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

Posts Tagged ‘whitepaper’


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™.


Tuesday, October 22nd, 2013

Use of Stability Studies in Drug, Combination Products & Medical Device Development are Reviewed in New Whitepaper

AGAWAM, MASS. — October 22, 2013 —The use of stability testing in new product development — of drug substances, drug products, combination products and some medical devices — is reviewed in a new whitepaper from Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

The paper, “The Use of Stability Studies in Pharmaceutical and Combination Product Development” (download from: http://microtestlabs.com/stability-studies), outlines how stability studies can be used to gather valuable information about a new product and prevent unnecessary manufacturing costs and time delays.

Stability studies can help determine formulation and manufacturing strategy, analytical assay development and validation — and help explain unexpected and failing results. They can also provide input to manufacturing controls, and help identify final packaging requirements. The paper examines three specialized stability studies as examples:

  • Forced degradation studies, which involve exposing the product to predetermined stress conditions in order to intentionally form likely degradation products;
  • Photostability testing, used to determine the product’s ability to withstand exposure to light without any adverse effects;
  • Temperature cycling studies, used to assess the impact of temperature changes on the product.

Two case studies, one involving a drug product and one a combination product, are also presented.

The use of stability studies in the development of new drug or combination products can ease both the planning and execution of a development strategy. Moreover, the studies may also help prevent unnecessary costs and time delays due to poor formulations, assay failures, and manufacturing problems.

Download the new whitepaper, “The Use of Stability Studies in Pharmaceutical and Combination Product Development,” from: http://microtestlabs.com/stability-studies.

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, USA, 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://microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.


Tuesday, September 10th, 2013

New FDA Regulations Streamlining the Governance of Combination Products are Detailed in New White Paper

AGAWAM, MASS. — September 10, 2013 — New Federal Food & Drug Administration (FDA) regulations have streamlined the governance of combination products — medical devices embedded with pharmaceutical or biologic components. A new white paper titled “Combination Products 3.0: Applying the New FDA Regulations in 2013” discusses the implications for manufacturers. The whitepaper is available to download at http://microtestlabs.com/combination-products-30.

Combination products are a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new FDA product submissions.

“Over the last 10 years, FDA regulatory centers have struggled with the changes and challenges that these new technologies present. For manufacturers, the convergence of drugs, biologics, and devices has created both a host of regulatory issues — and many exciting opportunities,” according to Steven Richter, Ph.D, President and Chief Scientific Officer of Microtest Laboratories, Inc., and author of the new white paper.

The new FDA publication, “21 CFR Part 4 — Current Good Manufacturing Practice Requirements for Combination Products,” revises regulations by establishing different categories of products. These included single-entity products (such as a drug-eluting stent) and co-packaged products (such as a packaged syringe and pharmaceutical). The rules also distinguished between a drug with a device, a biologic with a device, and a device with an HCT/P.

 

The new white paper discusses, in detail and example, how the new FDA rules guide a manufacturer into one of two approaches, depending upon the characteristics of their product.

 

According to Dr. Richter, “the FDA’s new streamlined approach for regulating combination products is a big step forward for the practitioner. It applies 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 4 closes the gaps in the 2004 guidelines and succinctly clarifies the process for establishing quality systems that ensure compliance and patient health and safety.”

Download the new white paper, “Combination Products 3.0: Applying the New FDA Regulations in 2013,” from http://microtestlabs.com/combination-products-30. The white paper is presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Based in Agawam, Mass., 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 about Microtest Laboratories, visit 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.


Thursday, April 11th, 2013

New White Paper Details What Compounding Pharmacies Must Know to Prepare for FDA Inspections

In anticipation of new US Food and Drug Administration (FDA) regulations, many companies are working toward correcting potential problems and attaining USP <797> compliance. A new white paper addresses the issues that compounding pharmacies must address prior to undergoing an FDA or state inspection. Titled, “Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA,” it is available to download at http://www.microtestlabs.com/whitepaper from Microtest Laboratories.

