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Posts Tagged ‘whitepaper’


Tuesday, April 21st, 2009

White Paper Helps Building Owners Minimize Risks and Costs Associated with PCBs in Construction Materials

Needham, Mass. – April 21, 2009 – A new, free white paper can help building owners, developers, and others minimize the very real risks and costs caused by the discovery of PCBs in their construction materials.

The paper titled “What You Need to Know About Managing PCBs in Construction Materials — An Emerging Environmental Issue” details the potential liabilities and current risk management strategies for dealing with polychlorinated biphenyls (PCBs) in construction materials.

“PCB-containing building materials represent a newly discovered and significant liability for building owners, real estate developers, REITS, financing institutions, and contractors, “says John McCarthy, President and co-founder of EH&E Inc., a Needham, Mass.-based environmental services consulting firm.

“The regulation-driven remediation efforts can dramatically impact the cost of renovation or demolition, quickly costing millions of dollars for a single, large-scale project. Public and private owners of real estate must be aware of the regulatory requirements and legal implications. They must have strategies ready to implement to effectively minimize their construction risk and remediation costs,” he said.

The discovery of PCBs in building materials generally occurs once a project has been contracted, resulting in costly project change orders that significantly impact the construction schedule and project costs.

This white paper details a proactive strategy to avoid regulatory mishaps, maintain a safe and healthful building, and accurately assess the need for and costs of any required remediation efforts prior to construction so that these costs can be predicted and minimized in the project budget.

Download the white paper “What You Need to Know About Managing PCBs in Construction Materials—An Emerging Environmental Issue,” at: http://www.eheinc.com/pcbriskmgmt.htm.

Or, for more information contact EH&E directly on the web at: http://www.eheinc.com/ or by phone at: 1-800-825-5343.

About EH&E Inc.
EH&E Inc. (http://www.eheinc.com/) has provided an extensive range of environmental and engineering consulting services for over 20 years. The EH&E team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry. The firm’s wealth of readily-accessible information is a powerful resource for its clients.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Posted in Buildings & Facilities |


Monday, March 16th, 2009

New White Paper Examines Advanced Mycoplasma Tests - How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers

AGAWAM, MASS. – March 16, 2009 – Contamination by mycoplasmal organisms is an ever-present concern in biopharmaceutical manufacturing. Their properties make them ready sources of contamination, while rendering them difficult and time-consuming to detect. A new free white paper, examines how PCR mycoplasma tests and analysis, deployed by a cutting-edge laboratory, minimizes testing delays and enable safe, high-volume biopharmaceutical production.

The new white paper, “Advanced Detection of Mycoplasmas: How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers,” explores relevant mycoplasma characteristics, established testing solutions, and the use of real-time PCR analysis as an alternative testing method for fast, preliminary mycoplasma detection.

It also available for download from: www.microtestlabs.com/mycoplasmapaper.

“Of all the threats that keep quality managers awake at night, mycoplasmas rank high. In a career performing quality control or quality assurance for biopharmaceutical manufacturing anywhere in the world, a QC or QA specialist will probably encounter mycoplasma contamination of a production facility at least once. The resulting devastation to the site’s output and schedules, as well as to its staff’s peace of mind, makes it urgent to avoid any repetition of the experience,” says Dennis Champagne, author of the white paper and Director of Lab Services at Microtest Laboratories, a leader in biopharmaceutical and mycoplasma tests and services.

“Whereas the traditional direct cultivation method takes 28 days to provide results, modern real-time PCR mycoplasma tests and analysis in an experienced testing laboratory may be accomplished in an actual testing duration of only 24 hours, plus the time needed for sample collection, shipment, preparation, and handling,” he said.

The white paper identifies the shortcomings of traditional identification methods, such as direct culture (for cultivable species), indirect culture (DNA fluorochrome staining — for noncultivable species), DNA probe, PCR, enzyme-linked immunosorbent assay (ELISA), autoradiography, and immunofluorescence.

The white paper explains how, as opposed to traditional methods, PCR mycoplasma analysis accurately quantifies DNA and/or RNA, furnishes increased sensitivity and specificity, detects all known mycoplasma species and works whether mycoplasmas in sample are living or dead.

