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

Health/Medical Newsfeed


Wednesday, August 18th, 2010

AirPal Expands Line of Air-Activated Transfer Pads to include Multi-Purpose Patient Positioning Functionality

4c6bbb7a North Wales, Penn, August 18, 2010 – AirPal®, a leading innovator and supplier of lateral air transfer and positioning technology, has announced the expansion of its line of air-activated transfer pads to incorporate multi-purpose patient positioning functionality.
“This announcement marks the launch of an entire new series of AirPal Safe Anatomic Positioning™ systems,” said Jim Weedling, President AirPal, Inc. “Among other functions, these exciting new products will enable nurses, surgeons, anesthesiologists, and other caregivers to optimally adjust a patient’s angle of elevation for procedures that require precise airway positioning, and more easily transfer patients laterally before and after the procedure.”

Announced today was the AirPal RAMP® All-In-One, which stands for Rapid Airway Management Positioning All-In-One system. It is designed primarily for the Operating Room (OR) to facilitate airway management in applications such as pre-oxygenation prior to anesthesia intubation, airway axes alignment for tracheal tube insertion to improve POGO scores and optimize glottic exposure, assistance with extubation to minimize the threat of tissue trauma, and many other procedures that require precise ear to sternal notch positioning. Other potential application areas include use in intensive care situations, emergency medical transport, and certain clinical care procedures.

Safe Anatomic Positioning system

“The RAMP All-In-One is a Safe Anatomic Positioning system that combines lateral transfer technology and flexible patient positioning,” said Weedling. “Its objectives are to afford greater safety and comfort for the patient, provide new levels of convenience for surgeons and anesthesiologists, and to assist in the prevention of patient handling injuries.”

Injuries to nurses caused by transferring or repositioning patients have been cited as a significant factor behind the medical industry’s escalating worker’s compensation costs. AirPal pioneered the original concept of using air-activated pads to more safely and easily transfer patients from one surface to another.

Because the RAMP module enables the patient’s angle of elevation to be adjusted via a pneumatic AirPod™, OR staff will no longer be required to manually lift the patient and use linens or pillows to achieve the desired elevation. The RAMP differs from conventional patient positioning techniques because it offers continuous adjustability, unlike the static wedges or linen props that must be readjusted each time the patient is moved. The RAMP was developed over a period of several years in collaboration with leading medical practitioners.

For more information regarding AirPal Safe Anatomic Positioning systems and the newly introduced RAMP All-In-One, contact AirPal at 800-633-4725 or http://airpal.com.

About AirPal®-Patient Transfer Systems, Inc:

AirPal®-Patient Transfer Systems, Inc. is a privately held Pennsylvania Corporation with offices in Center Valley and North Wales, PA. Established in 1984, AirPal® was the first company to bring to market an air-assisted lateral patient transfer device and is most noted for their “Platform” line of lateral patient transfer pads. The new AirPal® RAMP® Safe Anatomic Positioning system integrates safe patient handling practices with patient positioning for airway management. AirPal holds multiple patents and has remained a leading innovator in the market that they created. AirPal can be reached at 800-633-4725.

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Press contact: James Weedling, President, jweedling@airpal.com, 800-633-4725 or 610-282-4849

Download high resolution photos for publication from: http://airpal.com/photos

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Posted in Buildings & Facilities, Health/Medical, Hearing Protection, Technology, Uncategorized |


Monday, July 19th, 2010

Free Seminars for Employers in Chicago, Cincinnati, Davenport, Indianapolis Will Focus on Occupational Hearing Loss Prevention, Hearing Protector Label Changes

hf_seminar_header_alberta2Free seminars focusing on the increasing critical importance – and rapidly changing regulatory environment — of occupational Hearing Conservation Programs will be held for employers in Chicago, Cincinnati, Davenport, and Indianapolis this September.

