Manufacturing

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

Articles

Decontamination, automation, and containment are important considerations
for aseptic manufacturing in isolators.


Understanding the Impact of Annex 1 on Isolator Operation

The expanded agreement will include aseptic fill/finish services at its San Diego, CA facility.

Aji Bio-Pharma Expands Agreement with AstraZeneca to Include Drug Product Manufacturing

Anne Marie Dixon-Heathman  is the owner and president of Cleanroom Management Associates, Inc.

Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garment life cycle. 


A Real-World Approach to Evaluating Cleanroom Garments

The GENiSYS R from AST (pictured) is a modular system that automates aseptic filling and the closing of vials, syringes, and cartridges.

Robotic Modular System for Small Batch Filling

Feliza Mirasol is the science editor for 

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Meeting Fill/Finish Challenges for COVID-19 Vaccines

The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.

LSNE Adds New Aseptic Fill Line to New Hampshire Facility

Consider a matrix of factors when choosing what type of cleanroom facility to construct.

Choosing a Cleanroom Infrastructure Technology

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

Thermo Fisher Scientific Expands Sterile Drug Product Development and Commercial Manufacturing

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

A holistic approach to validation and quality assurance is essential.

Prepping Fill/Finish Systems to Ensure Quality Output 

An optimal engineering design is crucial for aseptic operation and cleaning.

Aseptic/Sterile Processing