Optimizing Temperature Control for Biopharmaceuticals

This article first appeared in BioPharm International, October 1, Caroline Hroncich

Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey.

This article by World Courier delves into these relevant industry topics:

  • Common considerations for shipping biopharmaceuticals;
  • Temperature management in extreme climates;
  • Recent advancements; and
  • Looking ahead.

Learn more about optimizing temperature control for biopharmaceuticals in the article below!  

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Choosing Cartridge Dust Collector Filters for Processing Applications

As you face stricter air quality and combustible dust regulations, coupled with tighter internal cost controls, choosing and using the best dust collector filter for your process is more important than ever. Making an informed choice can improve your collector’s dust capture efficiency and reliability while reducing energy and maintenance requirements.

Dust collection systems are the preferred technology for most dry processing applications today, and there are many different pleated filter cartridges available for these collectors.

Find out more about types of filter media and selection tips, from Rick Kreczner at Camfil APC, to help you determine the best filter for your application below! 

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eBook: How Manufacturers Can Optimize CNC-Machine Tooling and Increase Productivity by 10-40%

As in many other industries, to be competitive in the world market, CNC manufacturing companies need to reduce their costs of production and increase their production output. More parts at less cost per part.

Unfortunately, with escalating raw materials prices, this becomes difficult. Therefore, manufacturers have to look to controlling tooling costs and costly downtime, while working to increase speeds and feed rates.

Are your toolholders fully engaged in the spindle of your CNC Mill?

Most manufacturing problems are a result of tooling issues

Find out how to increase your manufacturing productivity by 10-40% in the JM Performance Products eBook below!

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The Benefits of Manufacturing in Costa Rica

Plant location is a critical factor in manufacturing profitability and productivity, making the right regional choice is consequently of great importance. Factors such as labor-force, resource availability, proximity to market and available support services are all critical considerations when assessing regions.

Costa Rica boasts a robust supplier base, proximity to North American markets and competitive tax incentives.  As a plethora of high-tech multi-national companies are already thriving in Costa Rica we asked our friends at CINDE (Cost Rica Investment Promotion Agency) to help us understand some of the main benefits of manufacturing in the region.  The eBook below explains why thriving manufacturers have already chosen Costa Rica and provides information to help manufacturers assess their options.

CINDEManufacture & Design in Costa Rica – As low as 0% income tax for true ROI

Find out more about manufacturing in Costa Rica by joining CINDE at the American Manufacturing Summit 2016 taking place on February 29th – March 1st in Chicago.

 

 

5 Operational Leadership Skills to Develop

 

We have addressed the importance of operational excellence in a number of past posts and have discussed the key role that leadership plays in maintaining competitiveness in the current tumultuous environment.  The whitepaper  below builds on the information we have already explored by defining the more refined skills needed by today’s modern operational leaders. In the whitepaper below TBM Consulting, a firm that specializes in maximizing enterprise value and growth potential for their clients, shares their insights into the five skills needed for the modern operational leader.

TBM blog 1 TBM blog 2

For more insights, join TBM Consulting at the American Manufacturing Summit 2016 taking place in Chicago on February 29th – March 1st!  Be sure to stop by their booth, Booth #14!

End-to-End Supply Chain Synchronization: The importance of Predictive Analytics & Lean Pull

A major focus within this blog has been looking at methods to drive efficiency and enable operational excellence in manufacturing. One aspect we haven’t yet explored is end-to-end supply chain synchronization.  Synchronizing the supply network with final customer demand is a key factor in driving operational excellence.  By  using actual customer demand across the supply network  manufacturers can enable better service and conversion costs  with less inventory.

Shertrack LLC has released a fascinating case study that highlights the key elements in achieving end-to-end supply chain synchronization.

00010002To find out more about demand-driven predictive manufacturing and the benefits of synchronizing your supply chain, visit: http://shertrack.com/

The Benefits of Concentricity

“In GD&T, concentricity is a complex tolerance used to establish a tolerance zone for the median points of a cylindrical or spherical part feature. Concentricity is generally reserved for high-precision parts when there is a need to control median points.”  – eMachineShop

Precision-drilled custom tubing and tubular components are used in medical devices, aerospace applications, nuclearpower plants, industrial manufacturing plants, high temperature furnaces and many other designs.  When it comes to tubing and tubular components, concentric, seamless precision tubing is often chosen for its added reliability, rotational stability, strength and increased useful life.  Unlike welded tubing, seamless tubing is able to handle high pressure evenly, provides uniform fatigue properties and often reduces the frequency for inspections in high stakes uses.

Tube Hollows International specializes in manufacturing highly concentric tube hollows that meet critical design tolerances. The company machines ultra-high concentricity seamless precision tubing in the most challenging alloys, using gun drilling, trepanning, honing and other technologies.  I sat down with Tube Hollows to draw from their expertise and gain a greater understanding of the benefits of concentricity.  Tube Hollows’ Director of Business Development Alex Miller explained that when engineers define the component part and tubing requirements of complex engineering projects, they often must strike a balance between design specifications, cost, safety, and quality concerns.  The concentricity needs of a project can be determined by assessing how the part will function in its end use, whether or not the part will interact with other parts and the environmental factors influencing tolerances for the part.

