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402 Results
Type: Article
Section: Industry News > Regulatory
Materials
Partnerships and Expertise Guide Promius Pharma’s Serialization Efforts
Promius Pharma, a Dr. Reddy’s Laboratories subsidiary, sees its trading partners pushing to meet aggregation requirements earlier than current regulatory requirements.
May 4, 2017
From left to right, Javier Gonzalez, Director of Combination Products and Packaging Development, Promius, Prateek Lal, CEO, Adept Packaging, and Amit Kulkarni, Associate Director Package Engineering and Development, Promius.
Robotics/Automation
Chartwell Relies on Software to Comply with Track-and-Trace Deadlines
Scalable software helps pharma firm quickly serialize products from several bottling lines. New bottle labeler, camera and printer all contribute to a track-and-trace solution.
May 2, 2017
Scalable software helps pharma firm quickly serialize products from several bottling lines. New bottle labeler, camera and printer all contribute to a track-and-trace solution.
Pharmaceuticals
Taking a Multi-Layered Approach to Pharmaceutical Counterfeits
Tamper-verification, security features, serialization, and track-and-trace measures can help pharmaceutical manufacturers ensure their products are authentic.
May 1, 2017
An example of a serialized pharmaceutical carton.
Robotics/Automation
LSI Produces Labels In-House, Saving Costs and Maintenance
ERP system integration with TEKLYNX enterprise barcode labeling software reduces label process time from days to minutes.
April 28, 2017
LSI, TEKLYNX customer service.
Labeling/Printing
Exploring the Hidden Challenges of Serialization
Part I of a three-part series looks at decoding and verifying serialization to meet the FDA’s Drug Supply Chain Security Act.
April 27, 2017
DIN-ISO 15415 grades the data matrix code in six different categories.
Labeling/Printing
Lab Automates Serialization Efforts
A serialization system helps a laboratory meet DSCSA requirements in a small footprint, handling cartons or flat blanks.
April 26, 2017
Pineberry's CartonTrac helps a laboratory meet DSCSA requirements in a small footprint, handling cartons or flat blanks.
Pharmaceuticals
Temperature Issues that Affect Clinical Trials Packaging
From new therapies to direct-to-patient provisions, clinical trials processes have evolved. How are temperature controls keeping up?
April 19, 2017
Temperature-controlled packaging is focusing more on security around seals and tamper-evident closures, along with greater use of GPS tracking and geofencing to address DSCSA concerns for drugs in transit.
Packaging/Filling
Process Strategies for Serialization Success
From mobile serialization cells to customized equipment, serialization systems may be unique to each application, but there are common approaches to solving them. An expert discusses success stories, and what factors should influence your strategy.
April 17, 2017
Process Strategy #3 involves moving serialization equipment between lines, which may fit a company’s needs for flexibility.
Materials
Strengthening the Supply Chain
A chain is only as strong as its weakest link. This is becoming clear to the pharmaceutical industry as it struggles to comply with FDA regulations that will require the electronic exchange of serialization data.
April 13, 2017
When emergencies erupt, Direct Relief provides medical supplies that victims need to survive.
Materials
Packaging Machinery Helps Swiss Pharma Firm Produce Tibetan Meds
Blister packing, cartoning and case packing equipment from Romaco prove critical to PADMA’s automated packaging of herbal meds made and certified under internationally approved pharmaceutical guidelines.
March 30, 2017
Blisters are turned 90 degreesin a vertical twist prior to de-stacking.
Materials
Afton Scientific Uses Customized Serialization for Vial Cartons
Cartons and cases of aseptically filled glass vials are serialized and aggregated in advance of DSCSA deadlines.
March 28, 2017
Afton Scientific’s Kari Moore (left) and Ashley Umberger stand beside the packaging line where the serialization equipment is seen on the conveyor, with the aggregation equipment on the tabletop.
Pharmaceuticals
Allergan Introduces Restasis in a MultiDose Bottle
Preservative-free dispenser replaces single-use vials and reportedly represents the first time it is used for a prescription dry eye product in the U.S.
March 23, 2017
Preservative-free dispenser replaces single-use vials and reportedly represents the first time it is used for a prescription dry eye product in the U.S. (Photo courtesy of Allergan Inc.)
Inspection
Evaluating Materials for Container Closure Systems for Medical Products
Materials include glass, metal, plastic and rubber, each of which has advantages and disadvantages. Factors such as the physical performance, the nature of supply and the chemical compatibility of the material must be considered.
March 14, 2017
Emilia Hevelke prepares samples for testing in Smithers’ analytical chemistry laboratory in Leatherhead, U.K.
Materials
Panacea’s Cancer Vaccine Delivered Direct to Dermis
Panacea Pharmaceuticals’ Phase 1 clinical study of an innovative cancer vaccine reaches a milestone by dosing its first patient directly to the dermis via a 3M Hollow Microstructured Transdermal System.
March 7, 2017
Panacea Pharmaceuticals’ Phase 1 clinical study of an innovative cancer vaccine reaches a milestone by dosing its first patient directly to the dermis via a 3M Hollow Microstructured Transdermal System.
Traceability/Serialization
Serialization Lessons from a CMO
PACK EXPO East: Patheon, which has invested a lot of time and energy designing and building out serialization on pharmaceutical packaging lines, has learned a lot from the experience. Here’s what you need to know.
March 3, 2017
Christopher Howell, Patheon’s senior director of global engineering and technology.
Materials
MicroVention Improves Total Production Efficiency 50%
Enterprise-level label management system integrates with MicroVention’s ERP system to streamline global labeling process.
March 1, 2017
Shown here is a TEKLYNX vial scanner in use.
Materials
Addressing Serialization and Aggregation Head-On
CordenPharma Latina moves ahead of the curve when it comes to track and trace, serialization and aggregation as a full-service partner in the contract development and manufacturing of Active Pharmaceutical Ingredients (APIs), drug products and associated packaging services to the global pharmaceutical industry.
February 14, 2017
Shown here is a serialized folding carton for a CordenPharma product.
Adherence/Delivery
Top 10 Stories Focus on Commercial Package Innovations
Compliance packs, Mylanta and SmartMouth introductions, as well as an FDA ruling, and medical marijuana challenges resonate as HealthcarePackaging.com’s most-read stories in 2016—along with a video on shipping temperature-sensitive pharmaceuticals.
January 6, 2017
HCPC Compliance Package of the Year: Vertex ORKAMBI® Medication Package from PCI Pharma Services
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