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 A Berents BECOMIX planetary mixer, model RW 30, stainless steel construction, 60 liter total capacity, 30 liter working capacity, chamber rated -1/2 bar(-14.5/29 psi) at 134 c internal, jacketed for 4 bar(58 psi) at 152 c, top mounted variable speed agitator with side wall scrappers, bottom mounted homogenzier, dome top with lift/lower mechanism, cone bottom, with on board controls and external control panel, 3/50/400 volt, Fabr# 011/1-586, built 1996.

  • Isolators with product protection as a housing for aseptic processes, e.g., filling, loading and unloading of freeze dryers.

  • 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.

  • Used 79 gallon (300 liter) Inox reactor, stainless steel construction, approximately 24" diameter x 34" straight side, dish lid top with dish bottom, jacket and interior rated 30 psi and full vacuum at 300 F, 6" top access, with (1) 4", (1) 3", (2) 2" and (2) 1.5" nozzles on top, with bottom entering magnetic agitator, .75 hp with controls, 1.5" center bottom outlet, with load cells, all on portable frame, serial# 95011-2, CRN# K82555, built 1995.