PDA TR 75

PDA’s newly released Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1?m Mycoplasma Reduction Filtersdescribes a consensus filter challenge test for standardizing test parameters across laboratories. This report educates users and filter manufacturers about best practices for mycoplasma reduction filtration and suggests the implementation of a specific filtration testing method and positive controls for establishing a manufacturer’s claims of mycoplasma reduction. This technical document recommends a consistent method that filter manufactures can use to test and rate the effectiveness of mycoplasma reduction filters. The consensus method also provides cultivation parameters for Acholeplasma laidlawii as a challenge microorganism, if a risk assessment determines that process-specific evaluation is appropriate.

Published:

08/01/2016

ISBN(s):

9780939459919

Number of Pages:

22

File Size:

1 file , 490 KB

Product Code(s):

01075