General Microbiology
Microbiology testing identifies the type of microbes in an environment or on a product, to avoid contamination risk or large periods of production downtime should a contamination event occur. Microbial limits testing determines if the products comply with an established specification for microbial quality.
Our Tests
M600
Biological Indicator – spore strip population assay USP, 3 strips, one species
M601
Biological Indicator – spore strip population assay USP, 3 strips, dual species
M602
Biological Spore suspension population assay
M603A
Product Inoculations, Bacillus atrophaeus 106 per site
M603
Product Inoculations, Geobacillus stearothermophilus 105 per site
M604
BI Incubation Time Reduction Study (CDRH) FDA Method
M605
Bacteria Gram Stain, per ID
M607
Identification of Bacteria (IDS System)
M607D
Identification of Bacteria (DNA Sequencing)
M608
Identification of fungi
M609
Identification of yeast
M610
Total Coliform, presence/absence
M610A
Total Coliform, Standards Methods, Membrane Filtration
M611
Water Analysis – Heterotrophic Plate Count, per sample
M700
Bacteriostasis/Fungistasis Testing (USP) – two media, sex organisms
M701
Bacteriostasis/Fungistasis Testing, one media – SCD AAMI, three organisms
M702
Bacteriostasis/Fungistasis Testing, per organism
M703
Growth Promotion Test (USP)
M704
Growth Promotion Testing per organism
M705
Microbial Limits Test (USP) including preparatory test
M706
Microbial Limits Screening/Confirmation
M708
Contamination (bioburden) of Calcium Alginate Fiber, per sample
M709
Solubility of Calcium Alginate Fiber, per sample
M710
Zone of Inhibition – Diffusible Substances (AATCC)
M711
Antifungal Activity Assessment (AATCC)
M712
Yeast Analysis – Microbrewery
M713
Particulate Analysis, Medical Device, USP 788, per sample
M713A
Particulate Analysis, Medical Device, USP 788, multiple small items pooled, per test
M713B
Particulate Analysis, Solutions, USP 788, per sample
M714
Particulate Analysis, ISO 1135-4, per lot
USP Monograph <61> Microbial Enumeration Test and Monograph <62> Test for Specified Microorganisms (previously known as Microbial Limits testing) are new harmonized chapters that describe new requirements for the growth and recovery of specific organisms which include Psuedomonas aeruginosa, Staphylococcus aureus, Salmonella , Bile-Tolerant Gram negative bacteria, Clostidium, and Candida albicans. Please note that USP requires that products undergo a one-time validation (suitability test) be conducted before routine testing is conducted.
M740
System suitability, per organism
M742
Microbial Enumeration, includes standard plate count for bacteria, yeast and molds, per sample
M744
Absence of specified Microorganisms, per organism
M745
Qualification of Neutralization, plate count method
M746
1 Replicate, 5 Organisms, 7 Day incubation
M747
1 Replicate, 5 Organisms, 14 Day incubation
M748
1 Replicate, 5 Organisms, 7, 14 and 28 Day incubation
Sample Submission
Purchase Order
In line with current ISO/QSR purchasing requirements, all orders should be sent with a signed completed Purchase Order. This will help expedite the processing or your order. Standing Purchase Orders will be gladly accepted for routine continuing orders.
Sample Submission Form
Please download and fill out a Test Request Form for each sample/test submitted. Identify each submission clearly and completely. Please be specific with the description, Lot Number, PO etc. and specify the test desired. Please indicate the Test Code Number on the form also. This will greatly reduce turnaround time necessary to generate an accurate, final report.
Final Reports
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
Highlights For You
Microbial Aerosol Challenge Testing vs. Microbiology Testing
Learn the differences between microbial aerosol challenge testing and microbiology testing for parenteral products and combination products.
Microbiology Sampling For Regulatory Testing Of Inhalable Devices
Learn techniques for obtaining enough product from inhalant medical device packaging to perform microbiology sampling for regulatory testing.
Top 3 Water Sanitization Methods For Sterile Product Processing
Learn what the top water sanitization methods are for monitoring and controlling microbial contamination during sterile product manufacturing.
