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MedicalDesignTECHNOLOGY®

April 2006

Effective Development of Terminally

Sterilized Medical Device Packaging~ Too often, packaging is not given enough consideration in the product development

process and, as a result, manufacturers are left to resolve serious issues that could

have been avoided if addressed earlier. This exclusive article outlines the steps that

must be considered when developing a new or revising existing packaging for amedical device.

2: Review Regulatory Requirements

Be sure that all of the pertinent regulatoryrequirements are understood. If help isrequired, consult with the company's regulatoryaffairs department. For the United States,

review the U.S. Food and Drug Administration(FDA) Quality System Requirements and GoodManufacturing Practices. For Europe, reviewEN/TSO 11607. Although not required in theUnited States, AAMI/ANSI/ISO 11607-1:2006

and 11607-2:2006 are a part of the FDA recog­nized standards program and are harmonized

global standards.

3: Determine Real-World Conditions

When choosing the materials and packagingdesign, it is critical that the real-world condi­tions that the packaging will be subjected toduring distribution, handling, and storage areconsidered. This must include both physicaland climatic stresses, such as shock, vibration,

ing session to determine end-user require­

ments. Don't make this mistake. A]ways getinput from those who will actually use the

product. Conduct focus groups, interviews,and/or surveys to learn what these end-usersreally want-and need-in a new packagingsystem. Input from the company's sales andmarketing team can be helpful, especially togain a better understanding of competitiveofferings, but this information is not a substi­tute for obtaining the voice of the customer.

After gathering this information, be sure toget approval from appropriate groups that willbe affected by any design decisions, such as

marketing, product management, and opera­tions.

1: Obtain Voice of the Customer

It can be very tempting to rely on anecdotalinformation or to hold an internal brainstorm-

By Curtis L. Larsen, CPP

Inthe introduction ofISO 11607-1:2006, the

authors have written, "The process of design­ing and developing a packaging system forterminally sterilized medica] devices is a

complicated and critical endeavor." The processis definitely complicated and should always beconsidered critical to the overall success of a

medica] device. After all, even the greatest med­ica] device in the world does not become a

medical product until it is properly packaged,sterilized, and labeled.

But developing a new packaging system­defined in ISO 11607-1 as a "combination of

the sterile barrier system and protective packag­ing" -or making changes to an existing one canbe much easier if you do the necessary ground­

work in advance and have a detailed plan to fo]­low.

To aid in the development of that detailedplan, this article looks at seven basic cate­gories of activities that should be included. It

IS important to note that many of the activitieslisted here are intended to be performed con­currently. In addition, there may be instances

where some activities are not required due to aspecific situation. However, by referencing

these seven categories, a detailed plan can be

developed that will easily guide engineers

assigned the task of creating the finished

device packaging through the complicatedprocess of developing packaging systems forterminally sterilized medica] devices.

Used in virtually every form of

sterile medical packaging, DuPont Tyvek is the

material of choice for pouches and lidstock

(shown here), as well as breather patches

and headers for bags.

Curtis L. Larsen, CPP, who has more

than 35 years experience in sterilemedical packaging, is a package

engineering consultant for DuPontMedical Packaging. He is an active

member of ASTM International

Committee F02 Flexible Packaging,DIO Packaging, and F04 Medical

and Surgical Materials and Devices.

Larsen is past co-chair of the AAMIadministered US sub-TAG for

ISOfTCI98/WG7-Medical Packaging.

He was a co-author of the initial

draft of ISO 11607 "Packaging for

terminally sterilized medical devices"and has been active on the ISO task

group for the past three revisions.Larsen can be reached at

curtis. I. larsen @usa.dupont.com.

AT A GLANCE

• Regulatory concerns

• Compatibility issues

• Design and appearance

• Manufacturing guidelines

www.mdtmag.com

humidity, temperature extremes, and changesin altitude.

4: Define Product Package Requirements

The FDA requires a Master Product

Specification (MPS) be written for everymedical device. An often omitted element is a

section on packaging. Be sure to include all

the information gathered in categories 1,2,and 3. It is also useful to define and docu­

ment device fragility levels, languagerequirements, and unites) of sale packageconfiguration( s).

The device shelf-life should be included inthe MPS. Be sure that there is data on file

showing that the packaging materials andseals specified will meet the establisheddevice shelf-life.

