Medical Pack Solutions 


New EU Commission Publication (24th Jan 2013) of titles and references of harmonised standards applicable to: -

Directive 90/385/EEC
Directive 93/42/EEC
Directive 98/79/EC

Medical Pack Solutions
Provides a medical device packaging and labelling consultancy, developing solutions to packaging problems. An expert identifies and resolves causes of sterile-pack sealing issues and loss of package integrity during distribution or validation testing. Also offered is a functional package design service that includes validation support and guidance for compliance with EU labelling regulations.
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  Question 1: We validated our Eto sterilisation process some time ago. Seals are consistently good but we sometimes find  holes in our pouches after sterilisation. What can be happening?

  Question 2: Our blister lids are heat seal coated. Neither our sealing parameters nor our materials have changed yet we now find voids in the seal area. Can you help?

  Question 3: What is the minimum acceptable seal width? 

Some News Sources

October 2007 Consolidated version of MDD Directive 93/42/EEC

October 2007, Consolidated version of Active Implantable Medical Devices 90/385/EEC

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