Aseptic/Sterile Processing

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.

Cut-Resistant Gloves Improve Comfort and Dexterity

April 22, 2015

Ansell's HyFlex gloves made with Intercept technology yarns improve hand protection.

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.

Considerations for personal protective equipment when handling cytotoxic drugs

March 02, 2015

It is vital that companies involved in the manufacturing and handling of cytotoxic drugs ensure that staff are given the highest possible levels of protection.

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.