16 minute read
Cover story
from MPN EU Issue 55
by MPN Magazine
A minimal footprint
TOP: Launched at K 2019: Engel compact cell. This houses all the automation components and is still significantly narrower than standard safety guarding. (Engel ©)
ABOVE: Ypsomed is expanding. Most recently, a new production plant was built in Schwerin and equipped with allelectric Engel e-motion injection moulding machines. (Ypsomed ©)
BELOW: With its high degree of automation, the production of injection pens places high demands on the precision of the injection moulding process. (Ypsomed ©) MANUFACTURER ENGEL DISCUSSES HOW YPSOMED RELIES ON THE COMPANY FOR ITS PLATFORM STRATEGY, AS WELL AS ITS NEW COMPACT CELL WHICH HOUSES ALL AUTOMATION COMPONENTS.
The number of people suffering from diabetes grows globally by nine percent each year. For Ypsomed, a developer and manufacturer of injection and infusion systems for self-medication, this means increasing sales. The company, which is headquartered in Burgdorf, Switzerland, is consistently pursuing its worldwide course of expansion. Most recently, a completely new plant with 13,500 square metres of production space for injection moulding and assembly was built in Schwerin in Northern Germany. At its locations worldwide, Ypsomed produces pens, auto-injectors, and pump systems for administering liquid drugs, such as insulin, for large, brand-name pharmaceutical companies.
New products and manufacturing processes are developed at the company’s headquarters. This is also where the company’s own mould making and technology centre are located, and where new processes are trialled before they enter series production at the plants worldwide.
More efficiency and safety, as well as greater flexibility and faster industrialisation, were the main arguments which prompted Ypsomed to standardise its production processes in the course of further global expansion. Integrated system solutions by Engel play a key role in the medical technology company’s new platform strategy.
THE BIGGEST ADVANTAGE IS FAST INDUSTRIALISATION
For a long time, the global injection moulding machinery consisted of machines of different types and brands. “This was no longer compatible with our expansion strategy,” reported Frank Mengis, Chief Operating Officer (COO) of Ypsomed. This explains why, five years ago, a decision was taken to standardise. “The aim of the new platform strategy is to further improve efficiency, safety and quality while simplifying our processes.”
“Standardisation is becoming a trend in the medical technology industry, and not only for the big players,” Christoph Lhota, vice president, medical business unit with injection moulding machine manufacturer and system solution provider, Engel, observed. “Ypsomed is a role model here. At a very early stage, we defined all the specifications in detail together, worked intensively on the performance specifications and then implemented them consistently.”
To date, more than 100 all-electric Engel e-motion injection moulding machines have been supplied to Ypsomed locations worldwide on this basis. The clamping forces vary – 800, 1600, and 2800 kN – but otherwise the machines are identical. Future needs were considered when selecting the options. Not all machines make use of the entire feature set right from the outset. Instead, the aim was to avoid retrofitting and the requalification associated with this later on. In this way, the platform strategy saves a great deal of time and money during operations.
“We can now order injection moulding machines virtually off the peg at all locations worldwide,” said Mengis. “But the biggest advantage is fast industrialisation. The qualification plans are identical for all new machines. This means we can integrate new machines and new processes into series production far faster.”
The all-electric e-motion high-performance machines help Ypsomed ensure high-precision, zero-defect production. An important prerequisite for
competitive unit costs and trouble-free downstream processing of the injection moulded parts.
AUTOMATION ON A MINIMAL FOOTPRINT
The injection moulding machines started everything off . In the meantime, Ypsomed has also started to standardise the automation of injection moulding processes. The e-motion machines are now being equipped with Engelviper linear robots. And the new compact cell by Engel also plays a key role. When developing the compact cell, which was presented for the fi rst time at K 2019, Engel also focused on standardisation. Thanks to its standardised design, the new automation cell makes it particularly easy to integrate a wide variety of automation components and other downstream process units. It encapsulates all the components while remaining signifi cantly narrower than standard safety guarding. “In terms of footprint, the compact cell is unbeatable,” emphasised Marlon Trachsel, process manager production technology at Ypsomed in Switzerland.
UNIFORM CONTROL LOGIC FOR EVEN SAFER WORK
Like the machines, all the compact cells use an identical design to achieve maximum fl exibility. To avoid having to change the auxiliaries during every mould set-up, the compact cells integrate all components needed for both free-falling parts and for soft depositing using viper robots. The process units for bulk material and soft depositing are arranged one above the other. This helps the compact cell to keep the automation extremely compact. “Where we have fi ve production cells today, there will be six systems after the changeover to the standardised automation cells,” reported Trachsel.