“The FDA requires all compounding pharmacies to comply with USP section <797>, which outlines the different standards and regulations for environmental control, testing, and personnel training. Currently, the operations of large-scale compounders do not fall under the scrutiny and regulation of the FDA. However, these facilities may now face inspections from both the state regulatory authorities and the federal government,” said white paper author Steven Richter, Ph.D., president and scientific director of Microtest Laboratories — and a former FDA official.

In the white paper, Dr. Richter advises compounding pharmacies on the critical issues to resolve prior to an FDA or state inspection, including sterile compounding regulations, quality testing, sterility testing of compounded articles, disinfectant validations, and endotoxin testing.

“In the aftermath of the NECC case, FDA and state actions regarding compounding pharmacies are relatively certain: regulations and inspections will both tighten and increase. The FDA, in some instances, will assume the role of lead auditor for the compounding pharmacy’s operations,” Dr. Richter said. “It is critical for compounding pharmacies to maintain a state of control in their controlled environments. While there may always be excursions, it is the actions that are undertaken after the excursions that will influence an inspector’s responses and observations during an on-site investigation and inspection.”

Download a copy of “Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA,” at http://www.microtestlabs.com/whitepaper. Or, request a copy by calling Microtest Laboratories 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest Laboratories is a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest Labs’ environmental sciences group helps clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

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, USA, 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 at 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

 


Monday, March 5th, 2012

Eight Critical Factors in Purchasing Offshore Pilot Valves Are Detailed in New White Paper from ASCO Numatics

FLORHAM PARK, N.J. — March 5, 2012 — The evaluation and selection of stainless steel pilot valves — which play small but critical roles in the control of offshore platforms and other demanding oil and gas production operations — is the subject of a new white paper available for download at http://goo.gl/U3BgC.

Titled “Eight Critical Factors in Purchasing Offshore Pilot Valves,” the white paper guides panel builders, assemblers, OEMs, contractors, and operators as they consider the factors that bear on a given design’s reliability. The valves, which act as pilots for process and larger emergency shutdown (ESD) valves, are typically installed in a platform’s pneumatic logic control panels.

The April 2010 platform loss and oil spill in the Gulf of Mexico have dramatically sharpened the industry’s focus on reliability and related issues. In the case of pilot valves, this means that operators must have robust valves that perform efficiently each time, every time.

The white paper considers several problems that interfere with the efficient, reliable performance of conventional pilot valves in offshore use. It also highlights design changes that have addressed these problems in newer models.

Download the new white paper, “Eight Critical Factors in Purchasing Offshore Pilot Valves,” from http://goo.gl/U3BgC.

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

About ASCO Numatics

ASCO Numatics, a division of Emerson, 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

Emerson (NYSE: EMR), based in St. Louis, Missouri (USA), 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 2011 were $24.2 billion.  For more information, visit www.Emerson.com.


Tuesday, February 21st, 2012

“Reviewing Technology Breakthroughs: The Insiders’ Guide to Modular Gas Valves” is New White Paper from ASCO Valve

FLORHAM PARK, N.J. — February 21, 2012 — While the latest generation of modular gas valve designs feature breakthrough features and advantages, selecting the right valve for a specific application is critical to reaping those benefits. A new white paper, “Reviewing Technology Breakthroughs: The Insiders’ Guide to Modular Gas Valves,” provides that valuable guidance and is now available for download at http://bit.ly/h0iq7f from ASCO Valve, Inc.

Fuel gas shutoff valves represent the main line of defense in combustion devices such as burners and boilers. They’re key to the safe operation of equipment for nonresidential comfort heating, commercial and industrial heating, and power and steam generation applications worldwide.

Recent technological advancements offer higher flows, more compact footprints, and greater modularity and flexibility to enable downsizing of fuel train components, as well as broader temperature ranges, higher close-off pressures, more immediate availability, and reduced costs of ownership.

Tapping the expertise of valve manufacturing insiders, “The Insiders’ Guide to Modular Gas Valves reveals how original equipment manufacturers (OEMs) and end users alike can take maximum advantage of these new factors. In it, authors Gerry Longinetti, Marketing Manager, ASCO and James Chiu, Marketing Product Engineer, ASCO, offer useful guidance in choosing the right valve for a variety of vital applications.

