Assurance of Sterility for Sensitive Combination Products and Materials

1. Introduction: Sterilization or aseptic processing of single use combination products

Joyce M. Hansen, and Trabue D. Bryans

2. Sensitive combination products: Devices, pharmaceuticals, and biologics

Andrew L. Lewis

3. Terminal sterilization

Vu H. Le, Scott Weiss, Brad Lundahl, and Stan Lam

4. Aseptic processing

Hal Baseman

5. Package/container closures

Thierry Wagner, Jennifer Van Mullekom, Jane Severin, and Michael H. Scholla

6. Review of current practice in preventing health care associated infections

Donna Swenson

7. Risk to the patient-Quantifying assurance of sterility

Marc L. Speck, Harry Frederick Bushar, James Niederecker, and Byron J. Lambert

8. Developing new products

Stan Lam

9. Regulatory pathway for labeling combination products as sterile

Trabue D. Bryans, Eamonn Victor Hoxey, and Steven Turtil

10. Path forward

Byron J. Lambert, and Joyce M. Hansen

Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.

• Engenharia biomédica
• Ciência dos materiais
• Biotecnologia

sensitive combination products; terminal sterilization; Aseptic processing; validation; sterilization; super-bug; MRSA; implantable medical devices; material selection; product design; material compatibility