Cleanrooms are tightly controlled environments defined by ISO standards to prevent dust, organisms, and other particulates from entering and contaminating product. This webinar covers the ISO-defined and classified cleanroom — especially as regulated by the US FDA — and the systems used to establish, maintain, and monitor environmental conditions under “as-built,” “at-rest,” and “operational/dynamic” conditions.

The goal is an isolated environment strictly controlled for airborne viable and non-viable particles, temperature, humidity, air pressure, airflow, air motion, lighting, and microbiological levels. Smoke testing should demonstrate unidirectional airflow over critical surfaces; areas of air disturbance may require equipment movement or air-velocity adjustment. Validation studies must demonstrate that the desired classification is maintained in critical zones during routine operations.

Cleanrooms for medical products must be set up, operated, and maintained per ISO 14644, with easily cleanable smooth surfaces, controlled temperature and humidity, HEPA-filtered air under positive pressure with defined air turns per hour and laminar flow, and calibrated, cGMP-compliant monitoring equipment. Attendees receive the presentation materials and a certificate of completion.

Webinar takeaway:

• ISO 14644 Clean Rooms
• QMS and US FDA cGMP compliance issues
• Cleanroom operations
• Controlled Areas V&V
• Clean Rooms V&V
• Production and process controls for clean rooms
• Monitoring systems

After this webinar, attendees will be able to answer -

• How are cleanrooms classified under ISO 14644, and what conditions must be controlled to maintain that classification?
• What does it take to establish and monitor a cleanroom under “as-built,” “at-rest,” and “operational” conditions?
• How do smoke testing and airflow studies demonstrate unidirectional flow over critical surfaces?
• What are the cGMP and QMS compliance issues that apply to controlled areas and cleanrooms?
• How should validation studies confirm the desired classification is held during routine operations?
• What production and process controls and monitoring systems are needed to keep a cleanroom compliant?

This webinar benefits the following agencies -

The session is built around US FDA cGMP expectations and the ISO 14644 cleanroom standard, with attention to viable and non-viable particle, pressure, and airflow control. It is relevant to organizations operating cleanrooms for medical products across pharmaceuticals, medical devices, diagnostics, nutraceuticals, biologics, and combination products.

Who should attend?

This information applies to personnel and companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceutical, Biologics, and Combination Products fields, including:

• Senior Management
• Research & Development (R&D)
• Regulatory Affairs (RA)
• Quality Assurance (QA)
• Purchasing
• Production
• Engineering