Your source for news, trends and analysis of pharmaceuticals, biologics, medical devices, and nutraceuticals.

Two pharmaceuticals and one medical device package were among those to win the Institute of Packaging Professionals’ 2007 AmeriStar Awards. In the Pharmaceutical and Drug category, Mylan Pharmaceuticals chose MeadWestvaco Health & Beauty Packaging’s Shellpak (shown) to answer Wal-Mart's challenge to its generic prescription drug producers to provide cost-effective, patient-adherence packaging.

Packaged wet wipes give hospital personnel and patients a weapon to fight the spread of bacteria. Sustainable packaging of these wipes could be next. ...The healthcare community is understandably concerned with the spread of diseases such as MRSA (Methicillin-Resistant Staphylococcus Aureus), or staph, and C. Diff (Clostridium Difficile), a diarrheal disease. One way to combat such diseases, either in a medical facility or at home, is through hygiene, which may include the use of specialized wet wipes, contract-manufactured and packaged by Fredonia, WI-based Guy & O’Neill, Inc. for a wide range of customers and applications.

Jan Gates, principal sterile barrier (packaging) engineer, Abbott Vascular, offered the following recommendations when considering hiring a consultant, or working with consultants. Her comments come from the January 28 MD&M (Medical Design & Manufacturing) West Conference in Anaheim, CA:
• Hire a consultant when temporary assistance is required – new business deadlines, short term business problems, independent advise needed, searching for cost savings, etc.

A cloud of uncertainty hangs over the pharmaceutical industry in Puerto Rico following the expiration of tax incentives from Section 936 of the U.S. Internal Revenue Code. Could emerging combinations of biopharmaceuticals and medical devices provide a silver lining? A report from Interphex Puerto Rico.

Since incorporating in 1993, North Brunswick, NJ-based Artegraft Inc. has used glass tubes to ship its U.S. Food and Drug Administration-approved Class III natural collagen vascular grafts to hospitals, clinics, or hospital distributors. But occasional breakage during distribution and the desire to trim costs led the company to make a change this year to Eastman Chemical’s Eastar Copolyester MB002 resin. Eastman worked with O.Berk Co. to make the conversion. As a result of its transition to the tube, which incorporates a flat side, Artegraft is preventing breakage and saving money.

There exists “a great deal of misinformation” when it comes to accelerated aging of medical device packaging, said Curt Larsen of Spartan Design Group, LLC (952/380-1458), at the January 28 MD&M (Medical Design & Manufacturing) West Medical Device Packaging Conference in Anaheim, CA.

Certain types of cancer are becoming "chronic" diseases and call for changes in packaging, according to Dr. Joseph Gligorov, an oncologist in France. He made these remarks February 6, 2008, at Pharmapack in Paris, France, during a session titled, "Cancer Treatment: The Emerging Role of Packaging." While cancer rates are growing around the world, from 10 million cases diagnosed in 2000 to 15 million projected in 2020, many of these are due to the aging population, people who may also suffer from a variety of other ailments. More than 650 drugs to fight cancer are currently in the pipeline.

Attending the yearly HealthPack conference is an important educational opportunity for the medical device community, agree John Spitzley (shown in photo) and Curt Larsen, the event’s co-chairmen who developed the agenda for the March 4 – 6 event at the Sheraton Gunter Hotel in San Antonio. “At HealthPack 2008, the keynote speaker will be Mary Jo Steiert, president of AORN, the Assn. of periOperative Registered Nurses,” says Larsen.

A medical device packaging track chaired by Randall Troutman (shown in photo), CPP, Oliver Medical Products, will take place from 9 a.m. to 4 p.m. Monday, Jan. 28, during the MD&M (Medical Design & Manufacturing) West Conference at the Anaheim Convention Center, Anaheim, CA. MD&M will be co-located with six other manufacturing shows at WestPack.