DIGITALISATION DRIVES TREND TOWARDS SERVO-ELECTRIC MOULDS
Already at the K show, the compact cell was demonstrated with a medical application. Housing parts for medical devices were manufactured on an e-motion injection moulding machine using a two component process with the aim of achieving shorter cycle times. Since the wall thickness of the cylindrical devices cannot be reduced for stability reasons, the two-component process is the only available option for achieving shorter cooling and cycle times. In an eight-cavity mould using Vario Spinstack technology by Hack Formenbau, and featuring a vertical index shaft with four positions, the basic body is fi rst moulded from polypropylene. The second position is used for cooling while another layer of polypropylene is injected at the third position. The parts are removed from the closed mould at the fourth position parallel to the injection moulding process, making an additional contribution to achieving a very short cycle time.
The two-component precision mould has a fully servo-electric drive in this application and uses a software programme newly developed by Engel. This ensures that the servoelectric movements e.g. the core-pulls - can be controlled in the same way as those of hydraulic systems. This means that the user themselves can program the servo-electric movements without the need for additional qualifi cations. The software sees Engel paving the way for increased use of servo-electric moulds.
“Servo-electric motors off er more possibilities for sensitive monitoring of quality-critical process parameters to enable faults, downtimes and pending maintenance work to be detected at an early stage,” Gunnar Hack, managing partner of Hack Formenbau, made clear. At the K show, the Moldlife Sense System by Hack Formenbau demonstrated the huge potential that lies in digitalisation mould technology. Just like intelligent assistance systems, such as iQ weight control or iQ fl ow control by Engel provide assistance for injection moulding machines, it will also be possible in the future to counteract critical conditions in the mould before rejects are produced or damage occurs due to wear.
Smart assistance and artifi cial intelligence are increasingly making inroads into injection moulding production, supporting the idea that the system worlds of the injection moulding machine and the mould will collide in the future. This is also a major topic at Ypsomed. Standardisation has already been anchored in the company’s digitalisation strategy.
MARC VAN KEULEN, LEAD DESIGNER, AND SEÁN EGAN, DIRECTOR OF GLOBAL MARKETING & VOC DEVELOPMENT, BOTH FROM NELIPAK HEALTHCARE PACKAGING, LISTS DESIGN PROCESS CONSIDERATIONS FOR AUTOMATED HANDLING TRAYS.
THINKING AHEAD
For internal and external transportation of critical components or devices, automated handling trays play a crucial role in the automation process where speed, efficiency and high tolerances are a pre-requisite. At every step of the design process, decisions can significantly impact outcomes, creating a competitive advantage. Often there is more than one supplier of automated systems involved in decision-making related to positioning and handling of components and trays, and a wellqualified healthcare packaging partner can serve as an intermediary between all parties involved. By getting them involved in the project early, the best result can be achieved for the user and even the patient.
The first step of the handling tray design process is to identify the functionality the tray is intended for and determine specific logistics. By involving the packaging partner here, they can add maximum value by establishing where, by whom, and how the tray will be used and designing for optimal manufacturability. By visualising the complete story, requirements and even possible extra functionalities will be established.
SOME QUESTIONS TO ANSWER EARLY IN THE DESIGN PROCESS INCLUDE:
• What will the orientation of the part and the tray in the assembly line be? • Where, how and by whom will sterilisation and assembly be performed to create the final product? • What kind of protection is necessary for the products or for stacking purposes? (e.g. dust protection, anti-static, stability, etc.) • Are there options for different type of trays or end-user packs? • What are the dimensions of the pallet that will be used for transport? • Will transport occur by air, sea, or truck, and what are the dimensions of the transport container? • What will the packing and storing conditions of loaded trays be like? (e.g. moisture, air temperature, light, barrier bags/lidding, straps, etc.) • What will the inner/outer dimensions of the box be? • What is the allowed carrying weight of the box or stack of trays? • What tray size will fit on the existing automated line, conveyor or box, tub, crate? • Will this be a cleanroom or non-cleanroom product? • What will the product lifecycle be – single trip or reusable tray? If reusable, how many cycles and cleaning requirements? • What type of validation and transit testing (drop, vibrations and compression)/conditioning/sterilisation/stacking weight/height will need to be performed?
