INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • 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.

  • Basic Powder Flow Characterization [USP <1174>]:

    A powder flow analysis is an indicator of how well formulation will release from the hopper during the tableting. It is important to know that the developed formulation is showing ‘Mass Flow’ or ‘Funnel Flow’ or ‘Rat Holing’.

    Powder blend shows ‘Mass Flow’ when the entire solid bed is in motion during the discharge of material from the outlet. This is a ‘First-in-First-Out’ process. Hoppers offering ‘Mass Flow’ have steep and/or low-friction walls. This flow offers ‘No-Arching’, ‘Less Segregation’, and ‘Stable Powder Flow’.

    When the hopper is not sufficiently steep and smooth enough to ensure sliding along its wall, the powder blend exhibit ‘Funnel Flow’. Such hoppers are sensitive to arching and ratholing. In this case, powder discharge from the hopper is not predictable.

  • Isotube is an effective option for the safe loading and charging of multiple drums of HPAPIs.  Compared to the DCS® Drum Containment System for safely discharging drums, it is the preferred choice when charging lumpy and agglomerated products as a lump breaker system can be included in the lower part of the discharge hopper.

  • 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.

  • The big bag emptying stations of Dec are based on a modular design. This allows to be ideally equipped with systems for each product’s characteristics with corresponding docking systems for non-potent to highly active powders. Depending on the product flow, there is a range of discharge devices or lump breakers available. With the use of load cells, it is possible to dose accurately into the receptacle.