Analytical Tests

 
  • Analysis of Raw Materials and Finished Products
    This includes:
    Microbial Limit Testing USP <61> USP <62> 
    Sterility USP <71>
    Bacterial Endotoxin Test (BET) USP <85>
    Antimicrobial Effectiveness Test (AET) USP <51>
    Microbial Identification 
  • Antimicrobial Effectiveness Test (AET) USP <51>
    Antimicrobial effectiveness testing provides data on the effectiveness of antimicrobials present in the product. The product is inoculated with a high number of specific organisms and the capability of antimicrobials to reduce the population over time is monitored. It is suggested that facility resident organisms are also included. Testing can be performed on injections, parenterals, topical, oral, antacids and trandermal products.

    A neutralization study is performed to ensure that the chosen diluent is effective at neutralizing the antimicrobial components.
     
    AET Individual Organism format (USP <51> ,CTFA M3 and M4, EUPh 2.1.1, ISO 11930:2012)
    AET Mixed Organisms Format (CTFA M3 and M4)
    AET Product Neutralization (CTFA/USP)
  • Bacterial Endotoxin Test (BET) USP <85>
    Azzur Labs conducts Bacterical Endotoxin Testing (BET) using the most current technology available to ensure accurate test results are achieved in the least amount of time. We utilize the kinetic chromogenic methodology for accurate results. BET is used to quantify only the amount of bacterial endotoxin present in the product and is measured in endotoxin units (EU).

    Please contact us prior to submission if the product is:
    Opaque or has intense color
    Outside the pH range of 6 to 8
    Contains polypropylene
    Contains cells
    Packaged in polypropylene
     
    Product Testing
    Product analysis for endotoxin units. Sensitivity to 0.005 EU/mL
    Validation test – Three lots of the product must be tested to consider the method validated.
    Water Samples
    Endotoxin Product Spiking Recovery Test
    This test is required when the validated method requires manipulation other than dilution.
    Supplies - Low Endotoxin Vials
    We have low endotoxin vials available for purchase. Product samples can be submitted in the low endotoxin vials or original packaging.
  • Bacteriostasis and Fungistasis Testing
    Bacteriostasis and Fungistasis Testing (B and F testing) is necessary to perform on products that will require USP <71> Sterility Testing. The product is inoculated with specific organisms and it is confirmed that all of those organisms can be recovered. This ensures that the sterility test does not yield false negative results.
  • Bioburden Test
    The bioburden test is conducted to determine the total number of viable microrganisms on a medical device or other object. Bioburden testing is completed after manufacturing and prior to sterilization to identify the microbial load on a product. A significant increase in the microbial load can affect the sterility assurance level required by sterilization processes.

    ANSI/AAMI/ISO Guideline 11737-1, Sterilization of Medical Devices – Microbiological Methods, Part 1: Determination of a Population of Microorganisms on Products 
     
    • Bioburden Validation Testing ANSI/AAMI/ISO Guideline 11737-1 Exhaustive Recovery Method
    • Bioburden Validation Testing ANSI/AAMI/ISO Guideline 11737-1 Product Inoculation Method
    • Bioburden Validation Testing - Bacteriostasis and Fungistasis Testing
  • Biological Indicator Analysis
    Biological Indicators (BIs) may be used to monitor sterilization and decontamination processes.
     
    • Population reduction - Log reduction analysis
    • Population reduction - Positive/negative (go/no go)
    • Direct transfer- Strips, carriers and ampoules
    • Population verification

    For additional information regarding the requirements of BI analysis, please contact Azzur Labs. 

  • Brettanomyces Analysis
    Brettanomyces bruxellensis is a common yeast which can be problematic in the brewing and wine industries. Brettanomyces or "Brett" can alter the taste and aroma of final product. When found in lower levels it can be desirable, adding specific aroma and complexity of layers to some types of beverages. Higher levels can produce undesirable "spoiled" results to the finish of the end product.

