PDA TR 75
- Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1?m Mycoplasma Reduction Filters
- Report / Survey by Parenteral Drug Association, 08/01/2016
- Category: PDA
$325.00
$163.00
PDA's newly released Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1?m Mycoplasma Reduction Filters describes 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.
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