Engineering Solutions • Formulation
Formulation Effervescent Packaging Containment Transfer Systems

Engineering the Complete Pharmaceutical Formulation Process

At Mark Maker Engineering, we provide integrated formulation solutions designed for the demanding requirements of pharmaceutical manufacturing. Our equipment is engineered to support critical processing stages including mixing, granulation, drying, blending, milling, sizing and coating, with a focus on process reliability, product consistency and GMP-oriented design.

From individual processing equipment to integrated formulation lines, our solutions are developed around the specific product, batch size, process requirements and production objectives of each application.

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8 Critical Stages
SS 316 / 316L Contact Construction
cGMP & 21 CFR Part 11
Lab to High-Tonnage Scale
Integrated Architecture

Closed-Loop Formulation Line

Integrated Granulation and Formulation Line
Material Transfer Dust-Free Vacuum
Automation Level SCADA / PLC Recipe
Contact Metallurgy SS 316L (Ra < 0.4µm)
Compliance Standard USFDA cGMP Oriented

The Formulation Sequence

Mix. Granulate. Dry. Blend. Mill. Sift. Coat.

One integrated formulation equipment partner covering the full solid dosage manufacturing lifecycle.

01 Granulate Rapid Mixer Granulator 02 Dry Fluid Bed Dryer (FBD) 03 Vacuum Dry Vacuum Tray Dryer (VTD) 04 Blend Octagonal & Bin Blender 05 Mill Cone Mill & Multi Mill 06 Sift Vibro Sifter (VSFT) 07 Coat Auto Tablet Coater

Complete Portfolio

Complete Process Equipment Portfolio

Our formulation portfolio covers the major stages of pharmaceutical solid dosage manufacturing, enabling customers to build efficient and scalable production processes from a single engineering partner.

STAGE 01 Granulation & Mixing
Rapid Mixer Granulator (RMG)
High-Shear Impeller 10 L – 1,500 L

Granulation & Mixing

Rapid Mixer Granulators are engineered for rapid dry mixing, wet mixing, and precision granulation of pharmaceutical formulations. Designed with dual-speed impellers and integrated high-speed choppers for controlled binder dispersion and narrow granule size distribution.

Available Equipment & Systems
Rapid Mixer Granulator (RMG) → Wet Granulator Integrated High-Shear Lines
  • Dual-speed mixing impeller and high-speed chopper assembly
  • Pneumatic discharge valve with dust-tight mechanical seals
  • SS 316 / SS 316L mirror polished product contact bowl (Ra < 0.4µm)
  • Validated CIP wash-in-place spray nozzle manifolds
STAGE 02 Thermal Drying
Fluid Bed Dryer and Processor
2-Bar / 10-Bar Shock 5 kg – 500 kg

Drying

Fluid Bed Dryers / Processors provide controlled, uniform moisture removal from wet granules. Conditioned process air and homogeneous thermal distribution ensure gentle fluidization without thermal degradation or particle agglomeration.

Available Equipment & Systems
Fluid Bed Dryer (FBD) → Fluid Bed Processor (FBP) → Air Tray Dryer (ATD) →
  • Precision airflow and temperature control with HEPA H14 filtration
  • 2-Bar / 10-Bar explosion pressure shock-resistant construction
  • Top-spray granulation and bottom Wurster pellet coating configurations
  • Automated recipe-driven drying curve optimization via PLC/SCADA
STAGE 03 Blending & Homogenization
Octagonal Blender (OCB)
CV < 2% Homogeneity 25 L – 5,000 L

Blending

Octagonal Blenders and bin blending systems are designed to achieve uniform distribution of active ingredients and excipients while preserving particle integrity. Gentle tumbling dynamics prevent segregation and heat buildup.

Available Equipment & Systems
Octagonal Blender (OCB) → Conta Bin Blender (CPB) → Double Cone Blender → V Cone Blender → Multi Attached Blender →
  • Octagonal and bin geometries designed for high homogeneity (CV < 2%)
  • Interchangeable container clamping for rapid cleanroom turnaround
  • Safety railing and physical interlocks with pneumatic inching drive brake
  • Hygienic zero-dead-leg silicone butterfly discharge valves
STAGE 04 Vacuum Drying
Vacuum Tray Dryer (VTD)
Low-Temp / Solvents 6 – 96 Trays

Vacuum Drying

Vacuum Tray Dryers provide controlled low-temperature drying for thermosensitive active ingredients, hygroscopic compounds, and effervescent formulations under deep vacuum conditions, with integrated solvent condensation and recovery skids.