Validating heat sealers, dye penetration and burst tests, the consequences of designing packaging late in the product design process, and sterilization issues are among the topics that Jacob Kearns has answered in the past year on his "Medical Device Blog." Kearns is an engineer for a medical device company. Differing points of view may be shared on this blog.

Pharmaceutical firms seek packaging line improvements to cut costs, biologics present packaging challenges, and medical device growth is driven by aging baby boomers. These treatment advances bode well for the healthcare/life sciences packaging community. Packaging materials need to offer protection from point of manufacture to the “last mile” where healthcare products reach a patient. Packaging materials must provide barriers for moisture, oxygen, light and heat, and they may include overt and/or covert security measures to combat counterfeiting and diversion. Equipment will need to package products more efficiently, be validatable and versatile.

In this Q&A, Mel O’Leary, Jr., president and CEO of Meredith-Springfield Associates, describes how copolyester resin and supplier cooperation helped make the Artegraft tube. Meredith-Springfield is a plastic molder of technical hollow containers and custom bottles. It uses Eastman Chemical’s Eastar Copolyester MB002 resin to extrusion/blow-mold the Artegraft tubes.

A nurse/doctor forum convened by Rollprint earlier in the year served as the catalyst for the company’s new Duet functional peelable chevron header pouch. Designed to ease pouch access and improve aseptic presentation, the new-generation pouch was developed after operating room physicians and nurses from the Austin, TX, area participated in a packaging focus group. The intent was to glean insight into the pros and cons of existing sterile medical packaging and to better understand what innovative design improvements would help healthcare workers better perform their jobs.

* Arnitel VT 3104 film for medical applications such as gowns and drapes

* offers breathability and high melt point for sterilization

* optimized for cast extrusion and extrusion-coating processes

DSM Engineering Plastics

Packaging Hall of Fame inductee Edward J. Bauer, investigative reporter and award-winning author Katherine Eban, and Joint Equipment Transition Team (JETT) Chairman Jim John are among the speakers scheduled to make presentations at the upcoming Pharmaceutical Packaging Forum (PPF) 2008. Produced by Healthcare Packaging and Packaging World magazines, the event will be held on Wednesday, March 12, 2008 at The Rittenhouse Hotel in Philadelphia, the same venue that hosted the initial PPF March 29, 2007.

If ex-lifeguard Christine Doolittle has her way, patients who are unconscious or not breathing may one day be rescued thanks in part to an easy-to-access prefilled syringe pack she developed as a prototype last year while earning a Bachelor of Fine Arts Degree in Industrial Design from the Savannah College of Art and Design (SCAD) in Savannah, GA. The package is not being sold commercially. The prototype was developed as part of a Design Initiative between SCAD and Eastman.

* TPE materials said to provide oxygen barrier performance up to 10x better than conventional TPEs and equal to traditional thermoset butyl rubber for healthcare packaging and delivery systems

* avoid the risk of leaching into contents of medical containers or contamination of clean systems by eliminating the use of halogens and heavy metals used in curing thermoset rubber

GLS Corp.

* Plasma3 atmospheric plasma surface treater prints on materials used in medical device packaging, including Tyvek

"Continuous technological advancements in the medical device market coupled with an aging population provides wide opportunities for growth in the medical device packaging market," according to Urmila Kishore, analyst of the study The North American Medical Device Packaging Market from Frost & Sullivan.

“Continuous technological advancements in the medical device market coupled with an aging population provides wide opportunities for growth in the medical device packaging market," according to Urmila Kishore, analyst of the study The North American Medical Device Packaging Market from Frost & Sullivan. The study shows that the market earned revenues of $569 million last year, with that number predicted to rise to $918.8 million by 2013.

At a biomedical facility in Ireland, machine automation is coming into play in a validated environment that involves 21 CFR Part 11 electronic signatures, integrated robots and vision systems. The application is a real-world example of good automation standards providing real-world benefits. That’s according to Dr. Ken Ryan, director of the Center for Automation in Motion Control at Alexandria Technical College in Alexandria, MN. Ryan was recently interviewed by Ontheedgeblog.com blogger Keith Campbell. Also interviewed by Campbell was Shane Loughlin, president of SL Controls. Ryan and Loughlin were in Ireland at the time of the interview, investigating the healthcare packaging-related application that leverages automation standards to integrate best-of-breed equipment. The information in this article is excerpted from this recent interview. Listen to the complete podcast.

