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Boston Seminar to Assist Medical Device & Pharmaceutical Manufacturers with Environmental Monitoring, Risk-Assessment
Microtest Laboratories will present an environmental monitoring seminar and risk-assessment
workshop to assist medical device and pharmaceutical manufacturers with building,
validating, and maintaining their clean rooms and sterile manufacturing environments.
The event will be held at the MIT Endicott House in Dedham, Mass.
— just outside Boston — on Wednesday, October 24, 2012, from 10 a.m. to 2 p.m.
At the event, attendees will:
- Participate
in a hands-on workshop that focuses on risk assessment in the clean room
- Discover
the best practices for qualifying and maintaining a clean room facility
- Identify
and assess the risks commonly found in a clean room environment
- Test the
information they've learned in a mock clean room floor plan exercise
A networking reception, and lunch, is
included. For more information, or to RSVP, contact Julie Adamski at Microtest
Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com.
Registration for the event 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. 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.
# # #
Labels: Boston, clean room, cleanroom, Controlled Environments, disinfection, environmental monitoring, environments, manufacturers, medical device, pharmaceutical, risk-assessment, sterile manufacturing, validation
Environmental Monitoring and Certification in Controlled Environments - New White Paper
AGAWAM, MASS. – August 10, 2011 – 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. But a new, free white paper titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” available for free download at http://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 white paper is authored by Steven Wieczorek, Supervisor, Environmental Sciences, who leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services based in Agawam, Mass. Download the new, free white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” at http://www.microtestlabs.com/environmentpaper. 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. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs. # # # Press Contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com Labels: Controlled Environments, environmental certification, environmental monitoring, manufacturers, manufacturing, medical device, Microbial Control, pharmaceutical, regulations
New, Free White Paper: “Environmental Monitoring and Certification in Controlled Environments
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| AGAWAM, MASS. – April 21, 2010 – 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. But a new, free white paper titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” 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 white paper is authored by Steven Wieczorek, Supervisor, Environmental Sciences, who leads the Environmental testing, monitoring, and certification groups at Microtest Laboratories, a leading provider of regulatory microbiology and contract laboratory services based in Agawam, Mass. Download the new, free white paper, “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers,” at www.microtestlabs.com/environmentpaper. Or, for more information, visit Microtest Laboratories at BIOMEDevice, booth #1025, April 21-22, 2010 in Boston. Follow Microtest Labs on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs. 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, a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries, 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. | Labels: Controlled Environments, environmental monitoring, environmental testing, medical device manufacturers, Microbial Control, Pharmaceutical Manufacturers, regulations, white paper
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