“The ‘HearForever™: Best Practices in Hearing Conservation’ seminars will address an expanding range of need-to-know topics for employers ranging from implementing an effective occupational Hearing Conservation Program to impact of the changes to the Noise Reduction Rating (NRR) that the U.S. Environmental Protection Agency is expected to enact in September,” said Dr. Theresa Y. Schulz, Lt. Col. USAF (retired), Hearing Conservation Manager, Sperian Hearing Protection, LLC/Howard Leight.

Dr. Schulz will present the free three hour, 9 a.m. to Noon seminars. They’re scheduled as follows:
• Cincinnati, OH, Sept. 13, Monday, at the Hilton Garden Inn / Mason
• Indianapolis, IN, Sept. 14, Tuesday, at the Marriott Indianapolis North
• Chicago, IL, Sept. 15, Wednesday, at the Hilton Garden Inn / Chicago O’Hare Airport
• Davenport, IA, Sept. 16, Thursday, at the Radisson Quad City Plaza

To register, visit http://www.hearforever.org/hf2010midwest.theresa_schulz_2009-web2

Employers attending the seminars will receive practical information on noise-induced hearing loss, and the latest research and technology on hearing loss prevention. They will also explore the impact of the EPA’s imminent rule changing the Noise Reduction Rating labels on hearing protection devices. Topics will include:
• Basics of Hearing Conservation and Noise-Induced Hearing Loss
• Key Elements of an Occupational Hearing Conservation Program
• Impending Changes to the Noise Reduction Rating (NRR) and How They Affect You
• Reducing Costs for Occupational Hearing Loss
• Selection and Fitting of Hearing Protectors
• Employee Motivation and Training
• New Hearing Conservation Innovations and Technologies (In-Ear Dosimetry, Intelligent Protection, etc.)

Industrial hygienists, occupational health and safety professionals, safety managers, audiologists, and liability and risk management professionals are all encouraged to attend.

Continuing Education Units (CEU) will be available for members of AIHA and ASSE.

“Noise-induced hearing loss (NIHL) is the most common, permanent occupational injury in the world – yet it’s also most preventable form of on-the-job injury,” she said. “We’re providing safety professionals with the knowledge and confidence to effectively manage their Hearing Conservation programs for the benefit of their workers — and their own bottom line.”

Attendees will receive free Hearing Conservation training materials, posters, and literature, as well as samples of Howard Leight and other Sperian products. Following the seminar, attendees can participate in hands-on demonstrations of Howard Leight’s new VeriPRO® ear plug fit testing system and QuietDose™ in-ear dosimetry.

Dr. Schulz, who will present the seminars, is a past president of the National Hearing Conservation Association (NHCA), and also past chair of the Council for Accreditation in Occupational Hearing Conservation (CAOHC). During her 20+ year career in the United States Air Force, she was twice recognized as USAF Outstanding Audiologist of the Year. Most recently, she served as a senior service fellow at the National Institute of Occupational Safety and Health’s (NIOSH) Hearing Loss Prevention Program. Dr. Schulz holds a Ph.D. in hearing science from Ohio State University.

Howard Leight Hearing Conservation seminars have been presented to over 3,000 safety professionals on five continents over the past five years. They’re part of Howard Leight’s industry-leading HearForever™ initiative to raise awareness of the dangers, risks and consequences of noise-induced hearing loss.

To register, visit http://www.hearforever.org/hf2010midwest.

Follow on Twitter: @HowardLeight at http://twitter.com/HowardLeight and @HearForeverOrg at http://twitter.com/hearforeverOrg. Find HearForever on Facebook at http://www.facebook.com/HearForever.

About Howard Leight
Howard Leight/Sperian Hearing Protection, LLC is a leading global provider of passive and intelligent hearing protection solutions, and the founder of the HearForever™ initiative. For over 30 years, Howard Leight has pursued the prevention of occupational noise-induced hearing loss through innovation in hearing protection design, technology, performance and comfort, and the promotion of progressive Hearing Conservation Programs. Leading solutions include the highest attenuating Max® single-use earplug; patented Air Flow Control™ technology for optimal earmuff attenuation; QuietDose™ personal in-ear dosimetry; and the industry-changing VeriPRO® earplug fit testing system. Visit: http://www.howardleight.com. Follow on Twitter at http://twitter.com/HowardLeight.

