FortSchritt extends a special thank you to West without Borders

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West employees have forged a strong bond with many of the local organizations they support through the West without Borders fundraising initiative. This is particularly the case with Fortschritt Städteregion Aachen e.V. Employees at the four West sites in Germany continued their relationship with this worthwhile organization in 2015 and raised €3,762 to help them finance special therapy furniture that was made in Hungary.

The commitment from employees didn’t stop with financial support alone. Because they wanted to make sure that the furniture was delivered directly to the organization, West reached out to Hammer—an international transportation and logistics company—and secured free delivery of the furniture from Hungary to Stolberg, Germany.

In order to thank West and Hammer in person, FortSchritt invited representatives from both companies to its facility for a small reception on February 1. Heino Lennartz, Vice President and General Manager, Global Pharma, took the opportunity to present Wolfgang Tim Hammer, Chief Executive Officer, Hammer with a framed keepsake to underline their joint charitable efforts.

The visit also provided an opportunity for guests to attend a conductive education session, hear about the organization’s many success stories, and meet its members. To learn more about West without Borders and the company’s culture of giving, visit the West website.
Author:

Nadine Gerstler
Communications Specialist Europe
Nadine.Gerstler@westpharma.com

Modern Drugs Deserve Modern Packaging

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Moore’s Law states that the number of transistors in a circuit doubles approximately every two years. This once lofty prediction proved accurate and has been the basis for long-term planning, not just for the semiconductor industry, but research and development in general. Much like semiconductor circuits, advancements in scientific discoveries in the pharmaceutical industry have paved the way for explosive growth in biologic drug development. Pharmaceutical drug products, specifically biologics, are not a new concept. However the advancement of monoclonal antibodies and protein therapies are prompting manufacturers to examine the impact of packaging material selection in product development. With this knowledge in hand, manufacturers are thinking more about the significance of the entire container closure system and the important role it plays in delivering effective therapies to patients.

Pharmaceutical packaging and regulatory changes are responding to the rapid growth of biologics in the marketplace. A clear path of communication between the innovator and the packaging industry needs to be established to ensure the appropriate components are recommended. Biologic drugs are more sensitive to extractables, particulate, etc., which may alter the active pharmaceutical ingredient (API) of the drug. Thus, packagers must consider how container closure systems, and the materials used in their construction, can impact the quality of the biologic products they hold.

Change…adapt…adjust. All are synonymous with being reactive. Any advancement in the pharmaceutical industry triggers a cascading response for packaging, governance, and all other industries directly linked to a drug. If testing methods and legacy packaging standards are “grandfathered” without considering more modern, innovative standards for each product or delivery system, this could be problematic. So how can we reverse the trend of being reactive to becoming more proactive?

West’s NovaPure® product line has been designed using Quality by Design (QbD) principles to help maintain drug purity and efficacy and mitigate risk to the patient. High-value NovaPure components use our most modern elastomeric formulations with Flurotec® barrier film to minimize compatibility issues with drug products. To learn more about the proactive strides West is making in the packaging industry, contact Technical Customer Support.

 

Stephens, Jason 003 LR

Jay Stephens, Ph.D.
Senior Technical Account Specialist
Jason.Stephens@westpharma.com

 

 

 

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

FluroTec® technology is licensed from Daikyo Seiko, Ltd.

Coring and Fragmentation of a Rubber Stopper

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Coring and fragmentation are two typical events that can occur when a needle is pierced through a vial closure to withdraw drugs from the vial or expel drugs into the vial. Despite being used interchangeably, coring and fragmentation are two different mechanisms.  Coring happens when a needle shears out cores (or slivers) from a rubber closure as it pierces the closure. Cores are, at times, longitudinal in shape. On the other hand, fragmentation is the formation of characteristically small, irregular particles when a needle pierces through a rubber closure and abrades the rubber material.

