TechTips

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

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)

Due to the all-consuming nature of designing a brand new product, developers are frequently more focused on functionality than risk.

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

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