About Sperian Protection
With nearly 6,000 employees worldwide, Sperian Protection is resolutely geared towards international markets. The world leader in personal protective equipment (hearing, eye, respiratory and fall protection, gloves, clothing and footwear), the Group offers innovative products adapted to high-risk environments so that all workers in the manufacturing and services industries can work with confidence. Sperian Protection is listed on Euronext’s Eurolist and on the SBF120.

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


Tuesday, July 13th, 2010

InQ Biosciences Introduces First Fully Integrated Cell Research System

HUNTSVILLE, ALABAMA, U.S.A., July 13, 2010 — InQ Biosciences, a provider of innovative technologies for cell growth and research, announced its plans to launch the InQTM Cell Research System during the fourth quarter of 2010. InQ is the first fully integrated system that creates a high fidelity in vivo environment for studying stem cells, plus nerve, brain, and other mammalian cells for disease research.

“The InQ system is the only cell research instrument that combines a dynamic software-controlled sample environment with powerful imaging and real-time data collection,” said Aaron Hammons, President and Chief Technology Officer, InQ Biosciences. “Our system’s exclusive capability to tightly control environmental parameters with correlated sample feedback will create a new paradigm in cell biology research. Scientists will be empowered with novel and more relevant approaches to discovery as they pursue the causes of cancer and neurodegenerative and cardiovascular diseases,” Hammons said.

The benchtop system automates the cell culture process by enclosing the cells in a sealed, sterile removable cartridge that slides into the instrument. An onboard computer precisely controls the mix and flow of nutritive media and gasses and regulates the temperature. “Users will reap the benefits of extended cell growth and unprecedented experiment reproducibility and standardization. Now researchers can easily simulate hundreds of disease states, including stroke, heart attack, Alzheimer’s, and ALS,” said Hammons.

A built-in high-resolution microscope and camera record the assay at scheduled intervals, and can send the images to the researcher anywhere in the world via the Internet and smart phone. Adjustments to the experiment can be made remotely, as well.

The InQ System fits easily into research workflows and integrates with most laboratory information management systems. It requires fewer samples to attain study goals, generates more data points for greater accuracy of results, and dramatically reduces the number of failed experiments,” Hammons said.

Units will be shipped to early access partners beginning in September, with commercial launch scheduled in the fourth quarter. For more information on the InQ System, contact info@inqbio.com or 866-735-9684, or visit http://www.inqbio.com. Follow InQ Biosciences on Twitter at http://twitter.com/InQbio.

About InQ Biosciences

InQ Biosciences is a provider of innovative technologies for cell growth and research. The company’s InQ Cell Research System will empower scientists to unlock novel and more powerful approaches to cell-based discovery. The firm was founded in 2007 with technology originating from the University of Alabama in Huntsville. Series B financing was completed in May 2010 and commercial launch of its InQ system is scheduled for the fourth quarter of 2010. For more information, visit http://www.inqbio.com. Follow InQ Biosciences on Twitter at http://twitter.com/InQbio.

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


Tuesday, July 13th, 2010

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

microtest-logo1

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

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

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

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

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

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

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

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

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

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

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

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Posted in Biosciences, Health/Medical, Manufacturing |


Tuesday, July 6th, 2010

National Hearing Conservation Association (NHCA) Announces Call for Papers for 36th Annual Conference

nhcaWestminster, Colo. ― July 6, 2010 ― The National Hearing Conservation Association (NHCA) announces a call for papers for presentations and posters for its 36th Annual Conference, to be held February 24-26, 2011 in Mesa, Arizona. The theme of the conference is “The Future of Hearing Conservation: Technology & Innovation.”

