Quick Hits: FDA Gives Opioid Overdose Detector Breakthrough Status

The device contains a biosensor that detects fatal side effects of opioid abuse.

Mar 13th, 2020

RESPMETER

Medgadget

A recent Medgadget article reported on a new device aimed at combating the opioid crisis. The RESPMETER wearable biosensor from Altair Medical just achieved a breakthrough device designation from the FDA. The device is a wireless sensor that is worn on a patient’s chest to detect Opioid Induced Respiratory Depression (OIRD), a common deadly side effect associated with the use of opioid drugs. When the RESPMETER detects signs of OIRD, it notifies designated first responders who can intervene by administering naloxone.

To get better cybersecurity results, companies have started creating dedicated departments or teams within the IT department that are responsible for cybersecurity.

Personnel Training: A Critical Third Step in Cybersecurity

The best cybersecurity plan is only as good as the individuals tasked with carrying it out.

Attracting and retaining a quality workforce in manufacturing is a systemic key business challenge.

Attract and Retain a Quality Workforce, Insights with Gardner Carrick at PMMI’s ELC

NAM and MI programs and research bring information into labor outreach efforts and retention of a diverse, quality workforce.

High Desert Pure's Full Spectrum CBD Lotion in an airless pump container (3.5 oz).

Smudge-Proof Cannabis Batch Labels Offer Colorful Compliance

High Desert Pure employs on-demand printing for up-to-the-minute compliance and traceability information for its nearly 30 SKUs.

Leading Food Companies to Receive Sustainability Excellence in Manufacturing Awards at PACK EXPO Las Vegas

ProFood World is set to honor Conagra Brands, Smithfield Foods, B&G Foods, Liffey Meats, and Graphic Packaging International for outstanding sustainability achievements.

How B2B can pivot to B2C operations.

The Logistics of Pivoting from B2B to B2C

The pandemic has brought swift surges to e-commerce and D2C sales. How can a traditionally B2B company quickly pivot to the B2C market during these times?

PACK EXPO Las Vegas and Healthcare Packaging EXPO. Packaging. Processing. One Powerful Show.

Register for the Return of PACK EXPO Las Vegas and Healthcare Packaging EXPO

After more than a year without in-person trade shows, attendee registration is now underway for the only comprehensive packaging and processing trade show in the world in 2021.

Expedite Med Device Approval with FDA’s New Program

Medical device manufacturers can potentially speed review by testing to recognized standards performed at a list of FDA-accredited labs released in April 2021. Watch this Take Five video to learn more.

Check out the links to our coverage of the 2021 PDA Annual Meeting. While the live event has passed, the event site is full of on-demand content covering pharmaceutical filling, supply chain considerations, vaccine manufacturing, and more through May 16.

2021 PDA Annual Meeting: Trend Roundup

The Parenteral Drug Association (PDA) virtual conference offered plenty of new perspectives in aseptic filling, flexible facilities, and more.

The First Step to Increasing Cybersecurity is to Analyze Operational Vulnerabilities.

The First Step to Increasing Cybersecurity

There are a number of straightforward and understandable steps companies can take to protect their operations from cyberattacks. The first is to analyze operational vulnerabilities.

Enter AmeriStar Competition For Package Design: Deadline May 21

AmeriStar entries are accepted across 17 categories, and include three special top awards: Best of Show Award, Sustainable Packaging Award, and Design Excellence Award. Here's your chance to gain recognition for your innovative package design.

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A New Model for Digitizing Supply Chain Operations

Global supply chain leaders are collaborating to shape and transform next generation digital supply chain networks.

“The healthcare sector is both a significant contributor to the global planetary health crisis and uniquely burdened by it,” says Practice Greenhealth’s “Why Sustainability” page.

30 Sustainability Stories in Healthcare Packaging

In honor of Earth Month, we round up thirty stories of varying lengths and topics in life sciences and personal care packaging sustainability.

Steriline designed an auger filling head equipped with a customized screw shape added to the PVFCM50 to protect product integrity

Bess Pro Creates Small Batch System for Powder Filling Line

Turnkey system to improve vial filling from manual and lab-scale to up to 200 vials/min provided in only 10 months despite the pandemic.

Blake Griffin, senior analyst, Interact Analysis presenting on predictive maintenance strategies at PMMI's Executive Leadership Conference.

Live at the ELC: OEMs Can Monetize Predictive Maintenance

Predictive maintenance is an emerging technology for packaging and processing equipment that has the potential to disrupt the OEM business model.

Inputs for materials, equipment, and labor will be getting more expensive across the board, but a tight labor market will be the biggest limiting factor for CPGs. Automation is a great way to circumvent this.

Live at the ELC: Economic Forecast for Brands Timing Their Packaging Machinery Procurement

The U.S. and global economies are poised for a long period of expansion, meaning more consumer spending power and top line growth for brands, but also higher input prices for CPGs, including materials, machinery, and labor.

