Technical Report No. 62: Recommended Practices for Manual Aseptic Processes

Raleigh, NC
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The goal of aseptic operations is to prevent the contamination of materials intended to be sterile. For large scale automated operations where operator interventions are infrequent, the verification of the ability of the process to produce sterile products is evaluated by conduct of large-scale automated media fills in a manner analogous to normal production. Processes using all or partial manual procedures must also be evaluated by process verification testing. Such manual operations present unique operational and evaluation challenges not generally encountered with automated operations. Manual aseptic processes rely heavily on the individual operator proficiency. Operational personnel and their activities are generally recognized as the greatest source of potential microbial contamination during a process. Reproducible human performance cannot be assumed over time. These and other challenges posed by manual aseptic processes must be considered when designing the evaluation protocol.

This training course, based on PDA Technical Report No. 62: Recommended Practices for Manual Aseptic Processing, will provide a tutorial of suitable physical techniques, equipment uses, and processing operations that can be used to address the challenges posed in the design and control of manual aseptic processing. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual process simulations will be covered.

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

PDA Aseptic Processing Training Courses

  1. Explain the differences between an automated process simulation vs a manual process simulation
  2. Discuss the different environments MAP can be performed in as well as the personnel training requirements specific to a MAP
  3. Recognize the application of different equipment used in a MAP and how to handle the challenges of a manual process not presented during an automated process
  4. Evaluate a MAP case study

Standard Registration

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See Qualifying Criteria for Member Types.

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].

Day 1

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

Agenda is subject to change.

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.

Please visit the hotel’s website for more information.

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.