Early on, concept sketching is recommended in order to verify the requirements and expectations of all parties involved. This creates a clear 3D visualisation of different potential variations and makes sure everyone is in agreement. This can lead to quicker response times and a smoother overall process. Volume studies may be performed to establish the preferred orientation/ stacking direction and quantities of components, allowed tolerances of tray and part positions, construction features, material options, features for ease of de-nesting, and other important factors. All movements of the tray should be considered during all logistic steps. For instance, manual or automated, and with stoppers, grippers, suction cups and/ or conveyors. It should be determined whether indentations will be necessary in the side wall for manual handling unloading the box. The handling speed of the individual trays and orientation on the conveyor should also be established, as well as quantities per tray, box, pallet or stack if required. The injection mould configuration could provide some idea for quantities or layout configurations that will result in complete packaging density. Another question to address is how the system will detect the position of the tray, for example, with light barrier, mechanical stoppers or cameras.
By working together early and assessing critical logistical factors during the design process, handling tray functionality can be optimised, and maximum value can be added along the way. Later, CAD designs will be used to finalise concepts and placement of functionality features prior to prototyping.
ANNE-SOPHIE BELAMINE, EUROPEAN SALES DIRECTOR AT TEQ, SPOKE TO MPN EDITOR LAURA HUGHES ABOUT HOW THE ORGANISATION HAS INCORPORATED SUSTAINABLE PRACTICES.
Becoming eco-conscious
WHO ARE TEQ?
TEQ manufactures innovative thermoformed packaging, and the company develops products for a range of markets, including consumer, component handling and medical from its ISO- and BRC-certifi ed production facilities in the UK and central Europe, which includes cleanroom facilities. Established in 1979, TEQ has more than four decades of experience in the design and manufacture of innovative thermoformed packaging and has worked with multiple companies from across the sectors. TEQ, which was recently acquired by Sonoco, has rebranded its business having previously been known as Plastique across Europe, and TEQ Thermoform Engineered Quality more widely. As well as its two sites in Europe, TEQ operates three thermoforming facilities as well as one extrusion operation in the United States. The company also produces recyclable, moulded-pulp-fi bre packaging under the Fibrepak brand.
HOW IMPORTANT IS SUSTAINABILITY TO THE ORGANISATION?
TEQ is committed to incorporating sustainability into our overall business strategy, and helping customers achieve their environmental goals. Sustainability underpins our thinking in everything that we do – both the products that we design and manufacture, and the way we run our operations. We create products with an environmental conscience, products of minimal size and weight, but which deliver superb quality. We are constantly developing innovative solutions that provide sustainability benefi ts for our customers.
WHAT SUSTAINABLE PLASTIC OPTIONS DOES TEQ OFFER FOR CLEANROOMS?
TEQ delivers a range of medical packaging solutions that are produced in cleanrooms based in both the UK and Poland. Designed, built and commissioned by pharmaceutical cleanroom experts, the facilities are certifi ed to ISO 13485:2016, suitable for the production of precision-made and custom thermoformed medical packaging. The cleanrooms, which are located in Nottingham and Poznan, are designed to meet medical device and pharmaceutical manufacturers’ most rigorous packaging requirements. The two sites are fully certifi ed to meet the BRC IoP Global Standard which sets strict criteria for manufacturers of packaging for the food and cosmetics industries. Our packaging solutions include trays, procedure sets, clamshells, tubs, covers, lids, sterile barrier blisters and seal blisters. We also manufacture custom thermoformed handling trays suitable for high-speed production, with automated assembly and transit. Handling tray solutions include autoinjectors, dry powder inhalers, injection-moulded components, pre-fi lled syringes and pharmaceutical bottles.
The task of improving the recyclability of plastic products within healthcare is an enormous one. Our TEQethylene Sterile Barrier System (SBS) uses a new, proprietary blend of HDPE in combination with Tyvek, a breathable HDPE thermoplastic lidding material, for a complete SBS solution backed by data that can help customers meet the requirements of ISO 11607-1 for stability or dating claim verifi cation.
ARE THESE SUSTAINABLE OPTIONS AVAILABLE WORLDWIDE?
Having both a North American and European presence enables TEQ to off er supply opportunities to both European and multinational medical device and pharmaceutical customers.
FINALLY, HOW DIFFICULT IS IT TO ENFORCE MORE SUSTAINABLE MATERIALS AND PRACTICES INTO ENVIRONMENTS SUCH AS CLEANROOMS?
Our facilities enable us to manufacture innovative thermoformed solutions, such as sterile barrier packaging, engineered to maximise revenue, reduce cost, and increase our speed to market. Now, with identical machinery and tooling on both sides of the Atlantic, TEQ can off er multinational customers shortened lead times, repeatability and uniformity together with a single global validation across a range of packaging solutions for the medical and pharmaceutical industries. With 40 years’ experience working with many well-known brand owners, we’re proud to be able to off er our customers a range of custom-made solutions, developed in our cleanrooms in the UK, Poland and the US.
