Microbiological Testing Methods
Anandia Lab microbiological testing is performed in accordance to European Pharmacopoeia (Ph. Eur.) methods 2.6.12, 2.6.13, and 2.6.31.
Overview of Anandia’s microbiological testing services
|Test||Ph. Eur. Method||Equivalent Methods||Amount for testing||LOD* Ph. Eur. 5.1.8 Table C (Default)||LOD* Ph. Eur. 5.1.8 Table B|
|Total aerobic microbial count (TAMC)||2.6.12||USP 61||10g||10,000 CFU/g||1,000 CFU/g|
|Total yeast and mold count (TYMC)||2.6.12||USP 61||10g||1,000 CFU/g||100 CFU/g|
|Bile-tolerant gram-negative bacteria (BTGN)||2.6.31||1g||<10E2 CFU/g||<10 CFU/g|
|Escherichia coli||2.6.31||USP 62||1g||Presence/Absence|
|Pseudomonas aeruginosa||2.6.13||USP 62||1g||Presence/Absence|
|Staphylococcus aureus||2.6.13||USP 62||1g||Presence/Absence|
LOD = Limit of detection, USP = U.S. Pharmacopeia, CFU = Colony forming units
* Lower LOD testing available for TAMC and TYMC—please contact us for more information
Microbiology test variations
“Microbial: ACMPR Test Group” includes Total Aerobic Microbial Count (TAMC), Total Yeast & Mold (TYMC), Bile Tolerant Gram Negative Bacteria (BTGN), Escherichia coli (E. coli), and Salmonella testing only. Dilutions appropriate for Ph. Eur. 5.1.8 Table C limits, and 25g Salmonella test are assumed by default unless otherwise indicated on the chain of custody (COC).
Ph. Eur. 5.1.8 Table B vs Table C
Ph. Eur. lists different acceptable microbial limits depending on the material tested. Ph. Eur. 5.1.8 Table C is intended for products which were not processed or manipulated (such as dried plant material). Ph. Eur. 5.1.8 Table B is intended for processed products (like oils). Anandia Labs can test plant materials and processed products for either set of limits. Ph. Eur. 5.1.8 Table C is assumed by default, unless otherwise indicated on the COC.
The different acceptance criterion for Ph. Eur. 5.1.8 Table C versus Ph. Eur. 5.1.8 Table B are summarized in the following table:
|Test||Ph. Eur. 5.1.8 Table C limits||Ph. Eur. 5.1.8 Table B limits|
|TAMC||<500,000 CFU/g or CFU/mL||<50,000 CFU/g or CFU/mL|
|TYMC||<50,000 CFU/g or CFU/mL||<500 CFU/g or CFU/mL|
|BTGN||MPN: <10,000 CFU/g or CFU/mL||MPN: <100 CFU/g or CFU/mL|
|E. coli||Absent in 1 gram or 1 mL|
|Salmonella||Absent from 25 grams or 25 mL|
CFU = colony-forming unit; MPN= most probable number
Salmonella: 10 g versus 25 g
Ph. Eur. 2.6.31 requires 25 g or 25 mL of material to be tested for Salmonella (as specified in the Table 2).
Ph. Eur. 2.6.13 and USP 62 specifies the use of no less than 10 g or 10 mL of product for the detection of Salmonella.
Anandia Labs can perform Salmonella testing with either 25 g or 10 g (or mL in the case of liquids) . We can also test a smaller amount if the client prefers not to use such a large sample size. A 25 g Salmonella test is assumed by default, unless otherwise specified on the chain of custody form.
Acceptance criteria for Pseudomonas aeruginosa and Staphylococcus aureus can be found in chapter Ph. Eur. 5.1.4.
Additional microbiological identification tests such as mould spore identification, biochemical characterization/identification, or bacterial 16S rRNA gene sequencing are available upon request.
For more information about the available microbiological test variations and additional testing protocols, please contact us.
Microbiological Hygiene Consulting
Our microbiology team is specialized in hygiene assessments, and can conduct microbial sampling of the air and surfaces in your cultivation and processing facilities. A Hygiene Assessment includes a visual assessment and sampling for:
- Fungal spores in air
- Surface contamination
- Swabs for bacterial and fungal viability testing and enumeration
- Tapelifts for direct identification of mould spores by microscopy
Results are documented in a detailed report with recommendations, if needed.
Please contact us to learn more about these services or to request a quote.