Product/Service

Small-Scale Non-GMP Lab

Source: Mikart
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Mikart’s small-scale non-GMP lab accelerates development by enabling rapid testing and iteration at a lower cost.

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Mikart’s small-scale non-GMP lab accelerates development by enabling rapid testing and iteration at a lower cost. With flexible capabilities for handling small batches, it helps identify and resolve issues early, ensuring a smoother transition to GMP production. This approach reduces risk, saves time, and streamlines the path to market.

Benefits of non-GMP small-scale lab

  • Offers extra early-stage non-GMP development capability
  • Manufacture smaller batches with reduced active pharmaceutical ingredients (APIs)
  • Initiate projects without delay
  • Gather Initial Stability Data
  • Faster development timelines and Proof of Concept
  • Reflects Mikart’s expertise in both pilot and production capabilities

Non-GMP Capabilities

  • Capsule filling
  • Wet granulation
  • Milling
  • Blending (50 g to 6 kg)
  • Tablet compression
  • Fluid bed processing
  • Powder in Bottles (PIB) for reconstitutable products
  • Bottles and Blister Packaging
  • Liquids and Suspensions (up to 3L)
  • Film Coating
  • Bilayer tableting

Equipment

  • Torpac Manual Encapsulators
  • Silverson Homogenizer
  • Key KG-5 High-Shear Granulator
  • PK-Blend Master
  • Fluid Bed (Aqueous)
  • Glatt GPCG-1, Aeromatic Strea Top & Bottom Spray
  • Natoli RD-10A tablet press
  • Stability Oven (adjustable heat and humidity)
  • Elizapress EP 200 (B & D)
  • Elizapress EP 200L Bilayer,(B & D)
  • Film Coating (Aqueous)
  • Coating Pan LDCS (0.5, 1.5, & 6L pans)

Mikart