WHY FILL•TEK
Made for the way
your process runs
Your process has unique requirements, so we designed Fill•Tek with the flexibility to meet you where you are.
Specify the bag sizes, quantities, and fill volumes your steps call for, and our team of experts uses our validated modular platform
to build a custom fill line to match. We formulate, dispense, and test a single batch, then release it as one lot that arrives ready to use.
Set the fill volume bag by bag. Take full bags when your process is running at capacity, or partial fills when you need less.
Fill volume
Full bags Partial fills
Customize the connectors on your bags to match your system, so your product connects to your process without adapters or rework.
We fill QC samples in the size and number you choose to help streamline your incoming QC testing. Every order includes a 250 mL sample bag that is composite-filled to meet USP <71> standards. You can request additional custom-size sample bags and specify your sampling points: for example, samples filled after every third bag, to confirm consistency across the lot.
If you prefer to draw down inventory over time, we can hold your lot and ship it in stages, with a sample included in each designated shipment by request. We can also fill your stability study samples from the same batch.
Fill•Tek orders are formulated as a single batch and dispensed into the bags you specified so that your product is delivered as one single lot.
Our production batches run from 8 L for development quantities up to 2,000 L for commercial supply, so the same formulation follows your program from the bench to market, without having to qualify a new supplier. Learn more about our low minimums for custom orders.
Batch volume
8 L – 2,000 L (RUO, RUO+) 25 L – 2,000 L (GMP)
Fill•Tek orders are dispensed through a single filter. Our team matches the membrane to your product type and the pore size to your quality requirements, so there are fewer variables to document across the lot.
Membrane
PES (standard) PVDF Nylon PTFE
Pore size
0.1 µm (standard) 0.2 µm 0.45 µm 0.04 µm Bilayer configurations available
The entire process is validated as aseptic, from assembly through fill. Our experts bring every fill line together in our ISO 7 and ISO 8 cleanrooms, so each build is fully custom and fully validated.
No, you do not need to request it. When you send us a custom bag order, our team of experts reviews your requirements and determines how to best dispense it. Orders that combine bag sizes, call for quantities outside our standard fixed manifold designs, include additional sample bags, or need every bag from a single lot are where Fill•Tek delivers the most value. However your order is filled, lead times stay exactly the same.
You can customize the bag size and quantity, the fill volume, the size and number of your QC sample bags, your sampling points, and your connectors. Our experts handle the rest, including matching the filter membrane and pore size to your product.
You can order the exact quantity you want, down to a single bag, as long as your total order meets our batch minimum. Batches start at 8 L for RUO and RUO+ and 25 L for GMP, and run up to 2,000 L. Learn more about our low minimums for custom orders.
Need less than a full batch? We are happy to fill only the bags your process requires, but please note that the minimum production batch size will be priced into your quote.
Our filling process is currently validated for up to 16 bags in a single lot, including any additional sample bags you request. Those 16 can be any combination of sizes, up to 2,000 L total. Every bag comes from the same batch, so the whole order releases as one lot with one COA. If your process needs more bags per lot, talk to our team to discuss how we can support the additional validation your specifications would require.
Yes. We can hold your lot and ship it in stages on your schedule, with a QC sample included in every shipment if requested.
Fill•Tek is available in RUO, RUO+, and GMP manufacturing grades, so you can stay with one supplier as your program moves from research into commercial manufacturing. Learn more about our manufacturing grades.
There is no added time for ordering multiple bag formats in one lot. Fill•Tek runs on the same lead times as any of our custom orders, with standard timing of three weeks for RUO, four weeks for RUO+, and eight weeks for GMP, and our Express•Tek℠ Production service is available if you need it even faster. Learn more about our lead times for custom orders.