Available Equipment & Systems
Vacuum Tray Dryer (VTD) → Condenser & Solvent Recovery Skid Vacuum Pumping Skid
  • Low-temperature conductive heating via hollow dimpled heating shelves
  • Vacuum rating down to < 25 Torr for heat-sensitive compounds
  • Condenser and receiver system for complete solvent recovery
  • Sanitary SS 316L internal construction with full cGMP drainability
STAGE 05 Milling & Size Reduction
Dry Conical Mill (DCM)
De-Agglomeration 50 – 1,500 kg/hr

Milling & Size Reduction

Engineered to de-agglomerate dry granules and achieve uniform particle size distribution with minimal fines and negligible heat generation. Directly integratable inline with blenders and vacuum transfer lines.

Available Equipment & Systems
Dry Co Mill / Conical Mill (DCM) → Multi Mill (MML) → Wet Granule Sizing Mill
  • Uniform particle de-agglomeration with minimal fines generation
  • Interchangeable conical screens and knife/impact rotor geometries
  • In-line vacuum conveying or gravity-drop integration with blenders
  • Tool-less quick dismantling for effortless cleaning and validation
STAGE 06 Sifting & Classification
Vibro Sifter (VSFT)
1 to 3 Decks 20" to 60" Screen

Sifting & Classification

High-throughput gyratory vibro sifters ensure controlled particle separation, safety screening, and classification of powders and granules prior to downstream compression, coating, or filling.

Available Equipment & Systems
Vibro Sifter (VSFT) → Multi-Deck Classifier Ultrasonic De-Blinding System
  • Multi-plane adjustable vibration dynamics for varied bulk densities
  • Single or double-deck screening with fast-acting quick-release clamp rings
  • Dust-tight silicone sealing rings preventing cleanroom contamination
  • GMP design without crevices, suitable for rapid washdown and cleanability
STAGE 07 Tablet Coating
Automatic Tablet Coater (Auto Coater)
Anti-Bearding Spray 12" to 66" Drum

Tablet Coating

Automated perforated-drum coating systems provide controlled application of aqueous and organic solvent films. Features automated peristaltic spray dosing, anti-bearding spray guns, and precision thermodynamic bed airflow control.

Available Equipment & Systems
Auto Tablet Coater → Conventional Coating Pan Peristaltic Dosing & Solution Skid
  • Perforated pan with gentle mixing baffles for zero edge chipping
  • Anti-bearding spray gun technology with auto needle cleaning
  • Automated recipe-controlled bed temperature and negative pressure
  • Aqueous and solvent-compatible explosion-proof design options
STAGE 08 Pelletization & Preparation
Extruder and Spheronizer System
Controlled Release 10 – 300 kg/hr

Pelletization & Process Preparation

Precision Extrusion & Spheronization systems for controlled-release pellet formulations, alongside automated Paste / Binder Preparation Vessels (PPV) and jacketed solution tanks for homogeneous recipe preparation.

Available Equipment & Systems
Extruder & Spheronizer → Fluid Bed Coater (FBC) → Paste / Binder Preparation Vessel (PPV) → Solution Preparation Tanks
  • Twin-screw extrusion with precise cooling jacket temperature control
  • Spheronizer friction plate geometries for ultra-narrow particle size distribution
  • Sanitary jacketed vessels for binder paste preparation with anchor / planetary agitator
  • Full integration with downstream Fluid Bed Coaters (FBC) for sustained release coating

Architectural Integration

From Individual Machines to Integrated Formulation Lines

Pharmaceutical manufacturing rarely depends on a single machine. Process performance depends on how individual stages work together.

Mark Maker Engineering can support the development of formulation processes by integrating equipment across multiple stages — from granulation and drying to blending, milling, sifting and coating — while considering material flow, process requirements, utilities, automation and operational requirements.

This approach allows customers to develop formulation systems that are scalable, consistent and suited to their specific manufacturing environment.

01

Material Flow Engineering

Closed-loop vacuum conveying and gravity feed between RMG, Mill, and FBD, eliminating cleanroom dust and operator exposure.

02

Supervisory Automation

Unified PLC/SCADA architecture with continuous batch record logging, 21 CFR Part 11 electronic signatures, and recipe handling.