Download the new white paper on PCR mycoplasma tests, “Advanced Detection of Mycoplasms: How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers,” at http://www.microtestlabs.com/mycoplasmapaper.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, 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: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Posted in Biosciences |


Monday, January 12th, 2009

Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers

AGAWAM, MASS. – January 12, 2009 – Two new white papers detailing sterility testing essentials are now available for free download from Microtest (www.microtestlabs.com). The white papers, one which is customized for medical device manufacturers and one which is specialized for pharmaceutical manufacturers, presents the general concepts and problems associated with sterility testing and reviews different testing methodologies.

For medical device manufacturers, sterility testing of medical devices is required during the sterilization process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market. Medical device manufacturers can download the white paper at: http://www.microtestlabs.com/sterilitypaper/sterility-paper.htm.

For pharmaceutical manufacturers, sterility testing of pharmaceutical articles is an essential element of the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. Understanding sterility testing is beneficial in terms of designing a validation process. In addition, the need to provide adequate and reliable test data is an important quality assurance issue. Pharmaceutical manufacturers can download the white paper at: www.microtestlabs.com/sterilitypaper/pharma-paper.htm.

The author of the white papers is Steven Richter, Ph.D., President and Scientific Founder of Microtest, a leading provider of medical device and pharmaceutical services for medical device designers and manufacturers. The firm recently expanded its facilities, resources, and technology, and with more than 15 years of experience, is a single-source manufacturing solution.

For information on Microtest’s unique single-source solutions that minimize schedule disruptions and accelerate time to revenue visit Microtest on the Web: www.microtestlabs.com or toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, biotechnology industries. Based in Agawam, Massachusetts, USA, 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc. (http://www.tizinc.com/)

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Posted in Biosciences, Manufacturing |


Monday, December 1st, 2008

White Paper Addresses FDA Approval Challenges Facing Combination Product Manufacturers

AGAWAM, MASS. – December 1, 2008 – Even as the combination products market continues to experience dramatic growth, the approval process facing manufacturers seeking to introduce new medical devices embedded with pharmaceutical or biologics components is expected to become even more challenging and complex.

“Given the convergence of technologies, combination product manufacturers – often either medical device or pharmaceutical companies “crossing over to the new market” – must ensure their products meet cGMP practices as well as pass muster with the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and The United States Pharmacopeia (USP),” said Steven Richter, Ph.D., President & Chief Scientific Officer of Microtest Laboratories, and a former FDA official.

“The combination products market is rapidly moving forward with a new direction and emphasis regarding product safety and FDA requirements,” said Richter. “The process, already complex, is likely to become even more so,” he warned.

In fiscal 2007, the FDA received 333 original applications for combination products, a 42 percent increase over 2006. The FDA itself reports that combination product submissions “raise challenging regulatory, policy, and review management issues… (that) can impact the regulatory processes of all aspects of the product life cycle.”

In the free white paper, “Combination Products: Navigating Two FDA Quality Systems,” Richter provides a helpful overview of the challenges facing combination product manufacturers. Download the white paper at www.microtestlabs.com/combinationpaper.

“For manufacturers, the convergence of devices and drugs or biologics brings a host of new FDA testing guidelines, practices, and regulations unique to the development and production of combination products – and generally outside their original core competence in achieving regulatory approvals as either a medical device or pharmaceutical manufacturer,” he said.

In the white paper, Richter discusses: Defining the Convergence, FDA Responsibility, QC Drug Release Criteria, Biologics, New Developments in FDA Thinking, and Future Considerations.

According to the FDA, some estimate the total global value of the drug-device combination products market will grow to $11.5 billion in 2010, up more than double from $5.4 billion in 2004.

