DOCUMENTED CLEAN PRODUCTION FOR INJECTION MOLDING APPLICATIONS. CleanForm production cells

Transcription

1 DOCUMENTED CLEAN PRODUCTION FOR INJECTION MOLDING APPLICATIONS CleanForm production cells

2 IN PARTNERSHIP WITH INDUSTRY KraussMaffei is a premium partner for the plastics and rubber processing industries worldwide Automotive White Goods Construction Life Sciences Electrical / Electronics Whatever you aim to achieve in plastics or rubber processing, KraussMaffei is your partner. We are the only company with intensive expertise across the three main engineering fields. And we have a strong track record in integrating this expertise to develop new processes and systems. Ready for any challenge Our Injection Molding Machinery Division supplies machinery and systems from 35 to 4,000 tonnes for standard applications and for all processing variants, together with fully automated solutions. We have a strong customer base in all the relevant industries worldwide. Our Reaction Process Machinery Division supplies machines and complete systems for processing polyurethanes and other reactive materials. Completing our product portfolio, Automotive Component Systems supplies foam molds, cutters and routers. Our customer base is wide, with a focus on the automotive, construction and white appliances industries. Our Extrusion Technology Division supplies machinery and systems for compounding, for pipe, profile and sheet extrusion, physical foaming, and the production of technical rubbers and intermediates for tire production. Machinery from the company s range from single extruders to complete extrusion lines is used in many industries, including chemicals, pharmaceuticals, automotive, construction, furniture and packaging. People for Plastics We are the people for plastics. We are your partners from the first exploratory discussion, through development to commissioning, servicing and operating your system, and final disposal. At all times, you are assured of outstanding competence in planning and engineering, as well as reliable and fast spare parts, service and support. Adding value for customers We put our expertise to work for your success. With machine ranges engineered for modularity, we can deliver application-specific solutions based on our wide range of standard modules and specially engineered solutions. This strategy offers customers technical and cost advantages. Close to customers around the world As an international company, KraussMaffei has a presence in all the major markets for the plastics and rubber processing industries and employs around 3,000 people worldwide. Our sales and service network keeps us close to all our customers around the world.

3 CleanForm delivers controlled conditions for product and environment through operating excellence Packaging KraussMaffei s CleanForm technology offers production systems qualified to GMP for making plastics products in clean environments. KraussMaffei has wide specialist know-how in configuring technical and medical cleanrooms. Taking the product as their starting point, our solutions are tailored to conform with your requirements and applicable GMP guide lines. By systematically identifying and eliminating or isolating sources of contamination, our solutions make it possible to implement clean production areas up to Class 5 (DIN EN ISO ), Class 100 (US Federal Standard 209) and GMP Class A.

4 BASICS The clean route to success An effective cleanroom is created by systematically eliminating sources of contamination to achieve reproducible production of plastics items that meet specific cleanliness criteria. There are many different sources of contamination in injection molding; eliminating them cost-effectively demands focused measures tailored to the specific source. In injection molding, this means looking at each link in the production chain from raw material to packaging the finished part to eliminate contamination and ensure they are fit for purpose. There are three classification systems that are applied to ensure uniform standards worldwide for cleanrooms; these are ISO , US Federal Standard 209 and GMP. They specify cleanroom classes according to particle count and particle size and the number of pathogens (colony forming microorganisms). In order for the whole cleanroom area to qualify for a designated class, the injection molding machine and peripheral equipment must show a particle and CFO count that is substantially lower than the target class. The main types of contamination in this context are airborne dust particles and aerosols, pollens, bacteria and viruses. If these are deposited on the surface of the plastic during production, they will contaminate the end product. Surfaces that fail to meet customer criteria increase the reject rate; in healthcare products contamination can put people at risk. Cleanliness can be measured and classified Depending on the products intended use and on customer-specific criteria, different cleanliness classes will be appropriate for different products. People as a source of contamination People are a major source of contamination. Up to 40% is caused of the contamination in medical cleanrooms by operators and service staff. Even sitting or standing quietly, a person emits over 100,000 particles a minute > = 0.3 μm. This is well above the permissible limit for an ISO Class 5 cleanroom (see table below). In other words, if you entered a Class 5 cleanroom without protective clothing, contamination limits would be exceeded within 6 seconds merely as a result of your presence. Cleanroom categories Max. particle count/m³ Cleanroom classes EU GMP cleanroom classes particle count and CFM 2) 0.3 μm 0.5 μm US Fed. Std. 209E SI 1) US. Fed. Std. 209E SI 1) EU GMP cleanroom class at rest EU GMP cleanroom class in operation Equivalent to CFM 2) count/m³ A/B A < C B D C 200 1) Per cubic foot 2) Colony forming microorganisms CLEANLINESS CLASSES FOR AIR, PARTICLE COUNT, PARTICLE SIZE If production specifications for a plastic part require a Class 8 cleanroom (DIN EN ISO) or 100,000 part./cft (US Fed. Std.), then a cubic foot ( 28,3 l) of air may contain no more than 100,000 particles 0.5 µm. New standards to be introduced refer to particles of 0.1 µm. The current reference size 0.5 µm remain in force only until all measuring equipment is capable of registering and measuring this particle size. Page 4 CleanForm production cells

