West Authors Contribute Chapter on Primary Packaging Components

​West’s Mike Schaefers and Heike Kofler recently published a chapter entitled, “Primary Packaging Components Elastomeric Closures for Pharmaceutical Applications” to APV Basics Pharmazeutische Packmittel (Elastomeric Pharmaceutical Packaging). The chapter discusses the variable nature of medicinal products and their increased risk for potential interactions when coming into contact with materials used for drug product storage or targeted administration. The pharmaceutical industry has high expectations with respect to quality requirements, functional, physical and chemical properties as well as strict regulatory requirements. This has to be taken into account when manufacturing, processing and storing primary packaging that is in direct contact with the pharmaceutical product. The selection of suitable primary packaging according to design, toxicological, chemical and physical properties, and functional criteria is crucial to the successful development of a medicinal product.

Read the chapter (German language) here: APV_Packmittel_Kapitel_2.5.pdfAPV_Packmittel_Kapitel_2.5.pdf

New FDA Guidance Issued for Annual Reportable Changes

​A new regulatory guidance in the US has clarified expectations for pharmaceutical companies wishing to transition from an existing pharmaceutical component wash process to another, such as the Westar® Ready-to-Sterilize (RS) process.

The FDA has recently published the following guidance for post-approval manufacturing changes:

Guidance for Industry: CMC (Chemistry, Manufacturing and Controls) Postapproval Manufacturing Changes To Be Documented in Annual Reports (March 2014)

This supplements existing FDA guidances covering post-approval CMC changes and should be used in conjunction with those guidances when evaluating planned changes to a pharmaceutical manufacturing process.

In line with FDA’s Pharmaceutical Quality Initiative, the Agency has moved toward a risk-based approach for assessing pharmaceutical manufacturing process changes. Evaluation of post-approval CMC submissions has led FDA to identify a number of additional post-approval changes that represent a low risk to drug product quality and safety.

This final guidance outlines examples of changes that the Agency would now consider Annual Reportable. Of particular interest to customers contemplating a move to Westar RS products, the guideline clarified Agency thinking on changing contract manufacturing organizations (CMOs) for washing, drying or siliconization processes.

Transferring to a new CMO for washing, drying or siliconization of a primary container closure component is considered to be a minor change under the guidance. The application holder must certify that the CMO’s processes are validated, and that the CMO’s site has been audited and found cGMP compliant (by the application holder or a representative).

Validation of, and quality standards for, the Westar RS wash process are designed to meet regulatory standards. Please contact West’s Technical Customer Support for additional information regarding Westar RS products.

For more information, contact West today or visit our website at www.westpharma.com.

Author:

Steve LoCastro
Director, Regulatory Affairs
Stephen.Locastro@westpharma.com

Visit West at Upcoming Events

​It’s event season and West experts are out and about around the globe.  Visit us at the following events:

2014 International Society for Cell Therapy (ISCT) Annual Meeting
April 23-26
Paris, France
For more information or to register: http://www.isct2014.com/
Visit West at Booth #60

Respiratory Drug Delivery (RDD)
May 4-8
Fajardo, Puerto Rico
For more information or to register: http://www.rddonline.com/rdd/rdd.php?id=9

Extractables & Leachables USA
May 7-9
Silver Spring, MD
For more information or to register: http://www.eandl-conference.com/extractables-and-leachables-usa.aspx

AAPS Bio
May 19-20
San Diego, CA
For more information or to register: http://bit.ly/ShVR5R
Visit West at Booth #214
West’s Lloyd Waxman will present a poster!

PDA Packaging Conference
May 20-21
Washington, DC
For more information or to register: http://bit.ly/1diH2JU
Visit West at Booth #7

Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting
June 7-11
St. Louis, MO
For more information or to register: www.snm.org/am2014/
Visit West at Booth #200

MD&M East
June 10-12
New York City
For more information or to register: http://bit.ly/JxEP3h
Visit Tech Group at Booth #2039

West CEO Helps United Way of Kearney Area Celebrate 50th Anniversary

​On March 18, 2014, West CEO Don Morel was the keynote speaker for the Beacon of Hope dinner held to celebrate the United Way of the Kearney (Nebraska) Area’s 50th anniversary. More than 200 attendees were on hand to help celebrate, and to hear stories of West’ philanthropy, which included a $25,000 donation from West to help the United Way reach its 2014 campaign goal.

“It was a wonderful surprise,” said Lisa Reese Parish, executive director of the United Way.

Dr. Morel talked about what those gifts can accomplish, both tangibly and intangibly, and included a history of the West without Borders annual fundraising campaign, which will celebrate its 10th anniversary when it kicks off again in May.

Said Dr. Morel in a newsletter to employees, “I am proud and honored that our West family has continued to make such an impressive contribution to those in need around the world. To date, the West team has helped raise more than $2.2 million through a variety of company-wide and local campaigns.”

West is proud to support the United Way as well as many other local charities that aid children in need in the communities where our employees live and work.

Check back for more information and stories from the 2014 West without Borders global campaign!

West without Borders is not affiliated with Doctors Without Borders®, which is a registered service mark of Bureau International de Médecins Sans Frontières.

A History of Giving: West Supports Camp Victory

In 2004, Camp Victory, which is located in Millville, Pennsylvania, and operates camps for children who live with chronic health disadvantages including spina bifida, autism and cancer, added a wheel-chair friendly treehouse to their “Wish List” of needs. The tree house came with a hefty price tag and for several years, it sat on the list untouched. Just when Camp Victory was about to remove the treehouse from the wish list, it received a call from West’s CEO Don Morel and the campaign to build “Uncle Walt’s Treehouse” was born.

