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Cleaning Compounding Environments - Understanding Contaminants and How to Remove Them

Feb 06, 2020
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

The quality and purity of compounded sterile preparations (CSP) and other compounded products is affected by the cleanliness of the cleanroom environment and work surfaces. Wiping and mopping of these surfaces is one of the most common and effective methods of maintaining required levels of cleanliness and microbiological control. This comprehensive training course will examine the theory behind cleaning and disinfecting surfaces and provide practical information for the successful selection and use of tools used to clean and apply disinfectants.

Attendees will learn about the sources of contamination, challenges to effective removal and relative effectiveness of various approaches to contamination removal.

The training course also will explore environmental and workspace considerations and provide best practices for selecting appropriate cleaning materials and chemistries based on USP and other regulatory guidelines. Attendees will gain hands-on experience and proficiency in effective and proper use of cleaning tools in typical compounding environments. Several unique cleaning challenges will be discussed, and attendees are invited to bring actual cleaning issues and problems for discussion.

Please note that this training course has hands-on lab activities. Please wear long pants and closed-toe shoes.

For more options and/or related training courses, please visit the page(s) below.

PDA Compounding Training Courses

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Agenda

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  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Michael Myers
Michael Myers
Contec, Inc.
Bio
Michael Myers
Contec, Inc.

Michael T. Myers has been with Contec, Inc., since 1998 working in various roles including product development, sales management, and technical support. For almost ten years, he has been exclusively focused on Sterile Compounding Pharmacies. As the Clinical Support Manager for the Healthcare division at Contec, he is focused on developing educational materials and in-service teaching of pharmacy technicians regarding the best practices to clean and disinfect environments in 503A compliant compounding pharmacies – helping them become compliant with USP Chapters <797> and <800>. He holds a Bachelor of Science degree Communications from Appalachian State University.
David Nobile
David Nobile
Contec, Inc.
Bio
David Nobile
Contec, Inc.

With over thirty-six years of experience in developing products and processes for cleanroom as well as industrial applications, Mr. Nobile is a key technical resource in contamination control for the pharmaceutical, biomedical, microelectronic, disk drive, aerospace, and other critical manufacturing industries. He is currently Technical Services Manager for Contec, Inc.

Mr. Nobile has conducted numerous seminars, presentations, and webinars including “Wiping Theory and Techniques,” “Cleaning the Cleanroom,” and “The True Value of Presats.” He has written several articles related to cleanroom contamination control, and co-authored the technical paper “The Cleanliness of Wiped Surfaces: Particles Left Behind as a Function of Wiper and Volume of Solvent Used.” As a product development engineer, he has received multiple design patents for innovative cleanroom products.

Mr. Nobile is currently the Technical Vice President for the Contamination Control division of the Institute of Environmental Sciences and Technology (IEST) and is the past chair of the IEST Working Group to revise the IEST RP-CC-004 test methods “Evaluation of Wipers Used in Cleanrooms and Other Controlled Environments,” to be published in 2019.

Previously, he was Engineering Manager for Coventry Manufacturing, and holds a degree in Mechanical Engineering from California State Polytechnic University.
Mark Wiencek
Mark Wiencek
Contec, Inc.
Bio
Mark Wiencek
Contec, Inc.

Mark Wiencek, PhD is the Principal Microbiologist with Contec, Inc. He received a BS in Marine Biology from UNC-Wilmington, a MS in Microbiology from North Carolina State University and a PhD in Microbiology from the University of Maryland. During 25+ years of industrial experience in microbiology and microbial ecology, Mark has focused on control of objectionable microbes in multiple applications including water treatment, medical devices, and environmental surfaces in the built environment. Research interests include development of cleaning tools and chemistries for control of microbial and hazardous drug contamination in cleanrooms, pharmacies, and healthcare facilities.

 

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the sources of biological and hazardous drug contamination, and how correct behavior is necessary for effective control
    2. Explain why contamination control is critical to the quality of CSPs and other compounded products
    3. Select proper and effective tools and materials for consistently cleaner environments
    4. Demonstrate the relationship between the environmental control systems, cleaning tools and protocols, and compounded pharmaceutical product quality
    5. Discuss protocols and techniques for decontamination of hazardous drugs
  • Who Should Attend

    This training course is intended for professionals who are involved in compounding pharmacy.

    Departments
    Manufacturing, Quality Assurance Operations, Technical Operations, Training

    Roles
    Analyst, Supervisor, Technician, Operator, Pharmacist, Investigator

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

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Registration Fees

Early Registration
Registration Type Price By December 20, 2019
Member $1,799
Non-member $2,159
Gov't/Health Auth./Academic* $1,399





Regular Registration
Registration Type Price After December 20, 2019
Member $1,999
Non-member $2,399
Gov't/Health Auth./Academic* $1,399





* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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