Japanese Pharmacopeia Updates- Are you ready?

ELAS SER-042_S-127_20mm_Serum

The Japanese Pharmacopeia (JP) has updated chapter 7.03 “Test for Rubber Closures for Aqueous Infusions” and the last date to transition to the new version is September 30, 2015.

Are you ready?

Rubber components used in the Japanese market need to be compliant with the tests listed in this chapter. Below is a summary of the major changes including changes to test solution preparation and toxicity requirements, and some items to consider as we all move through this transition.

The Change: Prior to the update, test solution preparation was by weight (extraction volume was 10 times the mass of the material). However, extractable substances are impacted by the surface area of the sample being exposed to the extraction solvent. Therefore, different test configurations of the same weight could have different surface areas, creating a potential for differences in test solution concentration. Moving forward, the new revision requires the test solution to be prepared using a consistent sample surface area of 150 cm2.

What does this mean to me? The concentration of the test solution may not be the same for elastomeric closures that were tested prior to the change. While the test is now more consistent for various configurations of the same formulation of samples tested, it may not be consistent with results obtained from previous tests. An evaluation of product compliance to the new test method should be performed.

The Change: Three tests were removed in the updated version and are no longer required to demonstrate compliance of elastomeric closures: Foam, Pyrogen and Hemolysis. The requirement for when to perform the Acute Systemic Toxicity test was modified and is now only required when the sample solution does not meet the requirements of the Cytotoxicity test.

What does this mean to me? The removal of these tests should have no impact on products being used today. It is just important to recognize that these tests are no longer required in studies to evaluate elastomeric closures for JP compliance, except in the case of the Acute Systemic Toxicity test, which still needs to be performed when required.

The Change: A new Cytotoxicity method was added to JP 7.03 and it is a quantitative test that measures cell growth inhibition when exposed to serial dilutions of a sample test solution. The Cytotoxicity test states that other appropriate methods for evaluating cytotoxicity may be used in place of the method detailed in the JP. However, if test results obtained according to the other method are “questionable” the JP Cytotoxicity test should be performed. An example of an alternative method would be one that is commonly used for samples that need to demonstrate compliance in the United States markets and is described in the United States Pharmacopeia (USP) chapter <87>. The USP <87> MEM elution method is a qualitative test that classifies the amount of cell morphology changes (such as changes in cell shape, disintegration, or even potential cell death) by grades when exposed to a sample test solution (described below). Because there are differences in test solution preparation and the methodology used in the two different tests, the results are not directly comparable. When results obtained using USP <87> are Grade 0, the data could be used to justify that the JP cytotoxicity test is not required because in theory there would be no cell reactivity to quantify. However, if any results are greater than 0, this indicates the potential for cell reactivity to the test solution and the most conservative approach would be to quantitate the reactivity via the JP test.

USP<87> MEM Elution criteria

 

Grade

 

 

 

Reactivity

 

 

 

Condition of All Cultures

0 None Discrete intracytoplasmic granules; no cell lysis.
1 Slight Less than or equal to 20% of the cells are round, loosely attached, and without intracytoplasmic granules; occasional lysed cells are present.
2 Mild Greater than 20% to less than or equal to 50% of the cells are round and devoid of intracytoplasmic granules; no extensive cell lysis and empty areas between cells.
3 Moderate Greater than 50% to less than 70% of the cell layers contain rounded cells or are lysed.
4 Severe Nearly complete destruction of the cell layers.

What does this mean to me? A review of all current and planned studies and products should be conducted to determine if any are affected by the addition of the Cytotoxicity test requirement. If so, an assessment should be completed based on the relative risk of results obtained using the new compendia versus the previous version to determine if products require additional testing.

How can West help?

West has evaluated its current JP compliant formulas to ensure continued agreement with the changing test requirements and will update formulation characteristics, as appropriate. There has been no change to West items that were previously compliant based on the new requirements. West Analytical Services laboratory can support testing needs as part of a customer’s evaluation of this change as it is also the responsibility of the end user to confirm that the packaging components used in their products meet the necessary requirements. For any additional questions or for further discussion on this topic, please contact your West Technical Customer Support representative.

Authors:

Jessica Mangus
Project Specialist PPS NA
And
Lauren Orme
Senior Specialist TCS

West on the Road, Clearwater–Episode 2: Experience and Dedication Results in Excellence

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As a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products, we know that what we do has a direct impact on the health and well-being of our global community. In the second installment of West On The Road at our Clearwater, Florida plant, our employees talk about how knowing the impact they’re making on the delivery of healthcare fuels the collaborative dedication at the facility. As one colleague said, “When I’m going home, I go with a satisfaction…I know that I did something that will make a difference in somebody’s life.”

Coupling this passion for helping others with hundreds of years of collective experience at our Clearwater plant is largely what makes it a special place to work, and a place where colleagues can feel proud of the work that they’re doing. Many of the employees in Clearwater have been with West for more than 20 years.

