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Microtest Logo
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Steven Richter, Ph.D., President, Microtest, Inc.
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Aseptic Fill Finish Processing |
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Operations in a Class 100 Fill Finish Suite at Microtest Laboratories, Inc., photo #1
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Operations in a Class 100 Fill Finish Suite at Microtest Laboratories, Inc., photo #2
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Operations in a Class 100 Fill Finish Suite at Microtest Laboratories, Inc., photo #3
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Combination Products Testing |
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An automated LAL endotoxin assay being performed on a combination product
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A visual inspection of pharmaceutical vials
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Medical Device Services |
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Enhanced & expanded medical device sterilization validations, package validations, microbiology and clean room services
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New, state-of-the-art analytical services laboratory
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Upgrated analytical chemistry laboratory, showing an HPLC
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Endotoxin Plate Reader
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Pharmaceutical Testing Services |
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Media Fill Test photo #1
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Media Fill test photo #2
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Sterilty Quality Control Checks photo #1
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Sterilty Quality Control Checks photo #2
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Virology Laboratory |
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Microtest offers new virology testing clients “Free Lab Qualification.” New clients may submit three (3) samples – free – in order to qualify Microtest as one of their vendors.
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Detection of viruses can be achieved using fluorescent antibody staining techniques. Fluorescent antibodies can be used to stain cells to determine whether specific viruses are present. A fluorescent microscope is used to look for fluorescently stained cells, which would indicate the presence of a specific virus.
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Much of the work for virus testing is performed in a biosafety cabinet (BSC). The BSC protects the operator from infectious hazards posed by samples and viruses used in the tests, and also protects samples from inadvertent introduction of contaminants during manipulation.
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Microscopic examination of cells before, during, and at the end of virus assays is important for determining the presence of adventitious agents. Many viruses are capable of changing the normal morphology of cells after infection, therefore the cells must be monitored for morphological changes to ensure they remain healthy and free from detectable viruses.
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Contract testing companies are experienced in handling samples for virus testing, following GLP and cGMP, as appropriate. They are familiar with the tests that need to be performed and can execute the tests as per the relevant regulatory guidelines.
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White Papers |
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White paper image: "New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio)" Click here to download this image. |
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White paper image: "Six Steps to Qualifying Disinfectants" Click here to download this image. |
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White paper image: "Stability Program Management, Clinical Trial Materials: PTC When Using a Contract Stability Lab" Click here to download this image. |
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White paper image: "Reusable Medical Device Disinfection and Cleaning Validation Requirements" Click here to download this image. |
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White paper image: "USP Microbial Examination of Non-Sterile Products: New White Paper is Roadmap of Regulations for Manufacturers" Click here to download this image. |
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White paper image: "The USP 797 Compliance Challenge: Solutions for Compounding Pharmacies" Click here to download this image. |
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White paper image: "Combination Products: Navigating Two FDA Quality Systems"
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White paper image: "The Microbial ID Breakthrough: How DNA Sequencing Services Prevent Catastrophic Cleanroom Shutdowns"
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White paper image: "Navigating Two FDA Quality Systems"
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White paper image: "Pharmaceutical Sterility Testing: Essential Things you must know"
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White paper image: "Sterility Testing: Essential Things you must know"
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Zebrafish Toxicology Testing |
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Microtest Laboratories announces new fast-track toxicity testing for medical devices using Zebrafish embryos, photo #1
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Microtest Laboratories announces new fast-track toxicity testing for medical devices using Zebrafish embryos, photo #2
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