Aseptic/Sterile Processing

Improved efficiencies and reduced costs are clear advantages of automating drug manufacturing processes.

At INTERPHEX 2024, Pharmaceutical Technology® chatted with Dennis Powers from G-CON Manufacturing about podular cleanroom options and the benefits they offer for manufacturers.

The airlock solution for cleanrooms offers contamination controls for a highly controlled environment.

CDMO White Raven aims to reduce contamination risk and gain the capability to handle multiple product formats with the installation of Cytiva’s SA25 Aseptic Filling Workcell.

Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.

IREM can be used for effectively assessing and mitigating risks and improving the overall sterility assurance level in all types of aseptic processing lines.

Managing the intricacies of sterile product development is imperative for successful and compliant outcomes.

Novo Nordisk will invest more than DKK 16 billion (US$2.3 billion) to expand its production facilities in Chartres, France.

Washed seals save drug makers time and money.

Environmental monitoring data can help keep sterile environments sterile.

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

Data from environmental monitoring can assist in keeping sterile environments sterile.

Manufacturers must figure out how flexible they need to be to meet the numerous new requirements of the changing therapeutic and regulatory landscapes.

Aseptic techniques must be practiced throughout all stages of biologics production.

Todd Andrews, global director of Applications and Business Development at CPC, discusses sterile aseptic connectors, flexibility in manufacturing, and more in an interview held at INTERPHEX 2023.

Address needs for integrated, automated systems and service.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

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

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

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.

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.

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

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.