Cleanrooms are tightly controlled environments defined by ISO standards to prevent dust, organisms, and other contaminates/particulates from entering inorder to minimize product contamination.
This webinar will discuss the ISO-defined and classified cleanroom (especially US FDA-regulated) to include its systems for establishing and maintaining/monitoring environmental conditions (monitoring generally conducted under “as built”, “at rest” and “operational or dynamic” conditions), The goal, an isolated environment, strictly controlled with respect to: Airborne particles of viable and non-viable nature; Temperature; Humidity; Air pressure; Air flow; Air motion ; Lighting; [and microbiological]; Smoke testing should demonstrate unidirectional air flow over critical equipment surfaces; If areas of air disturbance are observed, may require movement of equipment or adjustment of air velocities. Validation studies should demonstrate that the desired classification is maintained in critical zones during routine operations.
Cleanrooms (focus on medical products) must be set up, operated and maintained to specific, strict requirements per the ISO 14644 standard. These considerations require, as appropriate: Easily cleanable floors, walls, and ceilings of smooth, hard surfaces; specific requirements for furniture and equipment; temperature and humidity controls; an air supply filtered through high-efficiency particulate air filters (HEPA) under positive pressure, and laminar flow, with defined air turns per hour; and appropriate calibrated monitoring equipment - all CGMP-compliant.
This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical, Biologics and Combination products fields. The employees who will benefit include:
John E. Lincoln is the Principal of J. E. Lincoln and Associates, a consulting company with over 41 years of experience in U.S. FDA-regulated industries, 27 of which as head of his own consulting company. John has worked with companies from start-ups to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China, and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation, FDA responses, new/changed product 510(k)s, process/product/equipment incl+D33uding QMS and software validations, ISO 14971 product risk management files/reports, Design Control / Design History Files, Technical Files. He's held Manufacturing Engineering, QA, QAE, and Regulatory Affairs positions at the Director and VP (R&D) levels. In addition, John has prior experience in the military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, including 5 chapters in the RAPs validation textbook, and conducted workshops and webinars worldwide on regulatory issues. John is a graduate of UCLA.