Aseptic/Sterile Processing

SmithKline Beecham Gets Warned for Contamination

July 19, 2016

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

Teligent Breaks Ground on Manufacturing and R&D Expansion

July 06, 2016

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

Cleaning Bioreactors and Fermenters with CIP Systems

July 02, 2016

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

Exploring the Use of Aseptic Spray Drying in the Manufacture of Biopharmaceutical Injectables

July 02, 2016

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

Clinical Supply Facility Warned by FDA

June 22, 2016

The agency cited the company for sterile manufacturing violations.

Equipment and Processing Report

Optimizing Accuracy in Pinch Valves for Sterile Injectables

June 03, 2016

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

Examining Blow-Fill-Seal Technology for Aseptic Processes

June 02, 2016

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

Protecting the Product and the Patient

May 15, 2016

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

Testing the Integrity of Lyophilized Product Containers

April 04, 2016

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

Packaging Alliance Brings Aseptic Filling Solutions to Market

March 28, 2016

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.