2010's Top Stories
What were you reading online at pmpnews.com in 2010? Below we list the articles and news stories posted in 2010 to pmpnews.com that had the most page views. You'll also find a few surprises from our archives.
Most-Viewed Articles Posted in 2010
Number 1: Devising Sterile Packaging Solutions
This feature article explored medical device manufacturers' goals in keeping quality up and cost down. While the pressure to reduce packaging costs is not a new trend, it is an ongoing challenge. Regulations keep the sterile packaging market fairly stable, but manufacturers are still looking for ways to hold down costs and enhance product sterility assurance, within mandated requirements. Suppliers are coming up with ways to help them.
In this article, George Wright from PIPS explains that the GS1 General Specification requires the use of FNC1 but the transmitted data are the same if GS (Group Separator) is encoded instead. Does it really matter? He asks. The four special bar code Function Characters (FNC1, FNC2, FNC3, and FNC4) trace their origins to the invention and introduction in 1981 of Code 128. According to the original Code 128 international symbology specification ISO/IEC 15417, these Code 128 symbology characters “define instructions to the bar code reading device to allow for special operations and applications.” These four symbol characters have no ASCII equivalent and are not intended to be transmitted. Many linear and 2-D symbologies invented subsequent to Code 128, including the popular 2-D symbologies Data Matrix ECC200, Aztec Code, and QR Code, incorporate these same characters and their defined functionality.
In this preshow report on the 2010 International Transport Packaging Forum, ISTA explained that attendees would shortly become familiar with emerging best practices in temperature control. During ISTA’s International Transport Packaging Forum held March 29–April 1, 2010, at Disney World in Orlando Florida, ISTA presented important new ISTA Standards relating to the qualification of temperature-sensitive-products packaging solutions. The results of two major projects that took place over the past couple of years will be presented, along with a certification program:
1. ISTA’s Heat and Cold Profile Study of the 2nd Day parcel shipping environment within the United States.
2. The development of ISTA Manual 20: A Thermal Qualification Process for cold-chain packaging.
3. Thermal Laboratory ISTA Certification Program.
Bayer Healthcare (Morristown, NJ) changed the packaging system for Bayer Aspirin and Aleve with a new oval-shaped bottle and user-friendly cap. Launched into retail stores earlier in 2009, the packaging eliminates the carton, representing Bayer’s first venture into cartonless products for analgesics and a first in the category. The system features a new cap design with a soft-touch thermoplastic elastomer cover, and a raised logo grip on the bottle sides for helping consumers grip the package.
Most-Viewed News Headlines from 2010
Number 1: J&J Expands Tylenol Recall
January 15, 2010: Johnson & Johnson announced that it is expanding its voluntary recall of over-the-counter Tylenol products. Fifty-four million bottles have been added to the recall, bringing the total to 60 million. J&J's McNeil Healthcare LLC linked the problem to the presence of a chemical in wood pallets used to transport and store packaging.
Number 2: FDA Issues Warning Letter to McNeil on Recalled Products
January 19, 2010: FDA has issued a warning letter to McNeil Healthcare stating that its Jan. 8 inspection of the company's Las Piedras, Puerto Rico, location identified significant cGMP violations. Since 2008, McNeil has received odor complaints regarding certain Tylenol products. In 2009, McNeil began recalling bottled OTC products after discovering that packaging may have been contaminated with a pallet pesticide. The recall now numbers 60 million bottles.
Number 3: Criminal Charges Filed against Guidant
February 26, 2010: The U.S. Department of Justice charged Guidant Corp. with concealing critical information from federal regulators on "catastrophic" failures in several models of its heart defibrillators. The rare filing of criminal charges culminates a four-year federal investigation that had its roots in the suspicions of two Minneapolis doctors.
Number 4: American Airlines Cargo Expands Program
January 27, 2010: American Airlines Cargo Division (AA Cargo) has redesigned its Business ExtrAA program to allow nearly all cargo customers to earn travel awards for booking cargo shipments. Pharmaceutical companies utilizing special handling can earn bonus points under the ExpediteTC program.
Number 5: Dramatic Effects of New Merck Heart Drug Stun Investigators
November 18, 2010: The experimental drug boosted good cholesterol so high and dropped bad cholesterol so low that doctors voiced hopes for an entirely new way of preventing heart attacks and strokes.
Most-Viewed Articles in 2010 from the Archives
Interestingly, these archived articles from 2008 and 2009 were also top reads in 2010.
In August 2008, the USP Packaging and Storage Expert Committee responded to industry's comments on moisture permeation testing for drug product packaging. Desmond Hunt, PhD, wrote that the United States Pharmacopeia (USP) had received comments from pharmaceutical companies concerning recent revisions to “General Chapter <671> Containers–Performance Testing,” which appeared in the Second Supplement of USP 30. This second supplement contained a revision to “General Chapter < 661> Containers,” which was split into <660> “Containers–Glass” and <661> “Containers–Plastic”; “General Chapter <671>” was renamed “Containers–Performance Testing.” The revisions also moved the container permeation and light transmission requirements for plastic bottles from USP <661> to USP <671>, including those for plastic containers that are used for manufacturer’s unopened multiple-unit packages and liquids packaged in PET and PETG bottles.
This article from November 2009 showed that drug companies are moving toward more innovative sample packages with a value-added approach as face time with physicians declines and nonpersonal sampling rises as selling strategy. Marketers are gravitating away from the traditional merchandising model for samples and are creating sophisticated starter kits to establish a customer-centric experience, improve patient compliance, and increase brand loyalty.
In this article published in July 2009, Patrick J. Nolan and Scott Levy of DDL Inc. and Karen Greene (now of Life Packaging) explain that the purpose of a distribution or transportation simulation test is to evaluate the performance of the complete packaging system. However, such testing is a conditioning element, as there is no specific or variable result derived from these tests. It simply subjects the test specimen to dynamic hazards (e.g., shock, vibration, or compression) inherent to the transport and distribution of products to the end-user.