Technical Report No. 62: Recommended Practices for Manual Aseptic Processes
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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.
- Discuss the challenges associated with manual aseptic processing
- Describe the elements involved in the design of a manual aseptic process
- 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
- Design a protocol for the conduct of a process simulation test for manual processing
- Apply the lessons learned to the design and conduct of manual aseptic processing operations in their jobs
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$3,799GovernmentMember Only
$2,279
Health AuthorityMember Only
$2,279
AcademicMember Only
$2,279
Non-Member
$4,559
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.
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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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PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, 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.