Continuous improvement is deeply rooted in the culture at Clearwater – and West as a whole – and as Andy Phillips, Director of Operations, highlights, a key component of this is fostering constant information-sharing and collaboration. At Clearwater, there are systems in place to ensure that everyone’s ideas are recognized and utilized whenever possible to make improvements.

After all, notes Andy, “We all understand that we are making products that are making a difference in the world.”

 

Planning for a Digital Future

McElfresh Mark Blog

West is pleased to share a Q&A with Mark McElfresh, Vice President of Operations and Supply Chain at The Tech Group, that recently appeared in Manufacturing Leadership Journal. 

MLJ: What is your role at The Tech Group?

MM: I am vice president of operations and supply chain for our contract manufacturing business. We have eight manufacturing plants across the U.S., Latin America, and Europe. The Tech Group, a West Pharmaceutical Services, Inc. company, is a global contract manufacturer serving the pharmaceutical, medical and consumer industries.

MLJ: What is the most pressing issue facing manufacturing?

MM: Talent development and acquisition are extremely pressing to manufacturing. As we move into digital factories, we need to find a workforce that can drive this sort of change at the shop floor level. But where do we find the operators and technicians that have the skills to integrate and optimize data acquisition and sensors as we drive them across the manufacturing floor? We’re working with some local community colleges and trade schools to develop tool makers, automation technicians, and robotic technicians to help us accomplish our goals for manufacturing innovation.

MLJ: What is your most important corporate initiative?

MM: We are currently in the process of integrating all of our manufacturing equipment—injection molding presses, automated assembly, and more—in terms of the data acquisition cycle for every part we make, tying that into an MES system and, ultimately, pushing that data in real time to our ERP system. We want to have a real-time look at where we are in our manufacturing processes. To be more competitive in the future, particularly in lower-cost markets, we can’t waste time running equipment when there is variation in the process. Gone are the days of making a product, then testing it to find out if it’s good or bad.

MLJ: What are the most important leadership qualities for the future?

MM: Leaders need to be well-versed in and well-rounded to understand all the technologies and regulations related to running a business. You have to be able to understand integration, ERP and shop floor data collection, how to lead people, how to recruit people, and how to drive that across the organization. It’s not enough now to know one specific discipline.

MLJ:  What will be the greatest opportunities for manufacturers over the next five years?

MM: The best opportunities will be found working in conjunction with suppliers, customers, and even competitors to develop more integrated, turn-key solutions. We’re working with pharmaceutical and medical diagnostic companies that, like everyone else, are under cost pressures. The more they can outsource from a service standpoint, the more competitive and flexible they can be. That means we need to work across multiple companies to drive the most effective solution in a very quick manner.

MLJ: What is your favorite activity outside of work?

MM: I play golf. I like to backpack. And I work as a referee in college lacrosse.

West is a proud member of the Manufacturing Leadership Council. Visit the organization’s website to learn more.

Regulatory Affairs – a Competent Partner Helping to Ensure Regulatory Compliance

Because differences exist between regulatory agencies from region to region, West regulatory affairs continually stays informed of new developments and changes in order to provide customers with accurate regulatory support regarding packaging requirements.

With a keen understanding of various regulatory agencies’ positions specific to our products, West’s regulatory affairs team offers unparalleled global submission support. In particular, West specializes in Common Technical Document (CTD) sections 3.2.P.7 for container closure systems, as well as 3.2.P.3.5 for process validation and 3.2.P.3.3 for process description related to wash and sterilization processes.

In the United States and Canada, West offers Drug Master Files (DMFs) for:

  • Rubber formulations and coatings
  • Westar® RS/RU processes
  • Westar® lined seals process
  • NovaPure® components
  • Daikyo Crystal Zenith® systems

West also provides a Letter of Authorization/Access to DMFs and responds to agency requests either confidentially or non-confidentially, where the response goes directly to the customer.

Knowing regional differences not only helps to navigate the regulatory process, but ultimately strengthens the composition of submission dossiers. West customers can trust that our regulatory team has the knowledge and the experience to deliver a complete submission within the respective region or country.

Please check back for upcoming blogs to learn more about West’s specialized experience with food compliance, animal derived substances and natural rubber/latex.

 hampe-jeannette-(2)

Jeanette Hampe
Regulatory Affairs Specialist, Europe
hampej@westpharma.com

 

Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

NovaPure® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

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

 

West on the Road–Welcome to Clearwater, Florida!

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West is on the road again, traveling more than 1,000 miles from our Jersey Shore, PA, manufacturing facility—where we visited during our first installment of West On The Road —to the sunshine state, where we’ll be touring our state-of-the-art Clearwater plant.

