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Focus on containment

practical experience in devising – and supplying – containment solutions. Clive Mullins Global business director Published by Foster Wheeler Shinfield Park Reading Berkshire RG2 9FW UK Managing Editors Carolyn Greenhalgh Jacqueline Hogarty Marketing Consultant T 0118 913 2167 E jacqueline_hogarty@fwuk. “Bringing together industry expertise from both engineering and operating companies in an informal setting to share non-proprietary knowledge and experiences allowed for open discussion and debate as to good engineering practices relative to containment system Produced by FW Graphics Group © Foster Wheeler “The Containment Forum held in Milano was a very valuable experience.FOCUS ON CONTAINMENT As a change from the norm. As part of our ongoing quality improvement program we recently held an information exchange forum on containment to which we invited a number of clients.fwc.fwc. to share our joint experiences based on real-life case studies and a wide range of projects. The contents of this focus issue are based on that event. to the point where we have been selected as global containment consultants by one of our key multinational customers.fwc. At Foster Wheeler we have gained considerable cutting-edge. this issue of focus is given over to a single topic. The increasingly risk-based regulatory framework and developments in containment technology are driving changes to the design and operation of containment devices. The protection of operators and the environment has always been a priority for the pharmaceutical industry.” Paul Richards Project & technology engineer Pfizer Global Research and Development . The production of active materials in smaller quantities with much higher potency is driving an increasing number of manufacturers of bulk drug substances and final dosage forms to examine their containment options. Corporate Communications & Global Marketing T 0118 913 2494 E carolyn_greenhalgh@fwuk. “I believe all involved gained some knowledge which will be applied to the improvement of future installations. an idea that the participants actively encouraged us to repeat in other technical areas.

for example in handling materials in an inert environment. Other changes involve increasing use of new solutions such as flexible plastic. Safety is. As well as the internal plant environment we are interested in preventing material escaping to the external environment. The use of personal protective equipment has been shown to be poorly effective in practice and its use for routine operations has been discouraged by regulation. now reinforced by ICH Q9. plant safety. All of this drives us to ensure better protection for the operator. Huw Thomas. Germana Molinari gives a review of fill-finish design on page 7. Their use in containment occurs both at macro and micro levels and John Nichols discusses this in an article on hierarchy and risk-based approaches on page 2. operator health may not be an issue but potentially there could be significant external environmental impact. in describing GSK’s forward strategy. reduced environmental impact. Huw Thomas describes what others are doing in dose form manufacture. focus 1 . and operational improvement. for example for cytotoxics. personnel. For some compounds. of course. and containment has to prevent contamination or cross-contamination of this product. We are also seeing production of smaller quantities of materials. David Ainsworth covers the need to treat the commissioning and qualification of facilities for nanogram containment differently on page 11. page 6. The use of risk assessments in many areas of life has become an everyday subject. The pharmaceutical industry is now prepared to learn to SWIPE. and David Ainsworth looks at a case study at a Janssen highly potent powder handling unit (Facility of the Year Finalist 2006) on page 8. We also see new guidance. The prime interest of the pharmaceutical product regulators is patient safety. ‘If an overall manufacturing facility consists of three components – pharmaceutical material. We see the need to handle increasingly active compounds. Typically. (Steal With Integrity and PridE) from other industries. We are seeing an increase in the need to contain not only powders but also aerosols potentially generated in liquid filling. In the pharmaceutical industry they are embodied in much guidance. product quality. This leads to a very complex subject and Paul Richards of Pfizer addresses this range of solutions on page 9. and the solutions will vary accordingly. page 4. Pam Davison. The mix of critical factors will change application-by-application.’ – ISPE Why is containment important? When considering containment there are multiple drivers. and partly due to demand.setting the scene A KEY TECHNOLOGY AREA IN THE SPOTLIGHT What is containment? Recent changes Pharmaceutical companies tend to specialise in certain therapeutic areas. The operational health impacts on the operator can be very serious. via the quality of the medicinal product. partly due to their activity. and Emilio Moia. page 10. address these two areas respectively. This is changing the associated method of containment and is addressed in ‘Nanocontainment and Small Scale Manufacture’ by Marco Mascarenhas on page 3. dominant. and increased use of gloveboxes. and the environment surrounding them – containment is the isolation of the first of these components from the other two. and the activity of their compounds reflects that. and the need to transfer techniques from other industries such as the nuclear industry. drivers will include operational hygiene for operator protection. addresses this area on page 5.

