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Regulatory: Page 69

Pharmaceuticals
Next Generation Blood Collection and Separation Technology Receives FDA 510(k) Clearance
A new BD plasma blood collection tube is now commercially available to improve laboratory efficiency.
November 15, 2016
Next Generation Blood Collection and Separation Technology Receives FDA 510(k) Clearance
Pharmaceuticals
HDA Surveys Show Promising DSCSA-Ready Results
Pilot Study for Saleable Returns recommends two scenarios to help with compliance. Meanwhile, majority of manufacturers say distributors will start to receive serialized products before the Nov. 27, 2017 DSCSA deadline.
November 14, 2016
Aseptic/Sterile
MG2: Pharma Zone Cleanroom Chambers
Three cleanroom chambers for pharmaceutical provide a safe working environment and can be used to increase the range of feasible tests.
November 11, 2016
MG2: Pharma Zone Cleanroom Chambers
Pharmaceuticals
Bell and Howell Helping Pharmaceutical Companies Navigate DSCSA
Company hosting Southeast Traceability & Serialization Forum Nov. 17. Agenda includes updates from Excellis Health and the Healthcare Distributor Alliance.
November 11, 2016
Bell and Howell Helping Pharmaceutical Companies Navigate DSCSA
Pharmaceuticals
Panel Offers Advice to Implement Pharmaceutical Serialization
Meeting the November 2017 compliance deadline needs top management commitment and involve packaging line operators.
November 10, 2016
Practical advice for serialization implementation
Packaging/Filling
Meeting looming pharma serialization requirements with off-the-shelf technology
A high-speed case packer has been outfitted with serialization equipment for aggregation with less integration time.
November 9, 2016
A high-speed case packer has been outfitted with serialization equipment for aggregation with less integration time.
Pharmaceuticals
A Personal Perspective on Serialization
With the U.S. serialization deadline only a year away, compliance is crucial, especially for patients whose lives may depend on the very medications requiring serialized codes.
November 8, 2016
Optel Vision's Mario Simard (at podium) and Steve Peterson co-presented 'Serialization-Regulatory Compliance' on Tuesday, Nov. 8
Traceability/Serialization
RM2 Launches a Smart Pallet, Uses AT&T's LTE-M to Harness IoT
RM2ELIoT, a fully integrated, zero maintenance, long-life, IoT-based track and trace solution uses AT&T’s LTE-M network to boost connections for IoT.
November 8, 2016
RM2ELIoT, a fully integrated, zero maintenance, long-life, IoT-based track and trace solution uses AT&T’s LTE-M network to boost
Materials
Considerations for Implementing Single-Use Filling Systems
More targeted medical treatment therapies push the single-use systems option for fill/finish operations.
November 7, 2016
Bosch
Labeling/Printing
How Invisible Code Supports Internal Pharma Supply Chain Traceability
Videojet demonstrates at PACK EXPO how invisible codes can assist in anti-counterfeiting, track and trace and serialization issues.
November 7, 2016
Videojet demonstrates at PACK EXPO how invisible codes can assist in anti-counterfeiting, track and trace and serialization issu
Inspection
New Image-Based Blister Testing
Non-destructive leak detection technology for pharmaceutical blister packaging boasts new and improved test time, data management and test sensitivity.
November 7, 2016
Sepha's VisionScan System
Pharmaceuticals
FDA: 21 Grants Awarded for Development of Products for Rare Diseases
The Orphan Products Clinical Trials Grants Program awarded over $23 million in grants to academia and industry. Many of the grants target cancer, pediatric needs.
November 4, 2016
FDA: 21 Grants Awarded for Development of Products for Rare Diseases
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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
An attack on refrigeration controls highlights the role of thermal packaging, independent temperature monitoring, and emergency transfer plans in protecting life sciences products.
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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Are Bacteria Cellulose Face Masks the Future of Skin Health?
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AI-enabled X-ray Inspection Software Platform
At PACK EXPO, Eagle launches SimulTask 6, which offers food processors advanced image analysis, real-time production monitoring, automated reporting, and task-based inspection.
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