5: Select Materials

Before specifying materials, it is important

not only to determine compatibility amongthe various materials being used in the sterilebarrier system and in the protective packag­ing, but also to determine compatibility ofthose materials with the device itself and the

manufacturing processes to be used.Packaging materials and components sup­

pliers can provide a wealth of compatibilitydata to aid in the selection process. Additionaltests should then be conducted. Some of the

things to consider include compatibility withthe manufacturing equipment, sterilization

process, and labeling that will be used.Finding out that the adhesive specified for alabel is incompatible with the sterilizationmethod is a minor problem when the discov­ery occurs during the materials selectionphase. It can become a real nightmare whenrealized at a later date and time.

Although tooling may not be thought of aspart of material selection, it is an importantaspect. Work with the company's sourcingdepartment for help with pricing and vendorselection. Perform a first article inspectionand approve vendor retained tooling, verify­ing that the requirements documented in theMPS are being met. Further, be sure to docu­ment all materials and component informa­tion.

6: Create Package Design and Verify

Performance

Be sure to receive final samples of the medicaldevice-not an early prototype-and all of the

A wide variety of products are packaged in pouches

made of DuPont Tyvek and a medical-grade film.

accessories and labeling that will be includedbefore creating a package design. Just a minor

modification in the size or shape of the deviceor the addition of an extra accessory could

require a major revision of a package designand a resultant delay in the planned productintroduction.

Don't overlook the impact of labeling on adesign. Remember, labeling includes thelabels that are affixed directly to, or printedon, the package components, as well as anypackage inserts or IFUs. Be sure to evaluatethe labeling stock and conduct shelf-life tests.In addition, approve prototype labeling tools.

Sterilization is another key factor that must

be considered early in the package designprocess. Contact the in-house sterilizationdepartment or contract sterilizer to discussthe sterilization method that will be used and

to document the process parameters. Then,conduct tests to ensure that the medical

device and sterile barrier system can survivewhen exposed to the stresses induced by thesterilization process.

Conduct preliminary screening tests for thereal-world physical and climatic stress condi­tions that were identified in category 3. Then,write a Design Performance QualificationProtocol that clearly documents how the test­ing and qualifying of the package design willbe performed. List the specific pass/fail crite­ria. Be sure that the test methods used to

examine the samples are validated for use.

Don't forget to include shelf-life testing in theoverall development process. If necessary,redesign and retest until the package design

meets or exceeds the established performancecriteria.

Finally, write reports and compile detaileddocumentation of the packaging assembly andcomponents. Be sure to include all drawings,parts lists, and custom assembly tooling.

7: Develop Manufacturing Process

To ensure that a design can be put into produc­tion, get involved in the package manufacturingdecisions. Determine what it takes to assemble

the package. Then, create an equipment specifi­cation document that details exactly what thepackaging equipment needs to do. Work with

the company's sourcing department for helpwith pricing and vendor selection.

After the equipment has been selected andinstalled, validate the process and the software,

if applicable. There are three major compo­nents to process validation: IQ (installationqualification), OQ (operational qualification),and PQ (performance qualification).

During IQ, determine by objective evi­dence that all key aspects of the processequipment and ancillary system installationadhere to the manufacturer's approved speci­fication. Be sure that all appropriate toolingis on the equipment. If printing inline, be surethat this equipment is also properly installed.

During OQ, identify and evaluate critical

process parameters, along with their operatingranges, settings, and tolerances. Establishprocess control limits and action levels that

will result in product that meets all predeter­mined requirements.

During PQ, demonstrate that the processwill consistently produce acceptable packagesunder normal operating conditions.

A documented review and approval process,known as process certification, should be thefinal step of the validation process. Work withthe packaging equipment production managerto determine the best layout for the productionline and to create work instruction documenta­

tion for the operators. Set up training for theoperators to be sure that they know exactlywhat needs to be done to put the design intoproduction.

ONLINE

For additional information on the products and tech-

nologies discussed in this article, see Medical Design

Technology online at www.mdtmag.com or DuPont

at www.medicalpackaging.dupont.com.

Reprinted from Medical Design Technology, April 2006. Copyright © Reed Business information, a division of Reed Elsevier, Inc. All rights reserved.Page layout as originally published in Medical Design Technology has been modified.

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