BFS packaging represents a significant advancement during the aseptic packaging of pharmaceutical and Health care products.
So as to examination these biological solutions it was required to Use a facility that might allow for progress of safe merchandise packaging. maropack (Zell, Switzerland) installed the primary neat-BFS-technology into a BSL-2 rated facility to supply a location to fill and offer all distinct type of biological products.
The exam showed that with suitable parameter settings and procedure modifications the open up parison BFS technique also will allow approximation of your product’s remaining temperature profile.
On top of that, numerous Areas in the employee parking heaps are reserved for Power efficient autos as part of our LEED certification.
The standard and historically most popular sealing methods – and the issues linked to them
It is usually Utilized in the food stuff and pharmaceutical industries for packaging many items. This technology aids automate the packaging procedure, growing performance, and cutting down the need for manual labor.
Use our manual for assist in selecting the sealing Answer that most accurately fits your requirements and specifications.
Stability facts including aggregation, chemical degradation, affinity and leachables indicated no substantial dissimilarities in between glass and ADVASEPT container units. Whilst it more info is tough to extrapolate from protein to protein, the review demonstrated that BFS is actually a viable and cost-effective process to provide aseptically filled biologic formulations.
Thanks to our continual and sustained financial investment in new superior-velocity BFS strains, our significant producing potential will allow us to tackle new jobs of any dimensions at any time.
Within this aseptic filling process, a filling mandrel equipped using a dosing needle for each container guarantees the sterile solution is sent into the freshly fashioned containers.
Reply: The sealing temperature is determined according to the plastic product Houses, such as its melting temperature and desired seal top quality.
“A lot of the troubles a drug product or service developer faces When it comes to BFS are the exact same for regular filling traces, like glass vials,” adds Myers.
These resources offer overall more info flexibility in container design even though keeping the necessary barrier Homes to shield the contents from exterior contaminants.
BFS is made use of throughout the world to package deal billions of doses of both of those substantial and modest molecule sterile drug products every year, which include vaccines.