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Friday, April 19th, 2013

Microbiology Quality Control Seminar to Assist Medical Device Manufacturers Validate Sterilization, Cleaning Processes

A seminar on microbiology quality control — designed to help medical device manufacturers validate sterilization and cleaning processes, and maintain controlled environments — will be held on Thursday, May 16, in Boston.

“For today’s medical device manufacturers, the challenge is to validate their sterilization and cleaning processes to ensure patient safety and product integrity. This seminar will focus on a host of issues pertaining to the sterilization of medical devices including sterilization validation, bioburden, sterility, and endotoxin testing, as well as submitting samples to a contract testing laboratory,” said Steven Richter, Ph.D., president and scientific director of Microtest Laboratories, which is hosting the event.

Topics at the “Microbiology Quality Control Seminar” will include:

  • MICRO 101
  • Sterilization Validation
  • Bioburden Testing
  • Sterility Testing
  • Endotoxin Testing
  • Testing Sample Submissions

The event will be held at the MIT Endicott House in Boston, Mass., on Thursday, May 16, 2013, from 9 a.m. to 3:30 p.m. Registration is 9 a.m. to 9:45 a.m. A networking reception and lunch are included.

To register, download the form from http://www.microtestlabs.com/pdfs/seminar-registration-form_1305.pdf. Or, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. The registration fee is $149.

The event is one in a series of technical seminars and workshops for medical device and pharmaceutical manufacturers presented by Microtest Laboratories, a Mass.-based, FDA-audited company with a history of exceptional regulatory compliance.

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

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Posted in Health/Medical, Manufacturing |


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.

 

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Posted in Health/Medical |


Wednesday, January 23rd, 2013

Technical Brief Details How DX AC Systems Can Meet ASHRAE IAQ and Energy Savings Standards

WOBURN, MASS. —January 23, 2013 — Engineers designing commercial HVAC systems for use in schools, hospitals, factories or office buildings face a host of conflicts and tradeoffs when trying to comply with both ASHRAE Standard 90.1 for Energy Efficiency and ASHRAE Standard 62.1 for Indoor Air Quality (IAQ). To help engineers achieve a successful balance between the two, a new technical brief, “No More Tradeoffs: Designing DX AC Systems to Meet ASHRAE’s IAQ and Energy Savings Standards” is now available to download from Rawal Devices, Inc. at http://resources.rawal.com/dx-ac-technical-brief.

Over the past decades, ASHRAE 90.1 promoted energy efficiency as a predominant design factor in air conditioning equipment. Standards for building design, insulation, glass, and ventilation were affected by the amount of thermal energy brought in from the outside air. More recently, ASHRAE 62.1 emphasized IAQ requirements and focused on proper ventilation and humidity control for operations and health issues. Studies meanwhile have confirmed the problems caused by tight, energy-efficient buildings that do not have correct ventilation. As a result, engineers face a balancing act between energy savings and IAQ in AC system design.

The new technical brief, “No More Tradeoffs…,” presents the solution as the use of the direct expansion (DX) air conditioning “discharge air temperature” reset concept (based upon outdoor air conditions), plus continuous capacity modulation for the refrigeration circuit. Discussing the limitations of DX AC design, the brief details the “temperature reset with capacity modulation” solution with sample data and calculations. Several effective approaches are explored, including the use of VFD and digital compressors, and the Rawal APR-E electronic control.

Download “No More Tradeoffs: Designing DX AC Systems to Meet ASHRAE’s IAQ and Energy Savings Standards” from Rawal Devices, Inc., at http://resources.rawal.com/dx-ac-technical-brief.

About Rawal Devices, Inc.

Rawal Devices is the manufacturer of highly efficient and cost-effective solutions that solve temperature and humidity control problems in industrial, institutional, and commercial building applications. Rawal’s APR Control makes any standard air conditioning unit a variable-capacity system. The Rawal device permits the system to extend the cycle of operation, continuously matching capacity to changing load conditions while keeping the system in a dehumidifying mode. Rawal’s unique combination of technology, expertise, and service ensures proper temperature and humidity control for greater indoor comfort, air quality, and energy savings. For more information, visit the website at http://www.rawal.com.

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Posted in Buildings & Facilities, Health/Medical, Manufacturing |


Wednesday, December 5th, 2012

“Processing Compounded Sterile Products,” Information Session Set for Dec. 12 in Springfield, Mass.