Download the free white paper at: www.microtestlabs.com/combinationpaper. For more information, visit Microtest on the Web at www.microtestlabs.com, or call toll-free: 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, 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 www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Posted in Biosciences, Manufacturing |


Tuesday, November 18th, 2008

White Paper Details Infection Control Challenges Hospitals Must Address During Construction Projects

Needham, Massachusetts – November 18, 2008 - Hospitals and healthcare institutions are challenged to devise policies and procedures that allow construction projects to take place while maintaining Environment of Care (EC) standards. A free white paper that addresses these challenges is available for download at: www.eheinc.com/infectioncontrol.htm.

The white paper, titled “Infection Control in the Healthcare Environment During Construction,” details the process required to establish hospital compliance with The Joint Commission (formerly JCAHO) while maintaining a high level of patient care services and critical institution functions.

The white paper will discuss the steps involved in ensuring infection control during hospital construction projects, including how to:

  • Create a construction oversight panel
  • Select which departments and personnel should be on the panel
  • Incorporate Infection Control Risk Assessment (ICRA) elements into construction documents
  • Establish clear-cut project phases.

Authored by Dennis Tremblay, CFPS, a Senior Scientist at EH&E (http://www.eheinc.com/), a Needham, Mass.-based environmental, health, safety, and engineering consulting firm, the white paper is based on the experiences of EH&E personnel while working with leading hospitals and healthcare institutions nationwide.

This white paper reviews the applicable Joint Commission (formerly JCAHO) standards and American Institute of Architects (AIA) guidelines, and describes a field-tested, successful solution for maintaining Infection Control Risk Assessment (ICRA) documentation. The paper will be interesting and informative to all those responsible for maintaining environmental health and safety compliance in hospitals and healthcare facilities.

To download the free white paper, “Infection Control in the Healthcare Environment During Construction,” visit http://www.eheinc.com/infectioncontrol.htm.

EH&E (http://www.eheinc.com/) has provided an extensive range of environmental and engineering consulting services for 20 years. The EH&E team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry and our wealth of readily-accessible information has become a powerful resource for our clients. EH&E’s new series of EH&E web compliance solutions (http://www.eheinc.com/ehe_web_solutions.htm) is just the latest example of our continuing effort to provide this knowledge and information to a wider range of companies.

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Download public relations images for publication from: http://www.eheinc.com/photos.htm

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

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Posted in Buildings & Facilities, Health/Medical |


Friday, June 20th, 2008

EH&E Launches Interactive Discussion Forum for Healthcare Environment of Care Professionals

Needham, Mass. – June 20, 2008 – EH&E, an environmental and engineering consulting firm for the healthcare industry, has launched “EHEConnect” – an interactive discussion forum dedicated to Environment of Care (EC) professionals – at www.eheconnect.com.

“The forum will act as a central resource for the exchange of ideas and issues central to the mounting, and increasingly complex, responsibilities of those accountable for a healthcare organization’s Environment of Care,” said Kevin Coghlan, M.S., C.I.H, Director of EH&S Compliance & Strategic Support at EH&E. “Our goal is to create a virtual community where EC professionals and others involved in EC issues can login and network with their peers around the country.”

“EHEConnect offers an informal way for EC professionals to exchange ideas, experiences and their solutions to challenges in the EC as well as keep up with The Joint Commission accreditation requirements,” said Coghlan.

EH&E’s team of EC consultants monitor and participate in forum discussions, adding their own professional insights and expertise to the dialogue.

Current topics being discussed include: life safety code documentation; new hospital EtO sterilizer regulations take effect December 2008; OSHA recommendations regarding protection of hospital security personnel in emergences; personal protective equipment for pandemic influenza; extreme temperature policies, interpretation of governing standards for showers and eyewashes.

To learn more and to join EHEConnect, go to: http://www.eheinc.com/forum.htm

EH&E offers a host of customizable services to assist hospitals with a variety of needs including: working to help create a healthy and safe work environment, reducing occupational illness and injury, minimizing workers’ compensation claims, increasing worker morale and productivity, reducing liability, costly litigation and unfavorable publicity, and helping to avoid OSHA fines and other expensive penalties.