July 20, 2007 is the deadline for presentations to be made at Interphex 2008 and at HealthPack 2008. Interphex 2008 will be held March 26 – 28, 2008 at the Pennsylvania Convention Center in Philadelphia. HealthPack 2008 will take place March 4-6 at the Sheraton Gunter Hotel in San Antonio, TX.

Based in Las Vegas, Med-Health is a combination of three independent businesses where Enterprise Resource Planning (ERP) technology from SAP will play a key role. Currently operating is a Med-Health business that sells medical supplies like gowns, gloves, sutures, and other "consumables." Opening this summer was a pharmaceutical drug wholesaler. And some time around January of 2008 will be the opening of a Med-Health pharmaceutical repackaging arm.

Compliance with ANSI/AAMI/ISO 11607-parts 1 and 2 involves more than crossing items off of a checklist.

Attendees of the “Medical Device Distribution Package Testing” conference at MD&M West seemed to appreciate Jan Gates’ description of what medical device management wants from new packages. Those attributes include the following:

Defining the end-user /device maker’s needs is the most crucial step of the entire thermoforming process, says MD&M West speaker.

The Food and Drug Administration continues to be challenged by limited financial resources. That was one of the messages from Donald E. Marlowe, FDA agency standards coordinator, during his March 8 keynote address that launched this year’s HealthPACK medical device conference in New Orleans.

Kerr Dental wanted to improve package durability and functionality for its OptiDisc Finishing and Polishing Disc Set, used by dentists.

The Freedonia Group forecasts that sales demand for high-visibility packaging in the pharmaceutical and medical markets will advance 7.9% annually to $1.9 billion by 2010. The organization refers to high-visibility packaging as packaging that allows consumers to see the product through the packaging. These include windowed boxes and bags, carded blister packs, skin packaging, and interlocking containers.

When a customer invests in a wheelchair, he or she wants it to be in pristine condition. So when some customers complained about nicks, scratches or dents on these medical devices, Longmont, CO-based manufacturer Sunrise Medical sought a cure. The occasional damage during shipping was attributable to the kraft paper Sunrise Medical had used to wrap metal wheelchair components such as arm rests or leg rests.

* made of clear, recyclable APET; available in four standard base sizes with common snap-lid

* flange may be heat-sealed to a Tyvek, paper, or film lid

* APET trays are EtO- and Gamma-sterilizable

Placon

Compliance with ANSI/AAMI/ISO 11607-parts 1 and 2 involves more than crossing items off of a checklist. It requires a medical device company to understand its applications and processes, the ability to read, visualize, and understand both parts of the standard, and the development of a strategic plan. That was the message from Randall J. Troutman, CPP and senior engineering manager with medical packaging supplier Oliver Medical during a Feb. 15 presentation at the Medical Design & Manufacturing (MD&M) show.

Growth in the medical device business in China is a mixed blessing, according to Chang-Hong Whitney, president of Whitney Consulting Ltd. “There is a belief that the country is growing too fast for its infrastructure,” she said in a presentation entitled “China: Opportunities in an emerging giant,” March 9 at HealthPACK 2007 in New Orleans. “But China has $1 trillion in foreign currency reserves, so it has the money to take care of this.”

The Food and Drug Administration continues to be challenged by limited financial resources. That was one of the messages from Donald E. Marlowe, FDA agency standards coordinator, during his March 8 keynote address that launched this year's HealthPACK medical device conference in New Orleans.

* Optym film line includes forming web materials, peelable lid stock, and other customized film-based disposable products and packages

* three- to seven-layer forming web materials provide excellent optics and seal to film, paper, and Tyvek lid stock

* printable in up to 10 colors; may be coextruded to beyond seven layers; do not require coatings for sealing

Pliant Corp.

