Thriving in a competitive market

According to the Chemical Industries Association the chemical and pharmaceutical sector is the UK’s largest export earner with annual exports of close to £50b and, while it’s global market share might still be relatively small, the country is widely recognised as being at the forefront of the pharmaceutical industry, in particular. And, as the Association of the British Pharmaceutical Industry (ABPI) points out, as well as developing new medicines for many diseases, the sector in the UK provides a myriad of benefits to the economy, including income, employment, expertise and major investment.

As part of its manifesto for the 2017 UK General Election, ‘Securing the Opportunity for UK Life Sciences by 2022’, the ABPI urges the next Government to implement a new industrial strategy that cements the UK’s position as a leading global hub for life science, and attract significant new international investment, by:

•    Reaching a target of 3% of GDP spend on research and development by 2022 through a strategic vision for publicly funded science research
•    Attracting global scientists to the UK and enable the UK to collaborate at scale in global scientific projects
•    Improving the global competitiveness of UK medicines manufacturing, through targeted infrastructure investment in advanced manufacturing
•    Ensuring the NHS is seen as a global early adopter of new cost effective medicines and vaccines.

Robotics upstream

While it is, indeed, vital that the Government works hard to ensure the sector continues to be the success it undoubtedly is, behind the scenes developments in technology are also driving standards and productivity. For example, as Neal Welch of Mitsubishi Electric explains, robots have become an established technology within the industry for precise and efficient processing and packaging of drugs and solutions, and that success is seeing the technology being steadily introduced further upstream, in the processing of live cultures and handling of cell tests. Helping to automate the research and development stages of new drugs, robots can boost accuracy and repeatability, increase production capacity without increasing floor space, and minimise the need for human intervention in physical production.

According to Welch as life science companies and institutions look to develop new drugs and treatments, the key challenges when processing of vast numbers of live samples and cultures for production and screening applications are volume, accuracy and repeatability. Traditionally, accuracy and repeatability have been very dependent on human skills, while increasing production volume has meant increasing lab floor space.

Lab floor space, though comes at a premium, while the requisite numbers of people required in order to ramp up volume also come at a cost. And there are limits on how much people can do and how long they can concentrate and still maintain accuracy and repeatability. Thriving in a highly competitive market depends upon accelerating time to market, increasing production effectiveness and minimising costs.

With modern, small, articulated robotic technologies able to meet stringent hygiene requirements, whilst becoming easier to integrate and more affordable to purchase, life sciences facilities have the opportunity to dramatically increase production capacity without increasing floor space. Mitsubishi Electric, for example, offers MELFA robots certified for use in ISO class 7 and 8 cleanrooms, with compact designs that provide flexible automation even where space is restricted.

Increasingly used to carry out even very delicate handling tasks, robots enable high cycle rates to be achieved while maintaining a high level of precision, enabling line efficiency to be increased. There is a reduced need for human intervention in physical production, with the robots taking over tasks that previously would have been physically demanding or manually-intensive, and enabling existing personnel to devote time to more value-adding tasks.

Mitsubishi Electric has recently provided robots for a number of challenging tasks within the life sciences sector that demonstrate robotic advantages. These include the handling of stem cells, where the robots are delivering a higher degree of repeatability, and an automated primary antibody screening work cell for early stage development of potential new treatments for central nervous system and immunology disorders. The robots in this application are helping to speed up the process of antibody discovery by automating the screening of billions of antibody-producing B cells.

Blister filling

Meanwhile in a more traditional robotic application, a Fanuc LR Mate 200iD robot has been selected by FlexLink for a cutting-edge medical assembly line located in Italy. Combined with a Fanuc M-1iA delta robot and an integrated iRVision system, FlexLink completely re-engineered the blister packing operation, automating an intricate and time-intensive job that previously performed manually. 

Increasing productivity enables the FlexLink system to consistently produce 60 blister packs per minute, the M-1iA delta robot starts by undertaking the first selection task. With a work diameter of 280mm, this specific model was designed by FANUC to deliver accurate movements and handling of small objects at high speeds, so suits the application perfectly.

Presented in bulk quantities on the conveyor belt, the delta robot picks up and using FANUC iRVision, quality checks each product component. “Integrating the visual system eliminates the need to orientate objects as the robot finds them. It meant we didn’t need further conveyors and devices that would have made the conveyor system more complex and cumbersome,” explains FlexLink’s engineering manager Davide Zuffa. Imperfect pieces are rejected at this phase of the process, remaining on the conveyor to be discarded.

With the quality inspection complete, the delta robot then places each product piece onto a middle conveyor for presentation to the blister-packing robot. This FANUC robot - the LR Mate 200iD – which undertakes the blister pack packing task was customised with a double gripper (EOAT). This enables it to handle and load two product pieces simultaneously resulting in an increased output.

But the unique positioning of the medical pieces means that they can’t simply be loaded into the blister packs and sealed. Instead, the robot is programmed to carefully manipulate and fold each medical device before delicately pushing into the blister pack. At this stage the vision system checks for correct insertion of the assembled medical device to ensure it is seated correctly within the blister pack. This guarantees a good seal and eliminates any rework.

Track & Trace

Perhaps more than any other industry, mandated serialisation standards across markets require pharmaceutical and medical device manufacturers to adopt specified standards to track and trace products across their supply chains. The newly updated serialisation solution from Rockwell Automation is helping these manufacturers and OEMs think beyond compliance and capitalise on major business benefits, such as long-term profitability, with a comprehensive, scalable, end-to-end supply-chain platform.

