Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes ...

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk. Keeping pharmaceutical facilities ...

ARLINGTON, Va., Aug. 25, 2022 (GLOBE NEWSWIRE) -- Medical device manufacturers have a new standard for “clean.” With the launch of ANSI/AAMI ST98:2022, Cleaning validation of health care ...

Microtest Laboratories has issued a management brief that discusses reusable medical device cleaning validation and testing practices in view of the FDA’s own discussions and actions around ...

This is a practical based course. We explore the issues and pitfalls you may experience when performing Cleaning Validation. Help, guidance and training is given on techniques to overcome the issues ...

Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

A review of Olympus presentations to the U.S. FDA over its duodenoscopes suggests the Japan-based medical-device maker may have been "hoist with his own petard" in its attempt to have cleaning ...

For pharma, maintaining stringent cleaning standards is non-negotiable. The stakes are high, and the margin for error is slim. Cross-contamination can compromise ...

This is a practical based course. We explore the issues and pitfalls you may experience when performing Cleaning Validation. Help, guidance and training is given on techniques to overcome the issues ...