The Basics of Bioburden Testing
What is bioburden? Bioburden is the quantity and types of native bacterial and fungal flora present on or in a device, substrate, or chemical (test unit). Bioburden plays a large role in determining what is necessary to achieve sterility, and can impac
The Basics of Medical Device Packaging
When developing a sterile barrier system for medical devices, there are several aspects that need to be considered in choosing packaging and qualifying your sterile barrier system (SBS)
The Importance of Risk Assessment
Due to the all-consuming nature of designing a brand new product, developers are frequently more focused on functionality than risk.
Transfer of Sterilization Dose, Verification Dose or Maximum Acceptable Dose Between Radiation Sources
This document answers many of the FAQs regarding radiation source transfers and addresses possible transfer types and areas for consideration.
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
What is Bioburden Recovery Efficiency and How to Approach Lower Than Desired Recovery Results
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
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