About EH&E
EH&E (www.eheinc.com) has provided an extensive range of environmental and engineering consulting services for 20 years. Our team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry and our wealth of readily-accessible information has become a powerful resource for our clients.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Posted in Buildings & Facilities, Health/Medical |


Tuesday, June 10th, 2008

White Paper Helps Hospitals Prepare Staff for Joint Commission Environment of Care Interview Sessions

NEEDHAM, MASSACHUSETTS – June 10, 2008 – Preparing for The Joint Commission survey process within the Environment of Care (EC) is challenging because virtually all internal services used to support patient care, including all areas of the EC, may be audited. As a result, a healthcare institution must be prepared for the survey interview session to proceed in almost any direction and to involve any staff member. EH&E has found that practice interview sessions, if done properly, can dramatically improve the performance of hospital staff in actual Joint Commission surveys.

The white paper titled, “Using Practice Interview Sessions to Strengthen Your Survey Preparedness Within the Environment of Care,” provides an overview of the practice interview technique and discusses “best practices” for conducting practice interview sessions, including how to:

  • Select survey topics that are most relevant to your institution.
  • Determine the right composition of staff members.
  • Create the proper ground rules.
  • Design questions that get to the important issues quickly.

Authored by Nanette E. Moss, M.S., C.I.H., Associate Director of EH&S Compliance and Strategic Support at EH&E (http://www.eheinc.com/), a Needham, Mass.-based environmental, health, safety, and engineering consulting firm, the white paper is based on the experiences of EH&E personnel working with leading healthcare institutions nationwide.

This white paper will be applicable to EH&S managers, facilities managers, Infection Control managers, pharmacy directors, and anyone responsible for maintaining Environment of Care compliance at a hospital or other type of Joint Commission accredited healthcare institution.

To download the free white paper, “Using Practice Interview Sessions to Strengthen Your Survey Preparedness Within the Environment of Care,” visit: http://www.eheinc.com/practicetracer.htm or call 1-800-825-5343.

About EH&E
EH&E (http://www.eheinc.com/) has provided an extensive range of environmental and engineering consulting services for 20 years. Our team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry and our wealth of readily-accessible information has become a powerful resource for our clients.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Posted in Buildings & Facilities, Health/Medical |


Tuesday, March 25th, 2008

Download New Free White Paper “Getting the Building You Paid For”

Needham, Mass. – March 25, 2008 - A free white paper is helping building owners avoid the complaints, business disruptions, and out-of-pocket costs that can result when they’re forced by the construction schedule to occupy new or renovated facilities prior to “system final completion.”

“There’s a disturbing trend in the construction industry towards final completion of building systems after occupancy,” says Mike Della Barba, Director of Commissioning Services at EH&E, a leading environmental engineering and consulting firm, and author of the white paper “Getting the Building You Paid For.” (On the Web at: www.eheinc.com/inchstonewhitepaper.htm).

“Tight construction schedules often result in owners occupying newly constructed buildings that don’t fully meet occupant needs in terms of heating, cooling, lighting, power or other systems. This often proves very costly to the owner in higher maintenance and energy costs and shortened equipment life,” added Della Barba.

The solution, however, is surprisingly simple, he said. By tracking key construction project deliverables – termed Inchstones, as opposed to milestones – building owners can often predict, and therefore prevent, possible schedule delays and the resulting performance shortfalls. Developed by EH&E after a detailed analysis of numerous construction projects, the Inchstones process is detailed in Della Barba’s white paper.

The 16-page white paper also details:

  • The expectations and reality of project completion;
  • The evolving definition of “completion;”
  • The three stages of completion;
  • The roles of the general contractor, commissioning engineer, and building owner;
  • The impact of incompletion on building occupancy and performance; and
  • Maximizing building value using the Inchstones process.

Download the white paper at: www.eheinc.com/inchstonewhitepaper.htm.

About EH&E
EH&E (www.eheinc.com) has provided an extensive range of environmental and engineering consulting services for 20 years. The EH&E team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry. The firm’s wealth of readily-accessible information is a powerful resource for its clients.

