TechTips

This document answers many of the FAQs regarding radiation source transfers and addresses possible transfer types and areas for consideration.

Background A verification (dose audit) or sterilization dose experiment requires a narrow and specific dose range to be applied to the samples used for tests of sterility as evidence that the routine minimum dose remains appropriate for delivering the

This TechTip provides guidelines on how to interpret the results of a VDmax25 audit

Significant figures are numbers that carry a contribution to a measurement and are useful as a rough method to round a final calculation. For more complex systems such as the uncertainty of a dosimetry system, or estimating the bioburden of a product, more accurate methods should be used

What is Recovery Efficiency (RE)? Recovery Efficiency (RE) is an important part of the validation of the bioburden test method. It is intended to provide an assessment of the efficiency of the extraction technique to remove viable microorganisms from a

This TechTip provides a summary of the information presented in AAMI TIR No. 14 – 2009, Contract Sterilization Using Ethylene Oxide.

The layout of the plant and manufacturing process is designed to fulfill international standards, including the quality management system standard for medical devices ISO 13485, ISO 11137: Sterilization of Healthcare Products – Radiation, cGMP and Food and Drug Administration guidelines.

X-ray irradiation is a practical alternative to a variety of other commonly used sterilization and contamination control methods