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Pharmaceutical Manufacturing and Packing Sourcer

Seeing the Light

In August 2010, the British Automation and Robotics Association (BARA) predicted a bright future for robotics in UK industry, particularly in pharmaceutical, medical and healthcare, which had seen a 194 per cent increase since 2006. The trade body noted that although these are encouraging figures, they are still some way behind the rest of Europe. However, one thing BARA didn’t address closely was the key to increased take up in pharma – robot vision. As a result, it is important to take a look at the future role of visionequipped robots in helping the pharmaceutical industry take full advantage of automated systems – in both the factory and the lab.

I have been to countless pharmaceutical plants in my time as an engineer and I would argue that not all manufacturers are taking advantage of the robotic technology on offer to improve efficiency. The overriding impression I have been left with is that the cost of the end product is the single most important thing. Naturally, the machines used to produce that end product must be appropriately validated – and the process itself must be sufficiently traceable to comply with all relevant regulations. But the bottom line, as usual, is cost. However, I would argue that there are both process and cost savings to be made by introducing more automation, particularly vision equipped robotics into both labs and manufacturing plants.

Meeting the Needs of Compliance

Of the numerous regulations that are applied to the pharmaceutical industry, two are of particular importance.These are 21 CFR Parts 11 and 211 – both FDA regulations. 21 CFR Part 11 has become the de facto world pharmaceutical industry standard. European countries have their own rules and regulations for the production of pharmaceuticals, but the pervasive footprint of the US in the world marketplace has made the US standard a global language.

21 CFR Part 11 relates to guidelines for trustworthy electronic records. This regulation requires companies to utilise a set of procedures and controls to ensure the authenticity, integrity and confidentiality of electronic records. In addition, 21 CFR Part 11 helps certify that an electronic signature is genuine. Part 211 spells out the minimum current good manufacturing practice (CGMP) for preparation of drug products, and includes aseptic processing, as well as any robotic equipment. Robotics used for pharmaceutical production must be routinely calibrated, inspected or checked according to a written program designed to assure proper performance. Although compliance is a requirement for all pharmaceutical manufacturing processes, whether they incorporate robotics or not, there are ways that robots can help achieve that compliance.

CGMP for instance, is fundamentally a list of rules on how to create your own rules, rather than a list of rules of what to do or not to do.While the regulations do not require the use of robotics, they state that if a company is going to deploy robots as a means of manufacturing pharmaceuticals, there are standards on how they are to be maintained, cleaned, inspected and calibrated.Unbelievably, these standards are met using a plan drawn up by the company itself.The role of the FDA is to examine and approve the company’s plan and to ensure that it is being followed faithfully. As a result, ironically, it’s the people writing these procedures that make them stringent – so they are more likely to be approved by the FDA.The automation designer, or systems integrator, has to follow these procedures, which involve design concepts, design reviews and peer reviews. If there is a change, the company has to have a change record, which must also be approved.However, because the company plans these procedures itself, there is a danger of over-elaboration.

Nevertheless, the requirement for electronic records is a perfect match with robotics and robot vision. It is a relatively simple part of work cell integration to have the robot record each step it undertakes so that data can later be tracked down.When equipped with vision, a robot can even provide permanent visual records of its actions and the elements of the process it can ‘see’. Furthermore, the data can be fed to a PLC, HMI or SCADA system to be analysed should there be a recall of the product by the FDA or if the process is being streamlined.

Another facet of 21 CFR Part 11 mandates there be an audit trail when it comes to generating data. These audit trails must be secure, computergenerated and time-stamped to independently record the date and time of entries. Any activity that creates, modifies or deletes electronic records has to be stored and made available should there be a need for the FDA to conduct an audit. Audit trails are required to specify who did what to the records and when this was done. If the robot cell is being used to control other elements of the plant’s equipment, which is possible where the robot controller incorporates a built-in PLC for instance, this can be achieved easily. Where the robot is equipped with vision, the PLC’s record can be complimented with one provided by the camera itself.

The date the data was collected, the conditions it was collected under, and who collected it all need to be included to comply with regulations.These are requirements that are extremely complementary to the use of vision equipped robotics.

Price Has Never Been More Important

However, while pharmaceutical regulations are prerequisites that are enforceable, once they are achieved, as I touched on at the beginning of this article, the next most important thing is simple – price.

I’ve seen lots of plants take the simplest possible approach to reducing prices – they don’t spend a great deal of money on technology in the first place. Clearly, pharmaceutical manufacturing is not in the dark ages; inspection in particular is highly sophisticated.However, one area where spending less doesn’t necessarily lead to lower costs is manufacturing efficiency. I have seen manufacturing plants that were very cheap to set up and represent extraordinary examples of lean manufacturing theory in practice. However, these same plants often fail to invest in machinery that could increase output and lower overheads because of the initial capital investment. As someone involved in the robotics industry, I believe this is the area where it is obvious that investment in capital would increase efficiency. Of course, by increasing efficiency the price of the drug itself can become more competitive. By automating the process, the cost decreases because there are fewer human interactions that need to be audited and validated.

