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

Posts Tagged ‘clean room testing’


Wednesday, May 30th, 2012

Clean Room Environmental Best Practices for Medical Device & Pharmaceutical Manufacturers are Focus of Boston Seminar on June 6

AGAWAM, MASS. – May 30, 2012 – Sterile manufacturing environments at medical device and pharmaceutical companies require effective cleaning and disinfection programs to maintain aseptic conditions and prevent microbial contamination. To help, laboratory testing experts will present “Clean Room Environmental Best Practices,” a special seminar in Boston on Wednesday, June 6, 2012.

The seminar is designed for all professionals responsible for building, validating, and maintaining controlled environments in the medical device and pharmaceutical industries. The program will include technical presentations on:

• Best practices for qualifying and maintaining clean room facilities

• “The people factor” in terms of containment control

• Qualifying and evaluating clean room disinfectants

• Difficult challenges: Practical advice and solutions

Opportunities for questions and continuing interaction will be encouraged.

Clean Room Environmental Best Practices” is scheduled for 10 a.m. to 2 p.m. on Wednesday, June 6, 2012, at the MIT Endicott House, 80 Haven Street, Dedham, Massachusetts — located just minutes from Boston. The cost is $149. Breakfast, lunch, and networking opportunities are included.

The seminar is sponsored by Microtest Laboratories, 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.

For more information, contact Julie Adamski, toll-free, at 1-800-631-1680, ext. 192, or jadamski@microtestlabs.com.

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.


Wednesday, September 21st, 2011

Building, Validating & Maintaining Controlled Environment Facilities is Focus of Oct. 18th Seminar in Boston Hosted by Microtest Laboratories

AGAWAM, Mass. — Building, validating, and maintaining a controlled environment facility is the subject of a daylong seminar on Oct. 18, 2011, hosted by Microtest Laboratories at the MIT Endicott House in Dedham, Massachusetts.

Titled “Keeping It Clean? The Building Blocks of Facility Control,” the seminar will focus on the clean room testing, disinfection validation, and related contamination testing issues that arise from manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

In each seminar program, industry experts will present practice advice and sound solutions in an interactive format that will encourage a high level of engagement by participants for questions, answers and discussion. The topics will include:

  • Killing The Bugs Without Killing Yourself: Disinfectant Qualifications
  • Feeling Like A Fish Out of WFI?: Water System Validation and Maintenance
  • Got A Lot On Your Plate: Clean-room Validations and Maintenance
  • The Old In & Out: Considerations On Insourcing vs. Outsourcing

Keeping It Clean? The Building Blocks of Facility Control” will be presented 8:30 a.m. to 3:30 p.m. on Tuesday, Oct. 18, 2011, at the MIT Endicott House, 80 Haven Street in Dedham, Mass., just outside of Boston. Registration and a complimentary continental breakfast is at 8 a.m. Lunch will be served at Noon. The cost is $149 per person and includes meals, refreshments, and workshop handouts.

To register or for more information, contact Julie Adamski at 413-786-1680, toll-free at 1-800-631-1680, or at jadamski@microtestlabs.com.

About Microtest Laboratories

Microtest Laboratories is a leader in controlled environment facility testing, laboratory testing, and contract manufacturing services 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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Press contact: Don Goncalves, Tiziani Whitmyre, 1-781-793-9380, dgoncalves@tizinc.com

 


Monday, September 21st, 2009

New White Paper: “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers” – From Microtest Laboratories

microtest-logo1

AGAWAM, MASS. – September 21, 2009 Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget.

In attempting to meet regulatory demands from sources such as the U.S. FDA and the European Pharmacopoeia, the greatest challenge for medical device and pharmaceutical manufacturers may be determining what exactly is required for compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs?

Unfortunately, there is no single reference document that U.S. manufacturers may rely upon to help them design, validate, and demonstrate room class compliance. Nor, given the monumental scope of the task, is it likely that one will be drafted anytime soon.

A new white paper, titled Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” and available for free download at www.microtestlabs.com/environmentpaper, may help.

The white paper reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. Topics include: What Is Required; Viable vs. Nonviable Particulates; Sampling Plans; Validation Management; Sterilization Programs; Cost/Product Savings; Critical Factors; and The Benefits of Experience. The paper also discusses how these challenges may be met with the assistance of an update-to-date testing laboratory.

The author of the white paper is Steven Wieczorek, Supervisor, Environmental Sciences. He leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services.

Download the white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” from www.microtestlabs.com/environmentpaper.

About Microtest

Microtest Laboratories offers reliable, accurate programs for testing of product bioburdens; viable aerobic, anaerobic, or fungal microorganisms; and nonviable air particulates. The company’s expertise at characterizing, controlling, and understanding environmental bioburden levels and trends are the cornerstones to defining and implementing a solid Environmental monitoring program which fully supports sterilization validation and release activities. Microtest is based in Agawam, Massachusetts, USA. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or 1-800-631-1680.

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


Wednesday, April 22nd, 2009

Microtest Labs Expands Clean Room, Contamination Testing Services

AGAWAM, MASS. – April 22, 2009Microtest Laboratories (http://www.microtestlabs.com/) has added new technology and professional staffing to expand its position as a proven, one-stop provider of contamination and clean room testing services for manufacturers of medical devices or pharmaceuticals.

Microtest helps manufacturers maintain control of their controlled environment to ensure regulatory compliance as well as to achieve greater productivity. Microtest assists manufacturers to identify, assess and resolve a wide range of clean room and environmental contamination problems while ensuring little or no process disruption or downtime.

Microtest’s environmental services group is comprised of highly trained microbiologists with extensive experience applying modern testing technologies in all varieties of clean room and other controlled environments. Their work meets or exceeds applicable clean room testing requirements for regulatory regimes including the International Organization for Standardization (ISO), the European Union (EU) Annex, and the U.S. Food and Drug Administration (FDA).

Microtest offers the following testing and support services:

    • ISO certification and clean room validation, to any ISO Class required, for all controlled environments, including clean rooms, laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and fume hoods.

 

  • HEPA filter repair, replacement, and installation for all controlled environments including clean rooms, laminar flow hoods, biological safety cabinets , compounding aseptic isolators, and fume hoods.

 

 

  • Viable sampling, including evaluating for contamination of aerobic and anaerobic microorganisms, surface testing and analysis, active air sampling, and collecting passive air samples. In-house MicroSeq® DNA-sequence-based analyzers provide results as fast as 24 hours to speed isolation and elimination of the source.

 

 

 

 

  • Disinfection validation, including dilution testing, phenol coefficient testing, sporicidal testing, and germicidal testing.

 

 

 

 

  • Compressed air/gas testing, including nonviable air particulate testing; compressed air testing for aerobic, anaerobic, and fungal organisms; and testing for hydrocarbons and water vapors.

 

For more information about Microtest Laboratories’ complete offering of contamination and clean room testing services for manufacturers of medical devices or pharmaceuticals, visit Microtest at BIOMEDevice in Boston, April 22-23, 2009 at booth no. 1023. Or, visit the Microtest website http://www.microtestlabs.com/, or call 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 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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