JOHN NICHOLS 2 focus . all factors should be taken into account in selecting equipment for a specific application. With the issue of ICH Q9. to be issued in 2007. Risk assessment Risk assessment using a variety of tools is a widely-used technique. taking into account particular circumstances. However. Ranking the exposure potential enables a better choice of an appropriate methodology for containment equipment selection. selection of containment elements by their capability for typical operations and a risk assessment technique for ranking the exposure potential. There is potential for improving the performance of standard equipment by adding additional layers of protection. recommends a similar holistic approach to that adopted for HSE. Foster Wheeler has developed a method for assessing the risk from widely different operations and has used it for a number of projects to identify highest-risk operations and to prioritise upgrade work. An holistic approach The containment chapter of the draft ISPE BPC Baseline Guide. its use in pharmaceutical containment has been reinforced. such as illustrated on the card by a downflow booth with several typical upgrades.holisticview THE HIERARCHICAL APPROACH TO CONTAINMENT John Nichols Global technology director Successful containment requires an holistic approach: development of the correct strategy. following the steps below in sequential order to alleviate an exposure potential wherever possible: ® ISPE Baseline® Approach: Hierarchy of Containment Modify process to remove hazard Sealed equipment and connections Localized containment devices Contain in the facility Use of procedures HSE Approach Eliminate Reduce Isolate Contain PPE/Discipline Selection of containment elements Values for the containment obtainable under typical operating conditions for an average material with good operating practice (as illustrated on the enclosed reference card) can be used as guidance for potential protection. and the ISPE RiskMAPP initiative.

crystallization. filtering. These trends clearly impact on the design of pharmaceutical facilities and equipment. and by custom and practice.including weighing/dispensing. and especially containment. drying and weighing/filling . MARCO MASCARENHAS focus 3 . the increasing activity or potency of active pharmaceutical ingredients for certain therapeutic areas has warranted some materials being given an occupational exposure level (OEL) of the order of 5-10 nanogram/m3 (plutonium is 0. Secondly. These trends are delivering some exciting innovations in glovebox isolators. and the prospect of manufacture of smaller quantities for responder groups and so on. some compounds are being manufactured in everdecreasing quantities.taking place inside one five-chambered isolator.1 nanogram/m3). plug and play concepts. bulk pharmaceuticals Two significant trends are impacting the manufacture of active drug substances. with some annual production quantities of less than 1 kg. Firstly. Establishing the ‘right’ technology is driven by analysis using risk assessment. solution preparation. A recent project executed by Foster Wheeler for a cytotoxic API involved the whole non-aseptic cytotoxic production . and we have even seen an instance of annual production of about 0.nano-containment EXTREME POTENCY AT A SMALL SCALE Marco Mascarenhas Manager. process interlinking. we see this type of facility becoming more common. Achieving 1-10 nanogram/m3 is highly demanding. With continuing increased potency of pharmaceuticals. Glovebox isolators are the chosen solution for smallscale nanogram operation and some ‘standard’ units are available from suppliers.1 kg. secondary containment and control. and it should be appreciated that the glovebox isolation technology for this level of containment is different from that required to achieve microgram containment. Established technology uses glovebox isolators with rapid transfer ports and measures to reduce the internal challenge to achieve the required containment. reaction.

be rendered harmless.fwc. a continuous research and development programme maintains Steril’s equipment at the forefront of LAF and containment technology. Pharma i Both of these developments were covered in more depth in the previous issue of focus which can be found at: http://www. • Containment solutions for gaseous decontamination involving products that are effective against biological agents but which can.cfm EMILIO MOIA 4 focus . Steril. Foster Wheeler’s manufacturing division. This is done in strict compliance with the exacting standards and design guidance for containment which include: ISO 14644-7: ISO 10648-1: ISO 10648-2: AGS-G001-1998: EN 12469: Separative devices (clean air hoods. etc) Containment enclosures – Part 1: design principles Containment enclosures – Part 2: classification Guideline for gloveboxes Performance criteria for microbiological safety cabinets In addition. Results from this development programme include: • An innovative isolator exhaust system that. after use. This development has been operating in a high potency drug facility in Italy since 2005. THE DRIVE FOR INNOVATION Emilio Moia Manager contamination control & containment Continuous development. has a zero transition time to safe operation. designs and manufactures a comprehensive range of vertical and horizontal laminar flow benches. gloveboxes. innovation and a stringent attention to detail in design and manufacture. bio-safety cabinets and isolators for powder containment. maintains our product portfolio at the cutting edge of technology. in the event of an accident.