    Azzur labs utilizes an ultra-sensitive Molecular Flow-Based Technology. The patented vertical-flow technology allows for the sensitivity of real-time PCR tests combined with a vertical-flow assay that improves testing accuracy. Our system is the next generation in powerful diagnostic tools to improve the quality of beer and wine.
  • C diff Monitoring
    Monitor the efficacy of your cleaning Protocols. Azzur Labs provides accurate testing for C diff on your surfaces.  Simply order the swabs from us, swab your surfaces and return to Azzur Labs for incubation and analysis.  
  • Hazardous Drug Residue Testing
    Azzur Labs supplies everything you need in an easy-to-use kit. These kits are designed to collect chemotherapy drug residues on non-porous surfaces in healthcare workspaces. It was developed in response to USP <800> and the NIOSH Drug Alert for safeguarding healthcare workers. Simply swab the surface with the provided materials, place everything back into the box, and ship back using the provided shipping label.
  • Legionella Testing
    Azzur Labs participates in the Centers for Disease Control & Prevention’s ELITE Program
    for Legionella Analysis. 
    Legionella Analysis - CDC Method 
    Potable Water
    Cooling Tower
    Hot Tubs
    Fountains
    Swabs
    Biofilm

    Develop a Water Management Program
    Legionella Risk Assessment for Buildings
     
  • Listeria Species and Listeria Monocytogenes
    Azzur Labs utilizes classic culture and rapid methods for detection of pathogens in food. Rapid methods include an ultra-sensitive Molecular Flow-Based Technology. The patented vertical-flow technology allows for the sensitivity of real-time PCR tests combined with a vertical-flow assay. The result is an effective and rapid system that minimizes sample preparation, speeds time to results, improves testing accuracy, and provides easy-to-interpret data for the end user. Our system is the next generation in powerful diagnostic tools to help manufacturers and government regulators keep the global food supply safe.
     
    • Environmental samples - Swabs and Sponges PCR, CC
    • RTE PCR, CC
    • Deli meat PCR, CC
    • Dairy PCR, CC
    • Chicken Carcass PCR, CC

    PCR – AOAC approved method – Rapid detection molecular method that couples PCR with a visual, flow based assay – 48 hours or less for results. CC – Classical culture method
  • Media Fill Testing
    Media fill studies play an important role in the validation of aseptic manufacturing processes and the requirements for these studies vary in the global market. Azzur Labs has the ability to test your media fill samples to meet a variety of compendial guidelines. Testing includes sterility confirmation and growth promotion.
  • Microbial Content Testing
    Microbial content testing, also referred to as microbial limit or bioburden testing, is conducted to analyze cosmetic products for microbial content. Preparatory testing is a required study that ensures the results obtained are valid and reliable.
     
    CTFA M1 is a quantitative test to determine the total microbial plate count.

    CTAF M2 contain qualitative tests for specified organisms. Any recovered organisms should be evaluated for possible effects on user safety and product degradation.
     
  • Microbial Identification
    Depending on your process, product or environmental monitoring requirements the identification of bacteria, yeast or mold may be neccessary. Azzur Labs utilizes the following methods.
     
    • Bacteria and Yeasts - Sherlock E-FAME™ (E-FAME), an acid-catalyzed GC-FAME extraction and analysis method. E-FAME has been optimized for Aerobic bacteria of importance to pharmaceutical QC (including all USP 61/62 strains) and Biochemical methodology
    • Macroscopic and Microscopic Morphological Analysis of Mold
  • Microbial Limit Testing USP <61> USP <62>/Bioburden Testing
    Microbial limit testing, also referred to as microbial content/bioburden testing, is conducted to analyze non-sterile pharmaceutical products, nutritional and dietary supplements for microbial content. Sterile products are tested according to USP <71> Sterility Test.

    Preparatory testing is a required study that ensures results obtained are valid and reliable.

    USP <61> and USP <2021> are quantitative tests that allow the client to determine the total aerobic microbial count and total combined yeast mold count of their product.

