Aseptic/Sterile Processing

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.

FDA Issues Warning Letter to Indian Facility

March 18, 2016

The agency cited Emcure Pharmaceuticals with CGMP violations.

Revised ISO Cleanroom Standards Improve Air Cleanliness Classification

March 16, 2016

Equipment and Processing Report

Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms.

Cleanroom Oven

March 02, 2016

The Class 100 cleanroom oven from Grieve is used for a variety of heat processes such as sterilizing, depyrogenation, curing, and drying workloads.

Best Practices for Handling Antibody Drug Conjugates

February 18, 2016

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.