Aseptic/Sterile Processing

USP Previews New Compounding Standards

September 28, 2015

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

An Ounce of Prevention: Cleaning and Preventive Measures Deter Contamination Events

September 16, 2015

Equipment and Processing Report

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

Generating Savings from Room Declassification

September 02, 2015

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.

Cleaning a Vial Filling Line

September 02, 2015

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

Biocontainer Assemblies Provide Repeatable Performance

September 02, 2015

Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.

Mylan Receives FDA Warning Letter for Manufacturing Sites in India

August 19, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

Industry Viewpoints: Can Sterile Manufacturing Turn the Ship Around?

August 01, 2015

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

Silicone Rubber Pieces Spur Recall of Teva Product

July 31, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.

Baxter Recalls IV Solution for Container and Particulate Issues

July 31, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.

Mobile Cleanroom Doubles Available Space

July 09, 2015

Walker Barrier Systems extended-width mobile cleanroom provides 1350 square feet of workable space.