An update on USP: Compendial Effort to Revise Packaging Material Standards

The American Association of Pharmaceutical Scientists (AAPS) held its annual meeting and exposition in Denver, CO from November 13-16. This meeting continues to be a major event in the calendar of pharmaceutical scientists in academia, the industry, government and research institutions who come to participate in training events and focus group meetings, hear subject matter expert presentations, and network with customers and suppliers at the 3-day exposition.

During the Annual Meeting, Dr. Desmond Hunt, Principal Scientific Liaison at USP, spoke on: United States Pharmacopeia: Compendial Effort to Revisit Packaging Material Standards: Glass, Plastic, Elastomer, Metal and Other. The purpose was to inform the pharmaceutical industry on completed, and proposed, changes in USP standards relating to packaging materials – changes that emphasize risk-based testing, and move away from the checklist approach.

Dr. Hunt’s session provided the following highlights:

Chapter 661: Containers-Plastics. It is key that materials and packaging must be evaluated in the context of the intended application – leading to flexibility in evaluation, i.e., away from the checklist approach. Chapters became official on May 1, 2016 – more updates are in consideration.

Chapter 660: Containers-Glass. The first focus is redefining Type 1 glass. Second is re-evaluating analytical methods [aiming to incorporate more recent methods (e.g., inductively coupled plasma), in addition to standard wet methods], and developing methods to differentiate internal surfaces (heel, sidewall, neck, etc.). The USP Glass Expert Panel is reviewing Chapter 660 and Chapter 1660 (Evaluation of Inner Surface Durability of Glass Containers) and will hold a public workshop in June 2017.

Chapter 381: Elastomeric Closures for Injection. Modernization is nearly complete. Chapter 381 will maintain focus on elastomers in injectable drug product packaging/delivery systems. Evaluations comprise: biological reactivity, physiochemical properties, extractable metals, surface properties, etc. A new Chapter (382 – Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/ Delivery Systems) will be launched comprising evaluations previously in Chapter 381: packaging integrity, needle/spike functionality, fragmentation, penetration force, self-sealing, spike retention/sealability, and functionality tests for plungers, tip caps, and needle shields. A public workshop will be held in May 2017.

Chapter – Metals Packaging. There is no USP standard for metals. The aim is to begin understanding what is needed by Spring 2017.

Chapters 87 and 88: Biological Reactivity Testing. Chapters were transferred to Packaging, Storage and Distribution Expert Committee in 2014 – and a workshop occurred in 2015. The focus is to replace in vivo testing, with a risk-based Quality by Design approach based on knowledge of the components and system.

Dr. Desmond’s full presentation can be found here. USP seeks industry participation/guidance and comments on standard drafts – a great way to be aware of, and contribute to, USP’s very important work. Visit the USP website to learn more.

 

 

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Fran DeGrazio
VP, Scientific Affairs & Technical Services
Fran.DeGrazio@westpharma.com

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West expands contract manufacturing capacity in Ireland and gives back to the local community

This week, during a ribbon cutting ceremony that included executive leadership and invited guests, West announced the completion of a 60,000 square foot expansion at our contract manufacturing facility in Dublin, Ireland. The expansion is in response to customer demand for medical device manufacturing—especially in the area of diabetes.

Government officials, including Mary Mitchell O’Connor TD, Minister for Jobs, Enterprise and Innovation; Leo Varadkar, the Minister for Social Protection; and Barry Heavy, the Head of Life Sciences, Irish Development Agency; were all on hand to celebrate West’s most recent investment in Ireland, which strongly aligns with the Government’s ongoing strategy to attract investment in high-quality, high-value, medical device manufacturing. As a result of the expansion, it is anticipated that 100 new jobs will be added to the business over the next five years.

During the event, West also announced that the contract manufacturing business—formerly known as The Tech Group—will now align with the West brand and do business as “West.” This transition reflects the significance of contract manufacturing in West’s long-term strategy as a leader in integrated packaging and delivery for injectable medicines.

The nearly 350 employees currently working in Dublin are passionate about the important role they play in delivering healthcare and equally as passionate about giving back to the community. For the past five years, the team in Dublin has supported the Temple Street Children’s University Hospital, one of Ireland’s largest children’s hospitals. This year employees helped raise more than 25,000 euros. To recognize this impressive, local fundraising effort, West presented the Temple Street Foundation with a corporate matching gift of 25,000 euros during the ceremony on November 30.

