At the time of writing (26.2.2026) these products are partially
compliant with 2.6.7.-12.2 because they are still compliant but ONLY if
they have already been used and previously validated. However - for any
new validations required by a change of matrix, equipment, incubation
times etc then users should refer to the new 2.6.7-12.2-compliant 10CFU
or 100 CFU standards.
10CFU™ Sensitivity Standards
European Pharmacopoeia 2.6.7 Mycoplasmas requires a sensitivity of 10 CFU/ml sample volume for NAT-based methods like PCR to replace the traditional culture method. This feature of the test method must be shown by the performing lab as part of the robustness testing in presence of the sample matrix. As most cell culture labs and production facilities cannot accept vital mycoplasma in their facility or do not have access to a microbiology lab able to cultivate mycoplasma, these preparations allow safe and reliable validation of the procedure.
The mycoplasma have been cultivated in culture broth described in EP 2.6.7, titrated immediately in culture broth and plated for quantification in colony forming units (CFU/ml). Each dilution series has been performed in multiple by different operators for highest precision. The mycoplasma broth was harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead mycoplasma particles and correspondingly a high GU*:CFU ratio. All strains have been obtained from the National Collection of Type Cultures (NCTC), UK, and cultivated in low passages.
Kit Components
3 vials with 10 CFU of the corresponding mycoplasma species, 2 negative control vials
For the mycoplasma set:
2 vials with 10 CFU of each mycoplasma species listed in the EP 2.6.7 (18 vials in total), 2 negative controls
Result evaluation
Use of a suitable Mycoplasma PCR kit, e.g. Intego® Mycoplasma
Required lab devices
Regular lab equipment (centrifuge, pipettes, etc.)
Shelf Life and Storage
Kit components are maintainable at 2 to 8 °C for at least 12 months.
Fig. 10 CFU have been resuspended in cell culture medium, 200 µl DNA extracted with the MB DNA Extraction and mycoplasmal DNA amplified with Intego® Mycoplasma. PCR was performed on a Corbett RotorGene®6000.
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