5 SYSTEMS FROM KRAUSSMAFFEI Ahead on cleanliness KraussMaffei injection molding machines provide the optimal basis for successful production under clean conditions. KraussMaffei s CX series is certified for cleanliness Class 5 (ISO ) and Class 100 (US Fed. Std. 209) and also as an isolator system to GMP biocontamination Class A (CFM count < 1 CFM/m³). This brochure will give you an overview of KraussMaffei s offering of machines and complete production cells for cleanroom production. The inside solution with the whole injection machine in the cleanroom area, for cleanroom Classes 7/8. Our EX machines make it possible to achieve Class 5 cleanrooms. The "inside" solution complies with GMP standards. The outside drop solution with the machine outside the cleanroom area. The parts are transported via a conveyor belt into the cleanroom area, for cleanroom Classes 6/7/8 The outside robot solution with the machine outside the cleanroom area and handled by a robot from the inside of the cleanroom, for cleanroom Classes 6/7/8 The room-in-room solution with only the clamp of the injection molding machine protruding into a sealed cleanroom zone, for cleanroom Classes 5/6/7/8 Page 5

6 DETAILED PRODUCT INFORMATION The inside production cell: achieving a controlled environment with fewer moving masses The whole injection molding machine, the robot and any peripherals are inside the cleanroom. The cleanroom area needs to be larger here than for any other KraussMaffei solution. This solution is generally suitable for cleanrooms up to ISO Class 7/8. With our all-electric EX machines, cleanrooms up to Class 5 can be achieved. An inside production cell could be considered for applications where clean surfaces are a critical part of the product specification, for example, cosmetic packaging or beamer lenses. The inside solution can be implemented with KraussMaffei EX, CX and MX machines. The injection molding machine used will comply with GMP (see page 14/15). This means it will have been modified to isolate or eliminate sources of contamination. Typically, documented changes will have been made to supply lines, heat ex - changers and paint surfaces. The effort and cost for this type of solution can be substantial. However, it is the most flexible solution once the infrastructure is in place. Electric injection molding machines are preferred for inside solutions, because electric drives are cleaner and emit less heat. The EX series engineered for highest cleanliness KraussMaffei s EX machines were engineered from the start for uncompromising cleanliness. They set new standards for cleanroom injection molding. The inside solution, the whole injection molding cell in the cleanroom Page 6 CleanForm production cells

7 Clean and precise, the all-electric injection molding machines in KraussMaffei s EX series are ideal for inside cleanroom solutions right up to Class 5. Few pivot points, central lubrication and lubricant-free tiebars The Z toggle has only eight pivot points less than half the number in conventional toggle de - signs. Fewer moving parts means less friction and fewer lubrication points. These lubrication points are completely encapsulated to form a closed system. The moving platen does not run on the tiebars, but in linear guides, so that the tiebars are always lubricant-free. These features mean that the mold area is clean by design. They re a significant factor in the low particle counts in the clamp area. Direct drive injection unit The principle that less is more also applies to the injection unit. In EX machines, the drive motors are coupled directly, not via belts, thus completely elimi nating one wear part and a source of contamination. All main drives are water cooled resulting in optimal heat dissipation for constant cleanroom temperatures. Technical information Page 7

