This Validation Guide provides information of PoreFilter PFL YP cartridge filter, including test methods,
performance, and specifications related to the pharmaceutical manufacturing process. This guide is
designed as a reference for the end user to validate PoreFilter PFLYP cartridge filter to meet requirements
of regulatory authorities within the pharmaceutical industry.
PoreFilter PFL YP cartridge filter contains a hydrophobic polytetrafluoroethylene (PTFE) membrane, which has a Brevundimonas diminuta (ATCC® 19146) removal rating of 0.22 m in liquids and a particulate removal rating of 0.0 I m in gases. PoreFilter PFLYP cartridge filter is designed for the sterile filtration of gases in pharmaceutical applications.
PoreFilter establishes and continuously maintains the company's quality assurance system in accordance with the requirements of ISO 9001:2015 quality management system and cGMP. All the products are manufactured under a strict quality system to ensure stable and reliable quality.
Raw Material Control
PoreFilter has established a rigorous supplier selection and periodic evaluation system. The core materials are selected from internationally renowned raw material suppliers and manage the suppliers hierarchically. The injection molding pellets, support layers, 0-rings and other materials or components are inspected according to the company's internal control standards to ensure the quality of raw materials is stable and reliable.
The entire manufacturing process of the PoreFilter filter from raw material storage to product packaging is completed in the ISO Class 8 clean area, which ensures the cleanliness of the product and prevents pollution. The air purification system is confirmed and maintained regularly to ensure that the cleanliness o f the environment continuously meets the requirements of ISO Class 8. The suspended particles, sedimentation bacteria, temperature, humidity, and differential pressure are monitored periodically to provide for a highly controlled clean environment.
Lot Release and Traceability
The sterilizing grade PoreFilter filter requires I 00% integrity testing before delivery. The test methods include bubble point, diffusion flow, and water intrusion. The specific test method can be found in the integrity test section of the quality certificate.
The product lot number and the serial number of PoreFilter filter are engraved on the cartridge cage. Customers can also find the corresponding product lot number in the product label and quality certificate. The product can be traced from the whole process o f raw materials, equipment, manufacturing process through the lot number and serial number.