In many applications, hydrophobic gas sterilization filters are reused or referred to as long-term use. The user of the filter first needs to refer to the manufacturer's manual, focusing on the cumulative sterilization cycle that the filter can withstand and the correct sterilization process to prevent the sterile production process from being compromised due to excessive use of the filter. The user cannot determine the actual life of the filter based solely on the data under laboratory conditions provided by the manufacturer, and the impact of actual process conditions needs to be considered.
The options for repeated/long-term use are as follows. Special attention is paid to the increasing risk of the following methods. Users should conduct risk assessment and selection according to the specific process requirements:
• Install the filters in parallel, and when one is in use, the other can be tested for integrity and pre-use.
• Use redundant filters, such as two filters connected in series, using a combination of periodic integrity checks and periodic replacements.
• Periodic integrity testing and periodic replacement, combined.
• Perform integrity testing only after the first sterilization.
• Perform integrity checks only after the installation is complete.
• Do not detect integrity and rely solely on historical data to determine the replacement cycle.www.inocofiltration.com