Frequently Asked Questions - OPUS® Columns
Repligen has experience packing many different resins from a variety of manufacturers. If Repligen has not had prior experience packing the resin of your choice, we recommend conducting a packing study. The packing study, performed in the Repligen OPUS® applications lab, will determine critical parameters which will be used as input to the packing process for pre-GMP and GMP OPUS® Columns.
- OPUS® Columns do not have an expiration date. Repligen recommends adhering to the expiration date of the resin pre-packed into the column.
- OPUS® Columns do not have a specified shelf life. However, QC stability tests shown below demonstrate that columns can be stored for a period of months without degradation in performance parameters.
QC Shelf Life Stability Test
- 18 months of data
- 20 x 15 cm columns packed with Sepharose® 4 FF
- Stored at 2-8 °C
- Acceptance criteria: As 0.8 – 1.6, N/m > 1500 @ 100 cm/h, and less than 15% change
- All columns tested for bioburden and endotoxin
Empty columns (10 cm, 20 cm, and 30 cm)
- Repeatedly tested for their ability to maintain pressurization at 4 Bar
- All have met specifications (+/- 10% for 60 mins) at 3, 6, 12, and 18 months
A small sample (10 – 30 ml) of resin is provided with every GMP OPUS® Column. A Repligen manufacturing operator draws the sample using a sterile pipette and dispenses it into a 60 ml gamma irradiated, tamper evident PETG (polyethylene terephthalate) bottle, which is shipped in the same box as the column.
If the column arrives at the customer site in damaged condition, Repligen will accept the damage risk and issue a replacement at no charge.
If the column fails passing specifications as agreed to on the OPUS® Work Order, Repligen will conduct troubleshooting efforts. If unsuccessful, Repligen will ask for the column to be returned for further evaluation. If the root cause of the failed test is determined to be a compromised packed bed, Repligen will pack a replacement at no charge.
If the column’s packed bed is compromised (i.e. a channel develops) and the root cause is packing, then Repligen will replace the column at no charge.
OPUS® 10 – 80R Columns are constructed from a medical grade polypropylene homopolymer, all product contact surfaces in these OPUS® Columns are EMEA 410/01 (or Animal Free) and Class VI Compliant.
| Component | Material of construction |
|---|---|
| 5 - 30 column tube | ポリプロピレン |
| 45R - 80R column tube | 70% w/w E-Glass / PP engineered composite structure |
| Flow distributors | ポリプロピレン |
| Inlet and outlet | ポリプロピレン |
| Bed support screens | ポリプロピレン |
| O-rings | Platinum-cured medical grade Silicone |
| Return line | Platinum-cured medical grade Silicone with a strong polyester fiber reinforcement |
OPUS® 1.2 – 8 Columns use different materials of construction and are not certified to be animal free or class VI compliant.
Additional product contact information is outlined in our Regulatory Support File.
A multi-cycle performance case study conducted with OPUS® Columns show they are compatible with multi-use applications, and can be used over long periods of time.
In general, Repligen uses the following approach for slurry preparation and percent solids determination.
- Decant off storage solution
- Perform defining of resin as specified by resin MFG.
- Suspended resin in packing buffer to target the desired % solids
- Combine resin bottles in a holding tank if required
- Pull resin samples
- Record mass and volume added for density calculations
- Spin samples in a centrifuge
- Read spin down solids volume
- Determine average % solids (solids vol. / total vol.)
- Assign target compression factor (CF = Target column vol./uncompressed resin vol.)
- Use empirical past data
- Resin manufacturer recommendations
- Repligen R&D recommendations
- Calculate target solids volume to add (Target bed volume / CF)
- Apply % solids (Step 9) and density (Step 6) to target solids calculations (Step 11) to determine mass of slurry required
- (Target solids vol. / % solids) * density = mass slurry to dose
Yes. Unpacking of non-compressible ridged media has not been studied and is not recommended. In general, these include Ceramic Hydroxyapetite, controlled pore glass, and silica based particles.
No, you do not need to purchase a tubing set with each OPUS® R Column. The tubing set is a standalone, off-the-shelf product, which will be available to ship within 1-2 business days of PO receipt.
Yes. OPUS® columns are compatible with conventional and newer disposable flow path chromatography systems. For more information about connecting and operating OPUS® Columns, please refer to the OPUS® Column User Guides.
Solvent compatibility of OPUS® Columns are summarized in the table below:
To reduce the risk of introducing air into the packed bed, the best defense is a robust connection and start-up method. Please refer to the Appendix in the OPUS® 10 – 80R User Guide for detailed instructions on recommended connection strategies.
View OPUS® 10-80R Column User Guide
If air has already been introduced to column, contact Repligen for recommendations on a bed reconditioning method to bring the column back to working order.
