Facility Design and Engineering

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

Consider the purity of exhaust air emitted by vacuum pumps in addition to the purity of compressed air used in the pharmaceutical process.

Datwyler is channelling more than CHF 100 million into building a new plant in the US state of Delaware, which will be used to manufacture elastomer components for injectable drug-delivery systems.

BASF announced that steamcrackers are slowly being restarted at the company’s plant in Ludwigshafen.

Oxford Genetics increased its laboratory space to 5700 sq. ft. with a move to a new location at Oxford Science Park.

A €15-million investment will be made over 2014-2016 in a biotech facility located in Tres Cantos, Spain

The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

Renovating a facility requires careful design and a plan to minimize production interruption.

Industry experts discuss recent trends in modular manufacturing.

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Different types of modular systems have advantages and disadvantages.

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.

This article examines the changes now taking place, and what the future might bring.

EMD Serono, the North American biopharmaceutical business of Germany’s Merck KGaA, will expand its R&D facility in Massachusetts, US.

GE Healthcare Life Sciences has expanded production capabilities at its Pasching, Austria facility for sterile liquids.

The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.

A strengths, weaknesses, opportunities, and threats analysis.

The company broke ground on a $79 million production facility at its Ravensburg Schuetzenstrasse site.

The module was installed in the company’s Watson laboratory information management system in Poitiers, France.

The inspection confirmed that the facility was compliant with GMP guidelines.

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

Choosing the right facility size requires tailoring the design for current needs as well as anticipating the future.

Q&A with David A. Steil, pharmaceutical market manager, Camfil Air Pollution ControlPharmTech: Recently there has been an emphasis on green and sustainable technology in the pharmaceutical/biopharmaceutical industries. In what ways does Camfil APC’s technology contribute to sustainability?

LabConnect built a biorepository facility in Tennessee.

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

Pharma companies reduce the impact of manufacturing on the environment with innovations in energy and waste treatment.

FuelCell Energy plans to install a 5.6 megawatt fuel cell power generation system for Pfizer to provide reliable and low carbon electricity and steam for its 160-acre R&D facility in Groton, CT.