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Regulatory authorities recognize the critical nature of a sterile barrier system.In fact, they consider packaging an accessory or a component of the medical device, which implies that the package system is nearly as important as the device itself.Product families are often established so that a representative product can be chosen to represent an entire product family for validation purposes.This can considerably reduce the costs associated with a validation.Package strength testing and package integrity testing provide the means to evaluate the packaging after such exposure. Whitehouse Laboratories is happy to assist customers to better understand the testing, the available options and how to execute packaging validation projects on time and on budget.We routinely execute many physical tests required by ISO 11607 on your sterile barrier packaging.ISO 11607 is the principal guidance document for validating terminally sterilized medical device packaging systems.Packaging must comply with ISO 11607 in order to satisfy European regulations and obtain a CE Mark.

Intertek provides packaging services for all household, commercial and industrial packaging, including notification support for food contact, pharmaceuticals and cosmetics.

ISO 11607 consists of four key areas: This ISO standard also addresses packaging materials by presenting requirements for their physical properties and material performance. DDL specializes in ISO 11607 package validation testing and is happy to assist customers better understand this testing, the available options and how to carry out packaging validation projects completely and cost effectively.

With two full-service dynamic and integrity labs equipped with a wide range of environmental chambers and materials testing capabilities, DDL offers the medical device industry a combination of technical expertise, quality and industry knowledge designed to provide device manufacturers with the best service possible. I especially appreciate your steady stream of communication as well as your willingness to do whatever is necessary to expedite our tests wherever possible.

The package must keep a device sterile throughout all the stresses and hazards generated by the manufacturing, shipping, and storage environments.

Ultimately, any device that is labeled as sterile but arrives nonsterile at the point of use can critically compromise patient safety.




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