	Self-driving vehicles and robots that pull items from shelves and deliver them to another location in a manufacturing facility or warehouse are not just science fiction anymore-these technologies and others are already being used for automated movement of materials and finished goods in various industries, including the pharmaceutical industry. Efficiency is a primary driving force for this type of automation, which increases accuracy and reduces labor costs. 

In the pharma manufacturing “facility of the future”-and in some facilities already today-automated systems will move raw materials or semi-finished goods from the warehouse to the production line or between departments, and they may also move finished goods from the line to the warehouse. Autonomous mobile robots (AMRs) have an intelligent navigation system with built-in sensors, cameras, and software that allows them to “identify their surroundings and take the most efficient route to their destinations, safely avoiding obstacles and people,” says Ed Mullen, vice-president of sales for North America at Denmark-based Mobile Industrial Robots (MiR). These collaborative robots can improve productivity and efficiency, and return on investment is typically less than a year, says Mullen.

	Transporting goods in and out of cleanrooms with AMRs offers time savings, because employees have to change gowning when moving in and out of cleanrooms. Transporting materials from the warehouse to production departments using AMRs also becomes more efficient. AMRs allow “warehouse employees to stage materials, load the robot with material for multiple departments, and send it on missions to deliver the material automatically in real time,” explains Mullen. Automated guided vehicles (AGVs) can similarly be used for transport and may run faster, but these require physically mounted guides, such as magnetic stripes or rails, and so are not as flexible for facility layouts that may change, he adds. “The trend to collaborative automation in warehouses as well as production was in its very early stage five years ago, but because of technology innovations, it is booming now. We will see an even greater tendency to use collaborative robots in the coming years,” predicts Mullen. “Warehouse automation is an obvious target for cost savings, and we see that more companies request mobile robots like ours because they can take over the internal transportation, and skilled employees can be redeployed for more valuable tasks than just moving parts from A to B.”

	In warehouses for finished pharmaceutical goods, putaway and retrieval, as well as functions such as case picking, can be automated. Technologies available include storage/retrieval machines (S/RMs), which replace work conventionally done by standard fork-trucks, and gantry or articulating-arm robots for case picking activities, which are generally combined with conveyance and sortation equipment, explains Dan Labell, president of Westfalia Technologies.

	If a company wants to consider automation, they should first evaluate the business case, considering labor savings goals, worker safety, and regulatory compliance, notes Jeff Christensen, vice-president of product at Seegrid. Automating the putaway process can be a first step towards a “smart” warehouse. “Companies can set up a pilot program that includes self-driving pallet trucks that replace manual forklift moves from dock to storage,” suggests Christensen. “Companies can also tie in small bin automated storage systems that carry items along conveyor belts from the sorting area to picking. Once these applications are tested, companies can expand their automation footprint by integrating software systems and increasing the number of self-driving vehicles on site.”

	Sophisticated warehouse management systems (WMS) support the movement towards more fully automated warehouses. For warehouses of finished pharmaceutical goods, such as those delivering to pharmacies and hospitals, the near future will see “more emphasis on software integrations to connect data across systems, manage inventory, and improve performance. These systems will include the WMS and software associated with smart machines, such as self-driving vehicles,” predicts Christensen.

	Cost-savings and better data tracking justify automation

	Automation can be justified for high-volume products, but it can also make sense for lower case volumes of high-value products with special cold-storage conditions (e.g., blood plasma), notes Labell. In general, warehouses have been densified to enable growth and reduce construction costs, and the savings in real estate and construction can often pay for a majority of the automation costs, he adds.

	Automated movement in warehouses of finished pharmaceutical goods will be needed to better track product and product serialization/lots and capture this information for everything leaving the pharma warehouse, says Brian Hudock, vice-president at Tompkins International. “The ability to scan product at the sellable level through multiple tracking devices and 100% data capture is important,” he adds.

