Ask The Experts http://euro.canon-experts.com The only place to get expert advice! Wed, 01 Feb 2012 18:18:40 +0000 http://wordpress.org/?v=2.7 en hourly 1 I am new to medical device packaging. Why do so many products have porous windows in their packaging even though they are not gas-sterilised? http://euro.canon-experts.com/2012/02/i-am-new-to-medical-device-packaging-why-do-so-many-products-have-porous-windows-in-their-packaging-even-though-they-are-not-gas-sterilised/ http://euro.canon-experts.com/2012/02/i-am-new-to-medical-device-packaging-why-do-so-many-products-have-porous-windows-in-their-packaging-even-though-they-are-not-gas-sterilised/#comments Wed, 01 Feb 2012 18:18:40 +0000 admin http://euro.canon-experts.com/?p=347 http://euro.canon-experts.com/2012/02/i-am-new-to-medical-device-packaging-why-do-so-many-products-have-porous-windows-in-their-packaging-even-though-they-are-not-gas-sterilised/feed/ There are legacy PVC medical device products on the EU market that have been used in large volume over at least the past three decades with, presumably, no deleterious effects. They would be expected to fail the current 10993 testing (as PVC is used as a positive control) for the least stringent criteria: limited duration, unbroken skin contact. How would you respond (or expect a manufacturer to respond) to a request from customers or regulators for 10993 test results? http://euro.canon-experts.com/2012/01/there-are-legacy-pvc-medical-device-products-on-the-eu-market-that-have-been-used-in-large-volume-over-at-least-the-past-three-decades-with-presumably-no-deleterious-effects-they-would-be-expected/ http://euro.canon-experts.com/2012/01/there-are-legacy-pvc-medical-device-products-on-the-eu-market-that-have-been-used-in-large-volume-over-at-least-the-past-three-decades-with-presumably-no-deleterious-effects-they-would-be-expected/#comments Wed, 01 Feb 2012 01:21:20 +0000 admin http://euro.canon-experts.com/?p=343 http://euro.canon-experts.com/2012/01/there-are-legacy-pvc-medical-device-products-on-the-eu-market-that-have-been-used-in-large-volume-over-at-least-the-past-three-decades-with-presumably-no-deleterious-effects-they-would-be-expected/feed/ I need to build an air-operated positive displacement type pumping system. Can I connect a hydraulic ram to an air cylinder to make a pump? http://euro.canon-experts.com/2011/02/i-need-to-build-an-air-operated-positive-displacement-type-pumping-system-can-i-connect-a-hydraulic-ram-to-an-air-cylinder-to-make-a-pump/ http://euro.canon-experts.com/2011/02/i-need-to-build-an-air-operated-positive-displacement-type-pumping-system-can-i-connect-a-hydraulic-ram-to-an-air-cylinder-to-make-a-pump/#comments Thu, 10 Feb 2011 19:11:35 +0000 admin http://euro.canon-experts.com/?p=333 http://euro.canon-experts.com/2011/02/i-need-to-build-an-air-operated-positive-displacement-type-pumping-system-can-i-connect-a-hydraulic-ram-to-an-air-cylinder-to-make-a-pump/feed/ I need to eliminate air bubbles in my dispensing. I have vacuum mixed material that gets placed inside a syringe. Once this happens, air is introduced into the material since it is too thick. I am using an air-assisted dispensing system, as well. Do you have a suggestion on removing air from the syringe and if I should use a positive displacement system to minimise air bubbles on my dispensing bead? http://euro.canon-experts.com/2010/10/i-need-to-eliminate-air-bubbles-in-my-dispensing-i-have-vacuum-mixed-material-that-gets-placed-inside-a-syringe-once-this-happens-air-is-introduced-into-the-material-since-it-is-too-thick-i-am-usi/ http://euro.canon-experts.com/2010/10/i-need-to-eliminate-air-bubbles-in-my-dispensing-i-have-vacuum-mixed-material-that-gets-placed-inside-a-syringe-once-this-happens-air-is-introduced-into-the-material-since-it-is-too-thick-i-am-usi/#comments Thu, 21 Oct 2010 11:51:33 +0000 admin http://euro.canon-experts.com/?p=322 http://euro.canon-experts.com/2010/10/i-need-to-eliminate-air-bubbles-in-my-dispensing-i-have-vacuum-mixed-material-that-gets-placed-inside-a-syringe-once-this-happens-air-is-introduced-into-the-material-since-it-is-too-thick-i-am-usi/feed/ My company has a new project that requires dispensing a thick medical-grade silicone through a small needle. We tried hand syringes, but the process was extremely difficult for workers to perform and took too long. Hand fatigue was a problem, and we were concerned about the possibility of long-term injuries. We hoped an air-powered dispenser with 