According to Tube Hollows and leading engineering professionals, concentricity in seamless precision tubing:

  • Increases efficiency (use of material, flow rates, etc.)
  • Helps parts wear evenly and predictably
  • Minimizes vibrations in rapidly rotating parts
  • Handles high pressures consistently and effectively
  • Yields higher quality and superior productivity for tube drawing processes that begin with a starting hollow
  • Helps ensure a tight fit between tubing and other fixtures

To illustrate these benefits, we highlighted some key points in the infographic below.

Contact Tube Hollows International for more information and insights on custom tubing.

The Benefits of Concentricity (2)

 

Balancing Competing Priorities in Medical Device Manufacturing

Medical device manufacturers must consistently work to balance competing priorities; everything from product development, regulatory compliance and quality to marketing.  Managing these priorities in disparate individual silos leads to a lack of efficiency, communication and productivity.  As a result, many manufacturers are turning to holistic enterprise operation solutions to streamline their processes from innovation through to the product end of life.

Dassault Systèmes Industry Solution Experiences for Life Sciences powered by the 3DEXPERIENCE® platform provide a major leap forward with a Single Source of Truth (SSOT) environment that spans the entire product lifecycle from conceptual design to end of life. These solutions for Life Sciences enhance global collaborative sharing, making compliance and innovation complementary processes that contribute to each other’s and the company’s success.

The Dassault Systèmes whitepaper “TRANSFORMING MEDICAL DEVICES WITH SUSTAINABLE INNOVATION”outlines some of the key benefits of this integrated technology for medical device manufacturers:

  • Manage and facilitate innovation without compromising quality and safety through one cohesive platform that allows collaboration of design information and visibility across the product lifecycle from ideation to end of life.
  • Increase patient safety by reducing the number and severity of recalls and field actions
  • Increase business agility by streamlining design collaboration and managing team activities to align project goals and user requirements.
  • Speed compliance processes by integrating regulations into product development (design for compliance) and e-submission.
  • Accelerate time-to-market by streamlining the complete regulatory submission and approval process (dossier assembly, review, submission, tracking, and renewals through end of life) by geo-global regions.
  • Reduce engineering re-design time and cost through simulation testing that can help expedite clinical trials and reduce product failure recalls.
  • Expedite product design transfer with current released documentation to facilitate the manufacturing process while maintaining end-to-end traceability throughout the product lifecycle.
  • Develop strategic suppliers and partners by bringing supplier quality history into the sourcing process.
  • Balance speed versus control by improving common enterprise processes, then tracking and measuring them as a basis for improvement.
  • Maintain complete product requirement traceability from ideation through development, design verification and validation, to commercialization and product obsolescence.
  • Drive part costs down by publishing part specifications across product lines, brands, and regions to create efficient procurement processes.
  • Achieve cost savings through lean and efficient re-use of Intellectual Property (IP).
  • Enable design and manufacturing outsourcing by creating centrally-managed global work teams and using a single repository to store all product information throughout the product lifecycle.

Dessault Systemes

Join Dassault Systèmes and Generis Group as we explore the challenges and opportunities in product development, quality management, speed to commercialization and manufacturing at the American Medical Device Summit 2015 taking place Next Week in Chicago!

 

Analyzing Potential Manufacturing Plant Locations

Establishing a new facility is a complex process that requires a large investment and detailed analysis of internal production needs, facility features and location requirements.  The first step in this process is to select the country and region that best satisfies manufacturing needs.  

Mexico has rapidly become a top destination for medical device manufacturing.  Executives and trade organizations cite major cost savings and ease of business processes as some of the main reasons for selecting Mexico.

I sat down with our friends at Co-Production International to gain a clearer understanding of how manufacturers analyze the opportunities available for site location and learned that some of the main factors influencing site assessment are:

  • Ease of trade: free trade zones & intellectual property rights (such as NAFTA)
  • Proximity to major markets (in Mexico’s case this is the US and Canada)
  • Social infrastructure: investor friendly attitude of the community
  • Established commercial infrastructure (land, facilities, transportation)
  • Labor supply: low-cost, highly skilled workforce
  • Supply chain access and exposure / proximity to potential new clients and suppliers
  • Economic stability, safety and security

Co-Production International explained that the reason for Mexico’s growing popularity is that it has strengths in all of the above categories.  From temporary imports for final assembly to full production operations, Mexico’s medical device sector is equipped to handle a broad range of medical device manufacturing activities.

Contact Co-Production International for a labor cost analysis that will demonstrate the overall cost of manufacturing in Mexico and how this expansion will impact your bottom-line profits. Or schedule a Baja Manufacturing Tour.

Co-Production infographic for blog post - edits round 1

Connect with both Co-Production International and Generis Group at the upcoming American Medical Device Summit 2015.  It’s only 17 days away!

Making the Right Choice: Crucial Steps for Site Selection (Manufacturing Facilities)

Establishing a new facility is a complex process that requires a large investment and detailed analysis of internal production needs, facility features and location requirements.  Once the decision to move forward with the development of a new facility has been made, and the plant requirements have been defined (plot size needed, resources that must be accessible, quality of the workforce etc.), then the hunt for a site can begin with a detailed search, assessment and screening of all locations that may meet these needs.

Balancing the predetermined plant requirements with the economic, environmental, regulatory, social and technical factors is a challenge that cannot be underestimated; every variable from ensuring access to raw materials and skilled workforce, to ensuring the economic stability of the region play a part in plant selection.

In the below infographic we look at the overarching, crucial steps to site selection:

Manufacturing- Steps to Site Selection (1)