Serialization & Track-and-Trace: Page 62

Traceability/Serialization
The healthcare community and the government shutdown
What’s the impact from the just-ended shutdown for makers of pharmaceuticals, biologics, and medical devices? Give us your opinion.
October 18, 2013
What does the recently ended government shutdown mean for the healthcare community?
Materials
Marchesini: Bottle track-and-trace line
Provides reliability and precision throughout all packaging line phases.
October 8, 2013
Marchesini: Bottle track-and-trace line
Materials
Serialization and unique device identification developments
Key regulatory developments could preempt California e-pedigree and provide clarity for manufacturers and packagers of pharmaceuticals, biologics, and medical devices.
October 8, 2013
TRAXSECURE UNALTERED. The TraxSecur™ security feature is printed, without a requirement for any special inks, as a background that looks similar to those seen on security paper, except that it is created as a unique “instance” relating to a single time and place, which inextricably links an individual package to its unique corresponding track-and-trace information; this is Serialized Security™.
Pharmaceuticals
U.S. House passes track-and-trace bill
H.R. 3204 now awaits Senate approval. If passed into law, the new bicameral bill would preempt California e-pedigree and give industry more time to comply.
October 1, 2013
The U.S. House passed a track-and-trace and compounding bill.
Labeling/Printing
Track and trace/serialization for bottles
Marchesini Group's NERI RE202 1T 1C automatic rotary labeling machine applies self-adhesive or glued labels; can be equipped with one to two label dispensing heads. Designed to position and label oval, shaped, or cylindrical containers.
September 27, 2013
Hp 48042 Thumbnail 2 B01fb053 V3
Traceability/Serialization
Fully-integrated turnkey serialization retrofit for existing packaging line
Acsis' Serialization in a Box solution allows for management of serialized and non-serialized product simultaneously through the bundle to the case and all the way out through packaging and distribution.
September 24, 2013
Hp 47997 Thumbnail 2 457633a3 V5
Materials
UPS survey finds global healthcare executives driving supply chain transformation to reach new markets
Investments planned in areas such as technology amid growing concerns over product protection, global regulatory environment.
September 17, 2013
UPS survey shows supply chain issues in North America.
Labeling/Printing
Marchesini: Track-and-trace labeler
Applies two tamper-evident labels; prints 2D codes and human-readable data onto cartons.
September 5, 2013
Marchesini: Track-and-trace labeler
Pharmaceuticals
Working with CMOs under California e-pedigree
For different products, manufacturers may fill the role of an exclusive distributor, a contract manufacturing organization, or a repackager. Each of these would be treated differently under the California law with respect to pedigree origination and updating.
August 28, 2013
Figure 1. Manufacturer A is probably acting as a contract manufacturer/packager on behalf of the NDA holder, manufacturer B.
Materials
PCI invests in Packaging's Future
Drug delivery developments and pending serialization requirements justify this contract packager’s capital equipment, facility, and personnel investments.
July 22, 2013
Packaging Coordinators, Inc. changed its signage recently at its Rockford, IL, location.
Inspection
Omega Design Corp.: Vision module for serialization
LabelSync 450 for matching line codes to serialized labels handles up to 300 bpm.
July 18, 2013
Omega Design Corp.: Vision module for serialization
Pharmaceuticals
Will generic pharmaceutical manufacturers serialize their drugs in time?
Consider what impact it might have on your business if your company is not ready.
July 11, 2013
Dirk Rodgers
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Top Stories
Under the TIA/MWF petition, a single QR code could stand in for the printed compliance leaflets that ship with smartphones today, linking to a regulatory page manufacturers could update after products reach store shelves. For phones, the device itself provides an offline backup. OTC and pharma brands considering the same swap for package inserts have no such fallback.
Labeling/Printing
Telecom Asks FCC to Let On-pack 2D Codes Replace Printed Regs
Telecom groups want the FCC to let a QR code replace printed regulatory text on device cartons, an idea the agency shelved in 2017. The questions it raises, from code standards to the 1 in 11 U.S. adults without a smartphone, may inform or shape how OTC, pharma, and CPG brands move leaflets and on-pack text online.
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Sustainability
Consumers Want Sustainable Health Packaging, but Not at the Expense of Quality
Commercial blood bank refrigerator with multiple shelves storing blood bags in a medical laboratory setting
Temp Control/Cold Chain
How a Blood Bank Cyberattack Put Remote Access on Blast
Sealed sterile syringe with needle in clear plastic packaging on dark background
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
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Robotics/Automation
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