Dr. Lehmann GmbH & Co. KG

Low risk products

After evaluating the microbiological risk of a product (e.g. via DIN EN ISO 29621), a low risk profile may be assumed for products that have the following properties.

 

- Products with an alcohol content of > 20 %

- Products based on organic solvents

- Products with a very high or very low pH-vlaue 

- Products with an aW-value < 0,75 ("water free")

 

For products that fulfill these criteria we offer a sol called challenge test exclusion in which we confirm the low risk profile and examine the product for microbiological threshold values.

For common product these should be the following (also refer to DIN EN ISO 17516):

maxx. 2000 cfu/mL aerobic total germ count (Bacteria, Yeast and Moulds) and none of the following germs in 1 gramm of the product

Escherichia coli
Pseudomonas aeruginosa
Staphylococcus aureus
Candida albicans

We offer these examinations under the following numbers

M02.05.01 (confirmation of low risk and determination of total aerobic count)
M02.05.02 (M02.05.01 + confirmation/examination according to DIN EN ISO 17516)

Further literature:

Commission Implementing Decision