A New Direction In Mycoplasma Control
By Martha Folmsbee, Morven McAlister and Jerold Martin, Pall Life Sciences
Martha Folmsbee, Morven McAlister and Jerold Martin at Pall Life Sciences discuss some of the challenges involved in the validation of sterilising filters for mycoplasma removal and the importance of the associated process-specific tests compared to the filter manufacturer’s standard tests
Mycoplasma are very small bacteria distinguished by the lack of a rigid cell wall, and have been reported as common contaminants of cell cultures and cell culture media. Presumably, due to their small size and lack of rigidity, they are known to be capable of penetrating 0.2 and 0.22μm rated sterilising grade filters, and even some 0.1μm rated filters. This can become a significant problem when filtration is necessary for the preparation of sterile culture media that cannot be sterilised by heat due to sensitive media components or large volumes. Primary applications for mycoplasma filtration include large-scale mammalian cell culture media and bacterial cell culture broth used for aseptic process validation by sterile media fill. Common culture media components, such as serum and soy protein digests, may also become a source of mycoplasma contamination along with operator carriers.