The Food and Drug Administration continues to be challenged by limited financial resources. That was one of the messages from Donald E. Marlowe, FDA agency standards coordinator, during his March 8 keynote address that launched this year’s HealthPACK medical device conference in New Orleans. “Packaging is one of the most important issues in designing medical products,” Marlowe told an audience that by unofficial count was about 160. He also said “packaging contributed to the largest number of product failures,” although not recalls. The problems included mislabeling and seal failures.

Compliance with ANSI/AAMI/ISO 11607-parts 1 and 2 involves more than crossing items off of a checklist. It requires a medical device company to understand its applications and processes, the ability to read, visualize, and understand both parts of the standard, and the development of a strategic plan. That was the message from Randall J. Troutman, CPP and senior engineering manager with medical packaging supplier Oliver Medical during a Feb. 15 presentation at the Medical Design & Manufacturing (MD&M) show .

Jan Gates, principal packaging engineer at Abbott Vascular, offered the following advice during her presentation, “Medical Device Distribution Package Testing,” during the Medical Device & Manufacturing MD&M West show.

Defining the end-user /device maker’s needs is the most crucial step of the entire thermoforming process, said MD&M West speaker Jason Crosby, medical business manager for thermoformer Plastic Ingenuity . Crosby’s comments were made at a conference session Feb. 15 at the Anaheim Convention Center during the Medical Device & Manufacturing (MD&M West) show.

Abbott Vascular's Jan Gates will chair a Feb. 15 Medical Device and Packaging session that includes Part I, Packaging Engineering, from 9 a.m. until 12 p.m., followed by Part II, Packaging Validation and Compliance from 1 p.m. to 4 p.m. The session is part of Medical Design and Manufacturing West event at the Anaheim Convention Center in Anaheim, CA. The conference will be held Feb. 12-15, while the exposition runs from 10 a.m. until 5 p.m. Feb. 13-14, and 10 a.m. to 4 p.m. Feb. 15.

Bioabsorbable stents, such as Abbott's Absorb, may soon open a new pathway in the treatment of coronary artery disease, and challenge the packaging process. In late October, Abbott Park, IL-based Abbott Laboratories delivered encouraging news regarding the initial results of a clinical trial involving its Absorb bioabsorbable drug-eluting stent for the treatment of coronary artery disease.

Vital issues include validation, FDA regulations, counterfeiting, and the challenges of shipping pharmaceuticals and biologics through the cold chain. (Part I of II)... Surely one of the most interesting developments to unfold lately in the healthcare product manufacturing arena is the formation of the Coalition for a Stronger FDA. The coalition came together officially on Sept. 25 with former government officials, patient group representatives, consumer advocacy organizations, and industry associations bringing it into existence.

By 2010, U.S. demand for such packaging is forecast to reach $4.4 billion. What's behind the projected growth? "Pharmaceutical and biological applications will lead growth as advances in the life sciences contribute new injectable and inhalation therapies for cancer, heart disorders and other diseases. "That's according to "Sterile Medical Packaging," a new study from The Freedonia Group, Inc..

By 2010, U.S. demand for such packaging is forecast to reach $4.4 billion. What’s behind the projected growth? “Pharmaceutical and biological applications will lead growth as advances in the life sciences contribute new injectable and inhalation therapies for cancer, heart disorders and other diseases.”That’s according to “Sterile Medical Packaging,” a new study from The Freedonia Group, Inc.

At medical device maker DePuy Orthopaedics, polyurethane protective packaging from Barger Packaging is playing a key role in getting hip and knee replacement products to DePuy's intended patients.

Warsaw, IN-based DePuy, a Johnson & Johnson Co., ships its hip and knee products in a conventional folding carton. Inside each carton, a sterilized product is hermetically sealed in a PETG thermoform with a polyolefin lidding material heat-sealed to its flanges.