AGAWAM, MASS. — Dec. 5, 2012 — A free information session focusing on the challenges of meeting U.S. regulations mandating tighter control of sterile preparations in compounding pharmacies, has been scheduled for Dec. 12, 2012, in Springfield, Mass.

The session, “Processing Compounded Sterile Products,” will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Designed for managers of controlled environments in the pharmaceutical industry, experts in the session will offer technical presentations, practical advice, and solutions on issues relating to General Chapter <USP 797>, including:

  • Environment contamination control and testing
  • FDA aseptic guidance
  • USP <797> and <1116>
  • Technician training and qualification requirements
  • Product testing that includes: sterility/endotoxin, potency/ID, beyond use dating
  • Assessing current practices and next steps

“Processing Compounded Sterile Products” is scheduled for Wednesday, December 12, 2012, at the Hilton Garden Inn, 800 Hall of Fame Avenue, Springfield, Mass., from 9:30 to 11:30 a.m. Registration is at 9 a.m. The session is free — complimentary entry, parking, and refreshments will be provided — but space is limited and advance reservations are required. For more information or to reserve admission, visit the Microtest Laboratories website at http://www.microtestlabs.com/pdfs/seminar-registration-form_1212.pdf, call 1-800-631-1680 extension 192, or email jadamski@microtestlabs.com.

Microtest Laboratories is a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest’s environmental sciences group helps its 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 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Posted in Biosciences, Health/Medical, Life Sciences |


Thursday, November 8th, 2012

Honeywell Safety Products Offers “Mold Remediation Overview” to Advise Hurricane Cleanup Workers on Protection from Mold Exposure

SMITHFIELD, RI — Flood waters caused by hurricanes, rising rivers from torrential rains, and other natural disasters leave a wake of destruction. After the immediate cleanup, workers are left a major health hazard — mold. To assist with workers’ questions about how best to protect themselves, Honeywell Safety Products is offering its “Mold Remediation Overview” for download at http://goo.gl/3TRZn.

Molds are fungi that can be found anywhere, growing on virtually any substance. All that is needed is moisture, oxygen and an organic source. Any remediation work that disturbs mold and causes mold spores to become airborne increases the degree of exposure. While many molds are innocuous, other molds can be extremely toxic — causing respiratory and other disorders. Inhalation is the route of exposure of most concern to flood cleanup workers.

There are no U.S. government standards or regulations for exposure. However, government agencies have provided guidelines on personal protective equipment for workers. The level of protection recommended increases with the size and scope of the infected site.

To help workers protect themselves from the hazards of mold exposure, Honeywell Safety has published a “Mold Remediation Overview.” The document is available to download from the Honeywell Safety website at http://goo.gl/3TRZn.

About Honeywell Safety Products

Honeywell Safety Products (http://www.honeywellsafety.com), a global manufacturer of leading personal protective equipment (PPE) brands such as Honeywell®, Uvex®, North®, Howard Leight®, Miller®, Fibre-Metal® and Servus®, offers a full range of quality PPE including respiratory, hand, footwear and clothing, welding, head, first-aid, hearing, eye/face, fall protection, lockout/tag out, and traffic safety products.

About Honeywell

Honeywell International (www.honeywell.com) is a Fortune 100 diversified technology and manufacturing leader, serving customers worldwide with aerospace products and services; control technologies for buildings, homes and industry; automotive products; turbochargers; and specialty materials. Based in Morris Township, N.J., Honeywell’s shares are traded on the New York, London, and Chicago Stock Exchanges. For more news and information on Honeywell, please visit www.honeywellnow.com.

This release contains certain statements that may be deemed “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical fact, that address activities, events or developments that we or our management intends, expects, projects, believes or anticipates will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this release are also subject to a number of material risks and certainties, including but not limited to economic, competitive, governmental, and technological factors affecting our operations, markets, products, services and prices. Such forward-looking statements are not guarantees of future performance, and actual results, developments and business decisions may differ from those envisaged by such forward-looking statements.

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Posted in Buildings & Facilities, Health/Medical, Public Safety |


Wednesday, October 24th, 2012

New White Paper Assists Medical Device Manufacturers with Changes to FDA Endotoxin Testing Guidelines

AGAWAM, MASS. —October 24, 2012 — A new white paper is available to assist medical device manufacturers with understanding recent changes to the U.S. Food and Drug Administration’s (FDA) thinking regarding endotoxin testing. The paper is available to download from the Web at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper.

