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Plan Now to Attend ASTM International Committee Meeting in Spain

May 7, 2012 – 5:23 pm

daphne11-2011-22ASTM International Committee F02 on Flexible Barrier Packaging will meet this fall in Barcelona, Spain, offering a number of technical and regulatory presentations. Speakers will include representatives from both Europe and the United States, including the U.S. FDA.

“Since ASTM International Committee F02 on Flexible Barrier Packaging met in Prague in 2009, there continues to be an active European membership base,” says Hal Miller of PACE Solutions Inc. “The Committee felt that we should demonstrate our support to them by meeting in Europe from time to time in order to provide an opportunity for them to participate, and a means for Committee F02 to further expand its membership.”

Scheduled September 26-27 at the Hotel Rey Juan Carlos I in Barcelona, the fall meeting will include topical presentations in each of the subcommittee and main committee meetings in order to generate new member interest, says Miller.

Speakers and presentations include the following:

  • Diane Trinsey, ASTM International: ASTM Mechanics and Overview
  • Franz Sturm, Lippke: “Future Trends in Permeation Measurements”
  • Thierry Wagner, DuPont Medical & Pharmaceutical Protection: “Microbial Barrier Test Methods for Porous Sterile Barrier Materials”
  • Henk Blom, Rollprint Packaging Products:”Towards a Package Durability Predictive Model”
  • Wendy Mach, Nelson Laboratories: “Package Integrity: Methods of Detection”
  • Hal Miller, PACE Solutions, LLC: “Use of Design Guide F2097 and U.S. FDA Recognition”
  • Pat Weixel, U.S. FDA: “U.S. FDA Perspective: The use of standards in premarket submissions and auditing the medical device packaging process”
  • Pat Nolan, DDL: “Sterile Medical Device Package Performance Testing and the Nebulous Effect of Vibration in Transit”

In addition to listening to these conference-type presentations, attendees “can also participate firsthand in the process of developing new flexible barrier packaging test methods,” says Miller. “Anticipated agenda items are new dye penetration tests for pinholes to 10 µm and channels in the seal to 50 µm, abrasion resistance testing, results of an extensive interlaboratory study on water vapor transmission rate using several different ASTM methods, and consideration of a new puncture resistance test using sharper instruments.”

Says the new ASTM Committee F02 chairman Dhuanne Dodrill, President, Rollprint Packaging Products Inc.: “Getting involved in committee F02 offers packaging professionals a great learning opportunity,” says Dhuanne Dodrill, president of Rollprint Packaging Products and the new chairman of F02. “Participants gain opportunities to discuss the thinking behind ASTM standards and even get to help develop future ones. They can also share their best practices and learn from others, which helps improve the industry as well.”

Further information may be found by clicking here.

Daphne Allen

USP Workshop To Focus On Common Approach For Supply Security

May 4, 2012 – 12:57 pm

The U.S. Pharmacopeial Convention (USP) has pulled together a broad swath of  stakeholders for a workshop this month on the complexities of protecting the supply chain.

The May 22-23 event in Rockville, MD will feature regulatory officials from Europe, South American, and Africa, and coverage of developing track-and-trace standards, among other topics. In looking to establish best practices for supply chain security, USP will solicit feed back on its proposed informational standard General Chapter <1083> Good Distribution Practices-Supply Chain Integrity.

With Chapter 1083, USP is providing guidelines covering all parties in a supply chain for securing API’s, pharmaceuticals, and medical devices against theft, diversion, and counterfeiting.

“The issues surrounding pharmaceutical supply chain integrity are not theoretical. On the contrary, they are very real, as evidenced by the discovery of counterfeit Avastin in various U.S. medical clinics in February and April,” says Praveen Tyle, Ph.D., executive vice president and chief science officer for USP.

“Legislative proposals circulating in Congress, continuing debate over product- versus- lot-level tracking, gray markets growing in the face of drug shortages, and other circumstances are converging, making it clear that the status quo is no longer adequate,” Tyle says.

The keynote presenter will be Ilisa B.G. Bernstein, director of FDA’s Office of Compliance, Center for Drug Evaluation and Research.

Approaches to supply chain regulation will be presented by representatives from California, Health Canada, Brazil, Argentina, the European Directorate for the Quality of Medicines, United Kingdom’s MHRA, the Turkish Ministry of Health, the Nigeria National Agency for Food and Drug Administration and Control, and the World Health Organization.

