- What do you recommend if my resin is not on your commonly packed resins list?
- What is the lead time for OPUS® columns?
- Do OPUS® columns have a shelf life and expiration date?
- How can my QC department perform identity testing of the resin when the GMP OPUS® column arrives?
- What happens if I receive a column that was damaged during shipping or did not meet my specified criteria?
- What types of materials are used for product contact components in OPUS® columns?
- Are OPUS® columns reusable?
- How is the correct amount of resin determined and dosed during the packing process?
- Is it possible to take the packed resin out of the column?
- In your OPUS® format, are there resins which cannot be unpacked?
- Is it a requirement to purchase a tubing set with each OPUS® R column?
- Are OPUS® columns compatible with conventional and disposable flow path chromatography systems?
- Can you tell me more about solvent compatibility of OPUS® columns?
- What happens if air gets into the packed bed of the column?
- What are the connection and port flow path sizes for OPUS® 10 cm - 60 cm columns?
- What is the pressure rating for OPUS® 10 cm - 60 cm columns?
What do you recommend if my resin is not on your commonly packed resins list?
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® column applications lab, will determine critical parameters which will be used as input to the packing process for pre-GMP and GMP OPUS® columns.
What is the lead time for OPUS® columns?
Lead time for OPUS® columns is 6 to 8 weeks. This may vary due to column configuration and/or resin lead time. Please contact your local sales representative or Repligen Customer Service for additional information.
Do OPUS® columns have a shelf life and expiration date?
- 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
How can my QC department perform identity testing of the resin when the GMP OPUS® column arrives?
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.
What happens if I receive a column that was damaged during shipping or did not meet my specified criteria?
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.
What types of materials are used for product contact components in OPUS® columns?
OPUS® 10 cm – 60 cm ID 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.
OPUS® 1.2 cm – 8 cm ID 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.
Are OPUS® columns reusable?
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.
How is the correct amount of resin determined and dosed during the packing process?
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
Is it possible to take the packed resin out of the column?
OPUS® columns are not designed to be taken apart. OPUS® 45R and 60R columns enable resin to be unpacked. Click here for more information.
In your OPUS® R format, are there resins which cannot be unpacked?
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.
Is it a requirement to purchase a tubing set with each OPUS® R column?
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.
Are OPUS® columns compatible with conventional and disposable flow path chromatography systems?
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.
Can you tell me more about solvent compatibility of OPUS® columns?
Solvent compatibility of OPUS® columns are summarized in the table below:
What happens if air gets into the packed bed of the column?
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 – 60 cm ID column User Guide for detailed instructions on recommended connection strategies.
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.
What are the connection and port flow path sizes for OPUS® 10 cm - 60 cm ID columns?
What is the pressure rating for OPUS® 10 cm - 60 cm ID columns?