8 DETAILED PRODUCT INFORMATION The outside drop production cell: low-budget cleanroom production In this solution, the whole injection molding machine, the robot and any peripherals are outside the cleanroom. The products are transported on an enclosed conveyor belt into the cleanroom area. Compared with an inside solution, the outside drop solution has the advantage of sharply reducing the volume of the cleanroom that must be installed and maintained. It s an excellent choice for products where specifications require production in cleanrooms to Class 6/7/8. In this solution, the production area/clamp unit is enclosed and fitted with a filter fan unit (FFU). Mold changing, running up, cleaning, servicing and repairs all take place outside the cleanroom. The chief advantages of an outside drop solution are fewer sources of contamination in the cleanroom, easy cleaning and a dramatic reduction in cleanroom volume. The outside drop solution can be implemented with KraussMaffei EX, CX and MX machines. Almost any injection molding machine variant can be used. CX machines have the advantage of a very small footprint thanks to their compact 2-platen design. MX and CX series 2-platen design for ultra-easy access KraussMaffei s hydraulic MX and CX machines are excellently suited to outside drop cleanroom solutions. There are fewer moving parts in a 2-platen machine than in a 3-platen machine. The machine can be positioned more flexibly and closer to the cleanroom area. The production area is smaller, so that operating and maintenance effort is reduced. The FFU can be moved out of the clamp zone as a complete unit for service. This makes mold changing fast and easy and boosts the productivity of the system. The outside drop solution: injection molding machine outside the cleanroom; parts are transported into the cleanroom on an enclosed, sealed conveyor belt. Page 8 CleanForm production cells

9 With KraussMaffei C and CX machines, integrating FFUs and almost any conveyor solution is simple. CX series 2-platen clamp for cleanliness and great flexibility The cantilevered clamp unit of CX machines ensures easy access for cleaning. Air moves freely, with less turbulence, and does not pick up contamination as in conventional toggle machines. Virtually any type of conveyor belt solution can be used. Parts can be transported away in any direction. Sprue removal or sampling systems using sorting chutes can be easily integrated, thanks to the generous space underneath the clamp. The conveyor belts are enclosed and supplied with clean air at over-pressure. Filter fan unit (FFU) integrated in the machine controller total, transparent quality monitoring Standard software integrates control of the flow box in the CleanForm machine monitoring system. In each cycle, FFU status and the condition of the FFU filter are monitored, ensuring that problems will never go undetected. The result is a more transparent process and full compliance with documentation requirements The cantilevered, 2-platen clamp allows parts transport in any direction. 3 Technical information Page 9

10 TECHNICAL INFORMATION The outside robot production cell: clean teamwork between machine and robot In this solution, as with the outside drop, the whole injection molding machine, the robot and any peripherals are outside the cleanroom. The products are demolded by a robot and transported into the cleanroom via a tunnel. The overpressure in the cleanroom causes the clean air to flow through the tunnel and flow out through the chute on the injection molding machine. Mold changing, start-up, cleaning, servicing and repair take place outside the cleanroom. Compared with an inside solution, the outside robot solution has the advantage of sharply reducing contamination and making cleaning easier. It s a good choice for products where specifications require premium surfaces and production in medium to high cleanrooms to Class 6/7. The "outside robot" solution is suitable for CX, EX and MX machines series. This solution combines the benefits of automated part removal with the cost savings and process advantages of having the injection molding machine completely outside the clean-room area. These include easy cleaning, service and maintenance without the risk of contaminating the cleanroom itself. Generous access to the clamp for easy robot integration All the advantages of a 2-platen machine listed for outside drop solutions also apply to outside robot solutions. In addition, the robot can be optimally positioned very close to the injection molding machine. This minimizes the operating volume and reduces the space that needs to be supplied with clean air. A highly standardized frame concept makes plug and play robot connection possible. The robot and peripherals are installed in a transportable cell which can be moved around and docked onto different machines. The outside robot solution: parts are injection molded outside the cleanroom and transferred into the cleanroom by a robot for post-mold processing. Page 10 CleanForm production cells

