Impact of Sterilization Method on Packaging Component Machinability Performance: Steam vs. Gamma Evaluation of the 1mL Long Plunger

Pharmaceutical manufacturers are faced with numerous challenges to produce, package, and ship products successfully to the patient or care giver.   Common concerns for all pharmaceutical manufactures include meeting targeted timelines, guarding against drug shortages, increasing speed to market, and generating revenue.  Maximizing operating speeds and minimizing operating down time are critical factors for all stakeholders.

For manufacturers of sterile liquid, lyophilized, and powder drug products, the filling and finishing (fill/finish) process can be a critical step in ensuring targeted timelines are met.  Operating down time associated with fill/finish line stoppages and clearances can impact operating speeds, drug product yields, deviation/investigation resources, and targeted timelines.  One of the leading causes for filling line stoppages and clearances involves machinability of the parenteral packaging components (containers, elastomeric components, and caps).

Considerable care must be taken to pair the parenteral packaging components, drug product, processing and fill/finish equipment to optimize and maximize line speeds; as well as to reduce the line stoppages and clearances. Numerous factors can impact the overall performance on the filling line, such as the properties of the parenteral packaging components.

Be sure to check out the November edition of Pharmaceutical Manufacturing to read more of Simon’s “Impact of Sterilization Method on Packaging Component Machinability Performance:  Steam vs. Gamma Evaluation of the 1mL Long Plunger.”

 

Author:

Simon Cote

 

 

 

 

 

 

Simon Cote
Senior Technical Support Engineer

West’s Zach Marks Presents at PODD

West will be exhibiting at the Partnership Opportunities in Drug Delivery (PODD) Conference on October 14-15, 2014 at the Renaissance Boston Waterfront Hotel. West’s Zach Marks will be presenting an overview of the SmartDose® electronic wearable injector.  Read the presentation abstract below:

Driven by trends towards increased use of delivery devices for self-administration, as well as the challenges created by modern biologic drugs, the need to evaluate and develop drug delivery systems in an integrated way, recognizing the needs and challenges of the patient, the drug, the drug container, and the delivery device has never been more critical. West has developed the SmartDose electronic wearable injector with all of those factors in mind. The system developed by West, and available for clinical studies, is based on a Daikyo Crystal Zenith® cartridge system within an electronic injector designed to provide simple and effective self-injection of a larger volume of medication (typically greater than 2mL) over a few minutes. This presentation provides an overview of the technology, focusing on the various steps necessary to create a system which is ready for human clinical studies with drug product, and has been extensively tested to help ensure optimum patient outcomes.

For more information about the conference, visit: http://theconferenceforum.org/conferences/partners-in-drug-delivery/overview/

West collaborates with HealthPrize Technologies to help improve medication adherence and patient outcomes

By Katrina Firlik, MD
Chief Medical Officer
HealthPrize Technologies

Although modern pharmaceuticals and advanced drug delivery systems save and improve the lives of millions of people around the world, there are countless others whose lives are not saved or improved—because they don’t take the medication at all, or often enough. Former Surgeon General C. Everett Koop summed it up best: “Drugs don’t work in patients who don’t take them.”

And, although drug cost has rightly been identified as a barrier to medication adherence for many patients, there is increasing recognition that cost is often not the only, or even the main, barrier. In fact, offering medication for free makes only a relatively small dent in the problem, as evidenced by a study published in the New England Journal of Medicine, and as demonstrated by similar rates of non-adherence in European countries in which medication is essentially free to its citizens.

So, what is the hidden barrier that looms large, contributing to poor outcomes and an estimated $290 billion in “otherwise avoidable medical costs” in the US per year? Motivation. Medication non-adherence—particularly to therapy for chronic conditions—reflects a psychological hurdle inherent in any behavior that offers mainly long-term benefits (similar to saving for retirement). A behavioral economist would call this “present bias,” or the natural preference for short-term rewards over long-term rewards. In a sense, this represents more of a “value” problem.

HealthPrize boosts motivation by adding short-term rewards for patients, enhancing the immediate value of sticking with chronic therapy. Our online and mobile platform leverages a points-based incentive program combined with education and gamification strategies. Patients on a HealthPrize program actually have fun engaging with our system and learning more about their condition. The fun factor is an important motivational element too often missing in healthcare.

Our new collaboration with West, announced here, ties our rewards, education, and gamification platform directly to West’s injectable drug delivery systems to form a compelling end-to-end connected health solution. Data on actual completion of self-injection will be captured, allowing adherence to be verified and rewarded in real time. The HealthPrize platform also tracks refills, with a focus on motivating patients to fill on time and to persist with therapy long-term.

We’re thrilled to be joining forces with West in addressing this “final mile” problem in health care. It’s a win-win for everyone, especially patients.

West Announces Plans for a New Pharmaceutical Component Manufacturing Plant in Ireland

Expands global capabilities to meet customer demand

On October 2, 2014, Ireland’s Prime Minister Enda Kenny, and Richard Bruton, Minister for Jobs, Enterprise & Innovation for Ireland, joined West Chairman and CEO Don Morel to announce that West plans to expand its global manufacturing operations to include a new site in Waterford, Ireland. The event was held at Tower Hotel, The Mall, Waterford.

The new facility will produce packaging components for insulin injector cartridges and other high value packaging components, in order to meet growing demand from pharmaceutical and biotech customers. Once operational, this new site could bring approximately 150 new jobs to Waterford and is intended to grow to support additional jobs through expansions in the future.

“With diabetes emerging as one of the fastest growing diseases globally, our pharmaceutical customers are expanding their production lines for injectable insulin. To meet this growing demand, we are announcing an expansion today that will help us address this need and continue to serve this critical patient population,” said Donald E. Morel, Jr., West’s Chairman and Chief Executive Officer. “In the future, we intend for this site to be a center of excellence for advanced packaging components to meet the future needs of our customer base for a range of sophisticated injectable therapies.”

