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  1. APIs: Bioreactor hoists with a multipurpose twist Peter Devenny of PalPharma describes the solution for a biotech facility in Switzerland designed to handle filled bioreactors across GMP areas to produce ten metric tons of...
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    President Trump signs order for “regulatory relief” for domestic pharmaceutical manufacturers The US President has signed an executive order to direct the FDA to review current regulatory procedures, such as by reducing inspection frequency
  3. Validex: A comprehensive data package for disinfectant efficacy evaluation David Collins, Principal Global Technical Consultant at Ecolab Life Sciences, shares Ecolab's Validex programme, which provides a standardised method for validating...
  4. Dec Group opens new Mumbai office and makes Singapore partnership The cleanroom containment expert has opened a new office with its Bectochem joint venture, and has made a partnership with Singapore-based Pharmedley
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    Integrity testing of HEPA filters: A practical approach Filtering the air in aseptic process areas is critical to maintaining the cleanliness of the production environment. Jesus Casas provides tips to ensure HEPA filters are fit...

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Pharmaceutical

AST celebrates 60 years of excellence in innovation and looks to the future of drug product manufacturing

This milestone celebration sets the stage for AST’s next phase of strategic growth, anchored by its revitalised mission, vision, and purpose statements
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AST welcomes Jason Rossi as Principal CQV Engineer

Rossi brings over 29 years of expertise and leadership in aseptic fill-finish and in the design, construction, commissioning, and qualification of pharmaceutical manufacturing systems and facilities
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AST brings new ATMP fill-finish production line to INTERPHEX 2025

AST to introduce its fully automatic isolated GENiSYS C in addition to new glove testing and digital twin solutions during the premier global pharmaceutical event at Javits Center, NYC
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HVAC

Annex 1 and “first air”: What is it and how is it used?

First Air as a concept is a major update in the new Annex 1 to continue global harmonisation of regulatory standards, but what is it and how is it used in the new document to improve clarity and compliance? Josh Russell, VP of Sales and Marketing at AST discusses
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Big automation, targeted application: advanced aseptic solutions for a smaller footprint

With advanced automated technology more available, the pharmaceutical industry is approaching the drug development lifecycle more holistically, as automated and data solutions address key operational friction points in areas like project scaling, validation, and technology transfer
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The AST Peristaltic Pump: shear ingenuity

AST’s approach uses pre-sterilized single-use fluid paths that can easily be installed in the pump in an isolated setting through the glove port, ensuring sterility and that the pump remains non-product contacting
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AST places next generation of flexible, isolated fill-finish system at Ascend Alachua Facility for advanced Adeno-Associated Viral Vector (AAV) production

AST, a leading provider of flexible aseptic filling systems, has announced the placement of a next-generation GENiSYS C fill-finish system at the Ascend Advanced Therapies (Ascend) Alachua, FL facility
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