Other presentations will consider the impact of tamper-evident packaging and implementation issues related to new technologies from the perspectives of wholesalers, pharmacies, and pharmacists, USP said.

The goal of the Chapter 1083 guidance is to provide an overall or holistic approach to the complex supply chain security issue, which currently is addressed piecemeal in guidance from various sources and differently by individual companies. USP is encouraging common approaches and comprehensive public standards.

General Chapter <1083> will be part of the United States Pharmacopeia-National Formulary (USP-NF), which contains quality specifications for medicines and their ingredients in the United States–standards that are also are widely used internationally.

 Dave Vaczek

Optel Vision Offers Webinars On Traceability

April 19, 2012 – 7:12 am

dave-pic-with-tie-2Optel Vision is kicking off a three-month series of webinars on track and trace and serialization, featuring case studies on industry implementations.

Three sessions will cover an introduction to track and trace, real use cases, and challenges in implementing serialization. Presented by Jean Pierre Allard, Optel Vision’s serialization solution manager, each session will be conducted three times, once every month, with dates posted on Optel’s web site. The webinars begin on May 15 with the first introductory session.

Resolving packaging line issues, worldwide regulations, and GS1 standards are among topics to be covered, says Ken Fallu, marketing manager.

“Enrollment is almost complete on the first session with a few spots left.  People who can’t be accommodated will be offered participation in a later round. We are limiting enrollment for each webinar to 25 people to allow for participation in the Q&A following each session. For our real use cases, we will be sharing our perspective on these recent track and trace initiatives using real packaging line equipment,” Fallu says.

Optel this week also launched a blog for prompting discussions on track and trace and inspection solutions, and topics including regulation. “We will be posting an article to the blog each week from pharma industry experts and our own experts to engage our visitors on these topics,” Fallu says.

 Dave Vaczek

Is Item Visibility Needed?

April 13, 2012 – 4:26 pm

daphne_102610The Pharmaceutical Distribution Security Alliance (PDSA) has succeeded in bringing together several manufacturers, wholesalers, and pharmacy chains in support of a federal law automating pharmaceutical tracking. Its proposed RxTEC Act would replace the “pedigree” requirements of the Prescription Drug Marketing Act as well as any state laws with a uniform federal standard that “would serve as a stepping stone/interim approach to supply chain security,” explained Vince Ventimiglia, counsel with Faegre Baker Daniels, who spoke before the California State Board of Pharmacy’s E-Pedigree Enforcement Committee (CA BoP) in March.

Elizabeth Gallenagh, vice president, government affairs and general counsel, Healthcare Distribution Management Association (HDMA), later told PMP News Senior Editor David Vaczek that “this is the first time that true consensus has occurred with all the stakeholders in terms of a proactive approach to pedigree at the federal level.” Read here for more details on the Pharmaceutical Traceability Enhancement Code (RxTEC) Act.

But what about California? Will the state with the most far-reaching pedigree law see RxTEC as satisfying the original intent of that law, which is to add item-level visibility anywhere, any time in the supply chain?

PDSA members who had joined Ventimiglia before the CA BoP stated that under RxTEC, serial numbers would be called for, but tracking would begin at the lot level only.

This did not appear to sit well with the CA BoP or even FDA, which spoke later.

PDSA representatives stated that the serial number would serve as “a forensic tool,” but all products would be “tracked at the lot level and suspect products would be dealt with at the serial number level.” There would be no mandate for dispensers to check serial numbers.

It is cost prohibitive to scan each bottle, someone stated.

CA BoP members asked the following questions: Lots are currently broken up, so how would someone be able to identify where individuals are under RxTEC? What if someone counterfeits serialized items and their lot number checks out? No one would be able to catch that the serial numbers have been duplicated if the lot number passes and no one is prompted to check the serial number.

FDA’s Connie Jung, acting associate director for policy and communications, CDER, later argued that “full track and trace should apply to all stakeholders.” In addition, “there must be some form of authentication of the number and who sold and received that product. Track and trace will enable us to detect bad products so much more quickly than we can now.”

“We have got to have serialization at the unit level,” she later said. “Every time that product changes hands, that product must be tracked and authenticated and the data captured in a track and trace database.” FDA is not yet sure whether that database would be centralized, semicentralized, or decentralized, but the “SNI would point to the database,” Jung said.