11 Cleanroom production cell integrating an industrial robot and a CX injection molding machine to produce displays for mobile phones. This type of system already has CE conformity certification. Automation solutions clean by design KraussMaffei automation solutions use cleanroom versions of robots from our LRX, IR or SR ranges, whichever best suits the application. The robots are engineered from the start to meet cleanroom criteria. Industrial robots for integration within the machine s housing already comply with ISO Class 6. Other automation elements can be configured for cleanroom compliance. We can also supply other optional modifications, eg, encapsulated energy supply lines, vacuum circuits, microfilters for off air and water-cooled drives. With this portfolio of modifications to draw on, KraussMaffei specialists can configure automation solutions for even higher cleanroom classes. The perfect team: robot and injection molding machine from the same supplier Especially for cleanroom systems, KraussMaffei s ability to supply completely integrated production cells as turnkey systems offers our customers huge advantages. In particular, it eliminates interface problems and wasted communication effort. In addition, there is a single focus of quality control responsibility for the whole system. CE conformity and GMP compliance With cleanroom solutions for the healthcare sector, you also have the advantage of uniform documentation. KraussMaffei also provides a single CE conformity declaration for the whole standard system of robot plus machine. KraussMaffei automation solutions, like this production system with a side-entry robot, making barrels for disposable syringes, comply with exacting cleanroom standards. Technical information Page 11

12 In a room-in-room solution, the production area is isolated from the service area, with the machine moving on tracks. DETAILED PRODUCT INFORMATION The room-in-room production cells: keeping the high class clean area small A room-in-room solution can produce cleanrooms up to Class 5 (ISO ) and GMP Class A, which are typically specified for medical or pharmaceutical applications. A major benefit of cleanroom production is to minimize or even eliminate the cost of post-mold sterilization. To keep costs as low as possible, the cleanroom is kept small and only the clamp with the mold protrudes into it. This type of production cell is often highly automated to avoid human contamination as far as possible. 2-platen clamp unit hermetically seals off the cleanroom The 2-platen design of the CX machines (up to 160 tonnes) produces a fully cantilevered clamp unit which can protrude into the cleanroom. Plates at each end of the clamp seal it off hermetically from the plas - ticizing unit. This solution keeps the volume of the cleanroom significantly smaller. The sealing plates at either end of the clamp unit are a simple and reliable Only KraussMaffei CX machines ( tonnes) have the cantilevered clamp unit which is essential for a clean room-in-room solution that complies with ISO Class 5. In a room-in-room solution, only the clamp, with the mold, protrudes into the Class 5 cleanroom. Page 12 CleanForm production cells

13 Production cells using KraussMaffei s room-in-room variant are capable of complying with specifications for cleanrooms up to Class 5 (ISO ). method of maintaining the pressure differential between the cleanroom and the rest of the production environment. 2-platen machines inherently have fewer potential contamination sources in the clamp area than 3-platen machines. An optional extraction unit on the clamp will remove residual contamination. Machines can be supplied with stainless steel and glass surfaces to meet pharmaceutical industry standards for resistance to cleaning agents. Clear separation between production and service zones Maintaining high cleanroom classes is cost intensive. The CX-based room-in-room solution provides a simple but effective method of keeping these costs as low as possible. In operation, the clamp protrudes into the cleanroom and is sealed off from the rest of the production area by a metal plate. For mold changing, service and repairs, the machine is run back on rails, until the cleanroom is completely sealed off by the second metal plate at the front of the clamp. Achieving highest cleanroom classes with KraussMaffei s CX machines The room-in-room is currently only possible with an injection molding machine from KraussMaffei s CX series. Worldwide KraussMaffei is the only manufacturer of injection molding machines with multiple implementations of Class 5 (ISO ) and Class A (GMP) cleanrooms to our credit. The machine is run back and completely sealed off from the cleanroom for service and maintenance. Technical information Page 13

