Manufacturing, Aseptic Processing

Material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill-finish system.

Two experts discuss best practices to achieve acceptable sterility assurance levels for aseptically filled products.

Isolators offer a safety and economic advantage for next-generation regenerative medicine products.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

FDA announced the recall, citing deficiencies in Medistat’s aseptic processing areas and in its environmental monitoring procedures.

Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.

Industry experts discuss challenges, trends, and innovations in fluid handling.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

Bill Hartzel, Director Strategic Execution, Advanced Delivery Technologies at Catalent Pharma Solutions, spoke with BioPharm International about blow-fill-seal for aseptic processes.

NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Removal of microorganisms is crucial when working with biologics. Sterile filtration offers a reliable, safe, and effective way to ensure product integrity.

Meritech’s CleanTech 2000SCA Automated Handwashing System delivers a 12-second wash and rinse cycle that removes 99.98% of dangerous pathogens from bare skin and gloves.

Hamilton’s EasyFerm Bio biocompatible pH sensor is designed for CIP, sterilization up to 140 °C, autoclavable temperature, and a pressure range up to 6bar.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.

It is important to understand degradation and processing to maintain product stability in biologics.

Evaluating the assembly design process, manufacture, and use helps mitigate risk.

Grand River Aseptic Manufacturing has announced that the company executed two commercial production contracts in one day.

PSC Investments announces the acquisition of a high potency, sterile fill/finish pharmaceutical manufacturing facility.

Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.

Unique Pharmaceuticals has issued a voluntary recall of sterile compounded preparations, but aired concerns about FDA?s recall demand.

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

Clinical Syringe Packages Increase Productivity

Integrated Single-Use Sterile and SIP Connector Provide Flexibility

Aseptic Valve Range Increases Sterility

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.