For a global player in healthcare and pharmaceutical products, Ward Automation Sligo engineered and manufactured a compact and flexible robot cell for the end-of-line testing, labeling and palletizing of 36,000 syringes per hour. Three Stäubli robots in hygienic design are responsible for the handling of the tubs.
What is the safest and most economic way to test and palletize 36,000 syringes per hour at 100 % and according to different criteria? A global manufacturer of pharmaceutical products posed this question to Ward Automation. Ward is well prepared to deliver an answer because the company – established 1995 in Ireland – is well-known for developing and building world-class bespoke automation solutions for the medical device and pharmaceutical industries. Solutions include assembly machines, filling machines, test and inspection machines, and other medical device and pharmaceutical equipment. Ward engineers cooperate with their customers from initial concept through design and build, right through to commissioning, validation and service.
Some details of the specification: The syringe comes in tubs with 100 samples, six tubs per minute. They have to be inspected, labelled and palletized, under the conditions of medical production (21 CFR Part 11) – with a high automation grade.
Beforehand, the process was fulfilled manually. Now the customer wanted to reduce labor and at the same time increase quality with inspection of syringes, labels and seals. John Walshe, Business Development of Ward Automation:” An important issue was to eliminate the risk of damaged syringes, missing syringes and missing anti-tamper seals. For reasons of production safety and traceability, the robot cell had to be integrated into the company’s SCADA system. And all process steps had to be executed in a very small envelope.”
Based on this data, Ward Automation Sligo engineered a robot cell with three Stäubli robots. The fully automated process runs as follows: At first, a Stäubli TX2-60 robot removes the nest of syringes for inspection. With a “flash” of two vision systems, the content of the nest is checked for damaged flanges, missing PRTC caps and correct number of syringes.
Tubs with reject syringes are diverted to a reject drawer. The HMI shows which syringe is to be removed from the nest and the vision system verifies that the correct syringe has been removed. After this, the tub is released to the operator to allow the tub to be replenished and reintroduced to the machine.
Labeling – inspection included.
Good tubs are conveyed to a label station where inner and outer labels are printed and inspected. Reject labels are automatically rejected and reprinted. Good labels are placed into and onto the tub. The inner label is placed using the same TX2-60 robot. At the end of this process, labels are checked for presence and position.
Of course, the tubs have to be sealed before palletizing and shipping. For this purpose, Ward Automation has invented an innovative lid separation station. This station presents a single lid to the second robot which is also a Stäubli TX2-60.
After vision systems have verified the presence of one single lid, the robot places this lid on a tub. A custom application head applies a tamper-proof seal to the lid, folding the label around this lid flange. The tub is rotated by 180° and a second label is applied. The robot then lifts the tub and places it on the buffer conveyor.
The processed tubs are stacked on a pallet using a Stäubli RX160L robot. John Walshe: “This robot offers the required reach in a small footprint.” 200 tubs are placed on each pallet. A zoned safety system with three individual virtual cells and a buffer between them allows the robot to be safely stopped for pallet changeover while the rest of the machine continues to process tubs. This contributes to the high productivity and availability of the robot cell.
The required flexibility is ensured by the modular design and the advanced control systems – with the result that the system can be configured to the customer’s needs. A two-pallet option is available and the syringe inspection process can be removed if not required.
Other printing options are also available such as laser or inkjet printing. In any case, the machine is capable of handling both 3” and 4” tubs with 100 or 160 syringes per tub. Compact design is – as required – also ensured: the cell fits a 3m by 3m footprint and can handle 600 syringes per minute.
A crucial factor for the customer is the hygienic design of the complete process. Here, Stäubli robots have a clear advantage. They are available in a “HE” version which means “Humid Environment” and denotes, for instance, that the robot can be installed in cleanrooms and production zones where extensive washdown processes are on the daily of shift-wise agenda. In this case, harsh cleaning agents including bleach were part of the specification.
Ward Automation Sligo has comprehensive experience with this type of requirements. John Walshe: “We have already used Stäubli robot installations in a similar environment exposed to a similar cleaning regime for over 10 years with no issues noted.” Concerning the approvals of medical technology, the robot cell is 21 CFR Part 11 compliant. Generating an audit trail and a batch report with electronic signatures on all GMP critical data was part of the design and manufacturing process.
Apart from their high hygienic standards, Ward Automation opted for Stäubli robots because they offer the necessary reach, speed, payload and high precision at high speeds: each single robot task has to be completed in ten seconds at maximum.
The machine is controlled by CS8C and CS9 controllers, each programmed with VAL 3. In the first step, the system was programmed offline using emulator software to simulate moves, check for reaches and set points. “Real” robots were not employed before fine tuning the programs. This saved time.
In the course of the project, Stäubli UK had supplied a demo robot for proof of principle testing and also training for the Ward Automation engineers and the customer who is very satisfied with the new and fully automated solution. John Walshe: “Our customer is able to fulfill 100% checks of syringes, labels and tamper seals – with the advantage that single syringes can be rejected and exchanged in the tubs with 100 items. Furthermore, various recipes for syringe sizes, tub size and number of syringes can be selected or programmed. This allows for the required flexibility.”