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Press release news from the public relations clients of Tiziani Whitmyre, Inc.

Posts Tagged ‘regulations’


Tuesday, July 8th, 2014

White paper Explains New Lead-Free Water System Regulations – and How to Specify Valves to Comply

NOVI, MICHIGAN, USA, — July 8, 2014 — New Federal regulations governing lead content tightening safety restrictions dictate much lower lead content for certain potable water systems and components than in the past. A new whitepaper explains the new lead-free water system regulations for OEMs and contractors — and how to specify valves to comply. It is available to download at https://www.ascovalvenet.com/pdf/LiteratureRequest/Lead_Free_White_Paper.pdf.

Manufacturers of potable water equipment and systems — including drinking water fountains, R/O (reverse osmosis) systems, coffee machines, and commercial kitchen equipment — as well as equipment maintenance contractors are affected. Many in the industry remain uncertain how the new lead-free water regulations will impact their manufacturing and purchasing.

A new whitepaper, “Understanding the New Lead-Free Water System Regulations – and Choosing Valves to Comply,” provides useful information to original equipment manufacturers (OEMs) and contractors to ensure their equipment for potable water systems remains efficient, safe, and compliant.

The new paper outlines relevant sections of the new lead-free regulations, and then focuses on the choices facing specifiers and purchasers who need to select important components of the affected potable water equipment — two-way solenoid valves — to comply. The paper also considers the calculations that must be made to determine average lead content. Finally, it discusses the pros and cons of common valve materials (brass, composite/plastic, stainless steel, and lead-free brass), as well as other selection advantages for use in potable water systems.

Download the free whitepaper, “Understanding the New Lead-Free Water System Regulations – and Choosing Valves to Comply” — for OEM manufacturers and contractors of potable water systems — from https://www.ascovalvenet.com/pdf/LiteratureRequest/Lead_Free_White_Paper.pdf. The whitepaper is presented ASCO Numatics, the world’s leading manufacturer of comprehensive fluid automation, flow control, and pneumatics solutions.

For more information, contact ASCO Numatics at 1-800-972-ASCO (2726) or visit http://www.ascovalve.com.

Follow ASCO Numatics on Twitter at http://twitter.com/asconumatics. Find ASCO Numatics on Facebook at http://www.facebook.com/asconumatics.

About ASCO Numatics

ASCO Numatics, an Emerson company, offers comprehensive fluid automation solutions, including fluid control and fluid power products, for a wide range of industry-focused applications. The ASCO Numatics product line in North America consists of more than 50,000 valves, an extensive selection of air preparation equipment, and a full line of actuation products. ASCO products include solenoid pilot valves, angle body piston valves, linear indicators, redundant control systems, and pressure sensors. The Numatics line covers valve manifolds, cylinders, grippers, filters, regulators, and lubricators. For more information about ASCO Numatics products, visit www.asconumatics.com.

About Emerson and Emerson Industrial Automation

Emerson (www.Emerson.com) is a global leader in bringing technology and engineering together to provide innovative solutions for customers in industrial, commercial, and consumer markets around the world. The company is comprised of five business segments: Process Management, Industrial Automation, Network Power, Climate Technologies, and Commercial & Residential Solutions. Sales in fiscal 2013 were $24.7 billion. Emerson Industrial Automation (www.EmersonIndustrial.com), a business of Emerson, provides automation and power generation technologies and services to a wide range of industries. With its global capabilities and deep industry expertise, Emerson Industrial Automation is a trusted partner for products and solutions that increase machine performance, efficiency, reliability, and availability. Its industry-leading brands include Appleton®, ASCO®, Branson®, Browning®, Control Techniques, Kop-Flex®, Leroy-Somer®, McGill®, Morse®, Numatics®, O-Z/Gedney, Rollway®, SealMaster®, and System Plast™.


Wednesday, November 2nd, 2011

New Scope of Reusable Medical Device Cleaning Validations is Examined in New White Paper from Microtest Laboratories

AGAWAM, MASS. – Nov. 2, 2011 – A new white paper detailing the new scope of reusable medical device cleaning validations is available free from Microtest Laboratories on the Web at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

“Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now be required instead,” writes white paper author Patrick Kenny, Manager of Analytical Services, Microtest Laboratories.

In the new white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” Kenny notes that “although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples.”

“An effective protocol and report that includes justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for the device’s submission,” he notes.

In the paper, Kenny also discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. His recommendations are based on several key documents relating to reusable device cleaning validations that are either in draft or final form. They include AAMI document TIR30:2003, a comprehensive guide to medical device cleaning validations. TIR30 is currently in revision, and an updated version is scheduled for 2011 release.

Kenny holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories. At Microtest, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide.

Downloada free copy of the white paper, The New Scope of Reusable Medical Device Cleaning Validations,from the Microtest Laboratories website at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

Microtest’s broad portfolio of medical device and combination product testing services include sterilization validation, reusable device studies, endotoxin and sterility testing, and package validation.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.


