课程描述The Integrity Test Training is an interactive course designed for manufacturing operators and other relevant staff to assure an understanding of the integrity test from basics of filtration and integrity testing, regulatory requirements, various types of integrity tests, instruments used, troubleshooting, and hands-on application.
- Courses designed and led by experts in pharmaceutical and biotech 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.
- QA/QC staff
Integrity Test Training CoursesAs well as offering complete training at our customers’ production sites, 颇尔 also offers courses at either 颇尔 facilities or other approved locations with predetermined dates.This training has been established to accommodate organisations that have a preference for training sessions away from their own site.
- Course includes practical section using integrity test instrumentation, as well as a quiz to measure competency and understanding.
- Certificate of Training is included for all attendees who have successfully completed the course.
- Course evaluations help 颇尔 improve content and delivery of training.
- Filter Purpose
- Filter Construction
- Lot Number
Integrity Test Basics
- Why Integrity Test?
- Test Requirements
- Regulatory Requirements
Types of Integrity Test
- Bacterial Retention
- Bubble Point
- Forward Flow
- Water Intrusion Testing (WIT)
- Destructive Tests
Troubleshooting (Forward Flow/Bubble Point Tests)
- What To Do
- Industry Reference (PDA) Decision Tree
- Pre/Post Use Recommendations
Water Intrusion Test (WIT)
- Why WIT?
- Concept and Correlation
- Summary/Wrap Up of Basic Training Session (“pre-practical summary”)
- Integrity Test Instrument Training
Course ObjectivesThe course delivery and content is customized to ensure that attendees:
- Understand the importance of testing filters for integrity as a critical step in the manufacturing process to make sure that the filter functions as intended.
- Understand how the theory and practice of the range of integrity tests available differ.
- Can apply practical experience of operating manual and automatic integrity test instruments and systems.
Course DurationTraining can be provided in 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Wherever possible, 颇尔 provides a fixed price in advance.When this is not possible, 颇尔 will give an estimate to assist you in budgeting and cost control.The final invoice provides detail on items such as labor, materials, etc.