145 (69%) had leaking respirators. Further. a behaviours program. and established partnerships with suppliers. PAM DAVISON focus 5 . Factors such as scale. when matching engineered control solutions to problems it is necessary to understand that it is not just a direct relationship to the Occupational Exposure Level (OEL).occupationalhealth AN OPERATIONAL PERSPECTIVE Pam Davison Technical director GlaxoSmithKline Adverse health effects related to chemical agents can seriously affect a person’s quality of life and in some cases be life-threatening. GSK’s integrated strategic approach includes documented established solutions. engineer training. it can fail to meet the desired application requirements. communities for engineers and hygienists. and API content can alter the most applicable control strategy for a given OEL. showed that of the 211 subjects tested. tracking performance. even 98% of the time. dustiness. GSK has set itself a challenge to have 80% of its unit operations respirator-free by 2010. Clearly the industry has a duty of care to protect workers from exposure to such agents. experience or training. A study looking at ten pharmaceutical manufacturing sites owned by different companies. The study also showed no correlation between the effectiveness of the respiratory protective equipment and the frequency of use. allergic and dermatitic reactions form a significant proportion of reportable occupational diseases. In addition it can be shown that if a respirator is only effective. process energy. hygienist networking and training. Of these. say.

000 μg/m3 5. Some useful containment figures: One sugar crystal One grain of sand 100 particles of pollen Household dust ~ ~ ~ ~ 1000 μgm 100 μgm 10 μgm 1000 μgm/m3 Typical airborne concentrations from open handling: Dispensing Manual charging Granulation (scraping) Drying (open transfer) Compression 1. with minimum disruption to manufacturing operations.000 . Future use of disposable containment may include the design of granulator and fluid bed drying glovebags. using the layered approach is a good underlying principle for containment selection and design.10. use was ® made of Spraylat floor covering to trap any potential surface contamination. tested. modified and extended to the other granulation sites in the facility. and we needed to implement short-term upgrades quickly before the next campaign.000 . Flexible. Although exposure was still affected by operator action. The operator exposure limit for the compound being handled was 10μg/m3. A recent project involved the specification of a containment upgrade to allow manufacture of a particular higher potency product in an existing small-scale tablet manufacturing facility with granulator capacity of 400 litres. There was a significant reduction in surface contamination. it was less so than with the use of personal protective equipment alone. Taking a wider viewpoint. Longer-term engineering improvements need to be made to areas not suitable for flexible containment. automated bin charging and discharging.300 μg/m3 Disposable / Flexible Containment Principles OPERATOR PROTECTION ONLY AIRBORNE CONTAMINATION CONTROL BEST POOR SURFACE CONTAMINATION CONTROL BEST CAREFUL DESIGN REQUIRED IMPLIED INHERENT FLEXIBILITY ERGONOMIC FLEXIBILITY HUW THOMAS 6 focus .000 μg/m3 10 . cost-effective containment in the right application. and the surface swabs were clean. made.000 .000 μg/m3 10. for example through-floor feeders. They are very adaptable and can accommodate a wide range of applications. The disposable Spraylat floor was peeled up.000 .50. thrown away. and it had to be designed. leading to a 20-fold reduction in room cleaning ® times.000 μg/m3 10. modified.flexiblecontainment A TABLET MANUFACTURING CASE STUDY Huw Thomas Senior pharmaceutical engineer Disposable systems can provide efficient.100. In addition to the flexible glovebags. but are not the best solution for all applications. installed and the operators trained in just thirty days! The results of personnel monitoring (outside air suits) showed exposure was reduced by up to 1000-fold by the use of flexible barrier containment. disposable containment was the key to this project.50.