“Waterford, Ireland, is an ideal setting for this new plant, given its business-friendly environment and the growing health science industry in the area,” Morel added. “On behalf of West’s Board of Directors, I would like to thank the many representatives of Waterford City, the Irish Government and the Irish Development Agency for their support.”

An Taoiseach Enda Kenny TD said, “I am delighted with this announcement of a new manufacturing facility in the South East by West Pharmaceutical Services which will create 100 construction jobs during its development and an initial 150 new jobs when operational. It is a massive boost for Waterford and the entire South East and I am happy that Government was able to assist through the work of the IDA. The Government is determined to secure economic recovery by incentivising job creation and further investment in the area.  Today’s announcement continues our strong track record on attracting employers in the medical devices sector and we will continue to prioritise Government support for sectors with real growth potential through our Action Plan for Jobs.”

New West Pharmaceutical Component Manufacturing Plant in Ireland

 

 

 

 

 

West Chairman and CEO Don Morel (left) with An Taoiseach Enda Kenny TD.

Construction is planned to begin in early 2015 on the 44-acre site at Knockhouse on Old Kilmeaden Road in Waterford, subject to the project obtaining requisite planning and zoning approvals, which the Company believes will occur later this year. This site will be a center of excellence for our proprietary elastomeric sheeting , which is used to package insulin for use in pen injectors. Future plans include additional manufacturing space for West’s proprietary injectable component product lines, which are integral to many injectable and dosage forms. With these planned expansions, the plant eventually could accommodate between 250 to 300 jobs total.

West has maintained a presence in Ireland since 2005 with a manufacturing and development center in Dublin, which is the European headquarters for The Tech Group, a West subsidiary that specializes in providing device design, development and manufacturing services for pharmaceutical and med-tech customers. Employing over 230 people at its Mulhuddart, Dublin facility, it is also undergoing an expansion as a result of securing a number of significant customer programs.

Read the full press release here: http://bit.ly/1vwZdol

West Brazil Hosts VII Technical Symposium – October 28, 2014

West Pharmaceutical Services Brazil is pleased to host the VII Technical Symposium on October 28, 2014, at the Melia Hotel Jardim Europa in Sao Paulo, Brazil. The event will feature a variety of speakers who will discuss such topics as:

  • Extractables and Leachables: Challenges in the Pharmaceutical Industry and Packaging Suppliers
  • USP: Packaging material overview and comparison with other pharmacopeias
  • New Packaging Technologies for Bio Products
  • Global Pharmaceutical Market Trends
  • And more!

Westpharma_English_VII_SIMPOSIO.

To register to attend, please R.S.V.P to Ligia Georgette or Adrianisia Alencar.

Linking Component Selection to Drug Delivery Strategies in a Highly Competitive Market

West’s Tibor Hlobik will present a poster at the 2014 PDA Universe of PFS and Injection Devices Conference at the Hyatt Regency Huntington Beach Resort & Spa, Huntington Beach, California, on October 6-7, 2014. The poster presentation will take place on October 7, at 10:00 a.m.

Companies developing biotechnology products in a prefilled syringes are faced with a highly competitive market in leading therapeutic categories. As a result, all players have to implement new strategies to continuously improve their existing drug brands as part of lifecycle management or introduce new, superior products with better patient outcomes. At the same time, these manufacturers are challenged to reduce total unit cost, increase quality levels and ensure dose accuracy. Plungers play a key role in these new strategies and must be carefully selected especially with auto-injector drug delivery formats. Costly issues such as particle contamination, high levels of leachables forming during long term storage, and poor dose delivery performance can be avoided by selecting the right plunger product. In this presentation, attendees will learn about the latest plunger technology including Quality by Design options that address drug development challenges, quality risks and that optimize reliability of self injection devices in a highly competitive market.

Elastomer plungers are complex components and many times overlooked during selection of prefilled syringes especially when used in an auto-injector to deliver biologics. The intent of the presentation is to educate the audience on new technology options, user requirements that must be considered, and how to make the best plunger selection using a risk based approach.

Visit West at Booth #210 on October 6-7 to learn more.

West is a proud exhibitor at this event, and representatives will be on hands to demonstrate technologies and customer solutions for self-injection, administration, packaging systems and components. In addition to Tibor’s poster presentation, Graham Reynolds will present at the event:

  • Global Market Trends – October 7, 4:00-5:30 p.m. Join Graham Reynolds, Vice President, Marketing and Innovation, West, as he moderates this session that will discuss the many factors which will drive and shape our industry in the coming years. Geographic expansion, increased access to healthcare, patient-centric solutions and the growth of biosimilars are examples of some of the topics to be explored.

Register now to attend the conference: http://www.pda.org/global-event-calendar/2014-pda-universe-of-prefilled-syringes-and-injection-devices

Recent Advances in Polymer Container Systems

Polymeric container systems are not new to the pharmaceutical industry, and their benefits in terms of break resistance, cosmetic quality and dimensional precision have been recognized by many companies around the world who have chosen to use a polymer vial or syringe.

More recently, issues such as protein aggregation, glass delamination, particles and the need for more precise and complex drug containers have led to an increased awareness and interest in polymer solutions as a preferred alternative to glass when considering new products. Increasing regulatory scrutiny of glass-related issues also has increased awareness of the potential risks to patients and the need to focus on safer solutions.

The various benefits of Daikyo Crystal Zenith® (CZ) cyclic olefin polymer systems, as well as a collaborative relationship among all parties can help create an effective integrated drug delivery system.

Learn more here.

Dr. Nicolas Brandes
Business Development Manager Daikyo Crystal Zenith

Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.

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