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Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control

Jul 23, 2020
Raleigh, NC

  • Education
  • The Americas

Overview

This training course is based on PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control. Since its issuance, it has been widely utilized by industry and regulatory sterilization professionals in the development and assessment of sterilization programs across the globe. This training course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control.

Moist heat sterilization processes are considered to be "special processes" since the output of the process, product sterility, cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat sterilization processes be properly designed, validated and controlled. Important moist heat sterilization topics also covered by this training course include:

  • Application of key terms including D-value, z-value, physical (F0), biological lethality (FBIO), steam quality and equilibration time
  • Considerations in the use of steam and water requirements for moist heat processes
  • Fundamentals in the selection and use of biological indicators and chemical indicators
  • Selection of a sterilization process type based on product attributes
  • Design considerations for key and critical parameters
  • Determination of cold spots
  • Practical application of semi-log survivor curve equation in sterilization calculations
  • Use the overkill approach and alternates to the overkill approach (product specific approach)
  • Use of master site and master solution approach
  • Use of bracketing approaches to optimize process qualification activities
  • Sterilizer suitability and equivalency
  • Parametric release of moist heat sterilized products
  • Impact assessment for product, process and sterilization equipment modifications

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

PDA Sterilization Training Course Series
PDA Annual Training Course Series

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Michael Sadowski
Michael Sadowski
Baxter Healthcare

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
    2. Use a decision tree to select the most appropriate sterilization process based on the attributes of the load type
    3. Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program
    4. Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods loads types
    5. List the critical elements of process performance qualification
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in the development and assessment of sterilization processes used in sterile drug manufacturing.

    Departments
    Manufacturing, Quality Assurance, Quality Control, Engineering, Process Development, Validation

    Roles
    Specialist, Supervisor, Manager, Engineer

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Travel

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Raleigh Convention Center

500 South Salisbury Street
Raleigh, NC

How to Get Here

By Air

The closest airport to the training course location is the Raleigh-Durham International Airport (RDU).

By Car

Parking is available at prevailing rates in parking lots and decks surrounding the Raleigh Convention Center. Parking in the Loading Dock or inside the center (except for loading or unloading) is strictly prohibited and violators will be towed at owner’s expense. Please click here for parking maps and additional details.

Other Options

N/A

Directions

Registration Fees

Regular Price
Registration Type Price
Member $999
Non-member $999
Gov't/Health Auth./Academic* $999



* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Jun 23, 2020, no fee will be charged. After Jun 23, 2020, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Jun 23, 2020, a full refund will be given minus a $200 fee. After Jun 23, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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