Titled “FDA Updates Medical Device Endotoxin Testing Program (New Guidance),” the new white paper is authored by Steven G. Richter, Ph.D., a former FDA official, and President and Chief Scientific Officer of Microtest Laboratories, Inc., a leading contract testing laboratory.

In the paper, Dr. Richter discusses the FDA’s recently published document, “Guidance of Industry Pyrogen and Endotoxin Testing: Questions and Answers.” The FDA document replaced the agency’s 1987 Endotoxin Guidelines — now considered out of date as a result of changes in the USP and pharmaceutical dosage forms. It presents the agency’s current position regarding pyrogen and bacterial endotoxin testing requirements for pharmaceuticals, biologics, and medical devices. Medical devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

In his new white paper, Dr. Richter reviews the FDA’s updated guidelines on endotoxin testing and explains how they relate to medical devices. Since the majority of pyrogens found on medical devices are bacterial in nature, the paper focuses on those contaminates.

Some medical devices that are required by the FDA to be tested for endotoxin are:

  • Intravenous catheters and tubing
  • Cardiac stents and angioplasty balloons
  • Certain implants such as pacemakers/defibrillators
  • Spinal catheters
  • Transfusion catheters
  • Intraocular lens implants
  • Cranial drills
  • Perfusion tubing
  • Dialysis tubing and filters
  • Vascular grafts
  • In vitro fertilization catheters

Download a copy of the new white paper, “FDA Updates Medical Device Endotoxin Testing Program (New Guidance),” from the Microtest Laboratories website at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper. Or, request a copy by calling 1-413-786-1680 or toll-free 1-800-631-1680.

About Microtest Laboratories

Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

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 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.

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Posted in Biosciences, Health/Medical, Manufacturing |


Monday, October 22nd, 2012

Honeywell Safety Products Launches Innovative Safety Products to Help Safety Managers Lead Their Workers to Safety

ORLANDO, FLORIDA — OCTOBER 22, 2012 — Honeywell Safety Products today announced a host of new, innovative safety products — across a wide range of applications — to help safety managers build an enduring culture of safety that minimizes injuries and maintains a more protective and productive workplace. The products were introduced at the opening of the 2012 National Safety Council (NSC) Congress & Expo in Orlando, Florida.

“A culture of safety exists when safety managers inspire workers to change their behaviors and make safe choices on their own for their own protection — as well as that of their friends and co-workers,” said John Montigny, Chief Marketing Officer, Honeywell Safety Products.

Studies have shown that an enduring culture of safety can be the most cost-effective and proven accident-prevention process — by avoiding workplace safety incidents before they occur, reducing the risk of injury, cutting incident rates, and improving productivity.

“In pursuit of that critical goal, today at NSC, Honeywell Safety Products is introducing new stylish, comfortable, high-performance personal protective equipment (PPE) that employees will want to wear and that meet the most stringent regulations. In addition, we are announcing the availability of new behavior-based safety education resources designed to encourage the proper use of PPE and the adoption of safe workplace cultures,” Montigny said.

The products and solutions announced today include:

 

  • The new Miller® AirCore™ Harness, which combines comfort features with functional components. The full-body harness is designed for a worker’s ultimate comfort and safety. Features include breathable, open-core padding technology; patented DuraFlex® stretchable webbing; easy, one-hand adjustment shoulder cam buckles; a stand-up back d-ring; a quick-connect chest buckle; and more. For more information: http://www.millerfallprotection.com/aircore.

 

  • Miller’s Fall Clearance Calculator. The new interactive tool enables managers and workers to calculate critical safety information — such as fall clearance and swing fall — anywhere and anytime via a computer, smart phone or tablet. Importantly, the Calculator can be used with any brand of fall protection equipment. It is available on the Web at: http://www.millerfallprotection.com/fallclearance.

 

  • The new Miller MightyLite™ Leading Edge Self-Retracting Lifeline. The Lifeline is designed to protect a worker if a fall occurs that involves going over an edge. The MightyLite LE SRL features a shock absorber integrated into the lifeline, lowering fall arrest forces. For more information: http://www.millerfallprotection.com.

