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Technical Report No. 48: Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance

Oct 12, 2020
Bethesda, MD

  • Education
  • The Americas
Cancelled

Overview

Please note this training course was formerly titled, "Steam Sterilizers - Getting it Right from the Beginning."

Steam sterilization is a crucial process to sterile and aseptic operations in the pharmaceutical and biotech industries. Assuring that steam sterilizers are designed, specified and qualified with the appropriate loads and cycles is a core quality system contributing to those sterile and aseptic operations. This training course will provide greater clarity in those steps, such as specification and design, and will ensure successful and cost-effective qualification and validation.

This is a comprehensive training course to understand sterilization processes using steam, designing the right steam sterilizer for particular applications, developing the load and cycle for those applications, performing qualification to demonstrate that the design and development were robust, and providing ongoing process controls to maintain the qualified state.

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

PDA Sterilization Training Courses

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Agenda

  • 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

Matt Hofacre
Matt Hofacre
STERIS Corporation
Bio
Matt Hofacre
STERIS Corporation

Matt Hofacre is Director of Applications and Project Management for STERIS Corporation Life Sciences Division, a leading provider of infection prevention and contamination control products and services. Mr. Hofacre has been with STERIS Corporation since 1999 with experience in the life science pharmaceutical/biopharmaceutical production, food and beverage, high containment, and laboratory research industries. He and his team are responsible for design applications, project maintenance, and technical guidance for VHP, Steam Sterilization, Washing, and Water Systems. Mr. Hofacre has a B.Sc. in Chemical Engineering from the University of Cincinnati and a MBA from Cleveland State University. He is a presenter and trainer at national and international conferences including The Parental Drug Association (PDA), International Society of Pharmaceutical Engineers ( ISPE), American Society of Mechanical Engineers (ASME), Tradeline, Asia Pacific Biological Association (A-PBA), and Medical Device Asia. Mr. Hofacre served as co-Author for PDA Technical Report 48 : Moist Heat Sterilization Systems and has contributed to numerous other articles on WFI water systems, VHP, and Pharmaceutical Equipment Selection.
Christopher J. Smalley
Christopher J. Smalley
ValSource Inc.
Bio
Christopher J. Smalley
ValSource Inc.

Chris Smalley has retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems and Isolators globally. He now is a consultant for Valsource, focused primarily on Compounding Pharmacies. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager.

Chris retired after 21 years of service as a LtCol in the USAF. Chris practiced as a compounding pharmacist across the military hospital system, compounding intravenous solutions and total parenteral nutrition products. Chris is a graduate of the Philadelphia College of Pharmacy. His graduate education includes a MBA from TU Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from TU School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University.

Chris has been a member of the PDA Board of Directors, the PDA Science Advisory Board, and is a member of the ISPE Disposables CoP Steering Committee and the Pharmaceutical Engineering Committee.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss sterilization models and how to calculate lethal rate
    2. Develop a robust user requirements document for steam sterilizers
    3. Test for steam quality and the importance of dryness fraction and value
    4. Design sterilization cycles appropriate for loads such as porous, hard goods and liquid
    5. Qualify steam sterilizers
  • Who Should Attend

    This training course is intended for professionals who are responsible for the use of steam sterilizers used in sterile drug manufacturing.

    Departments
    Manufacturing, Engineering, Validation, Quality Assurance

    Roles
    Technician, Operator, Specialist, Supervisor, Manager

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

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.

Directions

Registration Fees

Early Registration
Registration Type Price By August 28, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979

Regular Registration
Registration Type Price After August 28, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* 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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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