October 2010

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EN/ISO 11607-2 – validation requirements for packaging processes
aseptica special issue

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. and together they form the packaging system. to describe the minimum packaging required to perform the unique functions of medical packaging: to allow sterilization.g. the Installation Qualification. As soon as this documentation is available then process validation can go ahead. the international standard EN ISO 11607-2 and the packaging validation associated with it. Sealers you already own should be serviced and calibrated by the manufacturer or an authorised service company.com). For the first time uniform international definitions for the various terms were defined. to health care facilities. The sealing appliance is first of all set to the lower limit value (here 180°C). 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. the term »sterile barrier system« was introduced. »final package« and »primary package« all had differing meanings globally. whether the sealing appliance conforms to EN ISO 11607-2) and it is necessary to ensure that the users are trained properly. and wherever medical devices are packaged and sterilized. you should always check that conformity to the standard EN ISO 11607-2 is confirmed. This is why. nonwoven wrapping material. If your sealing appliance is an older model. Whereas for the Installation Qualification (IQ) just a few questions need answering (e. The sealing without SEAL CHECK serves as the evaluation of the peelability.hawo. The terms »package«. reel. Betriebswirt Christian Wolf hawo GmbH Obere Au 2-4 www. IQ/OQ/PQ). in operations. 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). Amongst other things the customary methods used in hospitals are named here. For further procedure one is referred to the requirements of the international standard. For this value one sealing without and one with a seal indicator (SEAL CHECK) is carried out. The recommended sealing temperature range is available from the data information supplied with the packaging material (e. In the event that critical process parameters exceed predetermined limits there must be an alarm. paper bags and sealable pouches and reels« and Part 9 »Use of sterilization containers«. to provide an acceptable microbial barrier. Through this. when buying a new sealer. Operational Qualification and Performance Qualification (IQ/OQ/ PQ). the validation requirements of the packaging processes.g. For the initial validation it is important that the new sealer is delivered with a calibration certificate. sterile barrier systems and packaging systems. However the pre-condition of this is that no changes have been made to the product (e.e.« 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.Focus EN/ISO 11607-2 – validation requirements for packaging processes C. It is vital that fraying does not occur at the Author Dipl. and to allow aseptic presentation e. you can enquire of the manufacturer whether it fulfils the requirements of the standard. is given even stronger significance.g. While the first part lists general requirements for materials. aseptica special issue sealing devices) or to the packaging materials (preformed Sterile Barrier Systems). 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. warning system or machine stop. the second part describes for the first time. for the Operational Qualification (OQ) the sealing temperature must be established.hawo. this also contains all relevant checklists for compilation of a validation plan. It is explicitly required that all packaging processes must be validated. Resulting from this. The standard is applicable to industry.g. For the sealing process using a heat-sealing device this has been clear for some time. Ingenieur/ Dipl. Whereas for the initial validation all the validation steps must be carried out (i. (English and French versions are available free of charge at www. As well as case examples. »Protective packaging« protects the sterile barrier system. for revalidation usually a further performance qualification suffices (PQ). 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. 180–200°C). Particular attention should be paid to Part 7 »Use of sterilization paper. These are: Pouch. Both parts now stipulate on a national basis that all packaging processes must be validated.com 2 . Validation in the example of the sealing process In order to validate the sealing process.

name of person conducting the test and the appliance number. All 3 sterile barrier systems are now marked (e.5°C). the temperature is set to the upper limit value (here 200°C). If batch documentation software is already installed or if the installation is planned. Finally only formal permission of process validation has to be established. too. aseptica special issue But whichever system is used – no system may be used that marks the packaging material in the area surrounding the medical device (Instrument). After this. The evaluations are summed up in the OQ checklist.g. This is carried out by manufacturers of sealing devices and packaging material. Af- ter sterilisation the integrity of the seal seam strength is evaluated. Modern sealing appliances have a socalled SEAL CHECK function. But in practice direct printing using the sealers internal printer or the use of labels has proved practical. Sealing devices conforming to the standard should work in a tolerance range (cut-off tolerance) of +/. the midpoint should be set as the defined seal temperature (here 190°C). In practise the seal strength tests according to EN 868-5:2009 or ASTM F88 are the established methods. Labeling Sterile barrier systems must be marked with various information.Focus Sealing appliances conforming to the standard monitor the critical process parameters automatically. If it has been established that acceptable results are to be expected between 180 and 200°C and that the appliance cuts off at 190 +/. Neither may the seal seam be printed or written on. If a parameter deviates beyond its limit value (e. opening. The cost is quite reasonable. This should be either carried out by the manufacturer or by an authorized service company of the manufacturer. because the printer needles or the pen could damage them. Then the documentation required in the standard runs automatically 3 . +/.5 °C. A. Before the periodic (usually annually) revalidation the sealing appliance should be thoroughly serviced and calibrated. Documentation According to DIN EN ISO 11607-2:2006 the critical process parameters should not only be monitored but also routinely documented.5°C. The printouts can be filed as routine documentation. then it can be presumed that every sealing is equally good and the results are thus valid. B and C) and each is put through a different sterilisation cycle. it would be vital to consider adding the heat sealers to it. Basically there are no rules about exactly how the sterile barrier system is to be marked. For the Performance Qualification (PQ) 3 bags or reels are sealed using the defined sealing temperature (here 190°C) (reels at both ends). The data from the test report are then recorded in the Performance Qualification checklist). time. If the peelability is given and the quality properties fulfilled. they interrupt the process and alarm the user. Here the appliance is switched into a mode that prints out the critical process parameters along with the date.g. These can be evaluated using a reference card. The seal with SEAL CHECK serves to evaluate the quality properties. For the evaluation the same procedure is carried out as for the lower limit value.

in the background. Irregularities (e. name of packer) is usually very time-consuming. Because the »chain« of reprocessing is only joined by the packaging »link«. 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. Using seal indicators the quality properties of the seal seam can be evaluated.g. 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.g. 4 aseptica special issue . the new IntelligentScan system from hawo) use a scanner to record names.g. The entry of data via the sealing appliance (e.Focus Information such as for example the name of the packer or batch identification often have to be altered. Proof for this requirement is made by the daily use of a SEAL CHECK indicator before and after each batch. Therefore be sure to ask the manufacturer when buying a new sealer. canals) are shown clearly on the indicator field. batch number etc. Intelligent entry systems (e. And chains are well known to be only as strong as their weakest link. quickly and accurately and then assign them automatically to the right symbol. Summary Non-validated packaging processes are no longer acceptable in hospitals.

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