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.
特色及优点
- 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.
谁需要参加
- 需要完整性检测方面的工作知识的生产操作者,监管者和经理。
- QA/QC staff
Integrity Test Training Courses
As 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.补充注释
- 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.
Course Content
-
Filter Overview/Basics
- Filter Purpose
- Filter Construction
- Lot Number
-
Integrity Test Basics
- Why Integrity Test?
- Test Requirements
- Regulatory Requirements
-
Types of Integrity Test
-
Destructive Tests
- Bacterial Retention
-
Non-destructive Tests
- 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
- 故障排除
- Summary/Wrap Up of Basic Training Session (“pre-practical summary”)
- Integrity Test Instrument Training
- Discussion/Q&A
Course Objectives
The 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 Duration
Training 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.
订购须知
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.