Steris Master Class: Cleanroom Control, Maintenance and Environmental Monitoring

Course Descriptor

This 2-day hands-on intensive course presented by invited industry experts covers best practices, regulatory expectations and current trends in cleanroom control, design, and monitoring.  It is intended for biopharmaceutical and medical device manufacturers wanting to develop, optimize, and maintain an effective cleanroom contamination control program that is compliant with current industry regulations.  The training addresses current challenges in contamination control, environmental monitoring, and disinfectant qualification, and provides case studies, best practices, and instructive hands-on experience using state-of-the-art bioprocessing equipment located in the NIBRT facility.

Steris Master Class: Cleanroom Control, Maintenance and Environmental Monitoring

SKU: steris-master-class-cleanroom-control-maintenance-and-environmental-monitoring Category:

1,500.00

Clear
Dates:
  • 25/09/2018 - 26/09/2018

    15 Places Remaining

Fee:
€1500
Suitable for:

Personnel from Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, Plant Management disciplines.

Who should attend

Personnel from Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, Plant Management disciplines.

Key topics covered

Topics Covered:

  • Cleanroom microbiology and design, classification of cleanrooms by ISO 14644, operator best practices, material handling and flow of personnel.
  • Current regulatory and guidance perspectives on cleaning and disinfection of controlled environments (HPRA, MHRA, FDA, USP, ASTM and EMA).
  • Application methods and best practices, disinfectant resistance, rotation, frequency, rinsing and residue removal strategies.
  • Standard operating procedure (SOP) recommendations for cleaning and disinfection that are effective, compliant, and practical for the end user.
  • A comprehensive look at attributes of an optimized environmental monitoring (EM) program. Topics covered include test methods (surface and air sampling), sample site selection, ISO 14644, excursions, and procedures to develop a risk and science-based EM program. Includes proven strategies to regain environmental control after new construction, planned and un-planned events.
  • Disinfectant efficacy testing
  • Industry Regulations for disinfectant manufacturer and end users (EPA, EN, and FDA), AOAC Testing for EPA Registration,
  • Fundamental principles for conducting effective Root Cause Investigations and CAPA for microbial contamination issues.
  • Strategies for minimizing contamination risk to product contact surfaces.

Learning outcomes

On completion of the course, delegates will be able to:

  • Identify critical attributes of cleanroom design and operation, and recognize issues that impact controlled environments.
  • Identify and apply the regulations surrounding cleaning and disinfection of critical environments.
  • Assess the cleaning and monitoring requirements for start-up and qualification of cleanrooms after construction, maintenance, malfunction or contamination.
  • Draft compliant procedures for cleaning programs that are practical for employees, including all essential elements, addressing training of staff, and avoiding common mistakes.
  • Develop and optimize an EM program that is risk and science based, fully aligned with regulatory expectations.
  • Recognize and explain the pertinent regulations and features of disinfectant efficacy testing (DET) involving coupon and suspension testing relating to EN-13697 (2015) and ASTM E2197-17.
  • Identify and overcome common errors in DET.

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