What is the dead volume or hold-up volume?
It is approximately 2ml. However, the sampling tube from the bioreactor may have a hold-up volume of between 5-15ml depending on its length.
What is the sample volume withdrawn for flushing?
Typically the flushing volume will be less than 30ml.
Can I change the syringes myself?
Yes, but we would recommend doing this in a laminar flow hood and using Luer-Lok® syringes of any volume up to 60ml (typically the largest). In most instances, the standard sample size required is 2-5ml.
Note: Changing any part of the Bioreactor Sampler system would mean you have to take care with your aseptic technique and the user would have to be aware of the risk of contamination.
How do I then remove the sample syringe?
By sealing the tubing between the SNAP-FLOWTM valve and the syringe using the Aseptika Tube Sealer. It takes 2-3 seconds to seal the tube by radio frequency and the seal can be separated easily with your fingers, by pulling apart the two ends.
Do the seals come apart or leak?
No, this technique is ultra reliable, providing instructions have been followed. See instruction manual.
Does the Bioreactor Sampler tube need to be empty in order to seal it?
No, it works perfectly well when full of cell culture.
Can I double seal the tube to be sure?
Yes, in fact we recommend that you make 3 seals and separate the middle of these 3 seals. Essentially the tube is then double sealed at each end for extra security.
Can I use the Aseptika Tube Sealer to seal other tubes?
No, the Aseptika Tube Sealer is designed and validated only for the Aseptika Bioreactor Sampler and should not be used to seal other tubing, which may damage it and invalidate your warranty.
How do you stop the solution in the waste bag returning to the large syringe?
The waste bag has its own non-return valve to prevent solution flowing out of the bag back into the manifold or the flushing syringe. The overall effect is a uni-directional pumping system into the waste bag, where the large syringe acts as the pump.
Can I flush the sample line with air to remove all the cell culture by pushing the culture back in to the bioreactor or fermentor?
Yes. Up-stream from the first non-return valve is a Luer-Lok® needleless injection port to which the operator could attach a sterile filter and syringe. The filter should remain attached to the Luer-Lok® needleless injection port thereafter and can be used to push air through the sterile filter to displace cell culture in the sample line and back into the bioreactor or fermentor. Whilst this is achievable, great care should be taken not to introduce contaminants and not to block the filter with cell culture media. Generally, we do not recommend this because of the risks of contamination and the flushing of the sample line into the waste bag makes this unnecessary and more complicated to operate than it needs to be.
If I only have a single sample line to my bioreactor and I also use this to inject other solutions (e.g. antifoam, IPTG, media, nutrients, etc) how do I do this if I’ve used the sample line to connect the Bioreactor Sampler?
(a) Either create a ‘T’ piece to split the sample line;
(b) Or use the needleless injection port up-stream from the first non-return valve to connect an additional tube or inject solution into the bioreactor via this port. The up-stream needleless injection port therefore acts as a ‘T’ piece (female Luer-Lok®).
For autoclavable glassand stainless steel bioreactors, how would you make an aseptic connection if you dont have a tube welder (which are very expensive)? Do you provide the appropriate Leur-Lok connection on the bioreactor side which can be autoclaved? Is the connection normally carried out in a laminar or can the ends be flamed before connection?
Very good questions! Aseptika can provide the same needless injection port that is incorporated into the Bioreactor Sampler, as a connector for a glass/steel system. These survive autoclaving once, but we would not recommend pushing them too hard by repeatedly autoclaving them. These needless injection ports are great connectors and can be supplied separately or attached to C-Flex tubing (for example, 20cm long, ID of 0.125 inches (3.2mm) and an OD of 0.25 inches (6.2mm), although other tubing can be supplied or sourced by the operator). Once the bioreactor is removed from the autoclave (if it is portable) it could be positioned such that the sample line from the bioreactor extends into a flow hood and the connection is then made under aseptic conditions. If the autoclave is not portable (i.e., is Steam in Place) then the connection could be made by spraying the needless injection port attached to the bioreactor with alcohol, and holding a flame within 10cm of the connector, making the connection to the Bioreactor Sampler. This requires some skill in aseptic techniques and should be practised before performing the procedure for real. Flaming the needless injection port can be done WITH GREAT CARE as they are plastic but should be avoided as over-heating will cause it to melt, distort and may no longer seal. A few seconds soaking with a spray of alcohol should be sufficient, and in the vicinity of a flame, the pocket of sterile air should be maintained. Clearly, great care should be taken with alcohol in the presence of a naked flame. If necessary, the flame may be omitted, but this does increase the risk of contamination. A picture of the needless injection port can be found via the following link: Click here.
Why is there a second Needleless Injection Port on the manifold?
This can act as yet another way of connecting other devices. This port can be readily cleaned and sterilized by spraying with ethanol and then by connecting to a male Luer-Lok® connector. This means you can add other devices, such as a continuous sampler, or even another sampler set to give limitless flexibility.
What are the materials made of?
All the materials of the Bioreactor Sampler are medical-grade USP Class VI. Data sheets on every component are available upon request. Note: The device is designed for research purposes only. However, cGMP-validated versions will be available in the future. Please contact us if you need a GMP-validated version immediately.
How is it sterilized?
Each Bioreactor Sampler is double wrapped and sterilized by Gamma Irradiation to 25-40 KGy to ensure sterility.
How are they manufactured?
The Bioreactor Sampler is manufactured under Class 10,000 clean room conditions to ensure the highest standard of cleanliness. Every batch of components is documented and the batch number of each component is recorded for each Bioreactor Sampler. Every Bioreactor Sampler has its own unique serial number and bar code, for future cGMP manufacture traceability.
If I want a different configuration of sampler, is this possible?
Yes, we will consult and work with you to design the configuration that meets your needs. Lead time is typically 6-8 weeks. Please contact us for further information.
What is the shelf-life of the Bioreactor Sampler?
We specify that the shelf life is 2 years.
What is the Warranty period?
We provide a warranty for the Aseptika Tube Sealer for 1 year. We warrantee the Bioreactor Sampler against defect for 3 months, which is limited to the replacement of the defective Bioreactor Sampler.
Can I use the Bioreactor Sampler in place of Category II Containment? Nothing should escape - right?
The use of the Bioreactor Sampler should significantly reduce or eliminate human exposure to the sample. However, this cannot be used as a replacement for proper containment facilities, in accordance with local regulations and Health & Safety policies. If you are in any doubt about these policies, you must consult with your local Health & Safety advisor. Using the Bioreactor Sampler should therefore be seen as an enhancement of, rather than a replacement for, your containment procedures