Aseptica Sonderausgabe102010 En

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FOCUSEN/ISO 11607-2

validation requirements for

packaging processes

asepticaspec

ial issue

October 2010

aseptica special issue


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Focus

One of the most critical characteris-

tics of a sterile barrier system and

packaging system for sterile medical

devices is the assurance of sterility

maintenance. The development and

validation of packaging processes are

crucial to ensure that sterile barrier

system integrity is attained and re-

mains until opened by the users of

sterile medical devices.

The International Packaging

Standard DIN EN ISO 11607

The international standard DIN EN ISO11607 Packaging for terminally sterilizedmedical devices was already published in2006. For the first time uniform interna-tional definitions for the various terms weredefined.

The terms package, final packageand primary package all had differing

meanings globally. Resulting from this, theterm sterile barrier system was introduced,to describe the minimum packaging requiredto perform the unique functions of medicalpackaging: to allow sterilization, to providean acceptable microbial barrier, and to allowaseptic presentation e.g. in operations. Pro-tective packaging protects the sterile barriersystem, and together they form the packagingsystem. While the first part lists generalrequirements for materials, sterile barriersystems and packaging systems, the second

part describes for the first time, the valida-tion requirements of the packaging process-es. It is explicitly required that all packaging

processes must be validated. The standard isapplicable to industry, to health care facili-ties, and wherever medical devices are pack-aged and sterilized. Amongst other thingsthe customary methods used in hospitals arenamed here. These are:

Pouch, reel, or bag forming and sealingFilling and closure of reusable containers

Sterilization sheets folding and wrapping

Not long ago the German standard seriesDIN 58953:2010 was harmonised with theinternational standard series. Particularattention should be paid to Part 7 Use ofsterilization paper, nonwoven wrappingmaterial, paper bags and sealable pouchesand reels and Part 9 Use of sterilizationcontainers. Both parts now stipulate on anational basis that all packaging processesmust be validated. For further procedureone is referred to the requirements of the

international standard.Through this, the international standard

EN ISO 11607-2 and the packaging valida-tion associated with it, is given evenstronger significance.

For the sealing process using a heat-sealingdevice this has been clear for some time.This is why in 2008 the German Society forSterile Supply (DGSV) put together an easyto handle guideline for validation of sealingprocesses for those practising it. (English andFrench versions are available free of charge

at www.hawo.com). As well as case examples,this also contains all relevant checklists forcompilation of a validation plan, the Instal-lation Qualification, Operational Qualifica-tion and Performance Qualification (IQ/OQ/PQ). Whereas for the initial validation allthe validation steps must be carried out (i.e.IQ/OQ/PQ), for revalidation usually a fur-ther performance qualification suffices (PQ).However the pre-condition of this is that nochanges have been made to the product (e.g.

sealing devices) or to the packaging materi-als (preformed Sterile Barrier Systems).

Validation in the example of the

sealing process

In order to validate the sealing process, thesealing devices need to control and monitorthe critical process parameters (according to

the current DGSV guideline these are as aminimum the sealing temperature and con-tact pressure). In the event that criticalprocess parameters exceed predeterminedlimits there must be an alarm, warning sys-tem or machine stop.

This is why, when buying a new sealer,you should always check that conformity tothe standard EN ISO 11607-2 is confirmed.If your sealing appliance is an older model,you can enquire of the manufacturer whetherit fulfils the requirements of the standard.

For the initial validation it is important

that the new sealer is delivered with a cali-bration certificate. Sealers you already ownshould be serviced and calibrated by the man-ufacturer or an authorised service company.

As soon as this documentation is avail-able then process validation can go ahead.Whereas for the Installation Qualification(IQ) just a few questions need answering(e.g. whether the sealing appliance conformsto EN ISO 11607-2) and it is necessary toensure that the users are trained properly, forthe Operational Qualification (OQ) the

sealing temperature must be established.The recommended sealing temperature

range is available from the data informationsupplied with the packaging material (e.g.180200C). The sealing appliance is first ofall set to the lower limit value (here 180C).For this value one sealing without and onewith a seal indicator (SEAL CHECK) is car-ried out. The sealing without SEAL CHECKserves as the evaluation of the peelability. Itis vital that fraying does not occur at the

EN/ISO 11607-2 validation

requirements for packaging processes

C. Wolf

Author

Dipl. Ingenieur/ Dipl. BetriebswirtChristian Wolfhawo GmbHObere Au 2-4www.hawo.com


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opening. The seal with SEAL CHECK ser-ves to evaluate the quality properties.

