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Recommended Practices for Manual Aseptic Processes

Mar 22 - Mar 22, 2018 |
Mar 22, 2018 |
Loews Sapphire Falls | Orlando, FL
  • Education
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile during these operations. For large scale automated operations where operator interventions are infrequent, the verification of the ability of the process to produce sterile product is evaluated by the 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. However, such manual operations present unique operational and evaluation challenges not generally encountered with automated operations. Manual aseptic processes rely heavily on individual operator proficiency. However, operational personnel and their activities are generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. Reproducible human performance cannot be assumed over time.

These and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol. This course will provide a description of how to address the challenges posed in design, control and evaluation of manual aseptic processing. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual aseptic processing process simulations will be covered. The course is based on a PDA Technical Report addressing the same subject.

This course will provide valuable practical insights into the technological challenges associated with designing, operating and evaluating manual aseptic processing. 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 in their own plants. They will also learn how process simulation testing to evaluate manual aseptic processing operations should be designed and carried out.

Who Should Attend

This course will be of value to operational personnel who design, carry out and evaluate manual aseptic processing; including personnel involved with compounding, filling, packaging, and quality assurance operations. Support staff, such as engineering and validation personnel will also benefit. The course will be suitable for supervisors and managers as well as personnel engaged in manual processing operations.

Upon completion of this course, you will be able to:

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



On or before February 5, 2018

After February 5, 2018


On or before February 5, 2018

After February 5, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by February 20, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


This course will take place at:

Loews Sapphire Falls Resort
6601 Adventure Way
Orlando, FL 32819
Phone: +1 (407) 503-5000


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Cheryl Custard, Principal/Owner, Custard Consulting Group

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #216 | ACPE #0116-0000-14-061-L04-P | 0.6 CEUs
Type of Activity: Knowledge

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 6 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 6 PDHs.