Air and Surface Quality and Testing for Sterile Compounding

September 29, 2016


The sterile compounding environment requires careful and meticulous maintenance and monitoring. It is through testing and monitoring that the efficacy of maintenance protocols can be assessed. This webinar details the processes of deactivation, decontamination, cleaning, and disinfection for sterile non-hazardous and hazardous drug compounding. A review of certification and recertification requirements of HVAC systems, pre-filters, and HEPA filters is included. The testing of air and surface quality, which involves sampling techniques, the incubation of these samples, and their interpretation, will be discussed. Upon testing the sterile environment for particulates and contaminants, the results can be used to establish relationships between any issues discovered and current maintenance protocols. With this concept in mind, interpretation of the results as well as corrective and preventive actions will be described, to ensure the return to appropriate environmental conditions.

Intended audience


  • Pharmacists
  • Technicians
  • QA/QC Specialists
  • Compliance Specialists
  • Pharmacy Managers
  • Auditors and Inspectors

Learning Objectives

FOR PHARMACISTS:
  1. Define particulates.
  2. Describe deactivation, decontamination, cleaning, and disinfection protocols.
  3. Relate HVAC system, pre-filter, and HEPA filter function to cleanroom maintenance.
  4. Outline non-viable airborne particulate counting and interpretation.
  5. Outline viable air and surface sampling, incubation, interpretation, and speciation.
  6. Identify relationships between environmental maintenance and monitoring.
  7. Indicate appropriate corrective and preventive actions in response to environmental testing.
FOR TECHNICIANS:
  1. Define particulates.
  2. Describe deactivation, decontamination, cleaning, and disinfection protocols.
  3. Relate HVAC system, pre-filter, and HEPA filter function to cleanroom maintenance.
  4. Outline non-viable airborne particulate counting and interpretation.
  5. Outline viable air and surface sampling, incubation, interpretation, and speciation in support of air and surface testing requirements.
  6. Relate environmental maintenance to monitoring in support of cleanroom management requirements.
  7. Recognize the importance of corrective and preventive actions following environmental testing.

Financial support: 

An unrestricted educational grant has been provided by MEDISCA Inc.

Hardware/software requirements


High speed internet connectivity and an updated internet browser is required to attend the webinar. The broadband recommended is 1 Mbps or better. The minimum browser requirements to attend the webinar are:

  • Google Chrome v39 or later
  • Mozilla Firefox v34 or later
  • Internet Explorer v8 or later
  • Microsoft Edge
  • Apple Safari v6 or later
Editors: 

NEIL COHEN, BSc
LP3 Network Program Developer
Dislcosure: MEDISCA Consultant

Course summary
Available credit: 
  • 0.10 CEU (ACPE)
  • 1.00 Contact Hours
Event starts: 
09/29/2016 - 12:00pm
Event ends: 
09/29/2016 - 1:00pm
Cost:
$0.00

MARK FILOSI, BS Pharm, RPh
Compounding Pharmacist and Co-Founder, Family Care Pharmacy
Disclosure: Accreditation Commission for Health Care Surveyor; MEDISCA Consultant


Mr. Filosi is a compounding pharmacist for a thriving non-sterile and sterile practice with over 20 years of experience. He is also a surveyor for the Pharmacy Compounding Accreditation Board (PCAB), a service of the Accreditation Commission for Health Care (ACHC). Additionally, Mr. Filosi is the owner of Family Care Pharmacy in Plant City, Florida, where he is responsible for the sales and marketing of the compounding segment of his business. His compounding practice ranges from non-sterile hormone preparations to high-risk intrathecal preparations.

He graduated cum laude from Fitchburg State College in Fitchburg, Massachusetts, and then went on to graduate cum laude in Pharmacy from Massachusetts College of Pharmacy in Boston, Massachusetts. Today, Mr. Filosi is a preceptor for Florida A & M University, University of Florida and Massachusetts College of Pharmacy.


CPE Credits: 1 CPE hour = 0.1 CEUs
Joint Accreditation Status (University of Florida College of Pharmacy/LP3 Network)
Activity Type: Knowledge-based
UAN: 0012-9999-16-384-L04-P/T for pharmacists and technicians
Release Date: September  29th, 2016
Expiration Date: September 29th, 2019

To receive CPE credits for the webinar, participants must be in attendance during the entire live event webinar and submit a completed evaluation. 

Participants registered in the United States can obtain a statement of credit from their NABP e-Profile. The University of Florida College of Pharmacy will report CPE credits to the CPE Monitor. Participants registered other than in the United States will receive a statement of credit by email.

International participants should verify with their respective governing board for accreditation equivalency. 

Accreditation Period

Course opens: 
03/01/2016
Course expires: 
03/12/2019

Price

Cost:
$0.00
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