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As part of the West without Borders 2007 campaign, West team members donated $240,000 to help build the treehouse. But West’s generosity didn’t stop there. More than 100 team members from the Jersey Shore, Montgomery and Williamsport plants helped build the treehouse.

“Over the course of eight weeks, West donated much of the manpower needed to help build the treehouse,” said Dave Bergerstock, Director of Operations. Bergerstock was the plant manager at Jersey Shore when treehouse construction began and participated in the ‘twig-breaking’ ceremony to mark the start of construction in April 2007. “It was a truly remarkable experience for us – particularly because we knew our hard work would amount to a terrific experience for the children.”

When complete, the treehouse was, said the children, “totally awesome.”

“Every group has found multiple uses for the treehouse,” said Jamie Huntley, Camp Victory Executive Director. “Sleepouts, music sessions, drumming circle, nature lessons, bird watching and just plain hanging out. We can’t thank West enough for making this dream come true.”

Since then West team members have continued to raise money for and aid Camp Victory with many volunteer hours.

Recently, West Corporate, through the H.O. West Foundation, once again donated $25,000 to the Camp, and the Jersey Shore and Williamsport facilities donated over $40,000 from their 2013 West without Borders campaign.  Both local facilities continue to make Camp Victory the recipient of its annual West without Borders efforts.  At an informal appreciation dinner in March, West’s long-term partnership with Camp Victory brought forth some emotional stories of what the partnership has meant to both West and the camp.

Noted Bergerstock, “West’s partnership with Camp Victory continues to benefit both organizations in an extremely positive way.  At the recent dinner, local plant representatives from Jersey Shore, Williamsport and Exton were able to share what this partnership has truly meant to them over the years with Camp Victory’s Board of Directors.  We are pleased and proud to have helped the thousands of less fortunate children that go to the various catered weekly camps, and we hope to continue to do so for many years to come.”

Watch for more stories about what the partnership with Camp Victory has meant to the West team over the years!

 

 

 

West without Borders is not affiliated with Doctors Without Borders®, which is a registered service mark of Bureau International de Médecins Sans Frontières.

 

Selecting the Appropriate Seal

When selecting parenteral packaging components, the vial and stopper are typically discussed, but the seal is often an afterthought. Seals do not have direct product contact and are considered secondary packaging. However, the selection of an appropriate seal is critical to assure proper container closure integrity as well as determine how the product will function for the end user. When selecting a seal to complete a container closure system, there are three critical dimensions to consider:

  • vial crown height
  • stopper flange thickness
  • aluminum seal skirt height

One helpful activity when making recommendations to customers is a theoretical calculation referred to as the “stack-up assessment.” This calculation allows West to determine the amount of excess skirt length available for completing the crimp under the vial crown by using the nominal or mean values for the glass vial crown height, stopper flange thickness and proposed aluminum skirt lengths. We make an assumption of approximately 20 to 40 percent rubber stopper flange compression (Check with your equipment vendor for specific recommendations for your specific system.) To determine the excess skirt length achieved, the below calculation is performed:

Excess Skirt Length = [(mean aluminum skirt length – aluminum thickness) – (vial crown height + (stopper flange thickness X percent compression))]

An aluminum thickness of 0.008 inches is assumed. An excess seal skirt length of approximately 0.030 inches or slightly greater is required for an acceptable crimp on a vial.

This theoretical calculation is a helpful guideline, but it is not a substitute for component testing. Each dimension mentioned has a tolerance, so there is some variation in the parts. Therefore, it’s important to ensure that the components in their final state are compatible via appropriate container closure integrity testing. Refer to blog posting from Kristine Davidson, Container Closure Integrity: What does it mean?, for more information on container closure integrity and testing.

Author:

Jessica Saggers
Senior Technical Account Specialist
Jessica.Saggers@westpharma.com

West Joins Pharmaceutical Supply Chain Initiative

West is pleased to announce that it has joined the Pharmaceutical Supply Chain Initiative (PSCI). PSCI is a group of major pharmaceutical companies, all of which are West customers, that formed to “support pharmaceutical suppliers in efforts to operate in a manner consistent with industry expectations about ethics, labor, health and safety, environment and management systems.” PSCI members believe that through the application of principles for responsible supply chain management, better social, economic and environmental outcomes will result for all involved in the pharmaceutical supply chain. This includes improved conditions for workers, economic development and a cleaner environment for local communities.

At present, 17 companies have joined PSCI. West is the first pharmaceutical supplier to be invited to join.

“The idea of PSCI is that all member companies have requirements to audit suppliers in these non-traditional areas. Rather than each customer sending out individual auditors to every supplier facility, a single, third-party entity approved by PSCI will conduct audits that will be accepted by the full membership,” said Gary Wilson, Vice President, Corporate Social Responsibility and Sustainability. “PSCI membership benefits West in that we only have one audit per site, and benefits the industry in that one audit can serve multiple companies’ requirements.”

West’s Jersey Shore, Pa.; Eschweiler and Stolberg, Germany; and St. Petersburg and Clearwater, Fla. plants have been audited by PSCI, and additional plants will be audited in the future. West’s goal in participating with the group will be to aid in the development of the organization and work to engage the supplier community to help companies better understand why a third-party audit can help to ensure that systems and governance required by the industry are in place at all points on the supply chain.

“Joining PSCI shows that West understands what our customers want from their suppliers,” noted Wilson. “And that West has systems in place through its Corporate Code of Business Conduct and other policies and procedures that have ingrained the principles of PSCI into all of the company’s operations.”

PSCI Members:

Allergan
A
straZeneca
Baxter
Bayer
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
GlaxoSmithKline
Johnson & Johnson
Lilly
Mallinckrodt
Merck
Novartis
Novo Nordisk
Pfizer
Roche
West

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