Built on the latest Rockwell Software PharmaSuite manufacturing execution system (MES) software, the new serialisation solution v4.1 is more scalable to adapt to a wide variety of packaging-line technologies and production-management systems. Easy integration across control and enterprise levels means the solution provides a centralised platform for managing serialisation data and facilitates product traceability across the entire supply chain.

A new Logix-based unit controller with FactoryTalk View HMIs from Rockwell Automation enables scalability, allowing the company to apply this solution to a variety of delivery models – from full, turnkey solutions to retrofit and OEM solutions – to meet the needs of virtually any customer. The unit controller acts as the connection point between each production line and various system devices. Beyond providing serialisation, the solution helps manufacturers improve troubleshooting and proactive maintenance by providing direct visibility into the full, end-to-end process – production through distribution.

The updated serialisation solution includes a serialisation integration gateway with preconfigured channels for order creation and EPICS data exports to easily integrate into each customer’s system, greatly helping to reduce upfront engineering costs. The goal of Rockwell Automation is to build a comprehensive library of pre-engineered gateway channels to drive down costs and deployment of business systems integration.

Tool coating

As you might expect, when it comes to tooling, the pharmaceutical sector has some very exacting standards, which have been addressed by I Holland with its PharmaCote ECxtra , said to be one of the most advanced tool coatings on the market today. The coating has been engineered to protect tablet punches from a range of common manufacturing problems including wear and corrosion and formulation sticking issues.

Commenting on the product, Alex Bunting, I Holland Marketing Manager said: “It is not only beneficial in production with many major issues like sticking being addressed, but unlike traditional hard chromium, the most commonly used tooling form, it is applied by an advanced spluttering method, rather than electro-plating. This means we can eliminate problems encountered during the hard chromium coating process like hydrogen penetration and micro-cracking both of which significantly reduce tooling life.

“Due to the technique in which PharmaCote ECxtra is applied, we also avoid the environmental problems associated with the plating process of hard chromium, which produces a waste product containing hexavalent chromium, and has significant implications to worker safety and on the environment.  PharmaCote ECxtra is beneficial not only to tooling life and the bottom line, but it is also a relatively ‘green’ product.”

Customised inspection units

Following expansion of its solid dose operations, leading USA contract manufacturer, AAA Pharmaceuticals has recently installed customised Insight Pharmaceutical (PH) Metal Detectors from contaminant inspection equipment specialist, Loma Systems.

For over 20 years, AAA Pharmaceuticals has been providing manufacturing, packaging and distribution services for store brand and private label customers and national brands. The company markets a wide variety of over-the-counter (OTC) solid-dosage formulations that are comparable to national brands such as Tylenol and Advil.

Produced from polished stainless steel for hygiene and wash down benefits, Loma’s Insight PH Metal Detector’s compact design allows it to be located on virtually any production or packaging line without disrupting the plant layout.

The tablet presses at AAA Pharmaceutical are located in close proximity so Loma set up the frequencies on the metal detectors to avoid interference.

Jeff Biggs from AAA Pharmaceuticals comments: “Although I had experience of Loma metal detectors in another business, the Insight PH Metal Detectors were selected after a rigorous review process by AAA Pharmaceuticals.

Biggs continues: “We conducted an across the board comparison between six metal detector companies and even requested demonstration units so that we could properly assess both functionality and specifications. Loma was the first to respond to our request for a trial machine and it quickly became evident that their Insight PH model rated highly for performance and features.

“With the help of the Loma team, the metal detectors were installed quickly and have proved easy to use, clean and maintain. Our operators particularly like the simple, intuitive user interface.”

Loma has recently enhanced the Insight PH to further improve stability and manoeuvrability, allowing easy integration with tablet presses, de-dusters, polishers and encapsulation equipment commonly used by pharmaceutical and neutraceutical manufacturers.

The system offers full digital processing functionality for conversion of analogue signals to digital processing in the detection head and a voltage measurement read-out allows the customer to properly monitor calibration. It offers industry-leading calibrated detection levels of 0.3mmFE, 0.35mmNFE and 0.5mmSt/St while eliminating false rejects from vibration and product signal. Four password protected security levels are provided for operators, supervisors, engineering and administration.

The system is available with fully documented Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) validations for compliance with FDA, GAMP and GMP specifications. It is design and construction compliant with 21CFR parts 210 and 211 and certified to NEMA 4X / IP66.

Other key features include Loma’s Direct Digital Signal (DDS), which displays a clear graphical representation of events during the set up process, and 200 product pre-sets and permanent memory stores up to 8000 data events. The Insight PH is also available with 12 different reject options.

Warehouse cooling

Often it’s not just the processes in the chemical and pharmaceutical sectors than need to be closely controlled, it can also be the way in which products are stored and distributed. Merck Sante, based in the French city of Orleans, manufactures and distributes pharmaceutical products. The main warehouse is required to operate under the conditions of ‘controlled room temperature’, which for the range of products is less than 25°C .

To achieve this, 18 down discharge EcoCooling ECP16000 evaporative coolers were installed, feeding high level plenum chambers. These positively pressurise the warehouse and air is extracted using automatic vents. The coolers are all linked to a common control panel.

Temperature is monitored at three levels in the ware- house and the coolers controlled accordingly. A humidistat ensures that the internal humidity does not exceed 85%.

Similarly, at pharmaceutical product importer, Chemilines’ 90,000 sq ft repackaging and warehouse facility in Wembley, EcoCooling evaporative cooling was applied as part of a complete warehouse temperature control scheme. The existing heating system was incorporated into an integrated approach to heating, cooling and de-stratification. A central controller also provides data capture with remote access and automated alarm communication.

Full monitoring and data logging was provided together with SMS messaging of alarm conditions.