Ask The Experts http://pmpn.canon-experts.com The only place to get expert advice! Thu, 11 Mar 2010 18:24:48 +0000 http://wordpress.org/?v=2.7 en hourly 1 Is there an industry standard on the acceptable minimum seal thickness for a rigid tray to Tyvek lidstock? http://pmpn.canon-experts.com/2010/03/is-there-an-industry-standard-on-the-acceptable-minimum-seal-thickness-for-a-rigid-tray-to-tyvek-lidstock/ http://pmpn.canon-experts.com/2010/03/is-there-an-industry-standard-on-the-acceptable-minimum-seal-thickness-for-a-rigid-tray-to-tyvek-lidstock/#comments Thu, 11 Mar 2010 18:24:31 +0000 daphne http://pmpn.canon-experts.com/?p=504 http://pmpn.canon-experts.com/2010/03/is-there-an-industry-standard-on-the-acceptable-minimum-seal-thickness-for-a-rigid-tray-to-tyvek-lidstock/feed/ We are preparing dye penetration test with 20-L HDPE carboy containing bulk drug substance. This is the first time in our company and we have no ideas how to validate the test method. Except dye penetration test, which method is easier and reliable for 20-L carboy containing DS? And please suggest the method validation. http://pmpn.canon-experts.com/2010/03/we-are-preparing-dye-penetration-test-with-20-l-hdpe-carboy-containing-bulk-drug-substance-this-is-the-first-time-in-our-company-and-we-have-no-ideas-how-to-validate-the-test-method-except-dye-penet/ http://pmpn.canon-experts.com/2010/03/we-are-preparing-dye-penetration-test-with-20-l-hdpe-carboy-containing-bulk-drug-substance-this-is-the-first-time-in-our-company-and-we-have-no-ideas-how-to-validate-the-test-method-except-dye-penet/#comments Tue, 09 Mar 2010 19:11:26 +0000 daphne http://pmpn.canon-experts.com/?p=502 http://pmpn.canon-experts.com/2010/03/we-are-preparing-dye-penetration-test-with-20-l-hdpe-carboy-containing-bulk-drug-substance-this-is-the-first-time-in-our-company-and-we-have-no-ideas-how-to-validate-the-test-method-except-dye-penet/feed/ I would like to use food coloring rather than Toluidine Blue dye for dye migration. Section 5.5 of ASTM F1929 indicates that I may but must be experimentally determined, however it gives no specifics. http://pmpn.canon-experts.com/2010/01/i-would-like-to-use-food-coloring-rather-than-toluidine-blue-dye-for-dye-migration-section-55-of-astm-f1929-indicates-that-i-may-but-must-be-experimentally-determined-however-it-gives-no-specifics/ http://pmpn.canon-experts.com/2010/01/i-would-like-to-use-food-coloring-rather-than-toluidine-blue-dye-for-dye-migration-section-55-of-astm-f1929-indicates-that-i-may-but-must-be-experimentally-determined-however-it-gives-no-specifics/#comments Thu, 28 Jan 2010 23:17:17 +0000 daphne http://pmpn.canon-experts.com/?p=498 http://pmpn.canon-experts.com/2010/01/i-would-like-to-use-food-coloring-rather-than-toluidine-blue-dye-for-dye-migration-section-55-of-astm-f1929-indicates-that-i-may-but-must-be-experimentally-determined-however-it-gives-no-specifics/feed/ I stumbled across Ms. Allen’s blogs ( http://blog.pmpnews.com/?p=753 and http://blog.pmpnews.com/?p=720) and wondered where I could find options/approaches for doing this, do you have any ideas where to look? We are looking for tamper-evidence technologies and suppliers. We have products that are filled in hospital pharmacies, and we would like some approaches to tamper evidence application at time of filling and prior to use. http://pmpn.canon-experts.com/2010/01/i-stumbled-across-ms-allen%e2%80%99s-blogs-httpblogpmpnewscomp753-and-httpblogpmpnewscomp720-and-wondered-where-i-could-find-optionsapproaches-for-doing-this-do-you-have-any-idea/ http://pmpn.canon-experts.com/2010/01/i-stumbled-across-ms-allen%e2%80%99s-blogs-httpblogpmpnewscomp753-and-httpblogpmpnewscomp720-and-wondered-where-i-could-find-optionsapproaches-for-doing-this-do-you-have-any-idea/#comments Thu, 28 Jan 2010 23:04:13 +0000 daphne http://pmpn.canon-experts.com/?p=494 http://pmpn.canon-experts.com/2010/01/i-stumbled-across-ms-allen%e2%80%99s-blogs-httpblogpmpnewscomp753-and-httpblogpmpnewscomp720-and-wondered-where-i-could-find-optionsapproaches-for-doing-this-do-you-have-any-idea/feed/ How will item-level serialization influence line automation? Once marked with a unique code, products must remain in their original order for tracking blister-to-carton-to-case relationships, so how do we handle staging areas and others where products transfer in groups? http://pmpn.canon-experts.com/2010/01/how-will-item-level-serialization-influence-line-automation-once-marked-with-a-unique-code-products-must-remain-in-their-original-order-for-tracking-blister-to-carton-to-case-relationships-so-how-d/ http://pmpn.canon-experts.com/2010/01/how-will-item-level-serialization-influence-line-automation-once-marked-with-a-unique-code-products-must-remain-in-their-original-order-for-tracking-blister-to-carton-to-case-relationships-so-how-d/#comments