Manufacturing

Articles

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines. 


EU and Japan Strengthen Collaboration on GMP Inspection

Christian Dunne is Aseptic global product manager at ChargePoint.

The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including 
isolators, restricted access barrier systems, and split butterfly valve technology.


Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

Robotics Solve Aseptic Filling Challenges

Flow imaging microscopy can be used to identify particulates and their sources.

Identifying Contamination: Subvisible Particle Imaging

Josh Eaton is senior project manager for Scientific and Regulatory Affairs at the Parenteral Drug Association, eaton@pda.org

PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.

Industry Perspectives and Practices on PUPSIT

Rommelag will showcase its blow-fill-seal technology that collectively offers container production, aseptic filling, and container closure.

Rommelag Showcases Blow-Fill-Seal Technology at Achema 2018

Optima will also display the freeze dryer CS and the sterility test isolator STISO at the show.

Optima Presents Solutions for Small Batches and Flexible Filling at Achema 2018

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines. 

FUJIFILM Adds Late-Phase and Commercial Fill/Finish Capabilities

Pharmaceutical machine concepts for large and small factories of the future need to be readily available, flexible when it comes to processing variation, and modular in design. 

Groninger Presents Machine Range for Large and Small Factories at Achema 2018

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Innovations in fill/finish equipment and in solid-dosage moisture-control packaging technologies were on display at INTERPHEX 2018.  

Aseptic/Sterile Processing