14 GENERAL INFORMATION ON CLEANROOMS Qualified production and operating excellence It s essential to begin by looking at the clean production project as a whole from product design, through test runs and worst-case scenarios to quality control measures and defining the acceptable tolerances. Technical and medical cleanrooms The exact definition of clean as a product quality criterion will vary from application to application and so will the effort needed to achieve the required level of cleanliness. Technical parts, for example, must satisfy the customer s quality specification and the cleanroom must be engineered, for example, to prevent particle contamination of optical products. Production areas for medical and healthcare products, on the other hand, must usually meet binding national or international standards, for example, those set by the FDA. Krauss- Maffei has many years experience with meeting these standards in cleanroom projects. A short step from a product idea to a machine specification The quality of early, competent and prudent analysis and planning is a decisive factor in the long-term success of any cleanroom project. Including all project partners in the process at an early stage means that their input can flow into the project. Cleanroom technology is among the sectors where you benefit most from a system supply partner not only with a wide portfolio of technical solutions but also with a global network of specialists in medical technology applications. Supply partner competence and good communication can significantly shorten product development cycles. Friction losses in the course of the project are kept to a minimum and overall dev - elopment effort decreased. KraussMaffei machines are assembled in an advanced synchronized flow system, which guarantees full traceability and documentation for each machine. Page 14 Spritzgießmaschinen der EX-Baureihe

15 Good Manufacturing Practice (GMP) The framework for traceability is a quality management system in compliance with GMP. In products for the life sciences sector, a GMPcompliant quality management system is the key to meeting compulsory regulatory standards. Unless they meet these standards, these products will not be marketable. Specifications for injection molded products for the life sciences sector include qualification of the injection molding machine and peripheral equipment to FDA / GMP. Thanks to our solid experience in this area, KraussMaffei injection molding machines with FDA / GMP certification are currently operating in many successful medical cleanroom projects. Full documentation from planning to acceptance We open a file on each machine, as soon as we start with the planning specification for the project. As the project progresses, all the relevant documents analyses and decisions, instructions, test procedures and results, certificates, etc. are added to the file. It thus represents a complete record of the planning, configuration, production, assembly, installation and performance of the machine. Complete transparency in this part of the project facilitates validation of the whole production concept. It also illustrates what KraussMaffei can do for you. Good Manufacturing Practice (GMP) qualification stages and relevant activities Design qualification Installation qualifilcation Operation qualification Product Risk analysis Production concept GMP analysis Production process Risk analysis Production system Production cell design Preacceptance and acceptance process Preinstallation qualification (vendor site) Shipment, assembly, installation (customer site) Acceptance/installation qualification (customer site) Manufacturing process Machine performance audit to VDMA Test process limits Quality check through test run of worst case scenario Good Manufacturing Practice Page 15

16 BENEFITS Success in clean production The starting point for successful cleanroom production is your own commitment to uncompromising product quality. We at KraussMaffei share this commitment and we will give you our expert support throughout your project. High product quality through the assured quality of key production factors KraussMaffei builds its machines using advanced synchronized-flow processes. The outcome is complete transparency and a fully-tested and documented machine capable of highest performance within very tight tolerances. We supply a range of machines specifically designed, qualified and documented to GMP standards. The benefits for your production include a very stable and reliable process, with all system units operating at high repeatability under control of the MC5 controller. Your production process is closely monitored and documented using ultra-modern control technology based on a VARAN bus system. Low unit manufacturing costs even in Class 5 cleanrooms KraussMaffei s solutions help to cut your op erating costs, by keeping cleanroom maintenance costs down and by reducing or eliminating post-mold cleaning effort. This gives you clear competitive advantages. Our experience in cleanroom production systems has led us to develop innovative solutions for technical features. Typical examples are the very clean Z-toggle on our all-electric EX machines, or our room-in-room solutions based on the cantilevered clamp design of our CX machines. At present, these two machine concepts are the only ones capable of achieving ISO Class 5 cleanrooms. These are just two examples of the wide range of cleanroom concepts we have on offer. Clean production line, guaranteed by precisely specified quality characteristics, at Scandinavian Health Ltd. Page 16

