IEST Space Simulation Conference Project Case Study Presentation - from Concept to Completion

October 20-23, 2008--Annapolis, Maryland--Mr. Mackler presented a paper on a recent design / build cleanroom project that provides precision cleaning and packaging of optics and aerospace hardware to meet critical cleanliness requirements. This new facility is equipped with modern precision cleaning equipment including advanced process analytical technology and the project was commissioned after outsourcing solutions were investigated and found lacking in ability to meet quality specifications and schedule needs. Materials that can be processed include optics, composites, metals and various high performance coatings. Process analytical verification is performed routinely and the data generated is used to validate that particulate and molecular cleanliness requirements have been satisfied for sell-off. The new facility footprint is approximately half the size of a former operation and provides double the throughput.

The Space Simulation Conference is a major international forum in space hardware environmental testing for R&D and qualification. The conference provides a unique opportunity for engineers, technicians, and scientists from industry, government, and academia to present and exchange information and ideas on simulating the space environment to develop and test space mission hardware. The Space Simulation Conference is hosted by the Institute of Environmental Sciences and Technology (IEST) and co-sponsored by NASA, AIAA, ASTM, Canadian Space Agency (CSA), and Johns Hopkins University Applied Physics Laboratory (JHUAPL).

Clean & Controlled Environments 2006 Announces Advisory Board

AMHERST, N.H.--(BUSINESS WIRE)--Nov. 3, 2005--Controlled Environments Magazine and the Nano Science & Technology Institute have named several industry leaders to the advisory board for the Clean and Controlled Environments 2006 conference and exposition. Advisory Board members include:
-- Adam Giandomenico, President, Lighthouse Worldwide Solutions

-- Scott Mackler, Principal Consultant, Cleanroom Consulting, LLC

-- Conor Murray, Ardmac, Ltd. And Chairman -- Irish Cleanroom Society

-- Raymond K. Schneider, P.E., Consultant and Faculty Member, Department of Construction Science and Management, Clemson University

-- Dr. Howard Siegerman, Director of Technology, ITW Texwipe

-- Art Vellutato, Jr., Vice President of Technical Operations, Veltek Associates, Inc.

The advisory board will provide guidance in event and program development as well as speaker selection for the upcoming conference. Clean and Controlled Environments 2006 will be held in Boston, MA on May 8 - 9, 2006.

Clean and Controlled Environments 2006 is sponsored by Nano Science and Technology Institute (NSTI) and Controlled Environments Magazine, a Vicon publication. The conference and exposition will run concurrently with NSTI's Nanotech 2006, the largest U.S. event covering small technology (nano and micro scale particles). The combined events are expected to attract more than 3,000 industrial, academic, and governmental attendees, as well as hundreds of exhibitors.

"We are very pleased to be able to tap the experience of these industry luminaries," said Bart Romanowicz, Executive Director -- Technology Development for NSTI. "Their participation will assist us in delivering the most timely and effective information on contamination control trends, technologies, products, and services."

"As members of Controlled Environments Magazine's editorial advisory board and now the events board, these gentlemen have generously shared their depth of knowledge and time to this important event," added Paul Nesdore, Chief Editor of Controlled Environments Magazine. "Their willingness to provide insight and guidance has been vital to the success of our publication, and I look forward to working with them on this event as well."

New Cleanroom Projects successfully delivered on-time, on budget!

Rochester, NY, 23 October, 2005--Cleanroom Consulting is pleased to announce the completion of several thousand square feet of new Class 100, Class 1000, Class 10,000 and Class 100,000 facilities while serving as owner representative for a leading Fortune 100 high technology company.

This highly successful assignment included programming & development of process functional flows and user requirements (process support services, air changes, pressure cascade regimes, particulate settle-out, airborne molecular contamination, electrostatic discharge, etc.), design of project delivery strategies, identification and qualification of engineering firms, contractors, and specialized cleanroom service providers (unidirectional flow systems, critical cleaning, etc.), overall technical management of the system and detailed design including hardware and materials of construction selection, fabrication, installation, testing (FAT & SAT), balancing, commissioning and certification of the project, and the provision of operational protocols and training for the post-acceptance phase of the project.

CLEANROOM CONSULTING completes cGMP CLEANROOM Basis of Design for FDA Clinical Trials Facility

Syracuse, NY, 5 July, 2003 – Cleanroom Consulting, LLC, (Syracuse, NY) provided the conceptual (Basis of Design) engineering package for a recently completed and commissioned clinical trials facility which meets FDA cGMP’s for human drug production.

The facility was designed to test and certify as Class 10,000 operational (ISO Grade 7, M5.5) and the cleanroom suites were retrofitted into an existing light industrial building space that had formerly housed a commercial business. The new cleanroom consists of several fully populated suites with dedicated airlock/gown-up entry rooms, and completely separate and isolated HVAC systems - providing independent control of each processing suite with no cross-contamination.

Cleanroom Consulting also recently completed a detailed cGMP design review for a new FDA validatable cleanroom project. The cGMP design review included the aseptic processing, viral inactivation and related functional flows for an engineered mammalian tissue derived implantable medical device. Tissue engineering is an emerging, multi-billion-dollar field that is part of both the medical device industry and the biotech industry. Tissue engineering treats medical conditions by implantation of biologically active constructs that create the required environment for recovery and restoration of functional tissue. Tissue engineering products have applications in restoring the function of damaged tissues such as skin, bones, cartilage, abdominal wall, arteries, nerves etc.

Clean Manufacturing Projects Completed

CLEANROOM CONSULTING completes refurbishment of O2 cleaning facility and site assessment / revamp of high purity filtration production lines

December, 2001 – Cleanroom Consulting, LLC, (Syracuse, NY) recently completed projects to place into operation an idle O2 parts cleaning facility and to upgrade the operations of a high purity filtration manufacturing, packaging, and testing facility. Critical milestones achieved included the re-commissioning of both facilities, initiation of preventive maintenance programs, testing, balancing, certification, and cleaning of the existing cleanrooms, as well as preparation of SOP’s for cleanroom operation, housekeeping, and gowning, and revision and updating of specifications for precision (aerospace) cleaning. The cleanroom process equipment was all refurbished back to "like new" condition and new hardware was specified and procured for new production quality control lab operations.

Training in cleanroom environmental monitoring, contamination control, and cleanroom cleaning was provided along with base-line assessments, preparation of short-term and long-term action plans, and programming was initiated for on-going evaluation and tracking of contamination control action plan achievements vs. goals.

For additional information, contact:
Scott E. Mackler
Principal
Cleanroom Consulting, LLC
e-mail: sem @ cleanroom-consulting.com