Medical Pack Solutions 

 

Welcome to Rolande's Medical Device Packaging

Information for those who Package and Label Medical Devices.


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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FAQ

·  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

Directive 2007/47/EC: amending Medical Device Directives

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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