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

Bethesda, MD
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The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile. Processes using all or partial manual procedures must be evaluated by process verification testing. However, manual operations present unique operational and evaluation challenges not generally encountered with automated operations. For instance, manual aseptic processes rely heavily on individual operator proficiency, which is generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. This and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol.

Based on PDA’s Technical Report No. 62: Recommended Practices for Manual Aseptic Processes, this training course will provide insight into the technological challenges associated with designing, operating and evaluating manual aseptic processes. Participants will come away with an understanding of how manual aseptic processes differ from automated ones, and what should be addressed as they work with manual aseptic processes at their own plants. Participants will also have the opportunity to design, test and evaluate a protocol to perform a manual process simulation.

  1. Discuss the challenges associated with manual aseptic processing
  2. Describe the elements involved in the design of a manual aseptic process
  3. Explain the elements associated with training and qualification of personnel involved with manual aseptic processing
  4. Explain the differences to be considered when designing manual aseptic processing operations in unidirectional air flow and in isolators
  5. Design a protocol for the conduct of a process simulation test for manual processing
  6. Apply the lessons learned to the design and conduct of manual aseptic processing operations in their jobs

Early Bird Pricing

Early Bird Member Price

$3,419

GovernmentMember Only

$2,279

Health AuthorityMember Only

$2,279

AcademicMember Only

$2,279

Non-Member

$4,103

Standard Pricing

Standard Member Price

$3,799

GovernmentMember Only

$2,279

Health AuthorityMember Only

$2,279

AcademicMember Only

$2,279

Non-Member

$4,559

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].

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 , USA

The following hotels are located near the training course location:

Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814

Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814

Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814

DoubleTree by Hilton Hotel Bethesda
8120 Wisconsin Avenue
Bethesda, MD 20814


Please visit the hotel’s website for more information.

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.