Probiotics are products containing live microorganisms and most often it is lactic acid bacteria such as the species of Lactobacillus, Bifidobacterium and Lactococcus.

DB Lab performs a large number of microbiological analyses on raw materials, APIs and finished products of probiotics such as capsules, tablets, sticks and sachets.

The microbiolgical analyses are carried out according to methods developped by DB Lab or customers or according to official methods.

Examples of analyses:

• Cell counts (assay)
• Identifications (cell and colony morphology, PCR, API tests, biochemical tests)
• Quality control to detect foreign cells
• Water activity
• Disintegration tests
• Dissolution tests
• Uniformity of mass

 

DB Lab develop and validate new methods for enumeration and identifcation of lactic acid bacteria in probiotics according to ICH guidelines. Among other things, a validation may include examinations of the following parameters:

• Specificity
• Linearity
• Accuracy
• Precision
• Limit of detection/quantification

 

In addition, DB Lab carries out stability studies on probiotic products according to ICH guidelines according to which the typical storage conditions are:

• 5°C
• 25°C/60%RH
• 30°C/65%RH
• 40°C/75%RH