The white paper reviews:

  • Downsizing to reduce the size and cost of gas trains (including higher flow rates, small-footprint designs, low supply pressure)
  • Choosing the most flexible technology (incl. mixing and matching components, simplifying installing and maintenance, and applications in broad temperature ranges)
  • Benefitting from additional advantages (incl. higher close-off pressures, and availability issues)
  • Cutting the costs of ownership

The new white paper, “Reviewing Technology Breakthroughs: The Insiders’ Guide to Modular Gas Valves” is available for immediate download from http://bit.ly/h0iq7f.

Follow ASCO Valve on Twitter at http://twitter.com/ascovalve and on Facebook at http://www.facebook.com/ascovalve.

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 http://www.asconumatics.com.

About Emerson

Emerson (NYSE: EMR), based in St. Louis, Missouri (USA), is a global leader in bringing technology and engineering together to provide innovative solutions for customers in industrial, commercial, and consumer markets through its network power, process management, industrial automation, climate technologies, and tools and storage businesses. Sales in fiscal 2011 were $24.2 billion. For more information, visit www.Emerson.com.


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.


Monday, April 11th, 2011

New White Paper: “The Insider’s Guide to Applying Miniature Solenoid Valves,” from ASCO Valve

FLORHAM PARK, N.J. — April 11, 2011 — A new white paper, The Insider’s Guide to Applying Miniature Solenoid Valves, consolidates the expert views of designers and manufacturers to provide a step-by-step resource for applying miniature solenoid valves for myriad uses across multiple industries.

The paper is available to download from http://bit.ly/h0iq7f.

“Equipment designers frequently must incorporate miniature solenoid valves into their pneumatic designs. These valves are important components of medical devices and instrumentation as well as environmental, analytical, and similar product applications,” said white paper author Mike Elsigian, marketing manager, ASCO Valve, Inc.

In the white paper, Elsigian defines which requirements are critical for common applications. He details how the selection of miniature solenoid valves for the design of a given device usually involves finely balancing tradeoffs among competing pressures for reliability, service life, light weight, higher flow, optimized power use, standards compliance, and more.

Elsigian also highlights the introduction of newer valve technologies that can lessen or eliminate difficult compromises — while increasing performance. “New miniature solenoid valve technologies represent the fusion of several innovative approaches to meet the widest possible range of demands from knowledgeable designers across multiple industries,” he said.

“All too often, these designers find themselves frustrated as they face compromise after compromise. Pressure for increasingly miniaturized devices complicates every step of the design and valve selection process. And missteps can wreak havoc,” he said. “We’re hoping that the expertise we provide will assist designers in achieving the balance they need for success among the variety of often-contradictory performance requirements demanded by their applications.”

Download the new white paper, “The Insider’s Guide to Applying Miniature Solenoid Valves,” at http://bit.ly/h0iq7f.

Follow ASCO on Twitter at http://twitter.com/ascovalve. Find ASCO on Facebook at http://facebook.com/ascovalve.

Emerson Industrial Automation

Emerson Industrial Automation, a business of Emerson, delivers manufacturing solutions designed with leading technologies — including mechanical, electrical and ultrasonic — to provide the most advanced industrial automation possible for numerous and diverse industries worldwide. The company’s wide range of products and systems used in manufacturing processes and other equipment includes motion control systems, plastics joining, precision cleaning, materials-testing equipment, fluid control valves, alternators, motors, and mechanical power transmission drives and bearings. For information, visit www.emersonindustrialautomation.com.

About Emerson

Emerson (NYSE: EMR), based in St. Louis, Missouri (USA), is a global leader in bringing technology and engineering together to provide innovative solutions for customers in industrial, commercial, and consumer markets through its network power, process management, industrial automation, climate technologies, and tools and storage businesses. Sales in fiscal 2010 were $21 billion. For more information, visit www.Emerson.com.