Paper submission topics should reflect NHCA’s mission of “prevention of hearing loss due to noise and other environmental factors in all sectors of society.” Presentations may address basic scientific research, applied research, practical applications of research results, or other findings or concepts which may enhance hearing loss prevention efforts.

Submissions are being solicited for Platform (Panel) Presentations and Poster Presentations. All proposals must be submitted electronically – either online or by e-mail.
• Platform (Panel) Presentations proposals are due July 31, 2010. To submit, visit: http://ht.ly/21J5N
• Poster Presentations proposals are due September 1, 2010. To submit, visit: http://ht.ly/21J5N

NHCA’s conference features three days of engaging workshops, presentations, panel discussions and poster presentations on current issues relevant to the practice of hearing loss prevention. Key topics include the latest research on:
• Occupational hearing loss
• Music-induced hearing loss
• Hearing loss after impulse noise
• Novel strategies for measuring noise risk and pre-clinical effects of noise on hearing
• Hearing protection device innovations
• Public and personal health issues related to hearing loss
• Hearing loss prevention training and education
• Health communication strategies

Over 300 professionals attend the NHCA annual conference for professional development and networking opportunities.

About the National Hearing Conservation Association (NHCA)
The mission of the NHCA is to prevent hearing loss due to noise and other environmental factors in all sectors of society. NHCA provides networking, resources and professional development opportunities to improve skills, practices and services for over 600 members. NHCA’s membership includes audiologists, researchers, industrial hygienists, educators, professional service organizations, safety professionals, medical professionals, engineers, audio professionals, students, and others who have dedicated their work to the advancement of hearing loss prevention.

For more information about the National Hearing Conservation Association, visit the NHCA online at http://www.hearingconservation.org or call 1-303-224-9022. Follow the NHCA on Twitter at www.twitter.com/nhcaorg, on Facebook at http://bit.ly/vLRg5, and on LinkedIn at http://bit.ly/3X2DfT.

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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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Posted in Buildings & Facilities, Business, Health/Medical, Hearing Protection, Manufacturing, Public Safety |


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.

# # #

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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Posted in Biosciences, Health/Medical, Manufacturing |


Monday, May 24th, 2010

Get with the Program: Having a solid package validation program can prevent failure of combination products

microtest-logo1

FDA concerns regarding terminally sterilized medical products are based on years of data that implicate failures in primary packaging. Approximately 47% of failures occur due to inadequate package validation programs.

Read the new bylined article by Steven Richter, “Get with the Program: Having a solid package validation program can prevent failure of combination products,” for insight into the general requirements in a microbiological and physical testing program. It also discusses how combination products pose a unique set of challenges to package validation engineers.

Published May 2010 in MD&DI, at http://ht.ly/1P7lO

Steven Richter, PhD, is founder, president, and chief scientific officer of Microtest Laboratories Inc. (Agawam, MA).

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Posted in Biosciences, Health/Medical |


Thursday, May 20th, 2010

Texas Employers Urged to Attend Free June Seminars to Improve Hearing Conservation Programs

hf_seminar_header_alberta2May 20, 2010 — Texas employers across the state are invited to attend free seminars in June designed to improve their Hearing Conservation Programs and help prevent noise-induced hearing loss among workers.

The three-hour seminars, “HearForever™: Best Practices in Hearing Conservation,” are set for Dallas, San Antonio, Corpus Christi, and Houston, and will provide practical information on noise-induced hearing loss (NIHL) and the latest research and technologies to enhance occupational hearing conservation programs.

Dr. Theresa Y. Schulz, Lt. Col. (retired, US Air Force), Hearing Conservation Manager at Sperian Hearing Protection, LLC/Howard Leight®, will host the seminars. Dr. Schulz is past president of the National Hearing Conservation Association (NHCA) and past chair of the Council for Accreditation in Occupational Hearing Conservation (CAOHC). Dr. Schulz is a Texas native and during her career in the Air Force was stationed for a time at Brooks AFB in San Antonio. She holds a Ph.D. in hearing science from Ohio State University.