high containment valve. typically: Injectables Facility Dispensing Formulation Filling Lyos unloading Oral Solid Dosage Facility Dispensing Product transfer Tabletting/capsule filling Blistering/bottle filling LIQUID Low Standard Approach C-RABS (only for cross-contamination) Aerosol? Medium High Y Potency C-RABS (for personnel safety) Very High Containment Isolator HP : no PPE use Working area protection SOLID C-RABS N (only for cross-contamination) Low The range of containment devices applicable to the different operations is wide and includes: • contained connection .split valve. The essential first step is identification of the critical operations. continuous liner glovebox isolator closed restricted access barrier system (C-RABS) Medium Potency Very powdery? Almost not powdery? Y Y C-RABS (for personnel safety) High Very High N Containment Isolator • • HP : no PPE use Crucial is the awareness that there are no universal solutions applicable to every situation. more and more. Key to success is the correct combination of working area confinement and personnel gowning. the approach is to use primary containment at the very source of product exposure. powder spread activity duration . Three possible indicative decision trees are below: Working area protection N Previous solutions often relied on personal protective equipment (PPE) together with contained rooms or departments to protect the environment. The selection of the proper containment solution should include an analysis of the key features of the operation to be contained. high product form .occasional or shift-based product exposure . Now.liquid or solid product diffusion capability .fill-finish THE CONTAINMENT SOLUTION FOR YOUR OPERATION Germana Molinari Senior finishing & formulation engineer In the absence of a ‘one size fits all’ solution to the containment of fill finish operations. using secondary containment as a back up solution and PPE as an emergency/short-term intervention protective device.meeting HSE and GMP requirements product potency issue or only crosscontamination prevention Potency Product Transfer SOLID Open process allowed or Closed process with butterfly valves Low Medium Closed process with standard split valves High Tight closed process with high containment valves Very High Tight closed process with RTP parts and glove box HP : no PPE use GERMANA MOLINARI focus 7 . typically: • • • • • • • product potency . rapid transfer port. medium.aerosol or closed activity aseptic processing requirements . a logical approach to the design of effective protection is required.low.

sieving. The site has almost 100 reactors and manufactures a wide range of materials of varying levels of potency. which is given to the best performing contractor at Janssen’s Geel and Beerse sites in Belgium. Foster Wheeler and local Belgian partner BnS worked together to deliver a high containment solids handling facility. Recently. AA. flexible connections were needed in the powder transport piping system and full nitrogen inertion was necessary to prevent explosions! The design containment level of 50 nanograms/m3 was achieved. Foster Wheeler is continuing to support Janssen with the BOD-B (FEED) phase of the project. The most potent product’s OEL of less than 5 micrograms/m3 means very high containment requirements. Glovebox design had to take full account of the processing needs and also enable full disassembly and cleaning of the solids processing equipment.highlyactivepowders CASE STUDY OF AN AWARD WINNING PROJECT David Ainsworth Principal consultant Janssen’s major primary pharmaceutical manufacturing site at Geel in Belgium produces thousands of tonnes per year of active pharmaceuticals and intermediates. The process involved delumping. DAVID AINSWORTH 8 focus . in this award. in recognition of its contribution to the development of the concept study for the recently announced Chemical Development Pilot Plant (CDPP). Complex ergonomic mock-up models of the process equipment were developed to ensure that the design on paper was practical and enabled all of the required operations to be undertaken by an operator working via gloves. homogenizing and pack-off and all of these operations were designed to be undertaken within a series of bespoke gloveboxes. Foster Wheeler scored the highest possible rating. milling. the project was completed from concept to process start-up in two years and the degree of innovation achieved was recognized by the project being selected as a finalist in the prestigious ‘Facility of the Year’ Awards in 2006. Quality Award Foster Wheeler is delighted to announce that the General Technical Services Department of Janssen Pharmaceutica NV has awarded its annual Quality Certificate to Foster Wheeler. Heavy equipment was mounted either on hinges or slides.

