At ApiJect, we're advancing Blow-Fill-Seal to make sure that it may be the main container that delivers a wide array of parenteral medicines and vaccines. This will permit a lot more pharmaceutical and biotech organizations to consider using BFS as a suitable aseptic filling method for his or her liquid drug items.
It really is essential to consult the machine’s user guide and Keep to the advisable running parameters for exceptional general performance and solution excellent. The most crucial parts of the Blow fill seal equipment (BFS)
Bill supplies a powerful qualifications in State-of-the-art aseptic processing in blow/fill/seal and plastics, wherever he has several publications and displays around the matters. On top of that, Bill is around the Board of administrators to the BFS IOA and it has comprehensive practical experience in The only-Use “Disposables” Marketplace wherein plastics are the primary Speak to materials for biologic manufacturing.
Results from gasoline and water vapor permeation through the partitions of BFS containers may additionally need to be assessed in a very stability method. Both equally standalone and comparative steadiness studies with glass are required to demonstrate that plastic is a suitable different.
BFS is definitely an aseptic filling technology, but in the case of injectable products there is a regulatory need to execute an overkill terminal sterilization (Should the product or service can face up to the technique). The most common route for sterilization is steam autoclaving. The check here typical here is 121 °C.
We welcome you to join our pipe sealing professional, Will Hoffman inside of a webinar on pipe penetration seals inside the marine and offshore industries.
Once more, we’re managing a approach which was not Beforehand carried out so this was a first of its kind for us dealing with a vendor to develop this,” he mentioned.
Balance details like aggregation, chemical degradation, affinity and leachables indicated no substantial variances between glass and ADVASEPT container techniques. While it's tricky to extrapolate from protein to protein, the research shown that BFS is actually a viable and economical process to produce aseptically filled biologic formulations.
Various equipment styles call for diverse quantities of BFS molds, starting get more info from only one mould to your list of up to 20 duplicate molds.
The BFS course of action is sterilised in situ along with the sterile boundary is not really breached, practically removing the hazards associated with human intervention.
- supplies superior efficiency by using a 30:1 air amplification ratio that is definitely less efficient when compared to the Super Air Knife. It is actually a sensible choice every time a less costly option is necessary.
Reply: Important parameters incorporate heating temperature, heating time, and uniform heating to make certain proper plastic substance movement and molding.
Vaccines can also be coming to light-weight in regard to potential pandemic outbreaks. In this instance BFS technology can Participate in a task from the manufacture of large vaccine quantities in a brief length of time. The quality problem around glass and suppliers ability to promptly enormously broaden source in a short length of time is thought – e.g. It is impossible to head out and purchase two hundred million syringes tomorrow.
We'd be joyful to advise you on this: Simply just fill out the form under and tell us which compound you want to employ to test our blow-fill-seal packaging. We are going to then get in contact with you.