     USP <62> and USP <2022> are qualitative tests for specified organisms that may be present in the product. Any recovered organisms should be considered by the client for the affect on user safety and product degradation.

    Clients may refer to USP <1111> or <2023> for assistance in determining which test(s) are applicable for their product. For further guidance, please contact us to discuss your needs.
  • Organism Preparation/Storage - USP In-House
    Azzur Labs can prepare and store USP and resident microorganisms for inclusion in studies.

    Many of the studies required in the manufacturing of drug products require the use of microbial reference strains, as well as the inclusion of resident flora. Azzur Labs has the capability to produce frozen cultures for use in these studies.
  • Process/Utility Testing and Validation
    Test Includes:
    Water Systems
    Environmental Monitoring 
    Biological Indicator 
    Media Fill 
    Cleaning Validation/Verification
    Calibration Services
    Qualification Services
    Certifications
     
  • Salmonella Species
    Azzur Labs utilizes classic culture and rapid methods for detection of pathogens in food. Rapid methods include an ultra-sensitive Molecular Flow-Based Technology. The patented vertical-flow technology allows for the sensitivity of real-time PCR tests combined with a vertical-flow assay. The result is an effective and rapid system that minimizes sample preparation, speeds time to results, improves testing accuracy, and provides easy-to-interpret data for the end user. Our system is the next generation in powerful diagnostic tools to help manufacturers and government regulators keep the global food supply safe.

     
    Swabs (environmental) - Surfaces: Stainless Steel, Sealed Concrete, Plastic, Ceramic Tile PCR, CC
    RTE meat PCR, CC
    Dairy/Beverages PCR, CC
    20% fat ground beef PCR, CC
    Hot dogs PCR, CC
    2% milk PCR, CC
    Poultry rinses PCR, CC
    Other – CC
    PCR – AOAC approved method – Rapid detection molecular method that couples PCR with a visual, flow-based assay – 48 hours or less for results. CC – Classical culture method
  • Sterility Testing
    Medical devices may either be terminally sterilized or produced aseptically. In either case, sterility testing is required to ensure the sterility of the product. Azzur Labs has the capability to test the products in accordance with USP<71> and AAMI 11737-2.
  • Sterility Testing USP <71>
    This test is applied to substances, preparations or articles which are required to be sterile.
     
    • Direct transfer, also known as product immersion and direct inoculation
    • Flush
    • Filtration (preferred method)

    Bacteriostasis and Fungistasis (B and F test)  is sometimes referred to as the validation test or prepatory test. This study is required to verify that the product and method used to test are appropriate for recovering a low number of organisms and that the substance, preparation or article is not inhibitory to the growth of microorganisms.
  • Total Organic Carbon Testing (TOC)
    Total Organic Carbon (TOC) is an indirect measure of organic molecules in pharmaceutical waters measured as carbon. Individual monographs for water require TOC testing according to USP <643>.
  • USP <71> Sterility Test
    Medical devices may either be terminally sterilized or produced aseptically. In either case, sterility testing is required to ensure the sterility of the product. Azzur Labs has the capability to test the products in accordance with USP<71> and AAMI 11737-2.
  • Water Systems
    Water is widely used as a raw material and ingredient in the processing and formulation during the manufacturing of products.

    Water testing can be done in accordance to USP, EUPh, CTFA, and/or JP requirements.
     
    Total Organic Carbon Testing (TOC) USP <643> JP, EUPh
    Bacterial Endotoxin Testing (BET) USP <85>
    Heterotrophic Plate Count
    Screen for Fluorescent Pseudomonad Group and Coliforms
    Nitrate Testing – EUPh
    Conductivity USP <645> Stage I, Stage II, Stage III
    Resistivity
    Salinity
    Total Dissolved Solids
    pH

    Recovery Efficiency Testing is required on the first microbial sample.

    Water testing supplies can be provided by Azzur Labs.