Smart Metrology – The Next Step in Speeding up Development Cycles (Part 3)

The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 3.

Equipment standardization is a key element in cost savings for any company and covers a broad spectrum of equipment for manufacturing, but for metrology equipment it is vital. As discussed in an earlier blog, metrology loops and the data produced are becoming the long-lead process in tool acceptance and validation activities. Trusting the data and how or where it comes from is just as important. Standardizing metrology equipment is one way of establishing that circle of trust for the project team. Over time, a team will become more and more comfortable with the data sets they receive, and in a data-driven organization, this can be beneficial.

When companies strategically source and purchase equipment with the mindset of standardization, they win. When decisions are based on price, lead time, or immediate needs, the long-term effects can be detrimental to a company’s long-term goals. It may even negatively affect short-term project goals. Consider cost and timing for the following requirements that coincide with a non-standardized equipment purchase:

• Training, including learning curve (muscle memory, keyboard shortcuts)
• Programming in different software packages (job setup, no standardized file)
• Lack of plug-and-play option commonality (rotary indexer, laser scanner)
• New maintenance requirements and additional spare parts
• New work instruction creation
• Data collection system/file sharing handshake
• Validation protocol creation and execution

Read the full blog here: http://medicaldesign.com/blog/smart-metrology-next-step-speeding-development-cycles-part-3

2014 Singapore West without Borders Make a Difference for Children

This year, West Singapore partnered with Community Chest and the Care Corner Family Centre. The Centre offers a variety of special programs, including specialist tutoring, reading programs and the KidsBright development program, which is designed to address children’s underlying cognitive difficulty in learning and functioning. The program benefits children with learning disorders including ADHD, dyslexia, sensory/auditory processing disorder, dyspraxia and mild autism.

Brain-stimulating Movement Exercises

Brain-stimulating Movement Exercises

Specialist Tuition Program

Specialist Tuition Program

Over a period of three weeks, a sum of S$5,000 was raised through a series of fun-filled activities such as Charity Fruit Day, Road Show, Play for Charity and Celebrity Chefs to support KidsBright.  The Singapore team truly made a difference to others.

Smart Metrology – The Next Step in Speeding Up Development Cycles: Gage Repeatability and Reproducibility

By Keith Calvert
Engineering Director, Contract Manufacturing North America
The Tech Group

The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 2.

Measurement system development is a time-consuming task that process development teams often underestimate. The amount of information and data collected during development can be overwhelming. Measurement system analysis (MSA) helps to quiet the noise and allows the team to focus in on meaningful information, which gives everyone peace of mind. MSAs ensure data from the process, and are as accurate as can be with the chosen system/method adding limited variation.

A developmental team tasked with building four class 102 pilot tools must define:
• material/part shrink information (critical to quality and critical to function steel safe dimensions)
• gate design/fill characteristics (melt flow)
• cooling profile
• overall production tool designs

A developed measurement system’s data accuracy plays a considerable role in allowing a team to make correct decisions for each information point. Based on the critical need and accuracy of the information, team members should choose data from a challenged and qualified robust system. Too many shortfalls can occur from using a non-qualified measurement system, the two biggest being cost and time.

Read the full blog here: http://medicaldesign.com/blog/smart-metrology-next-step-speeding-development-cycles-part-2

Raising Hope for Canine Partners for Life

The purpose of a service dog is to assist and bring joy to someone’s life. To train a service dog is a massive undertaking, with the first year of that training coming in the form of “puppy-in-training.” West volunteers have had the privilege of sharing in the raising of three puppies in training as part of its ongoing commitment to Canine Partners for Life, an organization dedicated to placing service dogs. The most recent of those is an adorable black lab named Cret.

OLYMPUS DIGITAL CAMERA

“She’s really a joy to have at West,” said Diane Behler, who along with sister and fellow executive assistant Sandy Anastasi, has raised Cret from the time she was 8-weeks old. “West team members really like Cret, and there are a couple who want to take her home. It lifts the spirits to see her walking around, and she provides great fuzz therapy!”

The role of raising a puppy is not easy, and it’s certainly not for everyone. The dogs must stay close to their trainers at all times. Wherever the volunteer trainer goes, the dog follows, and the volunteer’s focus must be on the dog at all times.

