Aseptic/Sterile Processing

Aging Facilities: Aseptic Manufacturing Faces the Future

May 15, 2015

Aging facilities and inadequate quality systems create drug shortages. Preventing them will require harmonized regulations, and management support for continuous improvement and innovation.

Teva Parenteral Medicines Recalls Adrucil

May 06, 2015

The company voluntarily recalls select lots of Adrucil due to particulate matter.

Evaluating Disinfectant Efficacy of a Silver-Based Disinfectant

May 02, 2015

The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.

Hospira Italy Facility Gets Warning Letter

April 10, 2015

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

Baxter Recalls IV Solutions

April 10, 2015

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

Sight Flow Indicators Shorten Cleaning Cycles

April 09, 2015

Flow indicators maximize the view into sterile processes.

Considering GMPs In Room Design

March 02, 2015

Cleanability is crucial when choosing components for GMP manufacturing areas.

Sagent Pharmaceuticals Recalls Atracurium Besylate Injection

February 24, 2015

The company voluntarily recalls product due to FDA observations of potential sterility problems.

FDA Issues Warning Letter to India Facility

February 23, 2015

The agency cites Apotex’s Bangalore facility with quality system failures.

Equipment and Processing Report

Blow-Fill-Seal Equipment Can Be Installed in Cleanroom

January 21, 2015

Rommelag's all-electric aseptic blow-fill-seal packaging system encapsulates the filling point and can be installed in a cleanroom.