VDmax25 Quarterly Dose Audits: Interpretation of Results
This TechTip provides guidelines on how to interpret the results of a VDmax25 audit
What Are Significant Figures?
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
Written Agreement Between Product Manufacturer and Contract Sterilizer
This TechTip provides a summary of the information presented in AAMI TIR No. 14 – 2009, Contract Sterilization Using Ethylene Oxide.
X-ray Plant Design
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 Treatment Characteristics
X-ray irradiation is a practical alternative to a variety of other commonly used sterilization and contamination control methods