What ISO 11607 revisions mean to you

Compliance responsibilities that were clearly outlined in section 4.4 of the current standard have been omitted from the new International Standards Organization (ISO) 11607-01. Therefore, confusion may arise over certain areas of responsibility such as: • Who should test the packaging suppliers' seals? • Who is responsible for validating package sealing equipment? • Who is responsible for evaluating the biocompatibility or other material characteristics such as microbial barrier properties?

May 10th, 2006
Medical device manufacturers must take care up front with contractors and vendors to determine roles and responsibilities in the entire package development and validation process.

Most of the changes to the standard will have little effect on how you design your packaging and sterile barrier systems for your devices. However, there are some nuances that will require additional testing and some subtleties for performing a final package system validation as described in Clause 6. There are also other areas of relief from testing such as using previously documented studies for stability testing and documented evidence of previous evaluations for material compatibility.

For more information on how ISO 11607 revisions may affect you, listen to the DDL on-demand webinar. [HCP]

By Patrick J. Nolan

Patrick J. Nolan is COO of DDL Inc., a package, product, and material testing lab. He is part of the Task Group within the AAMI Sterilization Packaging Working Group that developed the revised Technical Information Report for the ISO 11607 revisions.
Screen Shot 2020 05 21 At 1 30 14 Pm
Human Factors Expert Interprets Nurses’ Wishes
Whether in the healthcare setting or the home, an end user may desire one packaging feature, but actually need another.
May 21st, 2020
Pat Reynolds Headshot
Packaging Post-Pandemic
Nobody can measure with any real accuracy what impact Covid-19 will have on packaging. But what packaging professional wouldn’t value a glimpse into how things might look post-pandemic, especially if that glimpse comes from an experienced veteran?
May 21st, 2020
Sustain 6
Looking Ahead to New Packaging Material Innovation
Packaging engineers and product developers must work together to create new sustainable initiatives in packaging material innovation.
May 22nd, 2020
Essex & Herts Air Ambulance (EHAAT) in the UK now carries blood supplies on board its helicopters and Rapid Response Vehicles (RRVs).
Transport Bag Offers Pre-Hospital Blood Protection on Air Ambulances
Air ambulance operations manager: “The decision to start carrying blood products on board our helicopters and RRVs was a major one for the charity, one which has significantly improved the care that can be delivered to patients.”
May 22nd, 2020
Along with a new focus on function, Ethan’s has changed the color of each bottle to reflect the shots’ unique flavors and primary ingredients.
Function-Focused Rebrand for Wellness Shots
Organic energy shot company Ethan’s redesigns the labels for its 2-oz shots to clearly convey the occasion of use for each as well as emphasize the flavor and ingredient profiles.
May 20th, 2020
Getty Images 124460253
Economic Outlook: 2020 and Beyond
Discussing the current economic outlook amidst a “double black swan event,” Alex Chausovsky of ITR Economics presented “Guidance in an Uncertain Economy” last week as part of PMMI’s Executive Leadership Conference.
May 18th, 2020
Screen Shot 2020 05 15 At 10 53 58 Am
Research Highlights Two in Five Hospitals Lack Formal Drug Diversion Programs
According to the study on drug diversion in the U.S., almost 9 in 10 healthcare professionals say they have met or know someone who has diverted drugs.
May 18th, 2020
BIC North America will be producing 2,000 medical-grade face shields per day at its factory in Milford, Conn.
BIC Uses Plastic Packaging Materials to Produce PPE
Global CPG BIC gears up to produce 2,000 medical-grade face shields per day at its Connecticut facility, using plastic packaging materials and scrap plastic from its lighter products.
May 18th, 2020
At-Home Saliva Test
Quick Hits: FDA OKs First At-Home Saliva Test for COVID-19
The FDA issued an emergency use authorization for the diagnostic test.
May 18th, 2020
Schreiner MediPharm’s Booklet-Label for the needle protection system used by Sanofi in a clinical trial encompasses 32 pages.
Sanofi Clinical Trial Benefits from Compact, Multi-Lingual Booklet Label
Specialty Label for Needle Protection System in International Phase III Trial.
May 15th, 2020
The slim, e-com shipper comprises a hinged tray fitted with movable inner trays that securely hold the bottle and product literature.
Smart Supplement Shipper is Letterbox-Friendly, Sustainable
Brain health company Heights launches its D2C supplement product in a unique bottle and shipper made from bio-based materials that together measure less than one inch deep.
May 15th, 2020
Getty Images 1170191165
Healthcare Market Equipment Investments Poised for Growth in 2021
Personal care and pharmaceuticals /medical devices are two markets that, not surprisingly, are holding their own and even expecting growth during COVID-19.
May 15th, 2020
Getty Images 1127958533 Drug Prices
States Focus Legislation on Prescription Drug Costs
