Micro Biological Testing
Microbiology testing is critical for ensuring that your different product type meets the required microbiological limits and determining the Antimicrobial Effectiveness Test (AET), Microbial limit test, as well as identifying microorganisms and contamination. Our dedicated microbiology laboratory is on standby to provide qualitative and quantitative assessments of non-sterile products using USP, FDA/BAM, and in-house methods. With over 40 years of experience in this field, we help our clients determine the tests that best fit their needs and support their products’ compliance with relevant regulatory requirements or support on research products microbiologically.
Microbiology: Testing Methods
| USP CHAPTER | TEST |
| <61><62> | Suitability Testing |
| <60> | Burkholderia cepacia |
| <2021><2022> | Nutritional and Dietary Supplements Testing and absence of a specified organisms. |
| <51> | Antimicrobial Effectiveness Testing |
| <62> | Microbial Enumeration Testiong - Total Aerobic Microbial Count - Total Yeasts and Molds Count |
| <62> | Bile Tolerant Gram Negative Bacteria |
| <62> | Escherichia coli (E.coli) |
| <62> | Salmonella |
| <62> | Pseudomonas aeruginosa |
| <62> | Staphylococcus aureus |
| <62> | Clostridia |
| <62> | Candida albicans |
| <85> | Endotoxins |
| <2021> | Heterotrophic Plate Count on Process Water |
| <2021> | Total Yeasts and Molds Count |
| <2021> | Bile Tolerant Gram Negative Bacteria |
| <2022> | Escherichia coli (E.coli) |
| <2022> | Salmonella |
| <2022> | Pseudomonas aeruginosa |
| <2022> | Staphylococcus aureus |
| <2022> | Clostridia |
Method Qualification & Release Testing
What is method qualification, and why is it significant? Method Qualification is an integral part of any microbiological test system. It allows us to determine the appropriate diluent/dilution factors/enrichment media required to neutralize any inherent antimicrobial properties of drug products and ingredients (tested according to USP chapters <51>, <61> and <62>) when sample preparations are challenged with specific, viable test microorganisms.
| Microbial Enumeration Tests - USP <61> Counting Method | |
| Counting Method (Total Aerobic & Total Combined Yeast/Mold Counts) | |
| Tests for Specified Microorganisms - USP <62> Test Method | |
| Bi le Tolerant Gram-Negative Bacteria,
Presence/Absence (Qualitative) Bile Tolerant Gram-Negative Bacteria, Most Probable Number (Quantitative) |
|
| * B.cepacia USP<60> | Presence/Absence |
| E.coli | Presence/Absence |
| Pseudomonas aeruginosa | Presence/Absence |
| Salmonella species | Presence/Absence |
| Staphylococcus aureus | Presence/Absence |
| Candida albicans | Presence/Absence |
| Clostridium species | Presence/Absence |
When and how often is this test administered?
Suitability testing is performed on a new product or change formulation or new testing site. Some of our clients request that we run several tests concurrently, including suitability testing, but we recommend that suitability testing be performed before any other tests. Should suitability testing fail for your product, then the results of any concurrent tests would be invalidated and unusable. it is required for regulatory submission for FDA approval for all products. CGMP regulations, which are enforced by the FDA, require that methods are suitable for a given product. The FDA will require evidence that the tests given are valid for a given product with a recorded demonstration of validity.
Facility Monitoring and Support
| Process Water Testing (EP/USP/JP/BP) |
| On-Site Sample Collection |
| Coliform Bacteria (presence/absence)-Qualitative |
| Coliform Bacteria Count (quantitative) |
| Total Aerobic Microbial Count (membrane filtration or pour plate) |
| Endotoxin Testing (By Gelclot Method) |
| Conductivity, USP <645> |
| Total Organic Carbon (TOC), USP<643> |
| Heterotrophic Plate Count |
| Heavy Metals Testing |
| Environmental Monitoring |
| On-Site Sample Collection |
| Total airborne non-viable particulate count by Met one machine. |
| Total Aerobic Plate Count, Viable Air Sampler or Settling Plates |
| Total Combined Yeast / Mold Count, Viable Air Sampler or Settling Plates |
| Total Aerobic Plate Count, Compressed Air Sample |
| Cleaning Validation |
| Total Aerobic Plate Count, Contact (RODAC)Plates |
| Total Aerobic Plate Count, Swab Samples |
| Total Combined Yeast/ Mold Count, Contact (RODAC) Plates |
| Total Combined Yeast/ Mold Count, Swab Samples |
| Total Organic Carbon (TOC), Swab Samples, USP <643> |
| Organism Identification of Isolates |
| Gram stain only |
| Coagulase Test |
| Oxidase Test |
| AccuPro-ID® (environmental monitoring & water samples) |
| AccuGENX-ID® (raw materials & product samples) |
| 1. AccuPro-ID® and AccuGENX-ID® are performed by subcontract Laboratories |