tools. A primary concern with split butterfly valves.pretty exacting stuff! In API plants. Some recommendations include: • • • • • • • • Contain at the source Avoid technique-dependent systems Many containment technologies are available and continue to evolve Transfer system selection is a key to successful containment Design below the operator exposure limit Consider ergonomics. the movement of materials. is material on the faces of the valves after undocking. cleaning. and concerns with cleaning extraction rings. The performance of an isolator is only as good as the transfer devices on the isolator. and recovery systems into and out of the contained environment is the key to successful containment. waste. material compatibility Provide redundancy/secondary containment Engineer out the reliance on personal protective equipment And the golden rule is. for example. wastes.bulkchemicalmanufacture A GUIDE TO CONTAINMENT OPTIONS IN API PLANTS Paul Richards Project & technology engineer Pfizer There are many engineering control options for containment. supplies. There are many different transfer devices available on the market. there is no silverbullet containment solution! PAUL RICHARDS focus 9 . But a useful starting point is: what are we trying to achieve? If we consider that 1 granule of sugar is about 3 milligrams. each with its own pros and cons. then a containment level of 3 μg/m3 is like dispersing 1/1000th of 1 granule of sugar in 1m3 of air . What option is most suitable for your application? What is the range of performance expected with various containment solutions? Who are the primary vendors? And what are the budgetary costs? Question. questions …. sampling.

The decision between a multi-purpose versus a dedicated facility is based on commercial or cleanability/GMP reasons. and there was good agreement on the factors considered. including an overview of current and possible future changes in processing and containment equipment. Census Results Background The pharma company currently has no OSD facility designed to handle actives of <10μg/m3.oralsolidsmanufacture SURVEY DEFINES BEST PRACTICE Huw Thomas Senior pharmaceutical engineer Foster Wheeler recently carried out a survey for the Global Containment Engineering Group of a multinational pharma company with a view to benchmarking its oral solid dosage (OSD) manufacturing of highly active products against current industry best practice.accepting trade-off of containment benefits versus increased changeover down-time More dedicated facilities are found in those designed for <1μg/m3 compared with 10-100μg/m3. Use of CIP is becoming the norm for new facilities . The census aim was to benchmark existing facilities to determine current best practice for OSD manufacturing facilities handling potent actives. key learning points. The census results included analysis. and these conclusions: • All manufacturers surveyed are seeing an increased number of potent products and hence a need for manufacturing flexibility All manufacturers surveyed are committed to moving away from routine use of PPE to control exposures in new facilities There is general agreement on a range of containment equipment performances . It has an increasing number of products in the pipeline that fall into the <10μg/m3 and <100μg/m3 categories and the company’s future production plans will dictate smaller batches of higher potencies. Many of its facilities currently require the use of personal protective equipment (PPE) to process <100μg/m3 actives. Cleaning Approaches for 10-100 μg/m3 • • Census Aim Split into two parts. The results identified key learning points and lessons to incorporate. • Cleaning Approaches for <1 μg/m3 • • HUW THOMAS 10 focus . lessons to take forward. requiring a more flexible facility. the census surveyed 11 global manufacturers. All agree that engineering high containment is not sufficient by itself. features.backed up by occupational health monitoring There is increased use of clean-inplace (CIP) in facilities for <1μg/m3 compared with 10-100μg/m3 facilities . covering 22 different facilities. not purely on potency All companies use risk assessment. and 9 equipment vendors.

A surrogate material. The container was docked onto the glovebox in the test area and the surrogate material introduced via rapid transfer port into the glovebox interior. Preparing for Testing.pressure and vacuum testing • containment performance .5 nanograms. the containers were then cleaned and passed out of the room for further cleaning outside the factory. Here a full cycle of the required operations was conducted. P&ID and materials checks • lighting and noise level checks • surface finishes. The surrogate test material was kept in doublesealed containers inside a small storage room (actually a garden shed bought locally!).surrogate material testing In particular the containment performance testing of each glovebox was stringent. Once the containers were thoroughly clean and free of any of the test material on the outside. factory acceptance testing at such levels can be pretty exacting. controls and sequences • documentation . At Foster Wheeler. DAVID AINSWORTH focus 11 . To demonstrate the performance of a number of high containment gloveboxes to be installed in an existing primary pharmaceutical manufacturing unit. both airborne and surface samples were collected from the surrounding environment.factoryacceptancetests HIGH CONTAINMENT ISOLATOR – CASE STUDY David Ainsworth Principal consultant Bearing in mind that a required containment level of less than 5 nanograms/m3 is the equivalent of one grain of pollen in an average-sized living room. the container was double-bagged and sealed and then brought back into the facility for use in the glovebox testing area. Test Enclosure. Sodium Naproxen. This was segregated from the rest of the factory by a temporary polythene sheeted antechamber to guard against inadvertently contaminating the glovebox test environment. Inside the Test Chamber. Surrogate test material to be used in testing each glovebox was loaded into sealed containers in this storage room. The entire operation was undertaken on three separate occasions to demonstrate the effectiveness of the glovebox.GA.operations. was used to mimic the actual operations that would be conducted in each glovebox. Testing of the units covered: • ergonomics . During this cycle of glovebox operations. operating pressure and inertion times • accuracy of instrumentation • connections to pressure systems • leak performance . detectable at levels as low as 0. we really do roll up our sleeves and get on with the job! Photos from l to r: Store. Foster Wheeler went to extraordinary lengths. cleanability and drainability • airflows.

