Aseptic filling, also known as sterile filling, remains one of the most critical processes in pharmaceutical and biopharmaceutical manufacturing. Its highly technique-driven processes and the potential safety impact to the end user require expertise and the highest level of quality. The safegards that must be in place for each batch are typically so involving that most asceptic filling manufacturers will not take on projects with requests of low vial numbers. There is very little available in the way of custom processes and requests.
Excite takes a different approach.
We Take our clients formula and compounds to their specifications and when that compound passes any in-process testing that is required of us then we are allowed to move forward. We have multiple ways of going about filling. Excite specializes in manual fills as well as fill line fills – both of which we are performing aseptic fills predominantly for the injectable market. An injectable, for instance, needs to be fully sterile because it is either A. going into an IV solution that is going into your blood stream or B. sometimes going directly into your blood stream from the vial.
To specialize in aseptic filling, we utilize the .2 micron sterilizing filter which removes all the microbe activity weather it is microbes of skins cells, soil, bacteria, pre-solution prior to getting into the vial.
Depending on what size the vial our clients choose, the final vial delivered is 2 mil, 5 mil or 10 mil. It will be a sterile solution in its final form ready for use. Our customers receive a finished product that is fully sterile, aseptic solution – ready to use. Weather that is into an IV diluted solution or direct inject.
Most clients come to us with a known volume – they know exactly what they want the end product to be, and they know how many vials they need. The issue many of our clients run into prior to contacting us is that they can’t get into a large filling operation because the numbers they want to produce annually are too low for most manufacturers to take on their project.
Excite solves this problem by offering high-end quality and service to low-number fill requests. smaller clients to come in and successful benefit their companies and ours. Our ability to work with and fill small numbers of vials makes us a perfect boutique option. We do things that can‘t (or won’t) be done at our larger competitors. The needs of our customers just aren’t being offered at the scale they need anywhere else.
One of the other advantages Excite offers is that since we are a GLP facility and a designated GMP facility, we have ability to handle both the analytical and the manufacturing side of our customers’ projects. From phase I, II, III through commercial, our customers have no need to take their projects anywhere else – or pay to transfer all the methods, protocols and validation between various organizations. By starting at the beginning of our customers’ pipelines, our analytical team is already familiar with the project(s), making the transition to commercial manufacturing much easier (and more cost effective).
That is not to say that we don’t accept projects that started their work elsewhere. We have several clients that transfer everything over and we do the manufacturing of their aseptic fillings. Again – the main reason why they come to us is because their volumes are not in the millions, they are inside the 10,000 range. Excite can manually fill minimal numbers of vials, syringes in a study setting but we also have the ability to manufacture both human and animal runs in the realm 5-10,000 units. We can fill minimal numbers for approval and then switch to the manufacturing side
Capabilities
Excite Pharma has multiple fill lines. We have one that specialized in the 2-20 ml range, one that specializes in the 100-500 ml range, and an ophthalmic line that can do a wide range volume – a multiheaded filler.
Any size bottle we can manually fill, depending on quantity requested for each batch. The manual fill is where we start to produce anywhere from 20 to 100 vials to get the client started. If a customer is only going to fill 500 units, they are better off doing a manual fill so as to utilize the most of their product and avoid wasting 10 liters getting a fill line ready to go.
If you have any questions about Excite Pharma’s aseptic filling services or any of our other analytical and manufacturing services, please contact us using the form below!