The two major factors causing coring and fragmentation are, of course, the rubber closure and the needle. Despite seeming simple to control, each comes with a number of variables that need to be addressed and regulated. Regarding the closure, the main concerns are the hardness of the rubber formulation and the thickness of the stopper diaphragm where the needle pierces through.

However, with regard to the needle, there are varying quality parameters (sharpness, consistency, etc.), designs (bevel angle, needle gauge, heel type, etc.) and textures (smoothness, siliconization, etc.). Also, there are different piercing techniques (speed, angle of puncture, number of times needle is reused, etc.) practiced by the many healthcare providers around the world and patients who are self-administering drugs at home.

To effectively prevent coring and fragmentation, it is critical that there is good communication between drug manufacturers and healthcare providers and/or at-home patients/caregivers. A drug manufacturer needs to understand the puncturing technique most commonly used by the intended healthcare providers. Similarly, healthcare providers should reach out to drug manufacturers to communicate their needs.

For more in-depth discussion about coring and fragmentation, please contact your Technical Customer Support representative.

Author:

Boo Jia Min
TCS Engineer
JiaMin.Boo@westpharma.com

 

Why connect an auto-injector to a smartphone?

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West is pleased to welcome guest blogger Katrina Firlik, MD, Chief Medical Officer and Co-Founder of HealthPrize Technologies. This is the second installment in a series on the West/HealthPrize collaboration.

The HealthPrize collaboration with West is designed to help enhance the patient experience surrounding injectable medications, encouraging greater patient engagement and adherence, both critical to clinical outcomes. This collaboration is, at its heart, part of the broader “Internet of things” movement, connecting everyday devices to the Internet.

The Nest® Learning Thermostat™ is one of the most commonly cited examples of this rapidly developing trend. It allows you to check the temperature inside your home remotely via your smartphone, and also adjust it as desired.

The Nest thermostat example makes simple sense. But why would a person with diabetes, for example, want to link their auto-injector to the Internet?

Given that smartphones are now so central to our everyday lives, it could be argued that the better question is: Why not? For a person with a “condition” who is, reluctantly, a “patient,” connecting their therapy to their phone (or any other Internet-connected device) is a way of integrating it into their everyday lives in a friendlier and more seamless way.

Nobody actually wants to inject themselves. It’s no fun. It hurts. Even worse, many drugs could have little to no immediate benefit, but rather long-term benefits—making the psychological hurdle even higher. With our collaborative West-HealthPrize solution, the fact that we can connect an auto-injector to our software allows us to offer a number of immediate benefits to patients on injectable therapy.

For one, we can add the “fun factor” of immediate points, redeemable for gift cards, merchandise, or charitable donations, similar to other loyalty programs that patients are accustomed to taking advantage of in their everyday consumer lives. In addition, the gamification elements of our program—sweepstakes, leaderboards—allow them to feel that they are part of a greater community of other patients also striving to “win.”

Once engaged, patients also then have access to daily and weekly educational offerings, with the benefit of strengthening the intrinsic motivation required to stick with medications long-term. And just as with any other Internet or app-based tool, patients can engage wherever and whenever it’s convenient for them.

And, of course, most similar to the Nest thermostat analogy, patients can collect and tap into their own data. How adherent were they last month? How many points have they earned? These data, aggregated and de-identified, also become valuable to the pharmaceutical companies and other healthcare constituencies that sponsor each program.

And finally, daily emails or text messages from the program serve as helpful medication reminders, particularly relevant as they are delivered to the smartphone that is most likely with a patient at all times.

Will all patients connect their auto-injectors to the Internet? No. Some won’t need to and some won’t want to. But given the magnitude of the adherence problem (the need) and the proven power of incentives and gamification (the want), many, many patients most likely will.

 

 

The Nest® Learning Thermostat™ is a registered trademark of Nest Labs, Inc.

