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eSubscription: Sterilization - Industrial Process Control Individual Subscription

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Description Individual Subscription to Sterilization - Industrial Process Control Collection includes 50 standards and guidance documents and is intended primarily for manufacturers who ship sterile products.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$490.00
List Price:
$660.00
Your Price:
$660.00


eSubscription: Sterilization in Healthcare Facilities

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Description Individual user subscription to Sterilization in Healthcare Facilities includes 14 sterilization standards and guidance documents, including TIR11, TIR12, TIR30, TIR34, TIR63, ST40, ST41, ST58, ST65, ST79 (plus a new self-assessment tool), ST90, ST91, and PB70.
AAMI Member:
$535.00
List Price:
$749.00
Your Price:
$749.00


eSubscription:Sterilization Equip Design and Use: Individual

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Description This sterilization collection for manufacturers and users of sterilization equipment includes 40 AAMI standards and guidance documents.

To learn about eSubscription options for organizations, please visit Enterprise eSubscriptions.

AAMI Member:
$490.00
List Price:
$660.00
Your Price:
$660.00


Industrial Sterilization for Medical Devices - October 2019

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Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Registration Fees:
  • AAMI Members: $2535
  • Nonmembers: $2835
  • Government Employees: $1050

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM 
Introduction
Key Concepts/Definitions
Microbes & Sterilization
Test Method Validation
Inactivation of Microorganisms


DAY 2 | 8 AM-5 PM 
Sterile Packagin
Radiation Sterilization - Introduction
Radiation Sterilization - Process
Definition and Dose Establishment
Radiation Exercises
Radiation Sterilization - Product
Definition and Routine Processing 



DAY 3 | 8 AM-5 PM 
Moist Heat & Ethylene Oxide Product 
Moist Heat Sterilization
Ethylene Oxide Sterilization



DAY 4 | 8 AM-5 PM 
Ethylene Oxide Sterilization
Contract Sterilizers & Laboratories
FDA Perspectives 






 

 

Program Objective

Participants will learn how to apply the principles of sterilization and address requirements during product design. Participants will also determine how to select and implement an appropriate sterilization process and how to identify the elements of a successful sterilization validation. Students will participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes and compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods.

 

Target Audience

This program is recommended for professionals relatively new to the sterilization process environment who need information to help them better understand the principles and science of sterilization. This course is designed for design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, or others directly involved in sterilization processes and responsible for meeting industry standards and FDA requirements.

 

Format

This highly interactive program combines classroom lecture with situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. In addition, participants will work through a series of case studies illustrating problematic situations. Case studies will cover various aspects and phases of sterilization processes...from design, to cycle development, to validation, to process control, to product release.

 

 

Materials

As part of the course materials, attendees receive copies of standards on the validation and routine control for industrial moist heat sterilization, ethylene oxide sterilization, and radiation sterilization as well as standards and a technical information report on packaging for terminally sterilized devices.



Start Date:
Tuesday, October 01, 2019
End Date:
Friday, October 04, 2019
Time:
8:00 AM - 5:00 PM Eastern Daylight Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$1,050.00 - $2,535.00
List Price
$1,050.00 - $2,835.00


Industrial Sterilization: Research from the Field

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance.
AAMI Member:
$68.00
List Price:
$113.00
Your Price:
$113.00
↑/↓ Full Details


Industrial Sterilization: Research from the Field (PDF)

This book presents 11 articles from leading experts on Industrial Ethylene Oxide Sterilization, Microbiological Methods, Steam Sterilization, and Quality Management Systems and Sterility Assurance. PDF format.
AAMI Member:
$68.00
List Price:
$113.00
Your Price:
$113.00
Available for Immediate Download
↑/↓ Full Details


Investigation of Sterilization Process Failures Video

This 35-minute instructional video provides information essential to the understanding of sterilization process failures.

Earn .5 credit hour CE through CBSPD and IAHCSMM.

The script was written by Rose Seavey, MBA, BS, CNOR, CRCST, CSPDT. It includes practical guidance on:
- Essential elements of sterility assurance
- Product sterilization identification and traceability
- Sterilization process monitoring tools
- Correct actions to take when physical monitors, chemical indicators, or biological indicators indicate a sterilization failure
- Available tools to clarify steps and guide the investigation of sterilization process failures
- Product recall process
- Ways to help prevent sterilization process failures
AAMI Member:
$132.00
List Price:
$220.00
Your Price:
$220.00
↑/↓ Full Details


October 2019 Sterilization Standards Week

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Description: October 2019 Sterilization Standards Week will take place in Arlington, VA at the AAMI Center for Excellence.