	Another driver for automation is the need to efficiently handle smaller shipments to support digital shipments. So far, says Hudock, US pharma companies have taken a limited approach to automation and have instead used third-party logistics (3PL) partners to handle distribution of smaller orders, such as those going directly to physicians, clinics, or home care. “Because most 3PL’s want longer contracts to invest in automation, the result has been mechanization for efficiency at best. The US distribution market, however, is on the verge of a major evolution as digital disruptors are entering the equation and are about to create a new channel in the form of increased direct-to-patient/home-care provider shipments,” predicts Hudock. He anticipates that Amazon and others will create changes in the supply chain that will justify automation at both manufacturers and 3PL partners.

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Automation systems, vehicles, and robots improve efficiency of transporting materials and finished goods in pharmaceutical warehouses. 

Smart Warehouses: Automating Transport in Pharmaceutical Manufacturing and Supply

	Tampering with pharmaceutical packaging is not only an economic issue but could be a matter of life and death. Therefore, Commission Delegated Regulation (EU) No 2016/161 requires pharmaceutical companies that commercialize prescription medicines in the European Union to provide pharmaceutical packaging with unique identifiers (i.e., serialization) as well as anti-tampering devices (1).

	Nature teaches us how first-opening protection works: after a banana, orange or macadamia nut has been opened, there is no chance to unnoticeably alter the content and to reseal the fruit in a way that keeps it intact. Such perfect tampering protection can make packaging professionals outright envious or motivate them to use “nature’s first-opening protection” as a source of inspiration for their own efforts.

	Of course, technical tampering protection has to be affordable, but first of all, it has to be efficient. Simply sealing a cardboard box by means of adhesive tabs is definitely not sufficient. A razor blade, a small amount of solvent, and a blow-drier are all it takes to open a box that has been “secured” like this and to restore its previous condition in a way that makes it impossible to notice that the box has been opened before.  Neither does a label that is normally applied across the lid and bottom provide adequate tampering protection. The reason is that if the decorative varnish that the box has been coated with has insufficiently bonded with the cardboard surface, it is usually easy to peel off a sticker together with the varnished area underneath it and, after the contents of the box have been extracted or exchanged, to reapply the label using some adhesive.

Generally, a label can contribute a lot to tampering protection but, in order to do so, it must be provided with some special features. For instance, if there is an attempt to peel it off, a label may disintegrate or change its color, or the label may destroy the surface of the box on which it rests (see 

). Another possible feature is that segments of the label may separate from it so that the label cannot be reapplied in the same place. Other options include the integration of indicators that show when the label has been exposed to heat or solvents, or marks being left after the label has been sliced along the edge that make it impossible to subsequently apply another label without this intervention being clearly visible. To comply with the EU Regulation 2016/161 or with the tampering protection devices stipulated by the Compliance Policy Guide 450.500 of the US FDA (2), one of these devices has to be integrated.

	But there are some caveats to be taken into account when using labels as anti-tampering devices. The quality standards of the cardboard and the varnishes is difficult to specify especially if multiple suppliers come into play. It is even more difficult to find an adhesive displaying an illegal opening that is suitable for all cardboard surfaces. Preferably, a disintegrating label is used in combination with a strong adhesive for the label.

	The EU Regulation 2016/161 describes the unique package identification by a serial number (serialization) and the need of anti-tampering devices as two components to improve patients' safety. Combining both requirements in one production step ensures compliance and patients' security and also helps reduce expenses in a reasonable way. Labels that accomplish this combination, as shown in 

, for example, are available commercially.

	1. EU Commission Delegated Regulation 2016/161 (Brussels, 2 Oct. 2015).

Compliance Policy Guide 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products

	Jürgen Höfling is product specialist in packaging technology and a technical writer based in Munich, Germany.

Labels must have special features to prevent tampering of pharmaceutical packaging.

Equipment and Processing Report-02-21-2018

Smart Warehouses: Automating Transport in Pharmaceutical Manufacturing and Supply

Using Labels to Detect and Prevent Tampering