under the management of Foster Wheeler Milan. Category Key Secondary General Infrastructure Validation API Biotech R&D Medical Devices Elsewhere. our clients continue to value the quality of our teams and the facilities we design and build.” “We have selected Foster Wheeler for this challenging project because of its ability to make available skilled resources from its various operations centers.” 12 focus . This will provide a firm foundation upon which to build for subsequent phases of the project. responsiveness to our needs and capability to mobilise highly qualified resources from its European offices.. There are too many names to mention individually.” “The team has a very proactive approach and the team members are not afraid to ‘roll up’ their sleeves.” “We have been working successfully with Foster Wheeler since 2001 … we are pleased with Foster Wheeler’s professionalism. but the whole Alliance team has made an outstanding contribution to achieving our business objectives. across the full range of technologies. “We are very pleased to work with Foster Wheeler again and have every confidence that our joint teams will work together to successfully complete this phase of the project on schedule..fwpharmasuccess GLOBAL ROUND-UP OF RECENT WINS We continue to secure significant new pharma business around the world.

. co-chaired a well-attended session which explored how to introduce continuous processing into pharma facilities. and is a significant achievement. John has contributed a great deal to ISPE. John Nichols participated in the session reporting on the latest update of the Bulk Pharmaceutical Chemicals Baseline® Guide. New York 24-26 April Visit us at booth #143. ISPE Brussels The ISPE year ended at Brussels where Foster Wheeler had a significant presence. Vienna Society of Chemical Industry At the SCI’s Process Development Symposium in Cambridge.. Arlington. Florida 12-15 February ISPE Copenhagen Classroom Training. ISPE Annual Meeting Once again. speaking on containment and the activities of the API Community of Practice. Virginia 4-7 June ISPE Singapore Conference 10-12 June focus 13 . Our presence in the exhibit hall (and in the committee rooms). & Come and meet us at: ISPE Tampa Conference. John was a member of the ISPE’s Facility of the Year Task Team which received the ‘Committee of the Year’ award. ISPE Washington Conference. presented on Continuous Technology. our principal facilities consultant. how and why we should change. will be presenting a baseline approach to modification of a WFI system. pharmaceutical technology director. John Nichols was course organizer and chair for the seminar on Continuous Processing in the Real World. ISPE Paris Conference. will be lecturing on Biopharmaceutical Process Development. contributed to the Oral Solid Dosage session with a paper on containment. will be discussing the Application of Commissioning and Qualification and Bob Davies. France 16-19 April John Nichols will be chairing a session on nanotechnology. In 2003. principal biopharma consultant. John Nichols. ISPE Appointment John Nichols. Denmark 26 February . as well as almost 300 table-top exhibitors. has been re-elected to the ISPE Board of Directors. Interphex. senior process engineer. This two-year appointment is John’s second. our pharmaceutical compliance manager. senior pharmaceutical engineer.Exhibitions Conferences ISPE Congress. and Paul Frey. Florida – attracted a large audience. the ISPE Annual Meeting – this year in Orlando.1 March Bob Adamson. He also regularly chairs and speaks at ISPE conferences promoting Innovation in the Industry. our global technology director. The Annual European Congress was attended by a large cross-section of technical specialists from across Europe and even beyond. Mark Dickson. highlighting the advantages of continuous processing over traditional batch operations for low tonnage products. Facility of the Year Committee. enabled us to make contact with a large number of key clients who were attending. Body of Knowledge Task Team and API Community of Practice (CoP) and CoP Council. He works on a number of ISPE committees: the International and European Education Committees. when. Huw Thomas.

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