Cartoners, Case Packers, and Palletizers for Track and Trace Serialization of Pharmaceutical Packaging Lines
Pharmaceutical manufacturers have many good reasons to implement
track and trace technology within manufacturing and packaging
processes. Serialization allows manufacturers to ensure the integrity
of their product and compliance with emerging pedigree laws. Designed
primarily as a response to the increase of counterfeit
pharmaceuticals, pedigree and e-pedigree laws (for electronic
documentation) require manufacturers to show the complete life cycle
of the drugs they distribute, from the manufacturing process through
the end-of-line packaging.
Unit level tracking methods have been in
place for years. Lot/Expiration codes are ubiquitous on a wide variety
of products. But recent changes to the law have shifted the focus to
implementing track and trace systems with case packers and
palletizers. This can present a number of challenges to pharmaceutical
manufacturers, so selecting a qualified packaging machinery supplier
to work with the track and trace system supplier is vital.
Pharmaceutical companies already invest heavily in capital equipment
for manufacturing and packaging. By integrating track and trace
serialization technology with automated end-of-line packaging
machinery, pharmaceutical manufacturers can meet pedigree requirements
and maintain their levels of productivity in a single robust solution.
Packaging Machinery for Track and Trace Lines
Serialization systems track the product from the time it is placed in
its primary package (bottle, vial, tube, jar, pouch, etc.) to its final
placement on a pallet at the end of the packaging line. This requires
integrating inspection and tracking equipment from a track and trace
system supplier with the packaging machinery at each step in the packaging
process. It’s important to select an equipment provider who understands
the requirements being faced by pharmaceutical manufacturers. Ideally, the
packaging machinery supplier is also an integrator who can work with other
OEMs to successfully implement a track and trace packaging line.
TaskMate(R) Robotic Systems
Medical Device Assembly Systems
Custom Designed Equipment
Track and Trace Integration
The track and trace systems incorporate several types of equipment. First
labeling or other types of coding equipment place a unique ID code on the
item being packaged, e.g. bottles, cartons, blister packs, bundles, etc.
Next cameras and other sensors that are capable of reading the ID are
integrated with the packaging machinery at various stages in the
packaging process such as cartoning or case packing. Print and apply
labelers are integrated to label the case with information about its
contents, and these labels are also inspected for accuracy. Reject
systems are integrated to allow improper product to be removed from the
The packaging equipment to be integrated with the serialization system
should also be considered carefully. Automated packaging machinery is
better able to handle production speeds needed to factor in the time it
takes to record the serialization information without diminishing
overall production rates. The process typically begins with the primary
packaging equipment. Individual products, be it bottles, cartons, trays,
or bundles, are labeled with a unique identifying code during the
primary packaging of the product. It is this code that the track and
trace system uses to create information about the contents of each
carton, case and pallet.
Storing Serialization Data
Track and trace serialization systems incorporate a means for recording
and storing the serialization data for each production run. This is
usually accomplished through a dedicated PC integrated with the printers,
cameras, and sensors. The centralized data point allows the system to
distribute serial number information to each packaging level at each
tracking point such as when the product is cartoned, when the carton is
case packed and when the case is palletized. These systems interface with
the packaging machinery controls to allow the exchange of information.
Robotic Track and Trace Inspection Systems
The simplest application for track and trace systems is the pick-and-place
inspection of products. Whether the product is an aggregation or an
individual carton or bottle, a properly programmed robotic cell with
well-designed end-of-arm tool (EOAT) can pick the object, pass it in front
of a vision inspection system or a barcode scanner and place it in a bin
or on a conveyor, depending on whether the product is rejected or passed
downstream for further packaging.
Robotic inspection works well in applications that require an aggregation
to be verified after individual products have been bundled, and
aggregation scanning equipment cannot be integrated into an existing
machine. The stand-alone robotic system can pick the bundle and move it
under or over a scanning device. The system allows for rescanning the
bundle in the event of a read error. The scanning device can also verify
the count, the bottle or carton status and create a list of each item in
the bundle. The robot places rejected bundles in a reject bin to be
reworked or discarded.
Track and Trace
Cartoners and Case Packers
Pick and place inspections systems are not the only robotic application for track and trace packaging machinery. Robotic systems can be used in an end-to-end packaging line to help track the first product in all the way to the finished pallet, ensuring the integrity of every product, every case, and every pallet throughout the production process. For example, a packaging line for pharmaceutical bottles begins as each filled and closed bottle is marked with a unique serial number, which may be printed on the label, on the bottle or on an RFID. In a cartoning application, sensors verify the code as each bottle enters the cartoner infeed, which may be robotically loaded. After the carton and any required leaflets are loaded, cameras and/or sensors verify the carton contents before it is sealed and labeled.
In a case packing application, bottles may be conveyed directly to a case packing cell with integrated serialization system. As products labeled with unique identifying codes enter the infeed and collation zone, cameras on all four sides of the product capture the code and store it in the system microprocessor. The products are then collated and loaded into the erected RSC case.
Robotic case packers for track and trace applications incorporate EOAT that uses a unique suction cup with integrated vacuum sensors that allow the EOAT to verify that it has picked all of the bottles in the pack. Automatic leaflet feeders with track and trace inspection verification may be added to the case packer to automate the full case loading process. Camera inspection systems take a picture of the loaded case and compare it to a picture of a correctly loaded pattern to verify that all components have been correctly packaged.
Cases with complete patterns are tagged as “good.” Incomplete cases are not tagged, causing them to be automatically rejected at the case packer discharge. Good cases are then labeled with track and trace information about the contents of the case. The label may include a 2D code, a barcode, human-readable code, a writable RFID tag, which is encoded after the case is packed, or a combination of all three. By tracking each serial number in the pack pattern and applying that information to a unique case, the manufacturer can know at all times exactly where each bottle is in the packaging process. This process would be the same if the product being case packed was a carton, bag, blister pack, or bundle.
Track and Trace Pallet Cells
Robotic palletizers also integrate easily with track and trace systems.
Prior to palletizing, labeled cases are verified at the case infeed
conveyor. The system either presents the label to the barcode reader or a
barcode reader positioned on the conveyor can read the label before the
case is picked. In either scenario, incorrect cases can be rejected for
rework. Robots can also be programmed to position the case label so that
it can be seen and scanned at pallet’s final location.
Robotic palletizers can be integrated directly with track and trace case
packers to create a complete end-to-end system. High speed case packers
integrated with stand-alone robotic pallet cells can handle up to 20-25
cases per minute using two robots, one to case pack and one to palletize.
Track and trace packaging lines requiring lower speeds, between 5-6 cases
per minute, can incorporate case packing and palletizing with a single
robot to create a very compact track and trace packaging solution.
Labelers and scanners are also integrated with robotic palletizers. Fully
loaded pallets are also labeled using RFID tags, bar codes or readable
codes to fully verify the contents of the pallet.
By integrating OEM serialization systems with packaging machinery,
pharmaceutical manufacturers can secure their supply line from
counterfeiting and meet current and future pedigree requirements. The
investment in integrated equipment provides a streamlined process that can
be easily reconfigured for future applications.