Aseptic/Sterile Processing

Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

Honeywell has launched a new range of gloves, Picguard Urban, which offers protection against needle stick and puncture.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.

This key bioprocessing segment is expecting continued growth

Wells Pharmacy Network is voluntarily recalling all of its products due to sterility concerns.

FDA sent a warning letter to an Illinois compounding pharmacy for violations of the Federal Food, Drug, and Cosmetic Act.

A process-specific preventative maintenance program improves productivity and reliability.

Visual inspection of parenteral vials is the first step in a root cause investigation.

Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?

Fresenius Kabi will add to its generic, sterile injectable manufacturing at its Melrose Park, Illinois site.

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.

PharmTech’s 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.

Quality, innovation, and new approval pathways open drug development options for the Chinese market, including injectable contract manufacturing.

While isolators may offer advantages in high-speed commercial manufacturing lines, RABS continues to be a flexible alternative solution for small-scale production of drugs for clinical use.

The company voluntarily recalls all lots of lyophilized HCG and sermorelin.

Gamma-stable fluoropolymers are an alternative material for single-use bags and assemblies in biopharmaceutical manufacturing.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

Teligent is expanding its manufacturing and R&D complex in New Jersey.

Early planning for the integration of clean-in-place systems for equipment cleaning is key.

Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.

The agency cited the company for sterile manufacturing violations.

Preheating pinch valves prevents drift in the volume of liquid dispensed.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

Intact enables aseptic filling in non-classified environments, maintains sterility throughout the process, and reduces costs, timelines, and contamination risks.

Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.

The Matrix Alliance was formed by Vanrx Pharmasystems with inaugural members ARaymond Life, Daikyo Seiko, Datwyler Group, Ompi, Schott AG, Schott Kaisha and SiO2 Medical Products.

The agency cited Emcure Pharmaceuticals with CGMP violations.