Designed for industrial hygienists, occupational health and safety professionals, safety managers, audiologists, and liability and risk management professionals, the seminars will cover:
• Basics of Noise-Induced Hearing Loss
• Key Elements of an Effective Hearing Conservation Program
• Impending Changes to the Noise Reduction Rating (NRR) and How They Affect Employers
• Selection and Fitting of Hearing Protectors
• Employee Motivation and Training Techniques/Resources
• New Hearing Conservation Innovations and Technologies

The seminars will run from 9 a.m. to noon:
• Monday, June 7 - Dallas, TX, Embassy Suites Dallas – DFW International Airport North at Outdoor World
• Tuesday, June 8 - San Antonio, TX, Holiday Inn Northwest / Seaworld
• Wednesday, June 9 - Corpus Christi, TX, Embassy Suites Corpus Christi
• Thursday, June 10 - Houston, TX, Marriott Houston South at Hobby Airport

Continuing Education Units (CEU) are available for AIHA and ASSE members.

Attendees will receive free training materials, literature and hearing protection samples. Attendees are also invited to participate in hands-on demonstrations of Howard Leight’s new VeriPRO® earplug fit testing system and QuietDose™ in-ear dosimetry. A complementary continental breakfast is included.

To register, visit http://www.hearforever.org/hf2010texas.

Howard Leight Hearing Conservation seminars have been presented to over 2,500 safety professionals on five continents over the past five years. They’re part of Howard Leight’s industry-leading HearForever™ initiative to raise awareness of the dangers, risks and consequences of noise-induced hearing loss (NIHL).

Follow on Twitter: @HearForeverOrg at http://twitter.com/hearforeverOrg.

About Howard Leight
Howard Leight/Sperian Hearing Protection, LLC is a leading global provider of passive and intelligent hearing protection solutions, and the founder of the HearForever™ initiative. For over 30 years, Howard Leight has pursued the prevention of occupational noise-induced hearing loss through innovation in hearing protection design, technology, performance and comfort, and the promotion of progressive Hearing Conservation Programs. Leading solutions include the highest attenuating Max® single-use earplug; patented Air Flow Control™ technology for optimal earmuff attenuation; QuietDose™ personal in-ear dosimetry; and the industry-changing VeriPRO® earplug fit testing system. Visit: http://www.howardleight.com. Follow on Twitter (@HowardLeight) at http://twitter.com/HowardLeight.

About Sperian Protection
With nearly 6,000 employees worldwide, Sperian Protection is resolutely geared towards international markets. The world leader in personal protective equipment (hearing, eye, respiratory and fall protection, gloves, clothing and footwear), the Group offers innovative products adapted to high-risk environments so that all workers in the manufacturing and services industries can work with confidence. Sperian Protection is listed on Euronext’s Eurolist and on the SBF120.

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Posted in Business, Health/Medical, Hearing Protection, Manufacturing |


Friday, April 30th, 2010

“Information Transfer for Early Stage Fill/Finish Clinical Trial Material” Presentation is Featured at BIO International Convention

microtest-logo1

AGAWAM, MASS. – May 3, 2010 – Alexander Mello, Director of Project Management at Microtest Laboratories, Inc. will present “Information Transfer for Early Stage Fill/Finish Clinical Trial Material” at the BIO International Convention, May 5, 2010 in Chicago.

Outsourcing fill/finish on an early stage/new clinical trial material has many challenges. The presentation will outline early stage clinical trial product information/technical transfer and detail out the challenges in educating the Contract Manufacturing Organization (CMO) about the nuances and special treatments for your product. Mello will discuss the issues involved with new large molecule products and product specifications that need to be discussed prior to subcontracting manufacturing to the CMO, including namely fill/finish, final release testing, storage and shipping.

