RFQ/OBP143/2026/27
To procure and deliver 20 x 0.45+0.2 micron capsule final filters
RFQ/OBP143/2026/27
All viral and some of the bacterial vaccines are being filtered through a 0.45/0.2 µn pre and a 0.45/0.2 µn and 0.2/0.1-micron final filter. For oils and sera, we start filtering with a 0.3-micron pre-filter Up to 45 batches per week are filtered depending on the production schedule. There is a 0.2 µn air filter on top of each 50L tank. All filters used by Raw Material needs to comply to the following standards: 1- Products must conform and meet all FDA requirements including CFR21. 2- Products must meet all Biological Safety requirements for USP Class 6 for plastics at 121Deg C 3- Products must be accompanied with full Validation guide which must have full description of the following section USP Class VI for plastic MEM Elution Extractables substances (What filter can add to product being filtered) Full correlation of integrity testing with liquid bacterial challenge Log reduction values should be >7/cm2 of filter area. (This is amount of bacteria /cm2) 4- Filters supplied must come with complete COC including integrity test data (For Gas filters WIT data)
Request for Quote
2026/08/05 16:00:00
No