Microbiology

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 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)

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 (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.

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 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.

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.  

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.

Pharmacopeia in the United States requires that the disinfectants used in facilities are proven to be effective. This requires the user to provide documentation that the cleaning agent(s) is effective on the hard surfaces present in the facility, as well as resident microrganisms. Learn about our microbial cleaning validation services to help you meet these stringent requirements. 

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. Microbial content for drug products and raw material testing can be found under USP <61> & USP <62>. Medical devices are tested acording to AAMI guidelines and information can be found under Bioburden Test. Sterile drug products are tested according to USP <71>.
 
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.
 

Depending on your process, product or environmental monitoring requirements the identification of bacteria, yeast or mold may be necessary. 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, 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.

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.

Test Includes:

• Water Systems
• Environmental Monitoring 
• Autoclave Qualifications and Biological Indicator Analysis
• Media Fill 
• Cleaning Validation/Verification
• Calibration Services
• Qualification Services

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.

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>
• Hemodialysis Water Testing
• Heterotrophic Plate Count
• Screen for Fluorescent Pseudomonad Group and Coliforms
• Nitrate Testing – EUPh
• Conductivity USP <645> Stage I, Stage II, Stage III
• Resistivity
• pH

Recovery Efficiency Testing is required on the first microbial sample. Water testing supplies can be provided by Azzur Labs.