AseptiProbe™ Bellow Assembly
Single use mixer systems and bioreactors require real time monitoring of various critical process parameters (CPP) such as pH, conductivity, dissolved oxygen etc. These systems are also available with preinstalled single use sensors, these disposable sensors have multiple challenges of in terms of accuracy, reliability, on site calibration etc. Such disposable sensors also reduce the overall residual shelf life of high value Single Use Mixers/ Bioreactors.
This makes reusable sensors the preferred choice, which can be calibrated and autoclaved before use for real time monitoring of CPPs in mixing (mixer systems) and cell culture expression systems (bioreactor).
mdi AseptiProbe™ Bellow Assembly provides easy to use aseptic connection systems for reusable sensors to Single use mixers and bioreactors.
| Materials of Construction | |
| Body | Silicone |
| Port Connector | Polycarbonate |
| Sterile Connector | mdi sterile connector |
| Specifications | |
| Autoclaving | Autoclavable at 125°C for 30 minutes |
| Microbial Ingress | Exhibit absolute resistance to microbial ingress against a challenge of 107 org/mL of B. diminuta |
| Bioburden Levels | Bioburden level is < 1000 cfu/device as per ISO 11737-1: 2018. |
| Bacterial Endotoxin Levels | Aqueous extracts exhibit <0.25 EU/ml as established by Limulus Amoebocyte Lysate (LAL) test as per USP <85>. |
| Assurance | |
| Fiber Release | Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release |
| Particle Release | Complies with USP <788> test for particulate matter in injections |
Please contact your local mdi representative or click on the link below for contact details.
| Datasheet | Download |