Fri, 22 Jan 2010 20:58:27 +0000 daphne http://pmpn.canon-experts.com/?p=492 http://pmpn.canon-experts.com/2010/01/how-will-item-level-serialization-influence-line-automation-once-marked-with-a-unique-code-products-must-remain-in-their-original-order-for-tracking-blister-to-carton-to-case-relationships-so-how-d/feed/ I would like to know what the differences are between positive and negative migration? http://pmpn.canon-experts.com/2010/01/i-would-like-to-know-the-differences-are-between-positive-and-negative-migration/ http://pmpn.canon-experts.com/2010/01/i-would-like-to-know-the-differences-are-between-positive-and-negative-migration/#comments Wed, 06 Jan 2010 23:37:09 +0000 daphne http://pmpn.canon-experts.com/?p=488 http://pmpn.canon-experts.com/2010/01/i-would-like-to-know-the-differences-are-between-positive-and-negative-migration/feed/ Please explain the theory behind prequalified containers and how using them influences my own validation efforts. Do I save any time or steps? Has FDA issued any statements on validating prequalified containers? http://pmpn.canon-experts.com/2009/12/please-explain-the-theory-behind-prequalified-containers-and-how-using-them-influences-my-own-validation-efforts-do-i-save-any-time-or-steps-has-fda-issued-any-statements-on-validating-prequalified/ http://pmpn.canon-experts.com/2009/12/please-explain-the-theory-behind-prequalified-containers-and-how-using-them-influences-my-own-validation-efforts-do-i-save-any-time-or-steps-has-fda-issued-any-statements-on-validating-prequalified/#comments Thu, 17 Dec 2009 22:20:15 +0000 daphne http://pmpn.canon-experts.com/?p=485 http://pmpn.canon-experts.com/2009/12/please-explain-the-theory-behind-prequalified-containers-and-how-using-them-influences-my-own-validation-efforts-do-i-save-any-time-or-steps-has-fda-issued-any-statements-on-validating-prequalified/feed/ What factors must be considered when selecting a thermal container for international cold chain shipments? http://pmpn.canon-experts.com/2009/11/what-factors-must-be-considered-when-selecting-a-thermal-container-for-international-cold-chain-shipments/ http://pmpn.canon-experts.com/2009/11/what-factors-must-be-considered-when-selecting-a-thermal-container-for-international-cold-chain-shipments/#comments Wed, 25 Nov 2009 23:14:56 +0000 daphne http://pmpn.canon-experts.com/?p=482 http://pmpn.canon-experts.com/2009/11/what-factors-must-be-considered-when-selecting-a-thermal-container-for-international-cold-chain-shipments/feed/ We currently perform a peel test on our medical tray/Tyvek lid before and after each shift. Three peel tests are performed per tray from each sealing die. I would like to reduce the number of peel samples. What is the industry norm for peel tests as an in-process control? http://pmpn.canon-experts.com/2009/11/we-currently-perform-a-peel-test-on-our-medical-traytyvek-lid-before-and-after-each-shift-three-peel-tests-are-performed-per-tray-from-each-sealing-die-i-would-like-to-reduce-the-number-of-peel-sam/ http://pmpn.canon-experts.com/2009/11/we-currently-perform-a-peel-test-on-our-medical-traytyvek-lid-before-and-after-each-shift-three-peel-tests-are-performed-per-tray-from-each-sealing-die-i-would-like-to-reduce-the-number-of-peel-sam/#comments Wed, 25 Nov 2009 17:58:46 +0000 daphne http://pmpn.canon-experts.com/?p=478 http://pmpn.canon-experts.com/2009/11/we-currently-perform-a-peel-test-on-our-medical-traytyvek-lid-before-and-after-each-shift-three-peel-tests-are-performed-per-tray-from-each-sealing-die-i-would-like-to-reduce-the-number-of-peel-sam/feed/ We want to start performing ASTM F1929 in house. Do you have any suggestions for making samples with known defects? We tried placing a 0.002-in. wire between our tray and Tyvek lid, but the wire breaks and remains in place during removal instead of leaving a channel. http://pmpn.canon-experts.com/2009/11/we-want-to-start-performing-astm-f1929-in-house-do-you-have-any-suggestions-for-making-samples-with-known-defects-we-tried-placing-a-0002-in-wire-between-our-tray-and-tyvek-lid-but-the-wire-brea/ http://pmpn.canon-experts.com/2009/11/we-want-to-start-performing-astm-f1929-in-house-do-you-have-any-suggestions-for-making-samples-with-known-defects-we-tried-placing-a-0002-in-wire-between-our-tray-and-tyvek-lid-but-the-wire-brea/#comments Wed, 25 Nov 2009 17:55:32 +0000 daphne http://pmpn.canon-experts.com/?p=475 http://pmpn.canon-experts.com/2009/11/we-want-to-start-performing-astm-f1929-in-house-do-you-have-any-suggestions-for-making-samples-with-known-defects-we-tried-placing-a-0002-in-wire-between-our-tray-and-tyvek-lid-but-the-wire-brea/feed/