FDA Cleanroom Requirements for Face Masks, Surgical Gowns and PPE Production
Question: “What Class clean room is required to manufacture FDA approved N95 masks, isolation gowns, surgical masks, etc.?”.
FDA
6 Heroically Tragic Examples of FDA Inspection Failures
Based on message receipts from internal FDA communications, readers get a glimpse into the high stakes, bizarre, heroic, tragic, and even comical ways that overseas drug manufacturers dupe the FDA (or at least attempt to).
FDA Regulation of E-Liquid Manufacturing
While most large scale production facilities have standardized manufacturing controls, those mixing liquids in small facilities without environmental controls may struggle to receive pre-market approval.
Aseptic Processing Guidelines – Most Common FDA Inspection Notes
The majority of contamination within aseptic processing cleanrooms involves personnel. Proper application of gowns, hygiene, and a work flow can often eliminate the majority of mix ups and contamination.
ISO 13485:2016 Medical Devices
ISO 13485 is designed for use throughout the life cycle of a medical device. It supports each stage of medical device development and operation from initial concept to production and disposal. The standard helps internal and external parties certify and validate processes which maintain the stability of quality management systems (QMS).
Should the Ban on a Specific Type of PPE Glove Worry Pharmaceutical, Electronic, and Packaging Manufacturers?
Should pharmaceutical, food, packaging, and electronics industries be concerned about new PPE regulations? According to the FDA, yes.
CleanPro Environmental Monitoring
CleanPro Critical Environment Monitoring Solution:Get real time reporting, alarm conditions, and instant traceability. CleanPro’s Monitoring Solutions are sophisticated computer-based monitoring systems for critical applications. They