“Cret knows that when the jacket is on, she’s working and at home when the jacket comes off, she gets to be a rambunctious puppy,” said Diane. One of the responsibilities of a puppy raiser is to assure the dog has varied and interesting experiences and attends puppy training classes twice a month. “Cret goes with me to work, grocery stores, shopping, restaurants and church, just to name a few. It’s the day-to-day routines and activities that are important for Cret and all service dogs. She learns patience and discipline and routine – all things she will need when she becomes part of a team.”

Many ask about the emotional toll of raising a puppy-in-training, who will one day leave Diane and Sandy to train at the CPL kennel before being placed as a full-service dog. For Diane, it was the love of dogs and desire to help enrich someone’s life that impelled her to volunteer.

“The dog is not yours, and while you try not to get too attached, it’s hard not to fall in love,” said Sandy. “You know she will leave one day, but when Cret is placed with a recipient, the sacrifice will be paid back with pride and joy in what dog and trainer have accomplished for someone else’s good.”

CPL is in need of puppy-in-training homes for the more than 60 puppies it currently has in its program, with more on the way to help keep up with requests for the dogs. Additional volunteer opportunities include temporary puppy home, dog walker and cuddler for the pups in the kennel.

If you would like to volunteer, contact CPL today at http://www.k94life.org.

Smart Metrology: The Next Step in Speeding up Development Cycles (Part 1)

Applying metrology–the science of measurement–to the art of medical device design.

The Tech Group’s Keith Calvert recently contributed a three-part blog on metrology to Medical Design Technology. The following is from Part 1.

All businesses and market segments embrace continuous improvement, some at faster rates than others. Rapid prototyping has made significant advances over the past 10 years by embracing three-dimensional models, high-speed machining, modular tooling, new steel alloys, and many more innovations. These innovations have reduced lead times while keeping costs in check. While the healthcare industry has made use of these technologies, demands on component and assembly validation have increased as well, resulting in an increase in the timeframe for validating molds that often exceeds the time needed to build the mold. There are, however, new technologies and processes that original equipment manufacturers can adopt to help streamline the validation cycle. One area of focus should be metrology.

Metrology is the science of measurement. Metrology includes all theoretical and practical aspects of measurement.

There are three aspects of metrology that I will address in this series of articles: product characterization, gauge development and repeatability, and metrology equipment and standardization. Each of these aspects must be considered individually and holistically in order to streamline the validation process, avoid schedule delays or redo loops, and lower developmental costs.

Read the full blog here: http://medicaldesign.com/design-engineering/smart-metrology-next-step-speeding-development-cycles-part-1

West without Borders 2014: Medimop Celebrates Children

In December, team members from West’s Medimop subsidiary spent a half-day with children with special needs. The group traveled to their school and kindergarten where they celebrated the Chanukah holiday with them. The celebration included arts and crafts, music, cakes and drinks.

“It was a very moving and exciting day for the employees and the children,” said Orly Eini, Human Resources Director, Medimop Medical Projects Ltd. “We all enjoyed the day!”

עמותת עמיחי - מדימופ

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

Extractables: Why should we care about them?

An extraction study is sometimes thought of by customers as an expensive and time-consuming exercise for filing. However, extractables studies are more than that. Performing an extraction study provides a thorough understanding of the materials used. It is a study that takes into account the primary packaging components and provides an understanding of the chemical species that may potentially come out over the shelf-life of a product. History shows the lack of understanding in the extractables of a drug’s packaging may lead to issues down the road such as interference in drug product, increased toxicity, formation of precipitates or reduced API concentration. Extraction studies should be performed under exaggerated conditions on the final components intended for use. Why is this? The extractables profile can be affected by any changes to the components, including: washing, sterilization, addition of coatings or films, age and the intended storage conditions.

West has many years of experience designing and performing extraction studies on pharmaceutical packaging along with a good understanding of what can impact the extractable profile. Using this experience, West developed a comprehensive package for two rubber formulations that takes into account many of the variables that need to be considered when performing extractable studies. The VeriSure® technical package is based on the knowledge of West’s 4432 and 4023 rubber formulations obtained over years of substantial testing. The VeriSure technical package examines a wide range of configurations, coatings, processes, manufacturing sites, and shelf life utilizing a larger sample size than an individual component study. This package is a living document that can be used as first-pass extractables data in lieu of performing multiple studies on multiple components within the same formulation.

Extractables should be considered proactively and understood early in the development process. The VeriSure technical package can assist in this part of the process. Please contact West Technical Support for more information regarding this package and how it can work for your drug product.

Author:

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

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

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