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West looks forward to strengthening our presence in Ireland with the expansion in Dublin as well as the development of our center of excellence for elastomeric sheeting and injectable component product lines in Waterford. The Waterford plant is expected to begin full commercial operations in 2018.

 

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Tiffany H. Burke
Director, Global Communications
Tiffany.Burke@westpharma.com

West Pharmaceutical Services’ Karen Flynn Receives Silver Stevie® Award

On November 18, during a gala event at the Marriott Marquis Hotel in New York City, Senior Vice President and Chief Commercial Officer Karen Flynn was awarded a Silver Stevie® Award. Karen won in the category  Female Executive of the Year – Business Products – More Than 2,500 Employees at the 13th annual Stevie Awards for Women in Business. She was recognized for her instrumental role in leading West’s development and execution of a long-term strategic plan, realigning the organization from a product-focused structure to a market orientation.

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The Stevie Awards for Women in Business are the world’s top honors for female entrepreneurs, executives, employees and the organizations they run. All individuals and organizations worldwide are eligible to submit nominations – public and private, for-profit and non-profit, large and small. The 2016 awards received entries from 31 nations and territories.

Throughout Karen’s career at West, she has passionately supported opportunities to help women of all levels succeed within West and in the greater community. Most notably, Karen helped establish and serves as the executive sponsor for the West Women Investing and Networking (WIN) Group, which is dedicated to mentoring, educating and developing women to foster their professional success at West.

Karen heads the global Commercial Team and is tasked with driving growth across three major markets: Biologics, Generics and Pharma. Her team spans more than a dozen countries and includes marketing, sales, contract manufacturing services, quality assurance, regulatory affairs, scientific affairs and technical services. Outside of West, Karen lends her professional expertise to several volunteer efforts, including serving on the Board of the Directors for the Chester County Economic Development Council and the Advisory Board for Downingtown STEM Academy, a top Pennsylvania school for students pursuing science- and technology-focused education.

Congratulations Karen! To learn more about the Stevie Awards for Women in Business and the list of Stevie Award winners visit the Stevie Awards website.

 

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Tiffany H. Burke
Director, Global Communications
Tiffany.Burke@westpharma.com

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Eyes on World Diabetes Day

On November 14, World Diabetes Day will be observed around the globe. Diabetes is a growing issue, with more than 415 million adults living with the disease, a number that is expected to increase to 642 million – or 1 in 10 adults – by 2040. World Diabetes Day asks that we keep an “Eye on Diabetes” and encourages early testing and diagnosis, which can help reduce complications associated with this growing problem.

Consider the following facts from the International Diabetes Federation (IDF):

  • One in two adults with diabetes is undiagnosed
  • More than 5 million people died from diabetes in 2015
  • Up to 70 percent of Type 2 diabetes cases can be prevented or delayed by adopting a healthier lifestyle
  • More than 12 percent of the total global expenditure on health care is currently spent on adults with diabetes, with the majority of countries spending 5-20 percent of their health care budgets

At West, we’ve been working for more than 90 years to meet the needs of patients dealing with health issues. In fact, our proprietary elastomer sheeting is used in nearly all insulin cartridge delivery and administration products. The sheeting is used in conjunction with a specialized seal to help ensure that insulin is kept sterile, stable and free of any contaminants. It is also a critical functional part of the cartridge in an insulin pen system.

To help meet the rising demand for high-quality insulin sheeting and seals, West is building a new facility in Waterford, Ireland. This unique facility will serve as a center of excellence for the sophisticated manufacturing processes required to meet the needs of the insulin market. The plant will be critical in addressing increased demand for injectable drugs that require high-quality products created using advance manufacturing techniques – including insulin sheeting, seals and cartridge components – and provides dual sourcing of this important piece of the diabetes therapeutic regimen.

It is our hope that by working closely with global customers to meet the needs of patients, we can help create a healthier world through awareness, prevention and treatment of this growing problem.

Learn more about World Diabetes Day here.

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Heino Lennartz
Vice President & General Manager, Global Pharma

 

 

 

 

 

Reference

IDF Diabetes Atlas 7th edition www.idf.org/diabetesatlas

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Celebrating Our Veterans

Every year, on November 11, countries from around the globe celebrate Veterans Day to honor the brave men and women who have served in the military. Veterans Day, also known as Armistice Day or Remembrance Day, is observed throughout many of the 52 countries that are a part of the Commonwealth, a political association of mostly former territories of the British Empire. Some countries included are Australia, the United States, Canada, New Zealand, South Africa, Sri Lanka, India and the United Kingdom. 

