INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program.

  • Used ACG Pam Mini Filled Capsule Sorter, model MCS100, stainless steel construction, 9" x 12" sorting area, serial# MCS-559.

  • The aseptic/sterile Fill-Finish equipment solutions need to be cGMP compliant, dependable and accurately designed to comply with the most recent revisions of the “Annex 1 Manufacture of Sterile Medicinal Products guidelines”. Newly designed equipment needs to accommodate for small batches, various speeds and containers, including RTU / RTF (Ready To Use or Ready To Fill) bottles, vials, cartridges, syringes and pre-sterile nested trays. Moreover, the filling equipment solution should also improve the ergonomic use for operators and maximize cleanroom efficiency.

  • With many of the blockbuster biologic drugs of the ’90s are coming off of patent, companies are racing to provide a clinically similar alternative to these pioneering products. Like any biologic drug, they require care and attentiveness throughout the manufacturing process. Therefore, it is necessary to maintain aseptic conditions throughout the production process of these drug products.

  • The IsoSphere-AF is a positive pressure unidirectional airflow isolator or RABS for small, medium and large volume aseptic filling.