Facility Design and Engineering

Gowning practices embody cGMPs and can be a tool to evaluate cGMP compliance.

What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär

The authors describe how modular systems can be applied to continuous solid-dosage and nutraceutical manufacturing.

Walker Barrier Systems builds eight mobile clean rooms for the Texas A&M Center for Innovation in Advanced Development and Manufacturing.

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

GE Healthcare Life Sciences announced that it will build a KUBio modular biopharmaceutical factory in China for JHL Biotech.

FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.

Mylan completes expansion of its transdermal patch facility in Vermont.

Parameter Stability Storage adds validated space in anticipation of pending contracts.

Aseptic connectors provide the flexibility and robustness needed for modern parenteral manufacturing operations.

The growing demand for targeted biopharmaceutical therapies is driving interest in modular production facilities that can be rapidly constructed while still minimizing risk and cost.

Pharmaceutical Technology spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.

A control strategy can maintain a low level of particulates, and thereby a low bioburden, in cleanrooms

VAI?s Sterile Cleanroom Wipers use innovative manufacturing technologies and a single source, dedicated supply chain allows for traceablility.

A Q&A with Michael Lacey of the National Institute for Bioprocessing Research and Training

Craig Sandstrom, director of process engineering at Fluor discusses his presentation Modularization overview and implementation strategies, which will be part of a panel discussion, ?Getting Excited about the Modular Experience? at Interphex 2013

Pär Almhem, President of ModWave and ModularPartners discusses modularization and his upcoming presentation at Interphex

A Q&A with Michael Lacey, plant manager at the National Institute for Bioprocessing Research and Training.

In the era of manufacturing capacity rationalizaton, tighter return on assets, and re-alignment of manufacturing assets to meet changing product demand, strategies for cost-effectively managing manufacturing and other facilities become ever-more crucial. A Q&A with UMS Advisory.

An efficient cleaning cycle begins with equipment and automation-system design.

The authors highlight costs, benefits, and implementation success factors across first, second, and third generations of facility management outsourcing contracts.

Modular factory concepts, which take flexible manufacturing to the next level, are beginning to take hold in the biopharmaceutical industry.

PTE quizzes Jaime Cassar, cleanroom category manager at Kimberly-Clark Professional Europe, about the importance of sterile garments for cleanroom environments.

A modular cleanroom construction is typically a freestanding, solid and robust structure that is suitable for use within an existing cleanroom, laboratory, manufacturing area or warehouse.

The fifth in a series of eight case studies from the Product Quality Research Institute focuses on nonsterile facility cleaning requirements.

A concentrated course providing the attendee an opportunity to get and keep right up to date with essential standards and best practice for cleanrooms intended for life sciences applications.

One of the biggest challenges in designing cleanroom doors for the pharmaceutical industry is in creating a sturdy door with a high hygienic performance that is light and easy to clean.

Modular cleanrooms are a flexible and adaptable solution that come on the back of a lorry and offer numerous benefits.

When it comes to monitoring the cleanroom, too much emphasis is often directed at the annual check, but ongoing monitoring is also crucial.

Contract Manufacturing Organisations offering manufacturing capabilities to suit specific industry sectors, niche segments or perhaps simply to meet the demands of individual clients? processes face a greater challenge when designing their facilities and cleanrooms when compared with an originator company or a single-product manufacturing facility.