In the cGMP notes located at http://www.fda.gov/cder/dmpq/cgmpnotes.htm <http://www.fda.gov/cder/dmpq/cgmpnotes.htm> , there is a question relating to your concern. http://www.fda.gov/cder/hdn/cnotesd8.pdf <http://www.fda.gov/cder/hdn/cnotesd8.pdf> http://www.fda.gov/cder/hdn/cnotes97.pdf <http://www.fda.gov/cder/hdn/cnotes97.pdf> http://www.fda.gov/cder/hdn/hdn695.pdf <http://www.fda.gov/cder/hdn/hdn695.pdf> (very good one) I agree with the other responses that the product dictates cleaning validation requirements. Some contaminate the equipment with riboflavin. Others actually use simulated product. It really depends on the situation at hand that you are addressing. If more information can be shared, a more targeted response can be offered. Joel C. Harder Quality Assurance Associate for Process Equipment Validation, NHQ * v-mail: 703-351-5942 * e-mail: [log in to unmask] -----Original Message----- From: Dalmaso, Gilberto [mailto:[log in to unmask]] Sent: Monday, October 11, 1999 3:24 AM To: [log in to unmask]; [log in to unmask] Subject: [PMFLIST] Endotoxin on production machine parts A question for our group: We have to determinate the pyroburden on our production machine parts as validation program. Is there any internationals procedure/methods or requirements for this porpose? is there any regulatory requirements? Have we to contaminate (recovery determinations) the piece? What is the rinsing method? How much LRW I have to use? As you know production pieces are quite big. Thank you in advantage ------------------ The PMFList (http://microbiol.org/PMFList_info.htm) is operated from The Microbiology Network (http://microbiol.org) and supported by our sponsors (http://microbiol.org/sponsor.htm) as a service to the scientific community. ------------------ The PMFList (http://microbiol.org/PMFList_info.htm) is operated from The Microbiology Network (http://microbiol.org) and supported by our sponsors (http://microbiol.org/sponsor.htm) as a service to the scientific community.
