Millipore Technical Publications |
 | Data Sheet - VB005 | |
Filtration Process Reviews; VB005An on-site filtration process validation service offered by Millipore | ||
| Authors: | ; VB005 | |
| Citation: | VB005 | |
| Year: | 1999 | |
| | |
Filtration Process Reviews
An on-site filtration process validation service offered by Millipore Millipore filtration process reviews are conducted by Validation Specialists at your facility. The review covers allareas associated with your filtration process. Validation Specialists will identify and make recommendations to aid with local and worldwide regulatory standards. All aspects of your purification and filtration processes which could be of interest or concern to regulators will be addressed.Areas Reviewed
The filtration process review is a comprehensive evalution of your filtration operations. Below are the specific areas reviewed:
- Operator Training
- Filtration Equipment Assembly and Use
- Control of Filter Devices
- Documentation
- Process Control and Environmental Monitoring
- Sterilization of Filter Devices
- Water Systems Filtration
- Validation of Filter Devices
The Review Process
Millipore Validation Specialists conduct the review at your facility. Filtration operating procedures and protocols are examined to ensure they are in compliance with the filter manufacturer's operating specifications and CGMP. The reviewer will also verify that hands-on operating methodologies for integrity testing, equipment set-up, sterilization and filtration comply with internal documentation and recommended industry practices. Filter validation protocols, methodologies and reports are reviewed to ensure they contain the appropriate information, techniques and conclusions.
Immediately after the filtration process review, a Millipore Validation Specialist will meet with your management to discuss the findings. This meeting is a good opportunity for management to ask questions and discuss any problems identified during the review. Recommendations will be made and a summary report will be issued.
The Benefit of a Filtration Review
Problems in your filtration process can compromise sterility which results in down-time and lost profits. Millipore knows the importance of complying with CGMP and can help you optimize your operation. Validation Specialists from Millipore have years of experience in pharmaceutical process filtration and they will usetheir expertise to ensure your filtration process is operating correctly and within appropriate regulatory guidelines.
How to Request a Millipore Filtration Process Review
To request a Millipore Validation Specialist to visit your facility to conduct a Filtration Process Review or to get information on other validation services offered by Millipore, call your Millipore Applications Specialist or the Millipore office nearest you. The Validation Services program at Millipore is only one of many quality
programs in place to ensure Millipore products meet the high standards and regulatory requirements of the pharmaceutical industry.