Best Practices for Cleaning and Material Handling in Sterile Compounding Facilities

Instructor: Kate Douglass
Product ID: 703807
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This webinar will clarify the cleaning and material handling requirements outlined in USP 797 and present additional best practice guidelines. It will discuss principles related to the selection, preparation and use of cleaning, disinfection and deactivation agents. The correct sequencing of critical activities related to daily and monthly cleaning of both primary and secondary engineering controls will be presented as well.

Why Should You Attend:

This webinar will detail why the USP Chapter <797> is one of the mission critical cornerstones to the achievement and maintenance of the state of microbial control necessary to ensure safe patient care, along with:

  • Identifying cleaning and material handling requirements outlined in USP <797>
  • Discussing principles related to the selection, preparation and use of cleaning agents and supplies
  • Sequencing accurately critical activities of daily and monthly cleaning
  • Listing personnel safety, training and competency considerations
  • Describing policy, procedure and documentation requirements

Areas Covered in the Webinar:

  • Definitions and differences between cleaning, disinfecting, sanitizing and sporicidal
  • Selection of agents to use to clean, disinfect and deactivate hazardous drug residues.
  • The truth about microbial resistance as it relates to cleanrooms
  • Sterile water vs. tap water
  • Required use of germicidal detergent vs isopropyl alcohol
  • Wipes: pre-saturated or dry; what is non-shedding?
  • Cleaning materials and systems
  • To use or not to use: anti-fatigue mats and tacky mats
  • Garb selection and storage
  • Daily cleaning of primary engineering controls
  • Sequence of items to clean in secondary engineering controls in daily and monthly cleaning
  • Additional cleaning requirements
  • Isolator cleaning, changing sleeves, gloves
  • New approaches: use of steam, UVGI and HPV
  • Material handling requirements and best practices
  • Staff training
  • Documentation

Who Will Benefit:

This webinar will provide valuable information to those who run sterile compounding facilities and are responsible for the development and implementation of cleaning and material handling processes from a variety of settings such as:

  • Hospitals
  • Home infusion and alternate site providers
  • Community based compounding pharmacies
  • Pharmacy outsourcers and central fill operations
  • Prescriber offices

Instructor Profile:

Kate Douglass, MS, RN, APN, CRNI is vice-president of CriticalPoint, LLC, a healthcare training and development company. She is a co-author of CriticalPoint's Interactive USP Chapter <797> Gap Analysis Tool and co-director of the annual USP 797 compliance study. Ms. Douglass has written numerous articles on sterile compounding quality and training. She co-authored a paper commissioned by the Pew Trust titled “Quality Standards for Large-Scale Sterile Compounding Facilities” and is a member of the Sterile Compounding Boot Camp Faculty. She has personally supervised the design, engineering and building of pharmacy compounding facilities that met or exceeded USP requirements. She is currently the project manager for the design and build of CriticalPoint’s Center for Training and Research in Totowa, New Jersey.

Topic Background:

Despite the NECC sterile compounding misadventure that resulted in 64 deaths and spread sickness in 687 others, preventable sterile compounding contamination continues to occur. On October 8, 2014, pharmacy sterile compounding again made front page headlines. Citing that in the almost 150 inspections of pharmacy made by the FDA between October 2012 and September 2014, almost 90% of those inspections identified objectionable conditions, typically related to safety and sanitation that warranted corrective actions. To complicate the issue, though USP Chapter <797> has pioneered the practice of sterile compounding, which has resulted in measureable improvement in sterile compounding practices, it has not been revised since 2008 and contains ambiguities, inaccuracies and omissions.

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