Cleanroom Design Build Articles

Annex 1 and First Air: Critical Considerations for Cleanroom Design and Compliance

The implementation of EU GMP Annex 1 marks a transformative shift for the sterile filling industry. With new requirements emphasizing barrier technology and “first air” contamination control, pharmaceutical manufacturers face critical decisions in adapting their processes. Johannes Rauschnabel of Syntegon explores how equipment suppliers can play a pivotal role in facilitating compliance and seamless integration of these advanced standards.

UL Solutions to Develop Battery Testing Laboratory in Auburn Hills, Michigan

UL Solutions, a global leader in applied safety science, announced today that it plans to open a new battery testing laboratory in Auburn Hills, Michigan, in mid-2024

KMM Group, Ltd. in Final Stage of 100,000 Sq Ft Manufacturing Facility Construction

KMM Group has announced the final construction phase for its new state-of-the-art manufacturing facility in Hatboro, PA.

Celerion Expands Early Phase Clinical Pharmacology Units

Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced completion of additions to its research capacity and services

Annex 1 and First Air: Critical Considerations for Cleanroom Design and Compliance

UL Solutions to Develop Battery Testing Laboratory in Auburn Hills, Michigan

UL Solutions, a global leader in applied safety science, announced today that it plans to open a new battery testing laboratory in Auburn Hills, Michigan, in mid-2024

KMM Group, Ltd. in Final Stage of 100,000 Sq Ft Manufacturing Facility Construction

KMM Group has announced the final construction phase for its new state-of-the-art manufacturing facility in Hatboro, PA.

Controlled Environment Systems Acquires Western Environmental Corporation

Controlled Environment Systems, LLC, a market leader in thermal construction and design of special environments, such as cold storage facilities and pharmaceutical / biotech cleanrooms, today announced its acquisition of Western Environmental Corporation (WEC), a company that designs, engineers, installs and certifies cleanrooms, coordinate measuring machine (CMM) enclosures, metrology labs, and environmental chambers that support various mission critical applications.

Bosch reaches milestone on the way to opening new wafer fab in Dresden

It is a milestone on the path to the chip factory of the future: at the new Bosch semiconductor fab in Dresden, silicon wafers are passing through the fully automated fabrication process for the first time. This is a key step toward the start of production operations, which is scheduled for late 2021. Manufacturing of automotive microchips will be a primary focus when the fully digital and highly connected semiconductor plant is up and running. “Chips for tomorrow’s mobility solutions and greater safety on our roads will soon be produced in Dresden. We plan to open our chip factory of the future before the year is out,” says Harald Kroeger, member of the board of management of Robert Bosch GmbH. The company already operates a semiconductor fab in Reutlingen near Stuttgart. The new wafer fab in Dresden is Bosch’s response to the surging number of areas of application for semiconductors, as well as a renewed demonstration of its commitment to Germany as a high-tech location. Bosch is investing around one billion euros in the high-tech manufacturing facility, which will be one of the most advanced wafer fabs in the world. Funding for the new building is being provided by the federal German government, and more specifically the Federal Ministry for Economic Affairs and Energy. Bosch plans to officially open its wafer fab in June 2021.

Matica Biotechnology, Inc. Announces Groundbreaking for New GMP Facility

Matica Biotechnology, Inc. (Matica Bio), a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, ceremonially broke ground today on its new 25,000 ft2 facility which will house its GMP virus production suites, development laboratories and company offices. The new building will be located in Providence Park at 2501 Earl Rudder Freeway in College Station.

SkyWater Announces MOU to Provide Domestic Advanced Packaging Capabilities as Reshoring Momentum Builds for Semiconductor Supply Chain

SkyWater Technology, the trusted technology realization partner, today announced it has entered into an exclusive, non-binding Memorandum of Understanding (MOU) with Osceola County, Florida to explore taking over the lease of the Center for Neovation, a state-of-the-art 200 mm semiconductor manufacturing facility, by forming a new public-private partnership for microelectronics manufacturing and advanced packaging capabilities. Following the MOU, SkyWater, the only U.S

Sorrel Medical Opens New Manufacturing Cleanroom Facility

Sorrel Medical, a developer and manufacturer of wearable drug delivery devices, today announced the opening of a new manufacturing facility with state-of-the-art cleanroom facilities to accommodate manufacturing scalability of its wearable drug delivery devices.

Grand River Aseptic Manufacturing Opens Large-Scale Injectable Fill/Finish Facility, Significantly Increasing Capacity

Grand River Aseptic Manufacturing (“GRAM”), an agile and modern parenteral contract development and manufacturing organization (CDMO), completed its major $60 million expansion project and recently took occupancy.

Manufacturers Join Together for Coronavirus Emergency Building Response

Together these five companies have put together complex build solutions in response to the coronavirus. Individually they were the best for being the fastest of their building type, together they provide the complete solution within weeks, regardless of the requirements. RPM acts as the quarterback pulling in a team of top North American manufacturers with the specific purpose of delivering rapid deployment Community Response Facilities (CRF) that are designed to meet each community’s critical needs. If the location requires conversion of an existing structure, a large building shell that goes up quickly, or mobile secure steel buildings, together we have it covered.

Biocontainment Unit Delivered for COVID-19 Vaccine Development

Germfree delivered a 53-foot biocontainment cleanroom trailer to a major US pharmaceutical company where they will work on a COVID-19 vaccine. This is the first, of what is expected to be, many mobile laboratory spaces that will be delivered to scientists and organizations working on virus and antibody testing, vaccine development, research, and deployment solutions.

Medivant Health builds generic drug production facility in Chandler

Medivant Health is currently building a 33,000-square-foot generic drug manufacturing facility in Chandler, Arizona. The first phase will create 10,000 square feet of manufacturing and laboratory space able to produce 40,000 vials of generic drug products every day. Medivant is a new Current Good Manufacturing Practice (CGMP) Manufacturer. Medivant is unique in that its sole purpose is to fill this generic drug shortage void. The facility is fully automated with minimal human intervention.

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