Aseptic/Sterile Processing

Recent technological advancements may have put cleanroom monitoring into a state of flux.

BFS technology can help maintain sterility during the biologics manufacturing process.

Various advances in contamination control are being utilized to reduce the chance pollutants contaminate a drug product.

Boehringer Ingelheim will use Virtuosi to train employees at three aseptic sites across its network.

Cleanroom monitoring may be in a state of flux after many recent technological advancements.

Pharmaceutical Technology editors interview aseptic and sterilization experts from Watson-Marlow Fluid Technology Solutions and Cherwell—diving into sterilization, aseptic processing, and the revised EU GMP Annex 1 guidance.

Validair Diamond Scientific has installed a new cleanroom for in-house testing, research, and training.

Point-of-use manufacturing may lead to a big change in the accessibility of medicines globally.

Industry experts discuss the need for stricter environmental controls, whether to incorporate single-use technologies, and areas for improved automation.

PCI Pharma Services is investing $100 million in manufacturing capabilities and capacity expansion to its Bedford, NH facility.

It is vital to consider optimal cleaning and disinfection practices when operating a cleanroom.

Exhibitors display primary packaging, secondary packaging, and machine innovations at this year’s INTERPHEX.

INCOG Biopharma has completed the construction of its cleanroom production area, marking a milestone in the completion of an overall $100 million investment in a new facility.

ten23 health is expanding its sterile drug product manufacturing site at Visp, Switzerland to enlarge cold storage and visual inspections capacity and add clean rooms.

Effective cleaning and disinfection along with contamination controls are imperative when operating and utilizing a cleanroom.

The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.

G-CON’s signature standardPOD cleanrooms will now be available in Europe.

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.

SKAN’s new Cellana isolator is designed for GMP manufacturing of ATMPs.

Fareva plans to use blow-fill-seal equipment and ApiJect’s prefilled injector technology to create fill/finish capacity in France.

New processes, automation, and digitalization were highlighted in 2021.

Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.

Sartorius will invest approximately €270 million (US$305 million) to expand its biopharmaceutical manufacturing activities in South Korea’s biopharm hub.

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.

Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Trends and technologies in pharmaceutical manufacturing were highlighted on the show floor and in the conference sessions on the INTERPHEX Innovation Stage.

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.