Topics will include:
• Initial discussions on product nuances and specifications
• Material handling
• Temperature control before, during and after the manufacturing process
• In-Process controls (testing and other process requirements)
• Fill/Finish restraints (shear, bruising, foaming etc)
• Inspection
• Release Testing
• Storage/Shipping

Alexander Mello is Director of Project Management for Microtest, a leader in pharmaceutical testing services. He has 18 years of experience spanning Aseptic Fill/Finish, Microbiology, Method Transfer, Stability of Drug Product, Medical Devices/Combo Devices, and Sterilization Sciences. He holds a graduate degree in Biological Sciences and is a Specialist Microbiologist (NRM).

The presentation, “Information Transfer for Early Stage Fill/Finish Clinical Trial Material,” is scheduled for May 5th, 2010, 2-2:30pm at Booth 3338. The presentation is sponsored by Genetic Engineering News.

For more information, visit Microtest at the BIO International Convention, booth #1944, May 3-6 in Chicago. Or, visit the Microtest website at: http://www.microtestlabs.com/pharmaceutical-testing-services/ or call 1-800-631-1680.

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.

# # #

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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Posted in Biosciences, Buildings & Facilities, Health/Medical, Lifestyle |


Friday, April 30th, 2010

Microtest Labs Provides Complete Fill and Finish Manufacturing Services for Clinical Trial Material

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AGAWAM, MASS. – May 3, 2010 – Microtest Laboratories will highlight its newly expanded fill and finish manufacturing service for all Phases of clinical trials at the BIO International Convention, booth #1944, May 3-6 in Chicago.

Microtest is a leader in providing flexible, customizable aseptic processing and fill/finish services for all pharmaceutical producers conducting Phase 1, 2, or 3 clinical trials.

“Virtual companies and smaller pharma manufacturers with no infrastructure for manufacture can partner with Microtest to provide their clinical trial material to clinics in an efficient and timely manner. Large manufacturers that don’t wish to divert high-capacity production lines will find Microtest a fast, efficient, cost-effective alternative,” said Alex Mello, Director of Project Management, Microtest. “Manufacturers of any size will discover a partner in Microtest with all the specialized knowledge, experience, and facilities they need.”

Microtest provides the flexibility for all types of pharmaceutical and biopharmaceutical manufacturing. Microtest will formulate per the approved batch record, which may include mixing, agitation, heating/cooling, etc. Microtest can provide problem solving experience to any of the specifics of a manufacturer’s process. Post formulation, Microtest’s analytical capabilities allow for a full spectrum of available in-process tests to ensure that the drug product is formulated to the strict specifications set by the manufacturer. Post in-process testing, filtration occurs utilizing the manufacturer’s specified filtration system, redundant as applicable. The product is filled into the designated vial type/size specified by the manufacturer as well as stoppered and capped using the manufacturer defined container closure system. Product is filled, capped and sealed under an ISO Class 5 environmental area.

Post fill, the product undergoes full 100% manual visual inspection, which is quality-controlled post-inspection by a qualified operator by performing an AQL inspection. Product is labeled per approved labels and stored in Microtest’s fully validated material control department at a multitude of storage conditions.

“As Microtest is a leader in testing of pharmaceutical drug products, we offer the full release package on-site thereby ensuring the most expeditious release of the product,” Mello said. “The specification documents allow for maximum efficiency when the samples are taken and released to our QC laboratories – both QC Microbiology and QC Analytical. Our representatives can discuss the testing on any final drug product specification and determine the most efficient release strategy.”

Microtest fill/finish operations comply with both U.S. FDA and European EMEA guidelines. Microtest has been inspected by the U.S. FDA, U.S. DEA, and Qualified Persons (QP) for both the manufacture and release testing of final drug product.

For more information, visit Microtest at the BIO International Convention, booth #1944, May 3-6 in Chicago. Or, visit the Microtest website at: http://www.microtestlabs.com/aseptic-processing/fill-finish/ or call 1-800-631-1680. 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.

# # #

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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Posted in Biosciences, Health/Medical |

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