“We have concerns about the value of tracking lots,” she added. “If no one is checking the serial number, [a duplicate number] will go undetected.”

PDSA and its supporters, which include PhRMA and the Generic Pharmaceutical Association and many of their supply chain partners (pharmacies and distributors), should be commended for building consensus for a safer supply chain. However, some argue that item-level track and trace would bring about the visibility needed to eliminate the gray areas of the supply chain.

But many in the industry continue to push back on item-level track and trace. One drug company sitting with PDSA said that it would take three years to implement new technology on its lines.

It is now up to Congress to determine how to secure the supply chain. FDA has been saying for some time that it lacks authority to require item-level track and trace. Will Congress grant the agency the authority it seeks, or will it favor PDSA’s proposal?

Daphne Allen

What About Wool?

March 20, 2012 – 2:53 pm

Almost all packaging devised for transporting temperature sensitive product relies on the unique thermal properties of water (H20) to keep product at required temperature. Is sheep’s wool another naturally occurring miracle substance for imparting performance attributes to packaging?

The Wool Packaging Company Ltd (WPC) (www.thewoolpackagingcompany.com), based in sheepy Shropshire, UK, is developing packaging for vaccines using felted wool, a material with many promising attributes for manufacturing and packaging.

Since WPC’s launch in 2009, its patented Woolcool insulated courier boxes, pouches, and envelopes have been used for fresh and frozen foods delivery. With the backing of a six-figure grant from the UK government Technology Strategy Board, the firm is moving from proof-of-concept to R&D stage, focused on a specialized pharmaceuticals version of the insulated packaging.

“We are already working closely with three Fortune 500 pharmaceutical companies and are conducting on-going validation trials together with them,” reports company spokesperson Nicky Fairweather.woolcool-box

Felted wool is a highly versatile product with advantages including superior thermal insulative properties. http://www.aetnafelt.com/felt_advantages.htm.

Woolcool has already been proven to maintain stable internal temperatures between 2°C and 8°C in excess of 72 hours, and this “more effectively than other packaging including polystyrene cartons, polyethylene foam, or air pocket products,” the company claims.

Felted wool incorporated in a packaging system could provide cushioning protection for fragile vaccine vials. In addition, sheep’s wool is available in abundance worldwide, and is compostable.

Could felted wool improve sustainability by reducing or eliminating polystyrene or polyurethane materials in transport containers? Hard to say. It depends on what the final packaging might look like, and the component parts used to protect the product against both climate and the rigors of distribution.

What we can say is there is an evident need for new approaches in protective thermal systems for vaccines. Vaccine wastage is running at above 50% globally, per WHO. Product exceeding storage temperatures is without doubt one cause of this waste.

Should felted wool perform as promised, and cost-effectively, it may yet develop as a welcome, natural alternative for cold chain shippers.

Dave Vaczek

Packaging Clues Needed

March 19, 2012 – 2:32 pm

daphne_1026101After counterfeit Avastin surfaced in February, the Institute for Safe Medication Practices (ISMP) reminded nurses, pharmacists, and doctors to remain vigilant when procuring and dispensing medications. Packaging and labeling play key roles in that vigilance. But do you give these professionals enough clues to go by?

In its March 8 newsletter, ISMP pointed readers to resources published by the Partnership for Safe Medicines (PSM). These include LEADER’s Guides for Doctors, Nurses, and Pharmacists, with LEADER being an acronym for the steps each professional could take when handling and dispensing drugs. For instance, the “E” in LEADER stands for “Evaluate suspect medicines,” and each guide stresses the importance of “evaluating products, packaging, and labeling.”

Also, doctors are also encouraged to “Dispense free samples,” because “sample packs can help patients establish a ‘baseline’ of a medicine’s characteristics, including its appearance, taste, texture, reactions, and packaging.”

PSM’s point about sample packaging is a good one, since samples can help patients become familiar with the product and packaging. “Examine the medicine’s packaging and look for differences in paper, printing, color and fonts (i.e., is it the same size, raised print, embossed, etc.),” the physician’s LEADER guide reads. “Physicians directing patients to keep a ‘drug diary’ with these characteristics can help keep the patient as part of the safety team and the last barrier to harm. In fact, recent cases of counterfeits were detected by patients.”

Trouble is, not all prescriptions are preceded by a sample package. And according to the Joint Commission, some organizations have stepped away from offering drug samples, moving instead to “starter prescriptions” dispensed by pharmacies.

