PDA #103
Location: PDA TRI Training Facility, Bethesda, Maryland
Date: September 2 - 4, 2009
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Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.
Registration Fee
| Member |
Nonmember* |
Government/ Health Authority** |
Academic** |
Student |
| $3,650 |
$4,050 |
$2,000 |
$2,000 |
N/A |
|
All rates in US dollars.
* Registration fee includes a one-year PDA membership. No additional payment is required.
** Must be a PDA member to receive this rate. In order to take advantage of this discounted rate, you must register by faxing or mailing a completed copy of your registration form to PDA.
|
Course Description
This combination lecture and laboratory course will offer a unique combination of interactive sessions coupled with hands-on activities to provide the attendee with intensive understanding of steam sterilizer operating principles, effective use and maintenance. The course will include practical exercises using PDA’s Fedegari steam sterilizer. The subjects covered during the 3 day course include:
- Microbiology of steam sterilization
- F/D/z measurements / introduction to biological indicators
- Autoclave design / operating principles – exercise
- Autoclave types and load
- Regulatory considerations for steam sterilization
- Steam sterilization cycle development
- Bioburden / Biological indicators – BIER exercise
- Validation of steam sterilization theory & practice – exercise
- Steam sterilization utility requirements
- Sterilizer maintenance
Course Outline
Day 1
- Microbiology of sterilization / Order of microbial death
- F/D/z - > physical measurements
- Autoclave design /operation principles (at sterilizer)
- Gravity
- Pre-vacuum
- Controller demonstration
- Types of loads / types of sterilizers
- Parts / Porous Loads
- Terminal / Liquid loads
- Minimum / maximum loads
- Regulatory perspectives 1
- FDA / PDA / USP
- EMEA / Annex 1 / EP
Day 2
- Cycle development
- Component Mapping
- Load Mapping
- Stability
- Cycle composition by controller
- Bioburden / Biological Indicators (BIER demonstration)
- Validation
- Autoclave validation exercise (at sterilizer)
- Gravity (lethality mapper)
- Pre-vacuum (air detector)
Day 3
- Utility Requirements
- Maintenance
- Calibration
- Preventive Maintenance
- Change control / software upgrade
- Re-qualification / Re-validation (remote access of sterilizer)
- Regulatory Perspectives 2 (demo at sterilizer at the end)
- EN 285 / ISO 17665 / HTM-2010
- Steam quality
- Equilibration time
- Air detection
- Parametric Release
Who Should Attend
The course provides practical guidance and hands-on exercises for the attendee that they can apply with their steam sterilization equipment. It also useful for individuals seeking to gain greater familiarity with steam sterilization processes.
The course is intended for personnel working in validation, sterilization microbiology, sterile production and quality assurance personnel. The focus of the course is pharmaceutical and biotechnology applications, but portions are appropriate to the medical device industry as well.
Prerequisites: A working knowledge of sterilization procedures is needed with an educational background in the sciences. No knowledge of microbiology is required.
Objectives
At the completion of this workshop the participant will be able to:
- Understand the basic principles of steam sterilization processes
- Understand the relationship between microbiological and physical methods for sterilization and where each is more appropriate
- Effectively use biological indicators for steam sterilization validation
- Qualify / validate steam sterilization processes
- Better understand the regulatory environment for steam sterilization
Faculty
James Agallaco, Agallaco & Associates
James Agallaco is the President, Agallaco & Associates , providing a range of technical services to the pharmaceutical and biopharmaceutical industry specializing in the areas of validation, automation and compliance. Agallaco has over 30 years of industry experience. He was formerly Director, Worldwide Validation and Automated Technology for Bristol-Myers Squibb and has worked in pharmaceutical production, project and process engineering at Merck and Pfizer.
Mr. Agallaco is past President of the Parenteral Drug Association, and served as an Officer of Director from 1982 to 1993. He has served on numerous PDA committees and is still an active member of the PDA. Agallaco has authored or co-authored over 90 papers and lectured extensively on sterilization, aseptic processing and validation at various PDA, PMA, ISPE and Pharm Tech meetings globally.
John Gillis, PhD, SGM Biotech Inc.
Location
The course will be held at the PDA Training and Research Institute:
PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814
USA
Contact
For more information, please contact:
James Wamsley
Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 ext. 137
Email: wamsley@pda.org