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Press Contact: Don Goncalves, 781-793-9380, dgoncalves@tizinc.com


Monday, December 6th, 2010

New Low-Power Solenoid Valve Technology Changes the Game for Manufacturers, Assemblers, Engineers: New White Paper Details How

FLORHAM PARK, NEW JERSEY – December 6, 2010 – Process plants worldwide often place considerable reliance on low-power solenoid valves. They are used as pilot valves to open and close larger ball or butterfly valves, or on control valves (installed between positioner and actuator) for fail-safe air release if there’s a loss of power or air. They work by pressurizing or depressurizing associated actuators.

A new white paper from ASCO Numatics, “How New Low-Power Solenoid Valve Technology Changes the Game,” details how a new generation of even lower-power valves is now changing the rules of the power consumption game. These products are of interest to designers working for original equipment manufacturers (OEMs) and valve assemblers, as well as for end-user engineers – anyone who specifies solenoid valves for projects in refining, upstream oil and gas, chemicals, pharmaceuticals and life sciences, food and beverage, and power. The white paper is available free to download at http://www.ascovalve.com.

The white paper taps the expertise of manufacturers at the forefront of low-power solenoid valve technology. It shows how innovation is offering new possibilities – and challenges – via topics such as integrated solutions, clogging and other reliability issues, usefulness in point-to-point and bus networks, other cost savings, remote applications, and relevant industry standards. Finally, it suggests which characteristics buyers should seek out in selecting the newest – and most consistently dependable – low-power valve technologies.

“Choosing low-power solenoid valves for process industry applications presents several challenges. Designers and users must carefully consider such issues as orifice size and clogging potential, pressure rating and other physical characteristics, bus compatibility, backup power needs, and relevant industry standards before selecting the right valve for the given process industry task,” said white paper authors Fabio Okada, Jack Haller, and Manny Arceo – all of ASCO.

Download the new white paper, “How New Low-Power Solenoid Valve Technology Changes the Game,” at http://www.ascovalve.com.

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

About ASCO Numatics

ASCO Numatics, a division of Emerson, offers comprehensive fluid automation solutions, including flow control and pneumatics 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 http://www.asconumatics.com.

About Emerson

Emerson (NYSE: EMR), based in St. Louis, Missouri (USA), is a global leader in bringing technology and engineering together to provide innovative solutions for customers in industrial, commercial, and consumer markets through its network power, process management, industrial automation, climate technologies, and tools and storage businesses. Sales in fiscal 2010 were $21 billion. For more information, visit http://www.Emerson.com.

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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


Wednesday, June 2nd, 2010

New White Paper Helps Medical Device Manufacturers Validate Cleaning Processes

microtest-logo1

AGAWAM, MASS. – June 2, 2010 – A new free, white paper that guides medical device manufacturers in the validation of their cleaning processes is now available from Microtest Laboratories.

As many medical devices are made of high-tech materials such as metallic alloys or synthetic plastics, manufacturers may require the use of various agents to aid in the manufacturing process, or produce contaminants that need to be removed. Thus, these products must be cleaned to ensure both patient safety and the continuing functionality of the device.

In a new white paper titled, “Five Steps to Validating the Cleaning Process of Medical Devices,” Patrick Kenny, Manager of Analytical Services at Microtest Laboratories, reviews medical device regulation under 21 CFR Part 820 – Quality System Regulation. (Download from: http://www.microtestlabs.com/cleaning-validation-paper.)

Several sections of Part 820 can be directly related to device cleanliness. For manufacturers, the challenge is to validate the cleaning process to ensure the devices are free of residue (chemical and particulate) in order to ensure patients are safe.

In the paper, Kenny presents a five-step process that provides a framework to assist medical device manufacturers in their cleaning validation efforts:
• #1: Evaluate the Process, Determine the Potential Contaminants
• #2: Determine the Limits
• #3: Identify the Analytical Test
• #4: Validate the Method for Use
• #5: Validate the Cleaning Process

Download a free copy of “Five Steps to Validating the Cleaning Process of Medical Devices,” from http://www.microtestlabs.com/cleaning-validation-paper.

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

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


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