 

  • The new ultra-lightweight Uvex® Carbonvision™ wide-view safety goggle, which promotes a safer workplace by improving worker comfort, protection and productivity. The style’s proprietary Uvex Dura-streme dual lens coating ensures maximum anti-scratch and anti-fog properties for longer lens life, clear vision, and improved worker protection from impact, dust and airborne particles, and chemical splash hazards — even in demanding environments. For more information: http://www.uvex.us.

 

  • The new Honeywell Eyelation™ program that makes enterprisewide prescription safety eyewear management easy, affordable, and effective. The automated system features onsite, Web-enabled, touchscreen kiosks that allow end-users 24/7 access to fit, select, and order prescription safety eyewear. The program delivers exceptional value to safety managers and human resources professionals who manage the traditionally labor-intense prescription safety eyewear benefit. For more information: http://www.HoneywellSafety.com/Eyelation.

 

  • North®’s new lower-profile respiratory cartridges and cartridge/filter combinations, which feature a sleek design that expands a worker’s field of vision and reduces the risk of catching or snagging in tight spaces. Re-engineered inhalation ports make fit-testing for workers with smaller hands easier. Threaded connectors tighten securely for long service life and unwavering reliability. For more information: http://www.northsafety.com.

 

 

  • Honeywell’s presentation of Oliver, a brand with more than 125 years of expertise in manufacturing premium safety footwear. Oliver work boots are well known in the mining, oil and gas, construction, manufacturing, and heavy metal fabrication industries. Oliver boots are engineered with premium full grain leathers and market leading technologies to ensure top-performance, longevity, and all day comfort. For more information: http://www.oliversafetyboots.com.

 

  • Honeywell Safety Products’ innovative “Lead Them to Safety” initiative which provides managers with a wide range of culture of safety-focused best practices, tools, resources, advice, and research — drawn from expert sources around the world. The Initiative is based on the Web at http://www.honeywellsafety.com/culture.

 

For more information, visit Honeywell Safety Products at the 2012 NSC Congress & Expo at Booth #1627 and Booth #181. Visit Honeywell Safety’s website at http://www.honeywellsafety.com.

 

About Honeywell Safety Products

Honeywell Safety Products (http://www.honeywellsafety.com), a global manufacturer of leading personal protective equipment (PPE) brands such as Honeywell®, Uvex®, North®, Howard Leight®, Miller®, Fibre-Metal® and Servus®, offers a full range of quality PPE including respiratory, hand, footwear and clothing, welding, head, first-aid, hearing, eye/face, fall protection, lockout/tag out, and traffic safety products.

 

About Honeywell

Honeywell International (www.honeywell.com) is a Fortune 100 diversified technology and manufacturing leader, serving customers worldwide with aerospace products and services; control technologies for buildings, homes and industry; automotive products; turbochargers; and specialty materials. Based in Morris Township, N.J., Honeywell’s shares are traded on the New York, London, and Chicago Stock Exchanges. For more news and information on Honeywell, please visit www.honeywellnow.com.

This release contains certain statements that may be deemed “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical fact, that address activities, events or developments that we or our management intends, expects, projects, believes or anticipates will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this release are also subject to a number of material risks and certainties, including but not limited to economic, competitive, governmental, and technological factors affecting our operations, markets, products, services and prices. Such forward-looking statements are not guarantees of future performance, and actual results, developments and business decisions may differ from those envisaged by such forward-looking statements.

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Posted in Health/Medical, Hearing Protection, Manufacturing |


Tuesday, October 2nd, 2012

Leading Physicians to Discuss “Advances in Bacterial Testing of Platelets: BacTx Field Experience” at American Association of Blood Banks (AABB) Annual Meeting

Boston, Mass. — October 2, 2012 — Bacterial contamination of platelets is the greatest infectious risk of blood transfusion today — and preventing it has become a priority for transfusion safety.

Two leading physicians will discuss their experience with Immunetics’ BacTx® rapid test — which addresses that priority and which can detect bacterial contamination by clinically relevant species in less than one hour — at the upcoming AABB Annual Meeting on Oct. 8th in Boston.

