Are You Looking for a Blow Fill Seal Alternative?
There are a number of reasons why Blow-Fill-Seal (BFS) manufacture of unit dose ophthalmic product is not always the best choice, particularly for early stage clinical trials.
For example, Blow-Fill-Seal manufacture can:
- Require large quantities of API (Active Pharmaceutical Ingredient)
- Large void volume of API
- Be prohibitively expensive
- Require large minimum batch sizes
- Have limited flexibility due to their system validation
- Give low priority to smaller, early stage clients
Bio-Concept Laboratories has developed a proprietary technique using 1 cc plastic bottles filled with 0.2 mL or 4-6 drops of clinical trial material. The bottles are manually filled in our ISO 5 Aseptic filling suite in 2,500 unit, or smaller, batches.
Our 1cc unit dose bottles match the plastic used in blow-fill-seal operations and because we maintain media fill validations for these bottles, can result in significant savings.
Not sure our 1cc bottles will suit your fill and finish manufacturing needs?
Give us a call and discuss it with one of our scientists.