Assembly Fill & finish
Here is an example of a fill and finish assembly. An assembly like this helps you save time while preparing the fill-and-finish step in the pharmaceutical production process. Such an assembly is delivered ready for use.
You no longer have have to execute CIP and SIP procedures because you can order a product like this gamma-irradiated, which makes it plug-and-play. Also, the sensor does not have to be calibrated.
Quality
Our single-use fill & finish assemblies consist of high-quality components, such as:
- Zenpure filters
- Overlook Oneshot filling needles
- SGPPL Pharmafluor FEP tubing, C-flex TPE tubing or silicone tubing from Sani-Tech
- Pendotech sensors
- Eldon James hosebarb connectors
- CPC AseptiQuick sterile connectors
All these components are qualified for use in cGMP environments. They are made of materials that comply with USP class VI and have well-documented extractable profiles.
Sterility
These fill and finish assemblies are assembled in our own cleanroom according to validated procedures. The TFF assemblies are part of our sterility program, which enables us to give a sterility claim on our gamma-irradiated assemblies.
Open architecture
In addition to our own standard range of single-use components, we can apply every component according to your specifications - as long as the components meet our minimum quality requirements. So you can specify the filter, the single-use tubing, or another sensor to have a single-use assembly built exactly to your wishes and requirements. In certain cases we may choose, in consultation with the customer, to source critical components such as a specific filter via the customer.
Flexibility
The assembly in the drawing below is an example. We can produce any desired design. You can supply a drawing yourself, or have one of our specialists make a design based on your application. After agreement on the design we can produce the assembly in any desired amount, with short delivery times.
Want to know more about these assembled and irradiated fill & finish assemblies? Contact us via chat, email of by phone +31 (0)297 - 514 714