These can be evaluated using a referencecard. The evaluations are summed up in theOQ checklist. After this, the temperatureis set to the upper limit value (here 200C).For the evaluation the same procedure is car-ried out as for the lower limit value. If thepeelability is given and the quality propertiesfulfilled, the midpoint should be set as thedefined seal temperature (here 190C).

Sealing devices conforming to the stan-dard should work in a tolerance range (cut-offtolerance) of +/- 5C.

If it has been established that acceptableresults are to be expected between 180 and200C and that the appliance cuts off at 190+/- 5 C, then it can be presumed that everysealing is equally good and the results arethus valid. For the Performance Qualification(PQ) 3 bags or reels are sealed using the de-fined sealing temperature (here 190C) (reelsat both ends). All 3 sterile barrier systems arenow marked (e.g. A, B and C) and each isput through a different sterilisation cycle. Af-

ter sterilisation the integrity of the seal seamstrength is evaluated. In practise the seal

strength tests according to EN 868-5:2009 orASTM F88 are the established methods. Thisis carried out by manufacturers of sealingdevices and packaging material. The cost isquite reasonable, too.

The data from the test report are thenrecorded in the Performance Qualificationchecklist). Finally only formal permission ofprocess validation has to be established.

Before the periodic (usually annually)revalidation the sealing appliance should bethoroughly serviced and calibrated. This

should be either carried out by the manufac-turer or by an authorized service company ofthe manufacturer.

Labeling

Sterile barrier systems must be marked withvarious information. Basically there are norules about exactly how the sterile barriersystem is to be marked. But in practice di-rect printing using the sealers internal print-er or the use of labels has proved practical.

But whichever system is used no systemmay be used that marks the packaging mate-

rial in the area surrounding the medical de-vice (Instrument). Neither may the sealseam be printed or written on, because theprinter needles or the pen could damagethem.

Documentation

According to DIN EN ISO 11607-2:2006the critical process parameters should notonly be monitored but also routinely docu-mented.

Modern sealing appliances have a so-

called SEAL CHECK function. Here theappliance is switched into a mode that printsout the critical process parameters alongwith the date, time, name of person conduc-ting the test and the appliance number.The printouts can be filed as routine docu-mentation. If batch documentation softwareis already installed or if the installation isplanned, it would be vital to consider addingthe heat sealers to it. Then the documentationrequired in the standard runs automatically

Sealing appliances conforming to the standard monitor the critical process parameters automatically. If a parameter deviates beyond

its limit value (e.g. +/- 5C), they interrupt the process and alarm the user.


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Summary

Non-validated packaging processes are nolonger acceptable in hospitals. This is abeneficial development when one considersthat a packaging system is significantly re-sponsible for the fact that medical products

remain sterile until their use. Because thechain of reprocessing is only joined by thepackaging link. And chains are well knownto be only as strong as their weakest link.

Information such as for example the name of

the packer or batch identification often have

to be altered. The entry of data via the sealing

appliance (e.g. name of packer) is usually very

time-consuming. Intelligent entry systems (e.g.

the new IntelligentScan system from hawo) use

a scanner to record names, batch number etc.

quickly and accurately and then assign them

automatically to the right symbol.

in the background. Therefore be sure to askthe manufacturer when buying a new sealer,whether i t is compatible with the softwareyou have or intend to buy.

Furthermore the German standard DIN58953 -7:2010 requires that the requirements

for quality properties of the seal seam becontinually attained. Proof for this require-ment is made by the daily use of a SEALCHECK indicator before and after each batch.

Using seal indicators the quality proper-

ties of the seal seam can be evaluated.

Irregularities (e.g. canals) are shown

clearly on the indicator field.

Documents

Aseptica Sonderausgabe102010 En