Dosage Forms

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Articles

Microorganism lethality requirements for process validation must always be balanced with the need to protect product integrity and patient safety.

Achieving Balance in Sterile Product Manufacturing

Baxter expands capacity for lyophilized cytotoxic oncology therapies at its fill/finish facility in Halle, Germany.

Baxter Expands Fill-Finish Facility

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.

Identifying Causes Of Delamination

Agnes Shanley is senior editor of Pharmaceutical Technology.

Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.

Better Days for Parenterals?

Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.

Addressing Parenteral Manufacturing Challenges

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

CMO Symbiosis Expands Scotland Facility

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.

Partnering to Address Particulates

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Manufacturers of parenteral drugs face challenges to increase efficiency, control particulates, control extractables and leachables, and eliminate product/package interactions; new containers and packaging equipment offer increased options.

Parenteral Packaging Advances

GEA’s Pony NS2006L is a self-contained, high-pressure laboratory and pilot plant homogenizer for product development of advanced fluid applications.

Self-Contained Laboratory Homogenizer Prepares Injectable Drugs

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

Parenterals and Injectables