Manufacturing, Aseptic Processing

The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.

FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

The company was cited by FDA for violations of sterile processing GMPs.

Excipient selection strongly influences lyophilization performance for biologic drugs.

John Ward, vice-president of Engineering at Patheon, discusses the potential for cross contamination in the manufacture of biopharmaceuticals.

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

Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.

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.

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

Industry experts discuss the challenges of using single-use systems in biopharma manufacturing.

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

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

The agency cited the company for sterile manufacturing violations.

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.