October 2010

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EN/ISO 11607-2 validation requirements for packaging processes

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EN/ISO 11607-2 validation requirements for packaging processes

C. Wolf
One of the most critical characteristics 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 remains until opened by the users of sterile medical devices. The International Packaging Standard DIN EN ISO 11607 The international standard DIN EN ISO 11607 Packaging for terminally sterilized medical devices was already published in 2006. For the first time uniform international definitions for the various terms were defined. The terms package, final package and primary package all had differing meanings globally. Resulting from this, the term sterile barrier system was introduced, to describe the minimum packaging required to perform the unique functions of medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow aseptic presentation e.g. in operations. Protective packaging protects the sterile barrier system, and together they form the packaging system. While the first part lists general requirements for materials, sterile barrier systems and packaging systems, the second part describes for the first time, the validation requirements of the packaging processes. It is explicitly required that all packaging processes must be validated. The standard is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. Amongst other things the customary methods used in hospitals are named here. These are: Pouch, reel, or bag forming and sealing Filling and closure of reusable containers Sterilization sheets folding and wrapping Not long ago the German standard series DIN 58953:2010 was harmonised with the international standard series. Particular attention should be paid to Part 7 Use of sterilization paper, nonwoven wrapping material, paper bags and sealable pouches and reels and Part 9 Use of sterilization containers. Both parts now stipulate on a national basis that all packaging processes must be validated. For further procedure one is referred to the requirements of the international standard. Through this, the international standard EN ISO 11607-2 and the packaging validation associated with it, is given even stronger significance. For the sealing process using a heat-sealing device this has been clear for some time. This is why in 2008 the German Society for Sterile Supply (DGSV) put together an easy to handle guideline for validation of sealing processes for those practising it. (English and French versions are available free of charge at www.hawo.com). As well as case examples, this also contains all relevant checklists for compilation of a validation plan, the Installation Qualification, Operational Qualification and Performance Qualification (IQ/OQ/ PQ). Whereas for the initial validation all the validation steps must be carried out (i.e. IQ/OQ/PQ), for revalidation usually a further performance qualification suffices (PQ). However the pre-condition of this is that no changes have been made to the product (e.g.
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sealing devices) or to the packaging materials (preformed Sterile Barrier Systems). Validation in the example of the sealing process In order to validate the sealing process, the sealing devices need to control and monitor the critical process parameters (according to the current DGSV guideline these are as a minimum the sealing temperature and contact pressure). In the event that critical process parameters exceed predetermined limits there must be an alarm, warning system or machine stop. This is why, when buying a new sealer, you should always check that conformity to the standard EN ISO 11607-2 is confirmed. If your sealing appliance is an older model, you can enquire of the manufacturer whether it fulfils the requirements of the standard. For the initial validation it is important that the new sealer is delivered with a calibration certificate. Sealers you already own should be serviced and calibrated by the manufacturer or an authorised service company. As soon as this documentation is available then process validation can go ahead. Whereas for the Installation Qualification (IQ) just a few questions need answering (e.g. whether the sealing appliance conforms to EN ISO 11607-2) and it is necessary to ensure that the users are trained properly, for the Operational Qualification (OQ) the sealing temperature must be established. The recommended sealing temperature range is available from the data information supplied with the packaging material (e.g. 180200C). The sealing appliance is first of all set to the lower limit value (here 180C). For this value one sealing without and one with a seal indicator (SEAL CHECK) is carried out. The sealing without SEAL CHECK serves as the evaluation of the peelability. It is vital that fraying does not occur at the

Author
Dipl. Ingenieur/ Dipl. Betriebswirt Christian Wolf hawo GmbH Obere Au 2-4 www.hawo.com

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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.

opening. The seal with SEAL CHECK serves to evaluate the quality properties. These can be evaluated using a reference card. The evaluations are summed up in the OQ checklist. After this, the temperature is set to the upper limit value (here 200C). For the evaluation the same procedure is carried out as for the lower limit value. If the peelability is given and the quality properties fulfilled, the midpoint should be set as the defined seal temperature (here 190C). Sealing devices conforming to the standard should work in a tolerance range (cut-off tolerance) of +/- 5C. If it has been established that acceptable results are to be expected between 180 and 200C and that the appliance cuts off at 190 +/- 5 C, then it can be presumed that every sealing is equally good and the results are thus valid. For the Performance Qualification (PQ) 3 bags or reels are sealed using the defined sealing temperature (here 190C) (reels at both ends). All 3 sterile barrier systems are now marked (e.g. A, B and C) and each is put through a different sterilisation cycle. Af-

ter sterilisation the integrity of the seal seam strength is evaluated. In practise the seal strength tests according to EN 868-5:2009 or ASTM F88 are the established methods. This is carried out by manufacturers of sealing devices and packaging material. The cost is quite reasonable, too. The data from the test report are then recorded in the Performance Qualification checklist). Finally only formal permission of process validation has to be established. Before the periodic (usually annually) revalidation the sealing appliance should be thoroughly serviced and calibrated. This should be either carried out by the manufacturer or by an authorized service company of the manufacturer. Labeling Sterile barrier systems must be marked with various information. Basically there are no rules about exactly how the sterile barrier system is to be marked. But in practice direct printing using the sealers internal printer or the use of labels has proved practical.
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But whichever system is used no system may be used that marks the packaging material in the area surrounding the medical device (Instrument). Neither may the seal seam be printed or written on, because the printer needles or the pen could damage them. Documentation According to DIN EN ISO 11607-2:2006 the critical process parameters should not only be monitored but also routinely documented. Modern sealing appliances have a socalled SEAL CHECK function. Here the appliance is switched into a mode that prints out the critical process parameters along with the date, time, name of person conducting the test and the appliance number. The printouts can be filed as routine documentation. If batch documentation software is already installed or if the installation is planned, it would be vital to consider adding the heat sealers to it. Then the documentation required in the standard runs automatically

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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 ask the manufacturer when buying a new sealer, whether it is compatible with the software you have or intend to buy. Furthermore the German standard DIN 58953 -7:2010 requires that the requirements for quality properties of the seal seam be continually attained. Proof for this requirement is made by the daily use of a SEAL CHECK indicator before and after each batch.

Summary Non-validated packaging processes are no longer acceptable in hospitals. This is a beneficial development when one considers that a packaging system is significantly responsible for the fact that medical products remain sterile until their use. Because the chain of reprocessing is only joined by the packaging link. And chains are well known to be only as strong as their weakest link.

Using seal indicators the quality properties of the seal seam can be evaluated. Irregularities (e.g. canals) are shown clearly on the indicator field.

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