Manufacturing

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Adoption of single-use systems and more flexible systems drive innovation.

The Next Generation in Aseptic-Filling Equipment

PIERRE FABRE MEDICAMENT PRODUCTION has 22 years experience in isolator technology for aseptic filling of high potent freeze-dried injectable products.

Isolator Technology for Aseptic Filling of High Potent Products

As an important method for improving the stability of parenterals, lyophilization is fairly well understood, but can still benefit from several advancements in the technology.

Lyophilization Technology: Slow Progress but Hopeful Outlook

The FPC50W is an aseptic filling system with full or partial stoppering and crimp capping of vials, delivering fill volumes ranging 0.1ml to 100ml and filling accuracy of +/- 0.5%.

Fully automatic aseptic liquid filling system

PharmTech speaks to Ray O'Connor from the National Institute for Bioprocessing Research and Training (NIBRT) for an overview of aseptic processing.

Aseptic Processing: A Primer

Room-temperature sterilization using nitrogen dioxide gas provides benefits for sterilizing the external surfaces of single-dose, parenteral drug containers.

Sterilizing Parenteral Drug Containers with Nitrogen Dioxide

An efficient cleaning cycle begins with equipment and automation-system design.

Designing a Clean-in-Place System

How to avoid invisible and airborne contamination.

Avoiding Contamination Risks in Aseptic Processes

Closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers.

Using Closed-Vial Technology in Aseptic Filling

Amy Ritter was Scientific Editor, BioPharm International.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.

Aseptic/Sterile Processing