Glenn York, Engineering Manager, and Andy Phillips, Director of Operations, walk us through a typical day at the facility where, through an unsurpassed focus on quality, cleanliness and efficiency, the facility produces 15 to 20 million Flip-Off®, Flip Tear-Off®, and Flip-Off-TearOff®, all-aluminum, lined and unlined seals and closures for pharmaceutical, ophthalmic, dental and veterinary products – totaling close to 3.5 billion seals in a given year.

Each seal starts as just a thin coil of metal, which is fed into a stamping press to form a shell. From there, the shells are fed through a variety of other processes to customize the seal based on our customers’ needs into the final product. This can include running through the West Spectra™ process to include customized colorization, wording and decoration to adding a rubber lining to taking a pass through the roll groove machine to create a specialized shape.

One of the things that sets West apart is our commitment to continuous improvement and pursuit of perfection. To that end, the Clearwater plant will soon be adding a high-speed assembly machine which, through the one-piece flow approach, will streamline the press to assembly process and allow immediate identification of any potential quality issues.

The 2015 Internship Program—a Success for all Involved

end of summer photo

The final week of the Ambassador Internship program is coming to a close, and the 31 students who have been hard at work since June now have the opportunity  to showcase what they have learned and reflect upon the entire experience during the program wrap-up.

At the beginning of the summer, interns received their project assignments—some individual and some group—that required research directly related to West’s core businesses and competencies.  The projects were designed to challenge the interns and also provide valuable insights to West—as  findings from each assignment have real meaning for their respective departments.   

Students shared their appreciation for the significance of the work during the final presentations this week. “In working with my manager, I quickly came to understand that I was working on something that really matters to him,” said intern Juile D’Ascenzo.  “I was brought into meetings and conversations with other West employees to better understand the project and its significance, rather than being stuck in my cubicle.”

Having the opportunity to see what their fellow interns did over the last several weeks also demonstrated the breadth of Ambassador Intern activities. “We all knew that everyone has been hard at work, but it wasn’t until I actually saw the presentations did I fully understand how different but equally important everyone’s role has been for West,” said intern Patrick Vincent.

Another closing event for the interns was a visit to the Jersey Shore, PA facility on July 15. The interns from Exton, Pa. and Washington, NJ  toured the microbiology lab and manufacturing floor, escorted by their Jersey Shore intern peers. It was an invaluable experience to see all phases of manufacturing West components.

“It’s extremely important for the interns to see the people and process involved in making our rubber stoppers, and what it takes to make the products so special,” said Marcia O’Connor, Talent Acquisition leader and coordinator of the Ambassador Intern program. “Everyone in Jersey Shore—and in all of our plants—take such pride in what they do, their contribution to the company overall needs to be understood.” 

As the students prepare to head back to school, West is grateful for the contributions that the Ambassador Interns have made over the last 10 weeks and looks forward to next year.

West Welcomes STEM Students throughout the Summer

STEM_july 2015

Since its inception in 2011, the Downingtown Science, Technology, Engineering and Mathematics (STEM) Academy has quickly earned the ranking as the number one high school in the state of Pennsylvania. With the STEM Academy located in the same district as West’s corporate headquarters, and a strong corporate culture of giving back to the community, a partnership between the two organizations was a natural fit.

West collaborates with the STEM academy in a variety of ways that harnesses that spirit of giving while also drawing upon the knowledge base available at West. One example is West’s work with teachers at STEM to create lesson plans that are project-driven and student-led. Additionally, West offers STEM students the opportunity to complete their 21 hours of required internship experience at the Exton headquarters over the summer months. The internship, along with 150 “Creativity, Action, and Service” hours, are required before graduation with the goal of creating well-rounded and community-oriented students.

“Having a strong technical talent pool is a requirement for West’s continued success,” said Karen Flynn, President, Pharmaceutical Packaging Systems. “If we want to ensure that students are prepared to earn advanced degrees and pursuing STEM careers, we need to support them early on.”

This year, 10 STEM students have been invited to West headquarters to fulfill their internship requirement over a four week period. The students have an opportunity to get answers to any questions they have about working in a corporate environment and are paired with a college student who is part of the West Ambassador Internship program.

On the STEM students’ first day of their internship, they attended a workshop to discuss what they wanted to gain from their experience and what was needed to develop their leadership skills further. Upon their return the following week, students were given time to shadow their mentors and learn about the projects they have been working on throughout their time at West this summer. Finally, STEM students attended a presentation that provided an overview of West’s products and the manufacturing processes involved.

“It’s very rewarding to see the STEM students engage with the Ambassador Interns, take an active role in preparing for their careers, and doing all of this while they are on summer vacation,” said Brian Stocker, Vice President, Human Resources, Americas.

West partners with the STEM Academy through their Business and Industry Advisory Board, which helps steer Academy initiatives and programs, including internships and other field experiences.

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