03

Utility Synchronization

Coordinated thermal, pneumatic, and electrical loads across drying, milling, and coating modules to maximize energy efficiency.

04

Regulatory Qualification

Turnkey Design Qualification (DQ), Installation (IQ), and Operational Qualification (OQ) protocols tailored for USFDA / EU-GMP audits.

Core Standards

Engineered for Pharmaceutical Manufacturing

Our formulation equipment is developed strictly with pharmaceutical manufacturing requirements in mind, prioritizing product purity, structural longevity, and process verification.

GMP-Oriented Equipment Design

Crevice-free geometries, smooth internal radii, and hygienic sealing that eliminate cross-contamination and simplify sanitation.

SS 316 / SS 316L Contact Construction

Product contact surfaces constructed from certified SS 316 or SS 316L with Ra < 0.4 µm mirror or electro-polished finishes.

Controlled & Repeatable Parameters

Closed-loop regulation of impeller speed, bed temperature, airflow velocity, and spray rates for reproducible batch kinetics.

Hygienic & Cleanable Design

Validated Clean-In-Place (CIP) and Wash-In-Place (WIP) spray assemblies with drain slope profiles that accelerate turnaround.

Batch-to-Batch Process Consistency

Engineered to deliver uniform particle size, blend homogeneity, moisture levels, and coating thickness across consecutive production cycles.

Automation & Process Control Integration

Industrial PLC architectures with 21 CFR Part 11 compliant audit trails, electronic records, password tiers, and SCADA connectivity.

Tailored to Customer Requirements

Custom engineering adapted to specific batch sizes, cleanroom ceiling heights, hazardous area classifications, and utility limits.

Scale-Up Development Support

Predictable process scale-up models from laboratory R&D (5L) and pilot trials to high-output commercial manufacturing plants.

Application Engineering

Built Around Your Process

Every formulation process has different material characteristics, batch sizes and operating requirements. We therefore develop equipment and systems around the actual process rather than treating every application as a standard configuration.

From individual machines to complete formulation sequences, our engineering approach focuses on reliable operation, maintainability, process control and seamless integration with upstream and downstream equipment.

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Technical Matrix

Formulation Equipment Overview

Quick reference specifications for formulation modules across capacity ranges, key mechanisms, and product applications.

Equipment Models Available Capacity Range Core Mechanism Contact Metallurgy
Rapid Mixer Granulator (RMG) RMG 5L to RMG 1500L 5 Liters – 1,500 Liters Dual-speed impeller & high-shear chopper SS 316 / SS 316L (Ra < 0.4µm)
Fluid Bed Dryer (FBD / FBP) FBD 5 to FBD 500 KG 2 kg – 500 kg / batch Fluidized bed drying with 2-bar/10-bar shock rating SS 316 / SS 316L
Octagonal Blender (OCB) OCB 25 to OCB 10000 25 Liters – 10,000 Liters Slow tumbling gentle blend with internal baffles SS 316 / SS 316L
Conta Bin Blender (CPB) CPB 50 to CPB 2500 50 Liters – 2,500 Liters Clamped bin container rotation, zero cross-contamination SS 316 / SS 316L
Auto Tablet Coater AC-24 to AC-72 4 kg – 900 kg / batch Perforated pan with automated spray & drying airflow SS 316 / SS 316L
Vacuum Tray Dryer (VTD) VTD-4 to VTD-96 4 – 96 Trays (12 kg – 288 kg) Low-temp conduction heating under vacuum (< 25 Torr) SS 316 / SS 316L
Dry Conical Mill (DCM) DCM 100 to DCM 250 50 kg/hr – 2,500 kg/hr Low-heat conical rotor & interchangeable screens SS 316 / SS 316L
Vibro Sifter (VSFT) VSFT 20" to VSFT 48" Multi-deck grading Gyratory vibratory screen motion with dust-tight clamps SS 316 / SS 316L
Paste Preparation Vessel (PPV) PPV 50L to PPV 1000L 50 Liters – 1,000 Liters Jacketed heating with anchor/propeller binder agitator SS 316 / SS 316L

Formulation Solutions by Mark Maker Engineering

Mix. Granulate. Dry. Blend. Mill. Sift. Coat.

One integrated formulation equipment partner. Talk to our application engineers to configure a custom formulation machine or integrated line for your solid dosage plant.

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