100 psi of output would be the answer, but while it resolved the hand fatigue issue, it is still too slow to be considered a permanent solution. http://euro.canon-experts.com/2010/06/my-company-has-a-new-project-that-requires-dispensing-a-thick-medical-grade-silicone-through-a-small-needle-we-tried-hand-syringes-but-the-process-was-extremely-difficult-for-workers-to-perform-and/ http://euro.canon-experts.com/2010/06/my-company-has-a-new-project-that-requires-dispensing-a-thick-medical-grade-silicone-through-a-small-needle-we-tried-hand-syringes-but-the-process-was-extremely-difficult-for-workers-to-perform-and/#comments Thu, 01 Jul 2010 03:18:06 +0000 norbert http://euro.canon-experts.com/?p=310 http://euro.canon-experts.com/2010/06/my-company-has-a-new-project-that-requires-dispensing-a-thick-medical-grade-silicone-through-a-small-needle-we-tried-hand-syringes-but-the-process-was-extremely-difficult-for-workers-to-perform-and/feed/ We need to lubricate the interior of a small cylinder with silicone oil. We have been applying it with swabs, with mixed results. If we don’t apply enough, the device won’t function properly. If we apply too much (as is usually the case) the oil seeps out, so that we have to disassemble the device, remove the excess, and test it again. Our rework rate is currently more than 30%. http://euro.canon-experts.com/2010/06/we-need-to-lubricate-the-interior-of-a-small-cylinder-with-silicone-oil-we-have-been-applying-it-with-swabs-with-mixed-results-if-we-dont-apply-enough-the-device-wont-function-properly-if-we/ http://euro.canon-experts.com/2010/06/we-need-to-lubricate-the-interior-of-a-small-cylinder-with-silicone-oil-we-have-been-applying-it-with-swabs-with-mixed-results-if-we-dont-apply-enough-the-device-wont-function-properly-if-we/#comments Tue, 29 Jun 2010 03:20:16 +0000 norbert http://euro.canon-experts.com/?p=314 http://euro.canon-experts.com/2010/06/we-need-to-lubricate-the-interior-of-a-small-cylinder-with-silicone-oil-we-have-been-applying-it-with-swabs-with-mixed-results-if-we-dont-apply-enough-the-device-wont-function-properly-if-we/feed/ We are using air-powered dispensers to apply a medium-viscosity material using 10-cc syringes. As the amount of material in the syringe decreases, we have to periodically increase air pressure to keep the shot size consistent. Is there a way around this issue? http://euro.canon-experts.com/2010/06/we-are-using-air-powered-dispensers-to-apply-a-medium-viscosity-material-using-10-cc-syringes-as-the-amount-of-material-in-the-syringe-decreases-we-have-to-periodically-increase-air-pressure-to-keep/ http://euro.canon-experts.com/2010/06/we-are-using-air-powered-dispensers-to-apply-a-medium-viscosity-material-using-10-cc-syringes-as-the-amount-of-material-in-the-syringe-decreases-we-have-to-periodically-increase-air-pressure-to-keep/#comments Thu, 24 Jun 2010 19:38:23 +0000 norbert http://euro.canon-experts.com/?p=305 http://euro.canon-experts.com/2010/06/we-are-using-air-powered-dispensers-to-apply-a-medium-viscosity-material-using-10-cc-syringes-as-the-amount-of-material-in-the-syringe-decreases-we-have-to-periodically-increase-air-pressure-to-keep/feed/ Cardiac catheterisation kits contain many types of devices including sterile drapes and gowns, syringes, hypodermic needles, glass drug vials and so forth. Is there a specific guidance document that deals with this type of packaging as opposed to single-device packaging? http://euro.canon-experts.com/2010/01/cardiac-catheterisation-kits/ http://euro.canon-experts.com/2010/01/cardiac-catheterisation-kits/#comments Wed, 20 Jan 2010 22:18:11 +0000 norbert http://euro.canon-experts.com/?p=298 http://euro.canon-experts.com/2010/01/cardiac-catheterisation-kits/feed/ Sometimes I get a slight variation in my deposit size. What might be causing this? http://euro.canon-experts.com/2009/11/slight-variation-in-my-deposit-size/ http://euro.canon-experts.com/2009/11/slight-variation-in-my-deposit-size/#comments Tue, 17 Nov 2009 14:23:45 +0000 norbert http://euro.canon-experts.com/?p=296 http://euro.canon-experts.com/2009/11/slight-variation-in-my-deposit-size/feed/ Do you produce dispensers that can be autoclaved? http://euro.canon-experts.com/2009/11/dispensers-that-can-be-autoclaved/ http://euro.canon-experts.com/2009/11/dispensers-that-can-be-autoclaved/#comments Mon, 09 Nov 2009 17:23:28 +0000 norbert http://euro.canon-experts.com/?p=293 http://euro.canon-experts.com/2009/11/dispensers-that-can-be-autoclaved/feed/