What are we talking about?
Aseptic sampling systems (ASESS: Aseptic Sampling Systems) are single-use, disposable systems, gamma-irradiated, designed for the aseptic sampling of fluids at various stages of pharmaceutical and biopharmaceutical processing. They minimise the risk of false positives and reduce cleaning requirements compared with traditional sampling systems.
Single-use aseptic filling lines offer customised solutions for the final filling of pharmaceutical products, overcoming flexibility and productivity constraints often encountered with more conventional equipment.
These ready-to-use filling assemblies, gamma-sterilised, are designed not only to ensure regulatory compliance, but also to enhance product and operator safety.
These configurations ensure:
- Short lead times
- Product safety
- Operator safety
- Reduced risk of cross-contamination
- No cleaning validation required
- Increased flexibility and productivity
These ASESS systems are customised to fit new or existing processes. They are designed in compliance with regulatory requirements such as “final sterile filtration must be performed as close as possible to the filling point” and “the integrity of the sterile filter must be verified before and after use” (Good Manufacturing Practices – GMP).
However, combining these two requirements within an Isolator/RABS* system is challenging.
* Restricted Access Barrier System
Single-use filling lines for isolator/RABS
These ready-to-use gamma-sterilised systems can be supplied in a specially designed bag with a Beta port for transfer into and out of an isolator or RABS.
These pre-validated, pre-assembled and pre-sterilised systems, including bags, tubing, connectors, filters and filling needles, placed inside a beta-port bag, allow easy and secure insertion and removal.
Customisation
The technical feasibility of the required design is established based on available components. A schematic must validate the design. Product prototyping and final approval then lead to the manufacture of a user-specific system.
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