But even if there is a sample package, subsequent prescriptions or refills may not be dispensed in branded packaging. Instead, pharmacies most likely will be repackaging refills into standard pharmacy vials that offer patients and doctors very few cues to drug authenticity.

In fact, many of the following packaging and labeling clues that PSM implores physicians to look for simply do not exist with pharmacy repackaging:

• Be properly sealed.

• Contain a package insert.

• Have a container and closure that protects the drug from the outside environment for the duration

of its shelf life.

• Have the appropriate container and closure for the drug inside.

• Have smudge-proof ink on the package insert or packaging.

• Have seals or sealing tabs over the product openings.

• Display an authentic logo or hologram (if applicable) that changes color when viewed from different

angles.

• Have a package insert that is printed on the same colored and quality paper as the original.

But should manufacturers issue samples for EVERY drug, including generic drugs? Absolutely not. Not only would drug manufacturers’ own costs increase, doctors’ offices and clinics would be overwhelmed by the sheer inventory volumes.

Instead, pharmacy repackaging should be strongly reconsidered. For physicians and patients to become detectives in their own right, they need actual packaging tools they can use to detect counterfeits.

Drug manufacturers can provide many of those tools through carefully designed packaging and labeling and communicate the basics of those tools through Web sites, patient educational materials, and yes, when appropriate, sample packages.

Daphne Allen

Cardinal Health Bag Offers Easy, Consistent Opening

February 24, 2012 – 2:19 pm

dave-pic-with-tie-2FDA guidance and developing standards from ISO and AAMI/ANSI have shifted more attention to device and package designs that consider the needs of end-users and reduce the likelihood of human error.

At Cardinal Health, the usability of product and packaging is formally considered as human factors in design are captured and documented as part of a Design Control system, says Dan Penny, director of packaging engineering. 

Cardinal focused on easy and consistent opening in developing a cost-effective bag for gowns, surgical kits, and other large disposable supplies. The goal was to improve performance compared with bags available in the market. 

In development, Cardinal’s nurse consultants–experienced nurses employed by Cardinal–sought insights from end-users. “The nurse consultants are a captive resource we use regularly to get feed back from customers on changes to packaging. Depending on the scope of the project, we may start with the consultants and then do further interviews with focus groups to gather Voice of Customer,” Penny says. 

Bags that claimed to be “easy open” were assembled and tested for tensile strength on a machine that duplicates the movement of a linear tear. The opening force required to open a variety of different structures was quantified.

On bags that have been in the field for years, nurses sometimes report they work great; other times they are very hard to open, Penny says.

“These complaints made sense when we started looking at the spread or standard deviation of the data, which correlated with the feedback we were getting. In some cases, the averages were all very similar, but with more data we started to see there was significantly more variability with some structures.”

Cardinal created quantitative data for a bag with an easy-open feel, specifying an ideal opening force and a window of acceptable opening force.

“This put us a step ahead and led us to the converter for material selection and design.” Cardinal collaborated with Amcor Flexibles to develop the DuraTear Film Bag, a vented polyethylene structure.

“We developed this material in an iterative process with Amcor to get the package material that gave us both the durability and the barrier we needed, and at the same time provided an easy-opening feature. There were several iterations of material development that went into that,” Penny says.

The notched bag features a low linear tear strength. Material design also had to address consistent opening, as nurses experience problems with tearing when they reposition their hands.

“Some of these bags are fairly large–we have a bag as large as 32 by 28 inches for larger surgical packs. Nurses have reported to us that if they start and stop they don’t get as clean an opening or can’t complete the tear. The opening feature had to reliably tear with the same ease and consistency,” he says.

The bag’s good contact clarity allows the user to see labeling delivered as an insert inside the bag, outside of the wrap. With on-demand insert printing, Cardinal reduces inventories, carrying one generic bag per size.

“We have 1000′s of different codes; we don’t want 1000′s of inventories of pre-printed bags. This allows us to do color-coding, and we use larger font sizes for critical label information such as size and protection level. Insert labeling has been a very manufacturing-friendly, cost-effective solution for us,” Penny says.

Used for Cardinal’s gown packaging and packaging of other large items, the bag combines necessary strength and resistance and sterile barrier, with easy opening.

“It’s a trade off. You need materials that provide abrasion, puncture, and flex-crack resistance, and enough strength to survive the distribution environment, created with a low notched tear strength in the machine direction so you can have the easy opening feature. The linear tear vented bag can be very cost effective, and still be perfectly functional.

