Millipore Technical Publications |
 | Data Sheet - VB004 | |
Integrity Testing Training and Certification, VB004A course teaching current theories and methods of integrity testing | ||
| Authors: | ; VB004 | |
| Citation: | VB004 | |
| Year: | 1999 | |
| ||
Hundreds of people from more than 30 multinational companies have attended Millipore's two-day certification course on integrity testing. The course objective is to teach participants membrane filter integrity testing theory and methods. Experienced instructors combine hands-on laboratory exercises with interactive classroom instruction to present the most up-todate methods of integrity testing.
Attendees perform bubble point and diffusion integrity tests on several hydrophobic and hydrophilic cartridge filters. These manual integrity tests are conducted at individual laboratory stations. Each laboratory is fully-equipped with all the typical instrumentation of an integrity testing lab, including automatic testing equipment.
Millipore offers integrity testing courses several times throughout the year at customer sites and Millipore facilities. Attendees receive a complete training manual that includes all the information covered in the course. Small class sizes guarantee individual attention.
To achieve certification, participants are required to conduct integrity tests on filters with documented integrity test results. A comparison of the documented results and the students' results determine if the attendee has mastered the methods of integrity testing presented in the course. Millipore presents an integrity testing certificate to participants who successfully complete this requirement.
Who Should Attend?
This interactive course is designed for pharmaceutical, biotechnology and medical device manufacturing personnel who use integrity test filters. Participants should include quality and validation personnel, operators technicians and supervisors.Why Is the Course Offered?
Current Good Manufacturing Practices (CGMP) require operators to be experienced and trained on day-to-day operations, including integrity testing. According to the Code of Federal Regulations 21 CFR 211.25, "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education,training, and experience, or any combination thereof, to enable that person to perform the assigned functions." Millipore's Integrity Testing Certification course will prepare participants to meet CGMP criteria.
About the Instructors
A proficient group of people developed and teach the course. Laboratory instructors have extensive experience conducting filtration integrity tests for the medical device, biotechnology and pharmaceutical industries. Class instructors are current on integrity testing theory, practice and validation requirements. They are also knowledgeable about new industry standards and will share their knowledge and experience during the course.How to Register
To request a registration form, get more information, or discuss on-site training on Millipore's Integrity Testing Certification course, call your Millipore Applications Specialist or the Millipore office closest to you. This Certification Program at Millipore is only one of many validation programs in place that ensure Millipore products meet the high standards of the pharmaceutical industry.To Receive More Information on Millipore’s Access Services For additional information call your nearest Millipore office.