 

 

 

Daikyo RSV® and RUV® Components Offer a New Option to Meet Today’s Packaging Needs

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There is an increasing trend in the pharmaceutical industry for ready-to-use components for a variety of reasons.   As a result, customers are looking to their manufacturing suppliers to help them address the following challenges:

  • Regulatory Risks: Because regulatory requirements are becoming more stringent for drug manufacturers, more attention needs to be paid to aging facilities and equipment, inadequate validation and testing, missing documentation, and lack of employee training.
  • Streamline Processing: The potential for on-site washing demands on-site expertise leading to higher utility, maintenance, personnel and insurance costs – as well as a larger manufacturing footprint. Often, these additional resources are not an option.
  • Increased Costs: Preparing components for use requires more personnel and production planning and allows for potential unforeseen events and shut downs.

Daikyo RSV (ready-to-sterilize validated) and RUV (ready-to-use validated) components allow customers more time to focus on their own drug manufacturing needs.  Daikyo RUV components are delivered to customers ready-to-use on their filling lines. The components are manufactured using high-quality elastomer formulations, pharmaceutically washed, 100% camera-inspected and steam sterilized.  The Daikyo RUV process is fully validated, filed in Drug Master Files in the U.S. and Canada, and utilizes an overkill method based on ISO 17665-1 to provide a sterility assurance level (SAL) of 10-6 or better.

Each batch of product is provided with specification for bioburden, particulate and endotoxin.  Daikyo RUV components adhere to rigorous quality standards and provide customers regulatory acceptance and flexibility.

Additionally, the RUV offering is available in small quantities to meet your clinical trial and scale-up needs and enable manufacturing flexibility.

To learn more about the latest component offering from West, visit our website or contact your Account Manager or Technical Account Specialist for more details.

Author:

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Kristine Davidson
Senior Technical Account Specialist
Kristine.Davidson@westpharma.com

 

 

Have you selected the right stopper for your freeze-dried drug product?

Lyophilization is widely used for pharmaceuticals to help preserve parenteral drugs that are unstable in liquid formulation, particularly biologics. Lyophilized drugs have many advantages like prolonged shelf life, easy dissolution and good stability. However, a suitable container closure system is necessary to ensure the successful lyophilization of pharmaceutical products while maintaining product quality. Therefore, the selection of suitable container closure components for a lyophilized drug application is an important consideration, especially the primary elastomer component—a stopper.

Container closure integrity (CCI) is crucial for maintaining the stability and sterility of the drug throughout its shelf life. The dimensions and the fit within the vial could have an impact on the CCI of the system. During the manufacturing of a lyophilized drug, immediately after the freeze-drying process is completed, the stopper acts as the only seal to protect the drug during its transportation from the lyophilization chamber to the crimping station. The initial seal is provided by the interference fit (typically 2–10%) of the stopper plug in the vial bore and the stopper should fit well with the vial1. If the plug diameter of the stopper is too big, it can be difficult to insert the stopper into the vial or even create a pop-up if not well-seated. On the other hand, if the plug diameter of the stopper is too small, it can create leak paths between the stopper plug and vial neck. Either way, the seal integrity is compromised. The long-term seal is formed by the aluminum crimp compressing the bottom of the stopper flange to the top surface of the vial crown (see  Fig. a. Sealed Vial1). Optimal initial seal and long-term seal are critical to achieve container closure integrity.

The stoppers commonly used for lyophilized drug are typically vented – igloo, 2-legged or 3-legged designs. During the lyophilization process, after the drug product is frozen, the ice crystals sublimate via the vent(s) in the stopper. It was observed that the rate of moisture transfer from the vial increased as the cross-sectional area of the vent was increased. However, this increase tapered off as the area of the vent approached approximately 6 mm2 and 10 mm2 when the temperature in the lyophilization chamber was at 0°C and 25°C respectively 2. As a result, it is conclusive that under normal conditions as mentioned above, the number of vents on a stopper does not have an impact on the rate of sublimation, since the size of a vent is typically already greater than 10 mm2. In regards to configuration, the igloo design (single vent) is usually preferred. The igloo designed stoppers tend to be more stable when placed on vials before and after the lyophilization process. These stoppers also have good machinability properties during filling operation with reduced incidences of intertwining.