After selecting your registration option, then selecting to "Register Yourself" or "Register Someone Else", select "Add" next to each meeting you would like to attend. To register another member from your organization, click "Register Someone Else" and look up their record. Once Found, select the meetings they are to attend.

Remote access details will be sent to the registrants on October 17th.




Start Date:
Monday, October 21, 2019
End Date:
Friday, October 25, 2019
Address:
901 N Glebe Rd
Ste 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$0.00
List Price
$0.00


Personnel Safety in Sterile Processing Departments Video

This 60-minute instructional video provides information essential to the promotion of personnel safety in sterile processing departments.

Earn 1 credit hour CE through CBSPD and IAHCSMM.

The script was written by P. Richard Warburton, PhD, JD; CTO & General Counsel, ChemDAQ, Inc. It includes practical guidance on:
- Legal duties and who's who among the relevant regulatory agencies and professional organizations
- Common hazards encountered in the sterile processing department
- Bloodborne pathogens and infection prevention
- Proper selection, use, and disposal of personal protective equipment (PPE)
- Relevant standards that pertain to the use of PPE, steam and chemical sterilization, and ethylene oxide
- Safe storage, handling, and disposal of contaminated items and chemical agents
- Key elements of engineering controls that promote safe handling of sterilants and high-level disinfectants
- Appropriate labelling of chemicals
- Responsibilities of employers and staff in preventing, managing, and reporting accidents in the workplace
AAMI Member:
$132.00
List Price:
$220.00
Your Price:
$220.00
↑/↓ Full Details


Radiation Sterilization for Medical Devices - November 2019

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This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. Some of the topics covered are: FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; and the 11137 series radiation sterilization standards.

Registration Fees:

  • AAMI Members: $2335
  • Nonmembers: $2635
  • Government Employees: $950

 

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Overview of ANSI/AAMI/ISO 11137-1
Microbiological Quality Tests
Gamma - Design & Operation
e-Beam & X-Ray
SAL
FDA Perspective Part 1



DAY 2 | 8 AM-5 PM
Process Definitions
Dosimetry
FDA Perspective Part 2


DAY 3 | 8 AM-5 PM
Sterilizer Equipment Validation
Maintenance of Validation
Routine Processing
FDA Perspective Part 3
Process Definition Sterilization Doze Method



DAY 4 | 8 AM-12 PM
Contract Sterilizers & Laboratories
Maintenance of Validation - Equipment
Changing Radiation Sterilization and/or Manufacturing Sites
FDA Perspective Part 4






 

 

Program Objective

Participants will understand FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance and scientific theory and principles of radiation sterilization. The course examines the global ANSI/AAMI/ISO 11137 series on radiation sterilization standards. Participants will learn integration of industry standards with the Quality System regulation, auditing processes for contract laboratories and sterilizers, and radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations


Target Audience

This course is for professionals currently working in or with sterilization processes, particularly related to radiation sterilization. This includes design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended they have a working knowledge of general sterilization principles.

 

Format

This course is designed to be highly interactive between faculty and participants and will include relevant real-life examples and “hands-on” exercises from a broad spectrum of medical device products.

 

Materials

Fee includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.


Start Date:
Tuesday, November 05, 2019
End Date:
Friday, November 08, 2019
Time:
8:00 AM - 12:00 PM Eastern Standard Time
Address:
AAMI Center for Excellence (ACE)
901 North Glebe Road Suite 300
Arlington, VA 22203
UNITED STATES
AAMI Member
$950.00 - $2,335.00
List Price
$950.00 - $2,635.00


Steam Sterilization in Health Care Facilities: A Review of ANSI/AAMI ST79:2017 (Webinar On Demand)

This webinar, led by two ST79 committee members, will discuss the process used to update ST79 and identify new and modified material in ST79:2017.
AAMI Member:
$20.00
List Price:
$35.00
Your Price:
$35.00
Available for Immediate Download
↑/↓ Full Details


Steam Sterilization Poster Set

This set of nine posters is a colorful and handy resource for any sterile processing department.
AAMI Member:
$130.00
List Price:
$215.00
Your Price:
$215.00
↑/↓ Full Details




Sterilization Resource Kit (PDF)

This collection consists of PDFs of 4 popular sterilization resources:
- Sterile Processing: Knowledge, Skills, Competencies
- Basic Concepts in Sterilization Processes: Verification, Validation, and Qualification
- Building for the Future: Construction and Renovation of Sterile Processing Facilities
- Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys, 2nd edition
For more info on any of these items, please select the links above.
Order the kit and save on a PDF copy of these important resources.
AAMI Member:
$375.00
List Price:
$580.00
Your Price:
$580.00
↑/↓ Full Details