MDR Effects on Cleaning and Sterilization Validations
The new Medical Devices Regulation (2017/745/EU) (MDR) aligns EU legislation with the latest technical advances, changes in...
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Establishing Maximum Acceptable Dose in Radiation Sterilization
Manufacturers utilizing ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the maximum acceptable...
Chemical Interactions between Leachables and Biopharmaceuticals
In the evaluation of pharmaceutical drug products, leachable compounds are typically assessed primarily for the toxicological risks...
Transportation and Distribution Testing for Medical Devices
An essential yet sometimes overlooked component of packaging shelf life validation is transportation and distribution testing. This...
Mass Extraction Container Closure “CCIT” for Rigid Containers
Mass extraction is a relatively new method for container closure integrity testing (CCIT) that has been included...
Biocompatibility: Applying the New ISO 10993 Standards
Biocompatibility is a critical aspect of medical device development, ensuring that devices are safe and do not...
Critical First Steps of an Ethylene Oxide (EO) Validation – Process Definition Process Definition The Critical First Steps in the Validation of an EO Sterilization Process
In this webinar, you will learn about the importance of process definition (fractional) work as a part...
What is a Sterilization Dose Audit and How are they Performed?
The performance of periodic sterilization dose audits is required when a sterilization dose has been established using...
Becoming Compliant with the MDRs, A Real Life Case Study
The new Medical Device Regulations (MDRs) became enforceable in May 2022. This significant regulatory shift requires that...
An Introduction to Radiation Dosimetry and the Mathmatical Model
This webinar offers an in-depth overview of radiation dosimetry, focusing on essential principles and calibration methods required...
