To obtain approval for the procurement of 30 x 0.1 micron capsule final filter

RFQ/OBP043/2025/26

All viral and bacterial vaccines are being filtered through a 0.45/0.2 µn pre and 0.45/0.2 µn and 0.2/0.1-micron final filter. For oils and serum, we start filtering with a 0.3-micron pre filter. Up to 45 batches per week are filtered depending on the production schedule. The filters for the Water Plant and Softener vary from 0.2 µn 5 inch up to 20 inch and the water filters from 8 µn to 90 µn filters. There is a 0.2 µn air filter on top of each 50L tank. The water filters protect the RO membranes, and the air filters are protecting the tanks from pressure build up and collapsing. The air filter protects the filtration tank from collapsing after sterilization and helps when media is filtered into the 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) 5- For liquid filters membranes need to provide high flow and low protein binding as membranes with high binding capacities may remove actives from product being filtered. Preferable membranes are Cellulose Acetate and Polyethersuplhone. All filters should be pre-flushed with ultra-pure water before final assembly. Products at OBP all have high protein actives and therefore it is essential that membranes used have low binding capacity. For air filters membranes need to be PTFE to prevent membranes from wetting out and there preventing gas flow. 6-Integral prefilter layer is a big advantage as it saves the cost of a pre-filter. 7- Cartridges should show data regarding regenerations for re-use and a minimum autoclave cycle at 121Deg C of 30 cycles. The following mediums are using the following filters: Bacterial medium Final Filter Pre-Filter TAS 0.2/0.45 µn 0.3 µn Leukopast 0.2/0.45 µn 0.2/0.45 µn RPMI medium 0.2/0.45 µn 0.3 µn Oils 0.2/0.45 µn Bot C and D medium 2 x 0.3 µn Saline 0.2/0.45 µn Saponin 0.2/0.45 µn 0.2/0.45 µn Viral medium Eagles 0.2/0.1 µn 0.3 or 0.2/0.45 µn Peptone Sucrose 0.2/0.45 µn 0.2/0.45 µn BLP 0.2/0.45 µn 0.2/0.45 µn 2SP 0.2/0.45 µn 0.2/0.45 µn ATV 0.2/0.1 µn 0.3 or 0.2/0.45 µn Alsevers 0.2/0.1 µn 0.3 or 0.2/0.45 µn Dispase 0.2/0.1 µn 0.3 or 0.2/0.45 µn Earls 0.2/0.1 µn 0.3 or 0.2/0.45 µn Penicillin 0.2/0.45 µn PBS Dulbecco 0.2/0.45 µn PBS Blood 0.2/0.45 µn 0.2/0.45 µn PBS without Ca / Mg 0.2/0.45 µn 0.2/0.45 µn Sterile Water 0.2/0.45 µn Streptomycin 0.2/0.45 µn Gentamycin 0.2/0.45 µn Phenol Saline 0.2/0.45 µn 0.2/0.45 µn Water plant and Softener Ro Plant 8 µn Water filter 0.2 µn air filter 10inch WFI plant 0.2 µn air filter 5 inches 0.2 µn air filter 20 inches Water Softener 90 µn Water filter 20 inches 50L Tank air filters 50 L Filtration tanks 0.2µn

Request for Quote

2025/05/25 15:00:00

No

RFQ/OBP043/2025/26