Tuesday, July 13th, 2010

New White Paper Helps Medical Device Manufacturers Apply New FDA Regs to Combination Products

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AGAWAM, MASS. – July 13, 2010 – A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/).wpcover1

Combination products are a large and growing segment of the medical device market, with some analysts estimating they represent over 30% of all new product submissions to the FDA. As the market continues to grow, it is further compounded by the introduction of human tissue and cellular products (HCT/Ps) incorporated in combination products, which in turn, raise a host of new challenges for testing, sterilization, and contamination avoidance.

Over the past 12 months, the FDA has addressed the dichotomy of dual quality systems by developing streamlined regulations for Good Manufacturing Compliance. These regulations, designated as 21 CFR Part IV, are anticipated to become law by the end of 2010.

Once promulgated, manufacturers will be held accountable for compliance and the FDA will use it as a legal document for enforcement. In the new white paper titled, “Combination Products 2.0: Applying the New FDA Regulations,” Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., addresses the implications for manufacturers. (Download from: http://www.microtestlabs.com/combination-products-20/). In the white paper, Dr. Richter discusses:

  • The New Regulations
  • Determining Principal Mode of Action — Device or Drug?
  • Stem Cells & Human Tissue in Combination Products
  • The Implications for Testing and Validation
  • An Example: Drug-Eluting Stents

“The new FDA regulations governing combination products are a major step forward for the industry. They apply to parts of both the QSR and GMP quality systems in a way that makes sense for the unique characteristics of each combination product. 21 CFR Part IV closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety. The ability of manufacturers to understand, establish, implement reliable testing procedures will be critical in complying with these new requirements,” Dr. Richter said.

Download a free copy of “Combination Products 2.0: Applying the New FDA Regulations” from http://www.microtestlabs.com/combination-products-20/.

Dr. Richter founded Microtest in 1984 after a distinguished career at the U.S. Food & Drug Administration. Under his leadership, Microtest provides the medical device, pharmaceutical, and biotechnology industries with premier testing and manufacturing support.

Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact, Boston:  Don Goncalves, dgoncalves@tizinc.com, 781-793-9380, for Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations


Monday, April 5th, 2010

New White Paper for Dietary Supplement Manufacturers Provides How-to for New Compliance Paradigm

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AGAWAM, MASS. – April 5, 2010 — Critical information that dietary supplement manufacturers must know in order to meet the Federal Food & Drug Administration’s (FDA) good manufacturing practices “compliance paradigm” is presented in a free white paper, available now for download from http://www.microtestlabs.com/dietarypaper.

The white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” provides how-to guidance for manufacturers of dietary supplements – a fast-growing market, which totaled $23 billion and more than 40,000 products in 2008.

Just 15 years ago, the production of dietary supplements was regulated as food ingredients without oversight. Today, the FDA regulates their manufacture under the current Good Manufacturing Practices (cGMP) for Dietary Supplements, listed in 21 Code of Federal Regulations (CFR) 111.

“Today, there’s a new paradigm for dietary supplement manufacturers – and it’s one of testing, manufacturing, and lot release. cGMP controls are used to assure that products meet the requirements of safety and have the strength and identity to meet the label claims. And label claims are the driver for all FDA regulatory actions,” said Steven G. Richter, Ph.D., RAC, SM (NRM), author of the white paper, and President and Chief Scientific Officer of Microtest Laboratories.

“In fact, this new ‘compliance paradigm’ dietary supplement manufacturers is very similar to pharmaceutical manufacturing. The problem is that, for many small- and medium-sized companies which produce dietary supplements, compliance with the spirit and intent of the cGMPs is proving to be a challenge,” he said.

For those manufacturers, the white paper provides a much needed overview and discussion of what’s required of the by the FDA, including how-to guidance on:
• Developing the Necessary Quality System
• Management “Buy In”
• Microbiological Testing/Practices In The USP Dietary Supplement Compendium and FDA BAM
• Chemistry and Manufacturing Controls (CMC)

The white paper is available at: http://www.microtestlabs.com/dietarypaper.

“The challenges for small and medium sized manufacturers are these: Testing dietary supplements and determining compliance requires the personnel and facilities to handle large-scale testing programs. The ability to train and retain these employees may be a challenge. And a full cGMP assessment is required for each manufacturer.

“Compliance with the intent of the law will be determined by management’s buy-in to a robust quality program with concomitant lab support,” Richter said. “Given all this, for many small and medium sized manufacturers, outsourcing the majority of their testing may make most economical sense.”

For a full discussion of the issues surrounding the FDA’s Good Manufacturing Practices (cGMP) for Dietary Supplements, download the new, free white paper, “Dietary Supplements — A New Paradigm for Manufacturers,” from http://www.microtestlabs.com/dietarypaper.

For more information, visit http://www.microtestlabs.com. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, U.S.A., the company’s expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact, Boston: Tiziani Whitmyre Inc., http://www.tizinc.com/public-relations


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