EH&E’s new Inchstone Project Monitoring solution (www.eheinc.com/inchstone.htm) is the latest example of the firm’s continuing effort to provide this knowledge and information to a wider range of companies.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Posted in Buildings & Facilities |


Thursday, February 28th, 2008

White Paper Details Environmental Health & Safety Compliance Strategies for Laboratories

NEEDHAM, MASS. – February 28, 2008 – A free white paper that details three specific strategies to improve laboratory environmental health and safety (EH&S) compliance programs is now available for download at http://www.eheinc.com/labprogram.htm.

“Small and midsized companies and institutions with laboratories must manage complex environmental health and safety compliance programs, involving federal, state, and local regulations with limited resources,” said Jack McCarthy, President and co-founder of EH&E, a Needham, Mass.-based environmental services consulting firm.

In the white paper, titled “Three Proven Strategies for Upgrading Your Laboratory Environmental Health & Safety Program,” EH&E experts outline the strategies they have developed to maximize the effectiveness and the efficiency of these programs.

“Due to the complexity and ever-changing nature of research activities, laboratory EH&S programs can be extremely challenging to develop and maintain, yet are critical to the success of the company or institution they serve,” McCarthy said.

The white paper will demonstrate how laboratory managers, laboratory technicians, and EH&S directors can:

  • Improve EH&S program organization and accessibility

  • Expand the laboratory inspection program

  • Take a blended approach to laboratory safety training

Download the free white paper, “Three Proven Strategies for Upgrading Your Laboratory Environmental Heath and Safety Program,” at http://www.eheinc.com/labprogram.htm.

Or, for more information contact EH&E directly on the web at: http://www.eheinc.com/ or by phone at: 1-800-825-5343.

About EH&E
EH&E (http://www.eheinc.com/) has provided an extensive range of environmental and engineering consulting services for 20 years. Our team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry and our wealth of readily-accessible information has become a powerful resource for our clients. Our new series of EH&E web compliance solutions is just the latest example of our continuing effort to provide this knowledge and information to a wider range of clients.

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Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Posted in Buildings & Facilities, Health/Medical |


Wednesday, January 23rd, 2008

White Paper Details Infection Control Challenges Hospitals Must Address During Construction

Needham, Massachusetts – January 23, 2008 - Hospitals and healthcare institutions are challenged to devise policies and procedures that allow construction projects to take place while maintaining Environment of Care (EC) standards. A free white paper that addresses these challenges is available for download at: www.eheinc.com/infectioncontrol.htm.

The white paper, titled “Infection Control in the Healthcare Environment During Construction,” details the process required to establish hospital compliance with The Joint Commission (formerly JCAHO) while maintaining a high level of patient care services and critical institution functions.

The white paper will discuss the steps involved in ensuring infection control during construction, including how to:

  • Create a construction oversight panel
  • Select which departments and personnel should be on the panel
  • Incorporate Infection Control Risk Assessment (ICRA) elements into construction documents
  • Establish clear-cut project phases.

Authored by Dennis Tremblay, CFPS, a Senior Scientist at EH&E (http://www.eheinc.com/), a Needham, Mass.-based environmental, health, safety, and engineering consulting firm, the white paper is based on the experiences of EH&E personnel while working with leading healthcare institutions nationwide.This white paper reviews the applicable Joint Commission (formerly JCAHO) standards and American Institute of Architects (AIA) guidelines, and describes a field-tested, successful solution for maintaining Infection Control Risk Assessment (ICRA) documentation. The paper will be interesting and informative to all those responsible for maintaining environmental health and safety compliance in healthcare facilities.To download the free white paper, “Infection Control in the Healthcare Environment During Construction,” visit http://www.eheinc.com/infectioncontrol.htm.

EH&E (http://www.eheinc.com/) has provided an extensive range of environmental and engineering consulting services for 20 years. Our team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry and our wealth of readily-accessible information has become a powerful resource for our clients. Our new series of EH&E web compliance solutions (http://www.eheinc.com/ehe_web_solutions.htm) is just the latest example of our continuing effort to provide this knowledge and information to a wider range of companies.

# # #

Public Relations contact: Tiziani Whitmyre Inc., http://www.tizinc.com/

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Posted in Buildings & Facilities, Health/Medical |

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