pall,颇尔,过滤器灭菌培训 - 最佳实践,PTS03C05SIP, PTS03C10SIP

产品名称:
过滤器灭菌培训 - 最佳实践
产品型号:
PTS03C05SIP, PTS03C10SIP
产品描述:

产品介绍

pall,颇尔,过滤器灭菌培训 - 最佳实践,PTS03C05SIP, PTS03C10SIP
pall,颇尔,过滤器灭菌培训 - 最佳实践

过滤器灭菌培训 - 最佳实践
One of the primary elements of a successful sterilizing filtration process is the sterilization of the filtration assembly¹, most commonly achieved using steam under pressure².Examples of processes requiring sterilization of sterilizing-grade filters are cell culture media and fermentation air, sterile bulk filling, sterile tank vents, and sterilization of drug product prior to aseptically filling.If not conducted properly, the steaming of filters can result in filter damage due to excess temperature, high differential pressure, or degradation of the materials of construction¹.

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.

 

 

特色及优点

  • 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

谁需要参加

  • 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

 

Course Content

  • Overview of Filter Sterilization
    • Methods/Key Aspects
    • Filter Construction
    • General Precautions
  • Industry Guidance for Filter Sterilization
  • Steam Basics
    • 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)
  • 故障排除
    • Practical Workshops to Examine Typical Issues
  • Discussion/Q&A

Course Objectives

The 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

补充注释

  • 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 Duration

Training 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.
 
描述 Part Number
Training at customer site (Half Day) PTS03C05SIP
Training at customer site (Full Day) PTS03C10SIP
 

 


pall,颇尔,过滤器灭菌培训 - 最佳实践
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