The rubber stopper is one of the primary packaging components that come into contact or close proximity with the drug product throughout the shelf life of the drug. Therefore, drug to closure compatibility is a critical consideration during the selection of a suitable closure. Rubber formulations are complex in nature. The extractables present in the stoppers used could contaminate the product during lyophilization (under high vacuum) or long-term storage 3. Therefore, pharmaceutical companies need to evaluate the stopper to determine its compatibility with drug. In some instances, a barrier lamination may be recommended to improve the drug-closure compatibility.

To maintain the moisture level in the lyophilized drug product cake during shelf life, rubber formulations with low moisture vapor transmission rates should be selected to prevent moisture ingress, and sufficient drying of the closure after steam sterilization is necessary.

You may click the following link for more information about managing residual moisture in lyophilized drugs.

https://westpharma.wordpress.com/2014/12/15/managing-residual-moisture-in-lyophilized-drugs/

Author:

Lynn Yao

Lynn Yao
TCS Engineer
Lynn.Yao@westpharma.com

 

References

  1. Wayne Curry, Samuel Conway. Reducing the risk of contamination of sterile parenteral products via ready-to-use closure components. AAPS PharmaSciTech, Vol. 11, No. 4: (1572-1579) 2010.
  2. Amol Mungikar, Miron Ludzinski, Madhav Kamat. Effect of the Design of the Stopper Including Dimension, Type, and Vent Area on Lyophilization Process. PDA Journal of Pharmaceutical Science and Technology. Vol. 64, No. 6: (501-516) 2010.
  3. Pikal, MJ, Lang, JE. Rubber closures as a source of haze in freeze dried parenterals: test methodology for closure evaluation. J. Parenter. Drug Assoc. 32(4): 162-173 (1978).

 

 

West’s NovaPure® Receives 2015 India Pharma Award for Outstanding Primary Packaging for Injectables

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We are happy to announce that West received the 2015 India Pharma Award for Outstanding Primary Packaging for Injectables for our high-quality NovaPure® components. The award was presented to West during the CPhI India Pre-Connect Congress.

Organized by UBM India, the India Pharma Awards recognize innovation and excellence by pharmaceutical companies and related stakeholders operating in India. The Outstanding Primary Packaging for Injectables award honors products and initiatives that have enhanced packaging to fortify product integrity and improve efficiency. West’s NovaPure components were recognized for their exceptional quality, cleanliness and reliability.

“We are honored to receive this award recognizing NovaPure components and West’s ongoing commitment to quality,” said Alagu Subramaniam, Country Manager & Director, West. “We work by the side of our pharmaceutical and biopharmaceutical customers to design and manufacture packaging and delivery systems that bring drugs from concept to the patient more efficiently, reliably and safely. NovaPure is a great example of this dedication.”

West opened its first manufacturing facility in India in 2014 in response to growing demand for high-quality drug packaging and delivery systems from customers in India and the broader Asia Pacific region. As industry guidance regarding particulate matter is becoming increasingly stringent, these customers are seeking cleaner, more consistent packaging components that minimize risk and variability.

NovaPure components are created through a product development process that incorporates scientific Quality by Design (QbD) principles and puts the patient first. West’s NovaPure offerings include serum and lyophilization stoppers and syringe plungers. These components help to mitigate the risks associated with particulates, including potential extractables and leachables, and help ensure that injectable drug products are safe for patients.

Located in India’s Sri City Special Economic Zone, West’s manufacturing plant produces components and seals used in primary packaging of injectable medicines manufactured by West’s pharmaceutical and biopharmaceutical customers throughout Asia. As production shifts to the India plant, West’s Singapore facility will add high-value product production to meet the future demands of the growing Asia market.

For more information about West’s NovaPure components, please visit http://www.westpharma.com/en/products/Pages/Novapure.aspx.

 

 

 

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