In order to avoid these undesirable effects on the filter assembly from improper autoclave or in situ steam (Steam-in-Place or SIP) sterilization, operators require a solid understanding of the conditions necessary to achieve sterility of the filter assembly or filtration system, while simultaneously preserving the integrity of the filter and other system components.The goal of this training is to prepare operators to successfully steam sterilize a filter assembly without causing damage to the filter.
课程描述The course is designed for manufacturing operators and relevant staff to secure an understanding of autoclaving and SIP, from terminology of steam sterilization (as discussed in PDA Technical Report No. 1)² to basics of good sanitary design.In addition to discussion of recommendations for successful autoclave and SIP processes such as those in PDA Technical Report No. 26, examples of stepthrough simulations of proper SIP processes of common system designs will be examined.
- Courses designed and led by experts in biopharmaceutical filtration applications
- Each course is customized to ensure maximum relevance to your operation following 1:1 discussion with our training experts
- Ensures optimal use of training budgets
- Can be held locally or at 颇尔’s specialized training facilities
- 颇尔 staff can work with your local training department to ensure course meets any specific requirements
- Manufacturing operators, supervisors, and managers requiring a working knowledge of moist heat sterilization techniques
- QC/QA staff
- Validation, process and project engineers
¹ Parenteral Drug Association (PDA) Journal of Pharmaceutical Science & Technology:Technical Report No. 26:Sterilizing Filtration of Liquids (Revised 2008); 2008 Supplement; Volume 62, No. S-5; Section 8.0:Sterilization Of Filters, page 40, paragraph 1
² PDA Journal of Pharmaceutical Science & Technology - Technical Report No. 1 (Revised 2007):Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control
Overview of Filter Sterilization
- Methods/Key Aspects
- Filter Construction
- General Precautions
- Industry Guidance for Filter Sterilization
- Steam and Steam Saturation
- Why SIP?
- Overview of Autoclave Sterilization
- Lethality and Fo Value
- Air and Condensate Removal
- Basics of Good Sanitary Design
Autoclave Sterilization Recommendations
- Simulations of Autoclave Processes
Steam-In-Place Sterilization System
- Simulations of SIP Processes
- Demonstration using live steam (if applicable)
- Practical Workshops to Examine Typical Issues
Course ObjectivesThe course delivery and content is customized to ensure that attendees:
- Can use steam to sterilize a filter
- Understand how to prevent damage to a filter of a system when sterilizing via SIP
- Understand good design principles for a system to be sterilized via SIP
- Understand the challenges of successful autoclave and SIP processes
- Course includes the discussion of critical factors to consider in the steam sterilization process, a practical section to examine successful system design to be sterilized via SIP, as well as extensive troubleshooting sections to discuss issues encountered during SIP.Real-world scenarios are analyzed in workshops for troubleshooting and optimization
- A Certificate of Training is included for all attendees who have successfully completed the course
Course DurationTraining can be provided in a half day or full day depending upon your specific needs and depth of training required.
位置On-site or at 颇尔’s local training facility.
费用Charges are based on customized course content.颇尔 provides a fixed price in advance based on agreed course content prior to finalizing course agenda.
|Training at customer site (Half Day)||PTS03C05SIP|
|Training at customer site (Full Day)||PTS03C10SIP|