syn·op·sis
A brief or condensed statement giving a general view of some subject.
The synopses provided are a general view of the methods and procedures that Advanced Scientifics follow in the manufacture
and handling of product. When possible and where applicable the Advanced Scientifics’ synopses follow FDA and ANSI
formats. The synopsis will summarize a method or procedure by providing; introduction, objectives, methods and conclusions.
Synopses Available:
Endotoxin - Bacterial testing of finished products and materials
Sealed Bag Assembly - Visual inspection, pressure decay, burst, and tensile testing to evaluate the seal strength and quality
Sterilization Validation - Sterility testing, or the delivery of the verifi cation dose, and bioburden performance
Inspection and Integrity - Inspection techniques conducted to ensure the physical and performance characteristics products
Manufacturing Routing Contents - Product path to market
Particulate Testing - Methods of controlling the particulates that are present in the manufacturing environment
Gamma Sterilization - Metal Study - Methods of sterilization for product containing plastics and metallic components
Overfill Capacity of EVA - Maximum fluid capacity of various size EVA bags and evaluation of internal fill pressures
Ship Test Studies - Testing is performed to ensure shipping containers can maintain the integrity of the internal bag
In addition to these summaries, Advanced Scientifics offers Validation Packages specific to individual product and supporting
documentation to test data.
