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

Posts Tagged ‘Manufacturing’


Monday, September 26th, 2011

Fluid Automation: Unsung Contributor to Plant Economic Performance — New Management Brief from ASCO Numatics

FLORHAM PARK, N.J. — Sept. 26, 2011 — While fluid automation products — valves, pneumatics actuators, and similar components — control the flow of a process liquid or a supply of compressed air, they can also help control the flow of profits, according to a new management brief from ASCO Numatics.  Titled “Fluid Automation: The Unsung Contributor to Plant Economic Performance,” the brief is available for download at http://goo.gl/9MMkH.

The speed and reliability of fluid control products can provide competitive economic advantages in industrial operations worldwide. This is due to their ability to extend overall equipment service life, reduce warranty costs, cut maintenance/repair/operations (MRO) inventories, and increase production uptime and productivity.

But the choice of fluid automation technology is critical. For end users, judicious selection of fluid automation components must play a key role in their performance improvement plans. For original equipment manufacturers (OEMs), the right fluid automation choices provide significant cost, time-to-market, and product competitive advantages.

The new management brief examines available solutions and discusses how they  have maximized both speed and reliability — and provided surprisingly strong contributions to the economic performance of industrial operations.

The contents of the brief include:

  • Changing the Rhythm
  • Feeding the Bottom Line
  • The Benefits of Reliability
  • The Power of Speeds
  • Advantages for the OEM
  • Advances for the End User

Download the new management brief, “Fluid Automation: The Unsung Contributor to Plant Economic Performance,” from http://goo.gl/9MMkH.

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

About ASCO Numatics

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

About Emerson

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

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

 

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Posted in Manufacturing, Technology |


Tuesday, July 13th, 2010

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

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

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

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

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

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

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

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

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

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

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

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

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Posted in Biosciences, Health/Medical, Manufacturing |


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.

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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 |


Tuesday, June 3rd, 2008

Microtest Labs Doubles Microbial Identification, Analytical Services

AGAWAM, MASS. – June 3, 2008 – Microtest Laboratories (http://www.microtestlabs.com/) has doubled their microbial identification and analytical services with the purchase of an additional MicroSeq® Microbial Identification System.

The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified.

“With the purchase of our second MicroSeq system, we are not only complimenting our existing unit but doubling our analytical capacity and ability to service our clients,” stated Dr. Steven Richter, Microtest President and Chief Scientific Officer. “As one of the only testing labs in the area with this technology, we are providing our customers with a significant competitive advantage.”

Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. Traditional bacteria and mold identification lab tests are often less accurate, and require up to a one-week turn around time.

“In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” stated Dr. Richter. “Our ability to provide rapid identification helps our customers minimize down-time, which directly affects their bottom-line. When manufacturing is halted or a cleanroom is shut-down and awaiting test results, there is no product going out the door and that translates to an interruption in sales.”

The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in:

  • Contract Manufacturing
  • Pharmaceutical Testing & Validation
  • Medical Device Testing & Validation
  • Environmental Control and Testing
  • Water Validation
  • Mold Identification
  • Biologics/Virology

The MicroSeq systems are 99% reliable with repeatable results, and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications. Made by the Applera Corporation, the MicroSeq Microbial Identification System is the most accurate and rapid bacterial identification system available today.

For more information about Microtest’s analytical testing and related services, visit contact the Microtest on the Web at: www.microtestlabs.com/medical-device-testing or by phone 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.

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Posted in Biosciences |


Monday, December 11th, 2006

Microtest Enhances Analytical Lab Services with Addition of Advanced Microbial Identification System

AGAWAM, MASS. – December 11, 2006 – Microtest has dramatically enhanced their analytical lab services with the installation of a new, advanced technology, MicroSeqR Microbial Identification System. The MicroSeq is a state-of-the-art DNA sequence-based system that enables Microtest technicians to more quickly and accurately identify bacteria isolates that are not viable or easily identified.

Using the MicroSeq system, Microtest technicians can provide precise and reliable bacteria, mycoplasma, and mold identification in a 24-hour time period. As one of the only testing labs in the area with this technology, Microtest is providing their customers with a significant competitive advantage. Traditional bacteria and mold identification lab tests are often less accurate, and require up to a one-week turn around time.

“In the highly competitive biotechnology industry, accuracy and speed cannot be compromised,” stated Dr. Steven Richter, Microtest President. “Our new MicroSeq system enables our specialists to provide customers with consistent and rapid results that, unlike previous equipment, ensures that the issues and concerns that prompted our clients to undertake their testing are properly analyzed and resolved, thus putting their production back on track.”

“Our ability to provide rapid identification helps our customers minimize down-time, which directly affects their bottom-line. When manufacturing is halted or a cleanroom is shut-down and awaiting test results, there is no product going out the door and that translates to an interruption in sales,” said Dr. Richter.

The MicroSeq system is integrated for use across the spectrum of services that Microtest provides. Customers that will benefit most are those that utilize their analytical testing services in:

  • Contract Manufacturing
  • Pharmaceutical Testing & Validation
  • Medical Device Testing & Validation
  • Environmental Control and Testing
  • Water Validation
  • Mold Identification
  • Biologics/Virology

The new MicroSeq system is 99% reliable with repeatable results, and is especially beneficial for companies with pharmaceutical and medical device manufacturing applications. Made by the Applera Corporation, the MicroSeq Microbial Identification System is the most accurate and rapid bacterial identification system available today.For more information about Microtest’s analytical testing and related services, contact Dennis Champagne, Director of Lab Services, at 1-800-631-1680 or email dchampagne@microtestlabs.com, or visit Microtest on the Net at: www.microtestlabs.com.

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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Posted in Biosciences |


Tuesday, November 14th, 2006

Microtest Offers New, Free White Paper: ‘Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistake’

AGAWAM, Mass., Nov. 14 — Microtest has announced the availability of a new, free white paper titled: “Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistake.”

Selecting and establishing an effective working relationship with an Aseptic Fill/Finish contract manufacturer can be a challenging task. The ramifications of making a poor decision can result in schedule delays, regulatory approval issues, and lost revenue.

In this new white paper, in addition to providing guidance on the selection process, John Dobiecki, Vice President/General Manager, Microtest, reviews the common mistakes made by potential clients.

These common oversights and their remedies are sourced from his collective experience base that covers contract aseptic fill/finish and bulk drug manufacturing.

Download the white paper, free of charge at: http://www.microtestlabs.com/asepticpaper.

Microtest offers fill/finish contract manufacturing services, integrated with stability and testing services, that lower costs, improve quality, and compress time-to-revenue for pharmaceutical manufacturers.

With 15 years of experience in medical device testing, Microtest is a single-source manufacturing solution.

Microtest is based in Agawam, Massachusetts, USA. 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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Posted in Biosciences, Manufacturing |


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