Design Verify Qualify Commercialize Guidance for ISO 11607 Compliance Design Verify Qualify Commercialize Idenfy packaging material and design Evaluate product and packaging interacon Evaluate human interacon for packaging presentaon Evaluate the supply chain and distribuon environments Verificaon and validaon tesng - ensuring the validity of the packaging system process Installaon Qualificaon - demonstraon that equipment has been installed correctly and operates as intended. Operaonal Qualificaon - demonstraon that the packaging process produces acceptable results at the limits of the process window. Performance Qualificaon - demonstraon that the packaging system process is stable and capable when run under normal manufacturing condions. Accelerated and real me aging- test material stability over me » Integrity Check - Cross reference your risk assessment, user, shelf life, and integrity requirements, which may include: · Sterile barrier integrity · Label legibility/integrity · UDI verificaon · Asepc presentaon Distribuon and Transit tesng - shipping a package through the supply chain environments: how does the product perform when shipped through the rigor- ous channel? » Integrity Check - Cross reference your risk assessment, user, shelf life, and integrity requirements, which may include: · Sterile barrier integrity · Label legibility/integrity · UDI verificaon · Asepc presentaon · Device funconality Ensure successful tesng, cGMP and GxP compliance Documentaon Artwork final verificaon Design transfer - ensuring ongoing compliance through commercial manufacturing Periodic review - maintaining compliance throughout product life cycle Contact us for assistance with your distribution testing www.adeptpackaging.com [email protected] +1.484.373.2504 About Adept Packaging Adept Packaging believes that packaging is more than a container-- it’s a powerful vehicle, connecng iconic brands to consumers, safely transporng life-saving medicines and devices and protecng the food and drinks we consume every day. Adept is the leading expert for packaging engineering and serializaon, providing teams with flexible, scalable service through staffing, engineering services, business processes and technology. Our porolio of accelerators and products capture and create value from packaging. In order to be compliant to ISO 13485 for sterilized medical device packaging, companies must achieve compliance to ISO 11607 for terminally sterilized packaging. The following stage gates mark major milestones that must be achieved in order to take medical device packaging from concepon to commercializaon. This cheat sheet outlines some of the main steps companies need to take to accelerate the process toward compliance.

Guidance for ISO 11607 Compiance - Adept Packaging · In order to be compliant to ISO 13485 for sterilized medical device packaging, companies must achieve compliance to ISO 11607

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Page 1: Guidance for ISO 11607 Compiance - Adept Packaging · In order to be compliant to ISO 13485 for sterilized medical device packaging, companies must achieve compliance to ISO 11607

ISO 11607-1 details the elemental attributes demanded of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices. It takes into consideration the vast array of potential materials, medical devices, packaging system designs, and sterilization methods.ISO 11607-2 describes the validation requirements for forming, sealing and assembly processes. The development and validation of packaging processes are crucial to ensure that sterile barrier system integrity is maintained until opened by the users of sterile medical devices.

Design Verify Qualify Commercialize

Guidance for ISO 11607 Compliance

Design

Verify

Qualify

Commercialize

Identify packaging material and design

Evaluate product and packaging interaction

Evaluate human interaction for packaging presentation

Evaluate the supply chain and distribution environments

Verification and validation testing - ensuring the validity of the packaging system process

Installation Qualification - demonstration that equipment has been installed correctly and operates as intended.

Operational Qualification - demonstration that the packaging process produces acceptable results at the limits of the process window.

Performance Qualification - demonstration that the packaging system process is stable and capable when run under normal manufacturing conditions.

Accelerated and real time aging- test material stability over time» Integrity Check - Cross reference your risk assessment, user, shelf life,and integrity requirements, which may include:

· Sterile barrier integrity

· Label legibility/integrity

· UDI verification

· Aseptic presentation

Distribution and Transit testing - shipping a package through the supply chain environments: how does the product perform when shipped through the rigor-ous channel?

» Integrity Check - Cross reference your risk assessment, user, shelf life,and integrity requirements, which may include:

· Sterile barrier integrity

· Label legibility/integrity

· UDI verification

· Aseptic presentation

· Device functionality

Ensure successful testing, cGMP and GxP compliance

Documentation Artwork final verification

Design transfer - ensuring ongoing compliance through commercial manufacturing

Periodic review - maintaining compliance throughout product life cycle

About Adept PackagingAdept Packaging believes that packaging is more than a container-- it’s a powerful vehicle, connecting iconic brands toconsumers, safely transporting life-saving medicines and devices and protecting the food and drinks we consume every day.

Adept is the leading expert for packaging engineering and serialization, providing teams with flexible, scalable service throughstaffing, engineering services, business processes and technology. Our portfolio of accelerators and products capture and createvalue from packaging.

In order to be compliant to ISO 13485 for sterilized medical device packaging, companies must achievecompliance to ISO 11607 for terminally sterilized packaging. The following stage gates mark majormilestones that must be achieved in order to take medical device packaging from conception tocommercialization. This cheat sheet outlines some of the main steps companies need to take toaccelerate the process toward compliance.