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Pre-Fabricated POD for Filling? Don’t Overlook One Key Topic | Modular: The Modern Way of Manufacturing Injectables

If you’re implementing a pre-fabricated POD at your facility, this Take Five video answers why you can’t overlook space for support systems. Also covered: As injectables increase, they become more customized, requiring modular, future-proof equipment.

No automation needed to be replaced with the switch from PET to aluminum, which was good news for Nature’s Baby. The existing filling line is capable of handling the new aluminum bottles with limited adjustments.

Organic Baby Shampoo & Conditioner Brand is Latest of its Ilk to Go All-In for Aluminum

Nature’s Baby Organics is another recent entry in the shift away from plastic, and toward aluminum, for packaging of personal care and bath products, particularly specialty products with elements like vegan, organic, or cruelty-free.

Adoption of AI in validation and other processes, including data collection and management, can result in valuable predictive qualities within a manufacturing facility.

Data and AI Accelerate Digital Transformation in Pharma

The PDA Annual Meeting emphasized the growing need for pharma manufacturing facilities to become digitalized to improve productivity, open the door to further technologies, and make the most of the ‘digitally native’ workforce.

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CANnabis or CAN’Tabis: Where is Cannabis Heading Amid New Administration?

Listen in as Healthcare Packaging's director of editorial content talks new directions for cannabis regulation, packaging updates, consumer behavior, and more.

Could FDA's ASCA program save submission time and boost pre-market testing consistency in the medical device industry?

Demystifying FDA’s ASCA on Biocompatibility for Expedited Review

Live from MD&M BIOMEDigital: Medical device manufacturers can potentially speed review by testing to recognized standards performed at accredited labs.

More in Home

The SentiAR Wearable Command Center is an interprocedural augmented reality (AR) system—with the user interface built off the Microsoft HoloLens—that enables the electrophysiologist to model the heart.

Medical Product Changes Stemming from User Centered Design

Live from MD&M BIOMEDigital: a startup, a consultancy, and a large brand owner talk about how interacting with end users changed their medical device and machinery designs.

The difference between IT and OT cybersecurity attacks.

Cybersecurity 101: The Difference Between IT and OT Attacks

There are two categories of cyberattacks, but they can create a bridge to one another, creating a potential avenue for cybercriminals to access the organization.

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5 Tips To Improve Your Remote/Hybrid Audits

Whether you’re a manufacturer or contract organization, audits are a key part of ensuring quality. Don’t overlook these tips from our 'Take Five with HCP' video when switching from in-person supplier audits to virtual or hybrid audits in the pandemic.

Communicating acceptance criteria with your lab is key in mechanical testing of passive shippers.

Mechanical Testing for Passive Thermal Coolers: Practical Q&A for Life Sciences

Live from ISTA’s TempPack: Experts discuss acceptance criteria guidance, payload selection, actual product versus placebo, testing multiple product configurations, and more.

Critical components need to be assessed to achieve a robust cybersecurity system.

Manufacturing Cybersecurity: Critical Components for Risk Assessment

By the second quarter of 2020, cyberattacks targeting manufacturers accounted for 33% of all incidents across all industries with losses totaling hundreds of millions of dollars. Small businesses are also at risk.

A prototype based on a single-click pump in collaboration with supplier NeoCeram.

Reducing Aseptic Risk During Filling

At #PDAannual, Novo Nordisk discusses innovative solutions to modernize aseptic filling in existing facilities while minimizing downtime, regulatory impact, and rebuild.

Each 'bird type' has specific ways of communicating, receiving information, and responding to crises.

Use ‘Bird Styles’ to Improve Your Communication in Crisis

Tips for communicating in a crisis so that people listen. Says one consultant, 'If you find yourself carefully crafting an email because you're instinctively cautious about how it might be received, don't write it.'

2021 Ista Virtual Forum Noblue

ISTA Forum Focuses on Packaging for Transport, and Temp Controlled Packaging

The 2021 Virtual ISTA Forum, including TransPack and TempPack, will be held on Tuesday, March 30th and Wednesday, March 31st.

GOLD AWARD—Technical Innovation—Amcor's Dual Chamber Pouch by Amcor Flexibles

Dual Chamber Pouch Keeps Medical Devices Safe

The FPA honored Amcor with a Gold Award in Technical Innovation for its Dual Chamber Pouch, a specialty multi-layer pouch consisting of a peelable medical device chamber and a non-peelable desiccant chamber.

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Blow-Fill-Seal Expands in Aseptic Filling, Vaccines

Live from #PDAannual: Recent developments in the technology have bolstered the use of BFS in aseptic processing, including temperature control and needle addition for pre-filled syringes.

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5 Tips on Remote Auditing Contract Organizations

Switching to hybrid or virtual audits? Check out these tips for a smoother transition. Additionally, PDA is holding a remote audit and inspection workshop Apr. 8.

'Your lovin' gives me a thrill, but your lovin' don't pay my bills.' From Money (That's What I Want) first released in August of 1959, written by Motown's Barry Gordy and Janie Bradford.

How does Your Salary Compare?

Are you among top earners or are you sorely in need of a raise? Calling for industry-wide response to annual salary survey conducted by IoPP and covered in Packaging World Magazine.