17 Applications across industry Cleanliness is in demand in many industries Packaging food packaging EX machines with their extreme cleanliness are inherently cleanroom capable. Highly dynamic, they are ideal for producing clean food packaging. Healthcare baby bottle teat Using a CX-based room-in-room production cell significantly reduces the capital investment required to set up a sterile production system. Automotive sliding sunroof elements CleanForm variants of MX injection molding machines can be relied on to produce large, polycarbonate glazing elements to high cleanliness standards. Medical/pharmaceutical vaccine vials Filling costs for these vials were significantly reduced because they were produced in a Class 5 cleanroom. Summing up CleanForm benefits: The best possible custom solutions for every project and cleanroom class Lower cost, less effort for cleanroom operation with KraussMaffei solutions Easier project management with a system partner turnkey system from a single partner No-risk route to an optimal solution thanks to complete documentation and no limits on machine qualification Applications across industry Page 17

18 SERVICE WORLDWIDE Service, support and spare parts when you need them, where you need them Rely on us for a fast and competent response to all your service needs anywhere in the world. Whatever you need from troubleshooting or training to spares or repairs we re on the job. We re dedicated to supplying service quality on a par with the outstanding quality of our machines and systems. We offer far more than spare parts and hotlines. We ll work with you to choose the best and most cost-effective solution for your operation. We ll help you test new applications and we ll plan customized service packages. All-round service Our service offering is broad. We ll configure your system, install and commission it, train your staff, plan measures to minimize your downtime risk and maximize productivity, and carry out maintenance, repairs and upgrades. You ll find us fast, reliable and competent. Our hotline is manned by highlytrained and experienced service technicians. If necessary, we ll get a technician to you quickly. Remote diagnosis, interfacing directly with your machine s control system, can be a practical alternative. Spares for all important wear parts are available at short notice. We re continuously expanding our service network to speed up spare parts shipment. Talk to us about the right service solution for your business. Customer trials and prototyping in our test lab The Injection Molding Division operates a test lab fitted with the latest machinery and equipment. We can run trials, produce prototype parts and fine-tune processes on your behalf. We can work with you to test and evaluate processes, machines and equipment in order to identify the best approach for a particular project. Our highlyqualified application engineers are there to help you. Training with high hands-on content Courses are held in our lab and training centre, or, optionally, on your premises. We offer clearly-structured basic and advanced training in operation, process control and maintenance for KraussMaffei injection moulding machines. On request, we ll plan and hold special courses on topics of your choice. All participants spend a high proportion of their training working hands-on with original KraussMaffei machines. A well-structured training program produces skilled operators and technicians, which will positively impact your up-time and productivity. Contact for training: Rupert Gruber Phone: Fax: rupert.gruber@kraussmaffei.com

19 At your service worldwide Team Europe Injection Molding Service Team Injection Molding Spare Parts Team Team America/Spain Injection Molding Service Team Injection Molding Spare Parts Team Team Asia/ Near East Injection Molding Service Team Injection Molding Spare Parts Team How to contact us Apart from you can contact us on the service hotline or by post at this address: Hotline Phone: Fax: Injection Molding Service KraussMaffei Technologies GmbH Krauss-Maffei-Str Munich Germany

20 KraussMaffei is a premium partner for the plastics and rubber processing industries worldwide. KraussMaffei machines and systems are used wherever plastics and rubber are converted into products. As a knowledge-driven technology company, we build on many decades of experience and a strong commitment to research and development. Key to your business success is producing clean products under a zero-defect regime. The standards you apply may be defined by regulatory standards, as in production for the life sciences sector, or by your own and your customers quality criteria. A cleanroom production cell is the way to meeting these standards. With our CleanForm technology, KraussMaffei offers you engineering competence, efficient cleanroom injection molding machines, robot solutions and the support of a network of leading moldmakers together with full documentation. We are the only injection molding machine manufacturer worldwide with a very successful track record in implementing Class 5 (ISO ) cleanrooms. 1.0 WE. 2nd edition 04/10. SGM 005 B PRO 11/2008 GB KraussMaffei reserves the right to make technical changes Printed in Federal Republic of Germany. KraussMaffei Technologies GmbH Krauss-Maffei-Strasse Munich Phone Fax