Veterans Day celebrates military servicemen and servicewomen from generations past, welcomes a new generation of veteran’s home from deployment, and thanks our future veterans who are still serving at home and abroad.

This holiday is celebrated in various ways around the world. Australia, along with several other countries who are part of the Commonwealth, observe two-minutes of silence at 11 a.m. every November 11. The United Kingdom honors veterans by pinning poppy flowers—a symbol for the blood shed of war—to their coats and jackets. The United States often has an official wreath-laying ceremony at the Tomb of the Unknowns in Arlington National Cemetery, while parades and other celebrations are held in other states around the country.

At West, we are especially proud to honor the many veterans with whom we work. The Company recruits veterans in the United States and aims to foster engagement among employee veterans. The recruitment effort—The Ties to Stripes—identifies veteran’s unique skills and offers assistance in transitioning from military life to careers that align with these capabilities and interests. To learn more about Ties to Stripes, visit our website.

Thank you to our veterans and their families for the sacrifices you make in service of country.

 

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Taylor Pendergast
Global Communications Associate Specialist
Taylor.Pendergast@westpharma.com

 

The Parenteral Drug Association Issues Report on Vial Closures

The Parenteral Drug Association (PDA) has just issued Technical Report no. 76:  Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging. This peer-reviewed document is especially intended for packaging manufacturers, and pharmaceutical companies that use rubber stoppers and aluminum seals with vials.

For the last four years, I co-chaired the task force of 24 industry experts who created this much-needed report, which standardizes terminology regarding components, designs and defects. Defects are described in detail: photographically, by location, and as critical/major/minor. This report will be a valuable resource in the pharmaceutical and packaging industries – for inspectors and those setting quality specifications.

To download, visit:  https://store.pda.org/ProductCatalog/Product.aspx?ID=3441.  PDA members may obtain this free through November 17.

 

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Andrea Straka
Senior Specialist, Scientific Communications/TCS
Andrea.Straka@westpharma.com

 

 

 

 

West Supports Fox Chase Cancer Center through the International Dragon Boat Festival

Paddling in the Philadelphia International Dragon Boat Festival has been an important part of West’s Fox Chase Cancer Center campaign since its inception. Through the campaign’s efforts, West has raised more than $1.5 million dollars to support cancer research. This year, approximately $20,000 was raised by the Dragon Boat team alone.

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West’s 2016 Dragon Boat team consisted of 22 members including employees and family members led by coaches Mark Glemser, Sr. Tech Support, and Curt Hoover, Sr. Specialist, Communications. “Seeing West employees join together for a common cause is my favorite part of this event,” said Curt.   Mark and Curt held three practices in the months before the race to teach paddlers stroke technique, commands, cadence and teamwork to help them on race day.

 

For some paddlers, the connection is extremely personal. “The first year I was scheduled to participate in the Dragon Boat Festival in 2013, I was diagnosed with breast cancer and was unable to paddle,” explained West paddler, Jo-Ann Adamson, Specialist, Compliance & Legal. “I was determined that when I recovered, I would paddle in the next Dragon Boat Festival. I have participated in the races in the years since my diagnosis and surgeries. This event has a very special place in my heart, because the money raised is for cancer research at Fox Chase Cancer Center where I received my treatment.”

“The Dragon Boat Festival is a fun way to spend the day with colleagues and come together for an important cause at the same time, said paddler Matt Curry, Senior Scientist. “We’ve all had friends and family affected by cancer, so fundraising and competing for one of the area’s leading cancer research centers is a really great feeling.”

This year’s campaign ran from September 21 to October 7. In addition to the support raised by the Dragon boat team, money was raised through bake sales, raffles, jeans passes, and general donations. The current total is over $100,000.

Visit the West website to learn about our culture of giving.

 

 

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Caitlin Storbeck
Global Communications Associate Specialist
West Dragon Boat Paddler                                     Caitlin.Storbeck@westpharma.com

 

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Christine Mendoza
Global Digital Communications Specialist
West Dragon Boat Paddler                                  Christine.Mendoza@westpharma.com