BacTx was FDA cleared in June 2012 as a quality control test for up to 6 units of leukocyte-reduced whole blood-derived platelets pooled within 4 hours of transfusion. The clearance was based in part on the results of clinical trials presented by W. Andrew Heaton, M.D., Sr. Director of Transfusion Medicine, NSLIJ Health System; and Michael R. Jacobs, M.D. Ph.D., Director, Clinical Microbiology, University Hospitals, Case Medical Center.

The two physicians will discuss their clinical trials at the AABB workshop titled, “Advances in Bacterial Testing of Platelets: BacTx Field Experience,” on Monday, Oct. 8, 2012, from 7 a.m. to 8:15 a.m. in Room 253A of the Boston Convention Center.

An estimated 1 in 2,000 platelet units is contaminated with bacteria — and medical studies are increasingly showing that such contamination is a significant cause of illness and death among transfusion recipients. Worldwide, more than 10 million platelet units are collected per year.

For more information, about the BacTx rapid test for bacterial contamination in platelet units, visit Immunetics at booth #662 at the AABB Annual Meeting & CTTXPO 2012, Oct. 6 to 9, 2012, in the Boston Convention Center, Boston. Or, visit the Immunetics website at http://immunetics.com/bactx.html, or call 1-617-896-9100 or toll-free 1-800-227-4765.

Immunetics has issued patents on the BacTx technology, which was initially developed with support from the National Institutes of Health. The company has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for Babesiosis and Chagas disease — both of which are emerging risks to the blood supply.

About Immunetics

Immunetics Inc. (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, and for more than ten years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. Its mission is to deliver better, cost-efficient care through more accurate diagnosis. Immunetics is headquartered in Boston. Follow Immunetics on Twitter at http://twitter.com/immunetics.

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Posted in Biosciences, Health/Medical |


Tuesday, October 2nd, 2012

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

AGAWAM, MASS. – October 2, 2012 – The new scope of cleaning validations for the manufacturers of reusable medical devices is examined in a white paper available for download from 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,” Kenny notes.

The paper discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. 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.

Download 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.

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.

About Microtest Laboratories

Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

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 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.

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Posted in Biosciences, Health/Medical, Manufacturing |


Tuesday, September 18th, 2012

White Paper Helps Research Institutions Implement BSL-2+ Biosafety Programs in Laboratories

Needham, Mass. – September 18, 2012 – A new, free white paper assists research institutions with the challenges of implementing biosafety level (BSL) 2+ practices and procedures in laboratory facilities.

BSL-2+ is the term frequently used to describe laboratories where work with microorganisms is conducted in a BSL-2 laboratory with biosafety practices and procedures typically found at BSL-3. The biosafety level is determined by a risk assessment process. In some cases the risk assessment reveals that safety practices over and above those required at BSL-2 are needed, yet a more complex BSL-3 laboratory facility is not necessary.

The paper titled “A Practical Guide to Implementing a BSL-2+ Biosafety Program in Laboratories” is based on a client survey EH&E conducted of academic, biotechnology and healthcare institutions focused on how institutions are managing implementation of BSL-2+ practices in laboratories. The survey identified three areas that are most challenging:

  • Determining what work or projects require BSL-3 practices
  • Ensuring that the researchers are properly trained in the use of BSL-3 practices in a BSL-2 laboratory
  • Ensuring that a project-specific Standard Operating Procedure (SOP) is developed

“The fact that BSL-2+ is not a recognized containment level in biosafety guidance documents makes it challenging for research institutions to determine when to use this hybrid approach and which biosafety practices to use,” says Betsy Gilman Duane, Associate Director of EH&S Compliance / Biosafety Practice Leader of EH&E. “Unlike biosafety levels-1, 2, 3, and 4, BSL-2+ is not a prescribed containment level. We’ve found that there is limited information available on this topic and developed the paper to serve as an additional resource for research institutions looking to create a BSL-2+ laboratory facility.”

The paper, “A Practical Guide to Implementing a BSL-2+ Biosafety Program in Laboratories”, addresses the challenges identified in the survey and discusses the critical steps to implementing a BSL-2+ laboratory.

Download the white paper “A Practical Guide to Implementing a BSL-2+ Biosafety Program in Laboratories” at http://www.eheinc.com/BSL2plus_guide.htm

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

About EH&E

EH&E (www.eheinc.com) has provided an extensive range of environmental and engineering consulting services for 25 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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Posted in Biosciences, Health/Medical |

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