RON PARTRIDGE, DAVID SEILER, AND IGNA VAN DER WEIDE, FROM MATERIALS TECHNOLOGY SPECIALIST, ZOTEFOAMS, HIGHLIGHTS THE USE OF POLY VINYLIDENE FLUORIDE (PVDF) FOAM IN CLEANROOM INSULATION APPLICATIONS.
The perfect cushion
As products in the life sciences sectors become ever more sophisticated and the regulatory environment commensurately stricter, the standards that apply to manufacturing become increasingly more rigorous. This is particularly important in the construction and operation of cleanrooms. The environment must be safe and sterile, resistant to contamination by particulates or microbes, and with materials robust enough to withstand aggressive chemical and high-temperature cleaning. Construction materials for cleanrooms must therefore combine chemical stability, durability, purity, and fi re resistance, as well as resist the development of mould, fungi, and other microbial species. Polymer-based materials, in particular fl uoropolymers, are often used in sheets or as a coating for walls, while foamed material is used to create lightweight structures, walls, partitions, ceilings, pipe and ducting insulation. ZOTEK F high-performance foams, manufactured by Zotefoams from Kynar PVDF polymer, are the material used to produce T-FIT Clean, a range of insulation products purpose-designed for use in cleanrooms. PVDF fi lms, coatings and foams are considered an appropriate choice, because covering exposed surfaces with PVDF provides a high purity ‘inert’ surface, which does not readily support the growth of microorganisms and provides the muchneeded resistance to withstand chemicals used today and possibly much harsher ones in the future for cleaning and sterilisation. It is also important to consider fi re resistance, low smoke generation, low moisture absorption, insulation values, abrasion resistance, and non-shedding characteristics to prevent the introduction of particulate contaminants into the manufacturing process, when selecting materials and surfaces.
ANTIFUNGAL PROPERTIES
The low surface energy of fl uoropolymers inhibits mould growth. ZOTEK F42 HTLS foam insulation was tested according to ASTM G21-15 (2015) Standard Practice for Determining Resistance of Synthetic Polymeric Materials to Fungi and the results showed no observed growth after the required 28-day exposure. The synthetic polymer portion of these materials is usually fungusresistant in that it does not serve as a carbon source for the growth of fungi. It is important to establish the resistance to microbial attack under conditions favourable for such attack, namely, a temperature of two to 38°C (35 to 100°F) and a relative humidity of 60 to 100%. Therefore, it is also important that materials used are hydrophobic in nature. PVDF polymer is inherently very pure and hydrophobic.
FIRE RESISTANCE
In order to limit fi re and smoke risk in cleanrooms, Factory Mutual (FM) has established a fi re and smoke standard called FM4910 (Cleanroom Materials Flammability Test Protocol). Insulating foams are particularly susceptible to the eff ects of fi re because of their high surface area, low mass, and high heat release rate. Many polymeric materials will readily burn and produce large amounts of smoke as well as contribute signifi cant fuel load should a fi re occur. They therefore require the addition of fl ame retardants to reduce the risk of fi re and fl ame spread. By contrast, fl uoropolymers, especially PVDF, prevent and minimise fi re hazards. PVDF is a pure polymer and is inherently fl ame-retardant without additives.
CHEMICAL AND THERMAL RESISTANCE
Fluoropolymers exhibit superior chemical resistance and can withstand the harshest cleaning and disinfecting agents. PVDF resins are also resistant to a wide range of chemicals, posing little problem for Kynar PVDF. High-temperature cleaning is a very eff ective way to control bacteria development. There are versions of PVDF insulation that can withstand continuous temperatures of 145°C and short excursions to even higher temperatures.
OTHER PROPERTIES
Additionally, PVDF is resistant to sunlight (UV) and radiation exposure. In the medical industry where gamma radiation is utilised for sterilisation, PVDF is known to be minimally aff ected by relatively large doses of radiation over time.
CONCLUSION
Materials used in the construction of cleanrooms must demonstrate excellent chemical and fi re resistance and must not support the growth of fungi and other microbial species. Stringent cleaning and disinfection procedures are also critical to controlling fungal contamination in the cleanroom environment. Cleanroom materials must therefore possess excellent chemical resistance to be able to withstand the most aggressive
Zotefoams ©
chemical cleaning methods.