“We feel that the best application of this bag is for larger bulky products such as surgical packs. And it is a cost-effective method of packaging when the product has a wrap to provide aseptic presentation.

“The feed back from the field has been positive,” Penny says.

 Dave Vaczek

Westpack Panel Addresses Automation and Cost Control

February 3, 2012 – 2:28 pm

dv-pic-with-tiePackagers are under enormous pressure to reduce production costs without compromising product quality.

Through upgrades in packaging machinery technology, peripheral equipment, and processes, manufacturers can improve production line efficiencies and reduce the errors that lead to product recalls and put consumers and patients at risk.

Approaches for improving packaging line performance and controlling costs will be addressed in an “Automation and Cost Control In Packaging” seminar on Wednesday, Feb 15, at Westpack in Anaheim.

Richard Bahr, president and CEO of MGS Machine will present three case studies on reducing labor and cost and improving sustainability. In one instance, MGS developed a cartoner and robot-based product handling system for a high-speed pharma blister line that eliminated wasted carton space, without increasing the existing footprint.

In another case, MGS automated a medical device maker’s manual packaging operations with the deployment of robots and vision systems.

Robb Clarke, PhD, director of the Auto-ID Research & Testing Center, Michigan State School of Packaging, will present on streamlining semi-automatic packaging systems to reduce lead times and increase quality, covering the incorporation of ergonomic machines and integration of quality control measures.

The relationship of package design to production efficiency has received increasing attention in the pharmaceutical space as lines are evaluated for overall equipment effectiveness (OEE), and industry explores real-time process measurements with statistical process control (SPC).

In a workshop opening the session at 2 pm, Scott Jost, vice president, Innovation and Design, Berlin Packaging, will look at harnessing innovative package design in  “Aligned Partnerships: An Integrated Innovation and Development Model.”

To register for the seminar, contact Nicole.Maisner@ubm.com. Tell her Dave Vaczek sent you.

Dave Vaczek

Pfizer Explains Birth Control Pill Recall on YouTube

February 1, 2012 – 3:20 pm

daphne_111610happyPfizer took to the Internet today to address its voluntary recall of approximately one million packs of birth control pills. Recalled are 28 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States.

Pfizer’s Chief Medical Officer Freda Lewis-Hall explained in a YouTube video that “there may have been an issue with the way some of these pills have been packaged,” resulting in “placebo and active pills [that] may have been placed out-of-order in some packs.”

Lewis-Hall says that Pfizer believes there are about “30 packs of birth control pill that may have received an inexact count or inactive tablet.” She added that because of “our high quality standards, should we identify even one package that does not meet our high standards, we will voluntarily recall the entire lot.” The 28 lots recalled amount to about one million packs.

View pictures of the affected products and lot numbers included in the recall by visiting:

Correctly Packaged LoOrval Blister Pack Image
Correctly Packaged Norgestrel Image
Lot numbers

When I had first watched the video, there had only been about 10 views, but within an hour of being posted on Twitter, it had 125 views. Patients can easily share such news on social media, so reaching out this way to share recall news is important.

Daphne Allen

Glass Breakage Corrected

January 30, 2012 – 6:36 pm

daphne_111610happyEarlier this month Bedford Laboratories updated guidance on its August 2011 recall of Polymyxin B for Injection USP and Vecuronium Bromide for Injection. Since there have been a number of recalls throughout the industry involving glass vials, we posed a few questions regarding the updated guidance. (Note: Bedford Laboratories is a division of Ben Venue Laboratories, of the Boehringer Ingelheim group of companies.)

Jason Kurtz, Associate Director, Communications & Public Relations, explained that “For background, Ben Venue manufactures sterile injectable products which must be packaged in glass vials. This recall was caused by an issue on a manufacturing line that caused glass breakage during processing which has since been corrected.”

The company is “working closely with our distributors to ensure the return of the affected lots. To date, there have been no reports of adverse events related to the products involved in this recall,” Kurtz reports.

We asked about Ben Venue Laboratories’ position related to item-level serial numbers on all drug packages. “BVL supports any initiatives that might help minimize supply disruptions or potential shortages,” he said.

The recalls were initiated on August 2, 2011 after the discovery of a visible glass particle in a limited number of vials within the lots listed above to the user level.

Daphne Allen