Bio Elpida can also handle semi-automatic filling of vials (Aseptic Technology®) with a dedicated equipment (filling and sealing) for ready to fill Crystal Closed Vials.
Of course, we are fully compliant with cGMP regulation and are able to perform such service for the production of clinical batches.
Fill & finish...
3 questions to Benoît PECH, Production Manager
What are the possible fill & finish methods?We propose three types of fill finish:
- Clean non-sterile filling,
- Filling followed by sterilization (autoclave or irradiation),
- Aseptic filling.
What are the possible aseptic fill & finish conditions for Bio Elpida?We have two environments, located in two distinct and independent Clean Rooms. The first one for the filling of finished product, is a 120 m² environment classified A in B (equivalent ISO 7) according to the GMP. The second one is used for the filling of active substance. It is a 70 m² environment classified A in C. We also have a level D working area that we use to manufacture the culture media used in the various productions or of non-sterile product.
Why a method rather than another?Our methods of aseptic fill & finish are adapted to experimental drugs that are often "precious" and very expensive to produce. We can distribute volumes ranging from 50 μL up to several liters, while reducing to its maximum dead volumes. The range of primary containers used varies a lot: glass or plastic bottles, ready-to-fill AT-Closed Vial® bottles, bags, syringes, etc.
A major asset of Bio Elpida is the flexibility of the solutions we can provide to our customers. It is also the close relationship we have that enables us to fulfill their requests. This diversity and these challenges are also a real source of motivation for our teams.