| Comment Record |
|
Commentor |
Dr. Peter Wojciechowski |
Date/Time |
2001-09-13 10:29:39 |
|
Organization |
Centocor Inc |
|
Category |
Individual |
| Comments for FDA General |
| Questions |
|
1. General Comments
|
The draft guideline mentions inactivation of TSE infectivity in 1N NaOH at room temperature (29-31 deg C). The temperature range given is not consistent with normal room temperature range of ~18-22 deg C.
Either the term room temperature is incorrectly used or the range given needs to be revised.
Sincerely,
Peter W. Wojciechowski,
Principal Research Scientist
Centocor Inc.
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