Robot Vision in Pharmaceuticals

By far the most common applications for robot vision in the pharmaceutical arena are in manufacturing and packaging, particularly end-of-line packaging.The key factors in this context are speed, payload and flexibility.

Speed is particularly pertinent in a pharma manufacturing plant where, for instance, a broken ampoule or spilt syrup can mean a breach of the aseptic environment – leading to costly down time and significant losses. Indeed, pharmaceuticals require more speed, precision and faster cycle times than typical robotic operations. In automotive production for instance, cycle times are generally greater than four seconds. In pharmaceutical applications, cycle times are usually less than four seconds.

Another significant factor is payload. While few laboratory applications require significant payloads, in pharmaceutical manufacturing or packaging applications, robots can often be required to lift quite heavy items.

The third of the three key issues to consider is flexibility. I have often encountered applications where SCARA, Cartesian or even six axis robots could all perform effectively and meet the same set of requirements.This illustrates the flexibility of the different kinds of robotic systems on the market. However, key things to consider are the ease with which the robot can be programmed and the space it occupies.The most important factor, of course, is programming simplicity. If, for instance, a single manufacturing line in a contract manufacturer is producing syrups for one client for the first half of the year and another client for the second half of the year, the re-programming of the robot should be as simple as possible to facilitate the changeover. Simple programming languages such as SCOL, teach pendant functionality and 3D simulation software can all be benefits in this context.

Finding the Errors

The pharmaceutical industry depends on automated process control and quality assurance systems to ensure that batch production is carried out repeatably, reliably and accurately. Like many other manufacturing industries, especially those concerned with the production of high-value products, pharmaceutical producers are constantly looking at ways to increase throughput, maximise yield, and improve the flexibility of batch manufacturing. Furthermore, there is no other industry where good quality assurance and control can make the difference between life and death.

Critical to this level of control is incoming material inspection and proofreading of labels. FDA guidelines specify that each package must carry a label exactly the same as the one originally approved by the manufacturer. This process is now improving thanks to the combination of barcodes and robot vision, but development in the industry is slow and it’s often still done by two human proofreaders comparing an incoming product to a master sample. The issue is that many human proofreaders, who are rightly proud of how much better at their job they are than the average Joe, believe they are also superior to a computer. However, the computer will perform 100 per cent reliably, in seconds, the task they may take several minutes to complete. As a result, a vision equipped robot can often be the answer.

Getting Things Clean

Further to these features, it is also beneficial to make use of a robot with a cleanroom option available. This is because, when this option is applied, it saves the significant cost of a human going in and out of the cleanroom. The human cost can be found in the protective suit, the time it takes to put the suit on and take it off and counteracting the potential for contamination each time a person steps over the threshold.When one factors this process into the equation four to eight times a day, the costs start to look significant.

Of course, a vision equipped robot drastically reduces the human intervention required in the process. In addition, if a human rarely needs to access the cleanroom, the space itself can be smaller. Some recently launched robots have arm lengths of only 250mm, making them small enough to fit in a very snug area, and are significantly more efficient and quicker than a human operative.

Inspecting for Defects

Vision systems can be used for a host of other applications within a pharmaceutical plant, including detecting particles within liquids, and checking for container defects including inaccurate dimensions, cosmetic flaws, and blemishes. The whole range of containers can be inspected including vials, ampoules, and syringes at speeds that a human system simply can’t replicate.

Normally, liquid-particle-inspection applications are based around a system where containers filled with liquid are rotated at high speed. When the rotation is stopped, the liquid and any dispersed particles continue to move inside the container. The vision system, which rotates in synchronisation with the containers, takes a sequence of images. These images are captured and delivered to the system image processor where they are compared pixel by pixel. Moving particles are identified as defects. Often, several vision systems will be employed on a single line.While systems in liquid particle inspection are not necessarily tied into a robot system, doing so can improve the versatility of the line by allowing the user to position an inspection station directly before a packaging station, for instance.

Conclusion

This range of vision applications in the pharmaceutical industry means it is one of the sectors with the most potential for growth in the entire field of robotics. Indeed, the scope of uses found for materials handling robots is only now beginning to become clear. If this potential is fulfilled, we might even see BARA’s positive sales figures repeated year on year.


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Nigel Smith began work at Toshiba International Europe Limited in the UK in 1986. He completed his MBA while working for the UK business, developing expertise in robot and PLC technology. When Toshiba Corporation restructured its supply chain into Europe, Nigel established TM Robotics (Europe) Ltd, to act as the European partner for the Japanese corporation’s robot sales in the region. He has written on the subject of robotics for magazines including Automation, Engineering, Food Processing and The Engineer. Email: nigel@tmrobotics.co.uk
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