Though attention has turned to COVID-19, state legislatures were already pivoting away from last year’s opioid legislation to address drug prices—an issue that requires the Healthcare Distribution Alliance to engage across all 50 states.
May 14th, 2020
Just like in this iceberg image, hidden operating costs can sink you. Total cost of ownership enables gathering better data and understanding for better informed decisions.
It’s All About the Cost, Not the Price
Just like all change management, total cost of ownership is a journey that has transformational results when successfully implemented.
May 14th, 2020
Sustain 4
Machine Efficiency and the Impacts of Sustainable Packaging
Many primary packaging lines are no longer dedicated to a single product as SKUs increase, impacting line efficiency. Sustainable material changes may also create challenges.
May 13th, 2020
Getty Images 1022854424
DSCSA and COVID-19
How is the pandemic response impacting the complex and evolving national traceability goals for pharmaceuticals?
May 12th, 2020
Each & Every has rolled out a 2.5-oz deodorant tube made from bioplastic and a special black colorant that the company says can be detected by infrared scanners for recycling.
Sugarcane and Corn: ‘Ingredients Matter’ in New Deodorant Packaging
Vegan, cruelty-free deodorant from Each & Every introduces primary packaging made from sugarcane-based plastic and a corn-based bioplastic shipping envelope.
May 11th, 2020
Sustain 4
Quest for a Plastic Packaging Circular Economy
Eliminating unnecessary plastic, sustainable innovation, and circulating plastic within the economy are the three goals of more than 450 global partner companies seeking to keep plastic waste out of the environment.
May 11th, 2020
Sustain 3
Sustainable Package Reformatting on the Rise
According to a new report by PMMI Business Intelligence, over half of CPGs are changing product packaging to meet sustainability goals by moving from one format to another.
May 8th, 2020
COVID-19 Symptom Throat Sensor
Quick Hits: New Throat Sensor Tracks COVID-19 Symptoms
Scientists at Northwestern have developed a small flexible device that tracks symptoms associated with the virus.
May 8th, 2020
More in Home
3D Printed Ear Guards
Quick Hits: Kid Invents Device to Prevent Ear Pain from Face Masks
A 12-year-old boy is 3D printing and donating “ear guards” to support healthcare workers on the frontlines.
May 7th, 2020
Midol Before After[1]
Redesign Reverses Course to Reflect Modern Women
Midol®, the venerable OTC menstrual relief brand from Bayer, underwent a striking packaging redesign, reversing course on existing iconography, typography, and messaging.
May 6th, 2020
VR Training
Quick Hits: Healthcare Workers Use VR to Learn Skills for Treating COVID patients
Health professionals with little to no experience in treating infectious disease are learning with virtual reality.
May 6th, 2020
South Korean Doctors
Quick Hits: South Korea Says You Can’t Be Infected Twice
Scientists believe reported cases of coronavirus relapse were actually due to test failures.
May 5th, 2020
Roche
Quick Hits: Roche Increases COVID-19 Antibody Test Output
The FDA granted emergency approval for the antibody test that determines whether people have been infected with coronavirus.
May 4th, 2020
Getty Images 685013243
Preparing the Supply Chain for a Coronavirus Vaccine
As we fight to “flatten the curve” of the coronavirus pandemic, scientists are urgently working to create a vaccine. Manufacturing and distributing hundreds of millions of doses when a vaccine is approved is yet another challenge to address.
May 1st, 2020
Experts opened unbranded packaging as if they were in the field, with the livefeed cast on screens in the main HealthPack conference room.
Recycling Device Packaging in the Operating Room
Two healthcare veterans discussed how recycling fits (or doesn’t) into their fast-paced OR operations at the Nurses’ Panel at HealthPack.
Apr 30th, 2020
A3 Webinar Covid Robotics Panel2
COVID-19 Brings Increased Visibility to the Role of Robotics
Presidents and CEOs of Fanuc, Universal Robots, Fetch, and Schunk discuss how robotics and automation are helping manufacturers through the pandemic and what the lasting effects might be.
Apr 28th, 2020
Ambient Distribution Getty Images 984835220
HDA: The Need for Distributor-Pharmacy Partnership During Pandemic
Healthcare Distribution Alliance is seeking to provide “a greater understanding of how distributors are working each day” to meet inventory needs for supply chain partners and patients.
Apr 28th, 2020
Getty Images 1207248534
Material Innovation Key to Achieving Sustainable Packaging Strategy
The market will continue to see innovations in the selection of sustainable packaging materials, as more companies embrace sustainable options.
Apr 27th, 2020
E Tk Ld6 J Ws Aa Exco
Global Impact of Covid-19 on Manufacturing
Three CEOs of leading manufacturers of packaging and processing machinery and equipment met virtually with PMMI to discuss strategies in conducting their operations amid the pandemic affecting today's world.
Apr 27th, 2020
Infographic
U.S. Packaging Machinery Industry Continues to Grow at Steady Pace
OEMs are feeling the pressure to accommodate market demands, such as offering complete packaging solutions, modular machines, traceability, and sustainability.
Apr 24th, 2020