.6.7 can take 28 days. Avoid this lengthy cultivation method with our Microsart® Mycoplasma qPCR detection kits. These kits are fast, highly specific, sensitive, and compliant with international regulations. Sartorius qPCR experts provide step-by-step support during your matrix-specific validation and beyond. Your Benefits Don´t worry about false positives due to highly specific TaqMan probes Let the Master Mix do...

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Microbial Enumeration Mycoplasma Detection Rapid Sterility Sterility Testing Sartorius Service Supporting Products Rapid Sterility: Rapid Detection of Bacteria and Fungi in Only 3 Hours Microsart® ATMP Sterile Release Kit Do you want to be sure that your Advanced Therapy Medicinal Products (ATMPs) are contamination-free before treatment? Detect bacterial and fungial contamination within 3 hours using proven TaqMan™ probes for real-time PCR in our Microsart® ATMP Sterile Release Kit. To ensure patient safety and reduce the need for prophylactic antibiotic treatment, release only...

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Continuous Active Air Monitoring Active Air Monitoring with MD8 Airscan® What if you could monitor for viable air during an entire production run using only a single plate? The MD8 Airscan® command unit utilizes a single, sterile gelatine membrane filter to capture and retain even the smallest airborne microorganisms, even viruses, over an 8 hour period. This USP-approved membrane filter can then be placed on any standard agar plate for routine incubation per your environmental monitoring protocols. Rule out false test results, ensure the most accurate data, and reserve valuable incubator...

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Microbial Enumeration Mycoplasma Detection Rapid Sterility Sterility Testing Sartorius Service Supporting Products Be prepared for the EU GMP Annex 1 Revision Multiple Configurations Available to Suit Any Microbiology Testing Need This includes Gelatine Membrane filters in Biosafe® bags for its aseptic transfer, via a Biosafe® port, into isolators, RABS and clean rooms. Gelatine Membrane Filter VHP* compatible sampling head Biosafe® Bags for safe transfer into isolators Active air monitoring with MD8 Airscan® MD8 Airscan® control unit Optional printer * Vaporized Hydrogen Peroxide For more...

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Redefine Your Standards for Sterility Testing Sterisart® NF System & Sterisart® Universal Pump How certain are you about your sterility testing? Sterility testing is considered one of the most critical tests conducted by the Microbiology team, and it’s common for many to wonder whether the testing was done correctly. Our Sterisart devices are designed to give you confidence in your results. If you are looking to move into rapid microbiology testing, our Sterisart devices are designed to allow you to aseptically sample via a septum while ensuring compliance with global regulations. Your...

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Microbial Enumeration Mycoplasma Detection Rapid Sterility Sterility Testing Sartorius Service Supporting Products Sartorius Service We Ensure the Quality of Your Results Services are essential to all pharmaceutical laboratories. Having access to the right resources will ensure you stay in regulatory compliance. We at Sartorius are dedicated to maintaining global regulatory compliance and offer worldwide support for you and your staff. Equipment Qualification (IQ | OQ) This service includes evaluation and adjustment of key instrument parameters. Results are fully documented and easy to...

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Supporting Products for Quality Control Quality Control begins with appropriate sample preparation. See how we can support your routine sample preparation workflow and analytical quality control tests for accurate and reliable results! Cubis® II Balances Cubis® II fulfills current and future demands of digital workflow management and pharma compliance. Plug and play connectors offer decreased complexity and simplified IT maintenance. Application conform weighing pans ensure reliability and increase measurement repeatability. Arium® Ultrapure Water Systems Arium® ultrapure water systems...

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Microbial Enumeration Mycoplasma Detection Rapid Sterility Sterility Testing Sartorius Service Supporting Products Picus® Electronic Pipettes The Picus® pipettes are kind to your hand with unbeatable ergonomic design that ensures reliable and repeatable experiment results. Speed up your work and save time in the lab with productivity increasing pipetting modes and customizable programs of Picus®. The pipettes are easy to get comfortable with, quick to use and they will reduce experiment and user-dependent variation. Octet® Octet instruments come with an optional GxP compliant 21CFR Part 11...

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