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PDA TR 75 PDF

PDA TR 75 PDF

Name:
PDA TR 75 PDF

Published Date:
08/01/2016

Status:
Active

Description:

Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1?m Mycoplasma Reduction Filters

Publisher:
Parenteral Drug Association

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$97.5
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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.
File Size : 1 file , 490 KB
ISBN(s) : 9780939459919
Number of Pages : 22
Product Code(s) : 01075
Published : 08/01/2016

History

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