Production Capacity

Automatic Capsule Filling Machine: Revolutionizing Pharmaceutical Industry
Automatic Capsule Filling Machine

Taj Pharma manufactures 40 million capsules per month, meeting large-scale demands for both domestic and international markets. The facility adheres to WHO-GMP standards, with upcoming PICS and EU GMP compliance, ensuring global regulatory acceptance.

Taj Pharma is a leading pharmaceutical manufacturer with a capsule production capacity of 40 million units per month at its state-of-the-art WHO-GMP certified facility in Sarigam, Gujarat. The company utilizes advanced technologies like the CT- 75 and CT-150 Automatic Capsule Filling Machine, capable of producing up to 75,000 and 150,000 capsules per hour. This high-speed, PLC-controlled equipment ensures precision, efficiency, and flexibility across a wide range of formulations including powders, granules, pellets, and micro-tablets.

The capsule manufacturing process begins with formulation and mixing, where active pharmaceutical ingredients (APIs) and excipients are uniformly blended using high-shear mixers or bin blenders to achieve optimal flow, content uniformity, and moisture control. For sustained or modified-release capsules, pelletization or micro-tableting techniques are employed.

Capsules are filled with the formulated content, sealed (if required), printed, and undergo rigorous in-process and final quality control tests—ensuring weight variation, dissolution, and stability standards are met. Both gelatin and HPMC capsule shells are supported, sourced from qualified vendors.

Taj Pharma’s capsule products span multiple therapeutic areas, including CNS, gastroenterology, antibiotics, endocrinology, antivirals, and nutraceuticals. With compliance toward PICS and EU GMP underway, Taj Pharma continues to redefine pharmaceutical excellence with robust production systems and global regulatory alignment.


Core Equipment: Automatic Capsule Filling Machine – CT 70 and CT-150

ParameterSpecification
Machine ModelCT-150 Automatic Capsule Filler
Output Capacity150,000 capsules/hour
Dosage Forms HandledPowder, granules, pellets, micro-tablets, combinations
Capsule Sizes SupportedSize 00 to 5
Fill Accuracy±2% for most materials
Control SystemPLC-based with HMI interface
Cleaning ModeQuick dismantling for dry cleaning; optional WIP system

Key Features:

  • High-speed turret system ensures uninterrupted operation.
  • Supports multi-component fills (e.g., pellet + tablet).
  • Anti-powder spillage vacuum system for hygienic operation.
  • Compatible with both gelatin and HPMC shells.

Technical Steps in Capsule Manufacturing

1. Formulation and Mixing

  • API and excipients are blended uniformly using high-shear mixers or bin blenders depending on flow characteristics.
  • For modified-release, pelletization or micro-tabletting may be involved before filling.
  • Critical Quality Attributes (CQA): Blend uniformity, flowability, moisture content.

1. Formulation and Mixing – Full Technical Depth

Purpose:

Formulation and mixing is the first and most critical stage in the capsule manufacturing process. It ensures uniform distribution of the Active Pharmaceutical Ingredient (API) with excipients to form a homogenous blend that meets performance, stability, and compliance requirements.


🔬 Objectives of the Mixing Step:

  • Ensure dose uniformity (every capsule contains the same amount of API).
  • Improve flow properties of the blend for consistent filling.
  • Control moisture and hygroscopicity to prevent degradation.
  • Enable compatibility between API and excipients.
  • Optimize particle size and surface characteristics for bioavailability.

A. Key Components Involved

ComponentRole in Blend
APITherapeutic active substance
DiluentAdds bulk (e.g., Lactose, MCC)
DisintegrantAssists break-up of capsule contents post-ingestion (e.g., Crospovidone)
LubricantMinimizes blend–metal contact friction (e.g., Magnesium Stearate)
GlidantImproves powder flow (e.g., Colloidal Silicon Dioxide)
BinderIf granulation used, ensures agglomerate integrity
Coated Pellets or MultiparticulatesUsed in sustained/controlled-release dosage forms

B. Equipment Used in Mixing at Taj Pharma

1. High-Shear Mixer (HSM) – for granulation

  • Application: When formulation demands moisture granulation (e.g., low-flow APIs)
  • Mechanism: Uses impeller and chopper to agglomerate powder into granules.
  • Advantage: Improves compressibility and uniformity.

2. Bin Blender / Double Cone Blender

  • Application: For blending dry powders.
  • Design: Stainless steel bins (IBC) rotate on a central axis to blend materials.
  • Capacity: Scaled from 25L (pilot) to 1200L (commercial).
  • Control: Variable RPM, PLC interface, batch recording.

C. Specialized Techniques for Modified Release

1. Pelletization (for Capsule Fills)

  • Involves extrusion-spheronization or fluid bed coating to form uniform spherical pellets.
  • Pellets may be:
    • Enteric coated
    • Extended-release coated with polymers (e.g., ethylcellulose, HPMC-AS)
  • These pellets are filled into hard capsules to achieve desired release kinetics.

2. Micro-Tabletting

  • Produces very small tablets (typically 1–3 mm) that can be coated and filled into capsules.
  • Ensures multi-unit particulate system (MUPS) for controlled-release or combination therapy.

D. Process Controls and Critical Parameters

Critical Process Parameters (CPPs):

  • Blending Time & RPM
  • Sequence of Addition
  • Impeller/Chopper Speed (HSM)
  • Granulating Fluid Volume
  • Pellet Sphericity and Size Distribution
  • Binder concentration (if wet granulation is used)

E. Critical Quality Attributes (CQAs):

AttributeTarget/SpecTest Method
Blend UniformityRSD ≤ 5% for API across 10 locationsAssay via HPLC or UV
FlowabilityAngle of repose ≤ 30°, Carr’s Index < 20%Bulk/tapped density measurements
Moisture ContentTypically ≤ 2% for powdersLoss on Drying (LOD), Karl Fischer
Particle SizeD90 between 200–800 µm (capsule fills)Laser diffraction or sieve analysis
Compressibility IndexIndicator of flow – should be < 20%Derived from bulk/tapped densities

F. In-Process Checks and Documentation

  • Sampling after blending (top, middle, bottom) to ensure uniformity of content.
  • All batches follow Batch Manufacturing Record (BMR) and Standard Operating Procedures (SOPs).
  • Operators use scanning and PLC-logged traceability during loading/unloading.
  • Cleaning validation and cross-contamination checks between different products are mandatory.

G. Regulatory and Compliance Aspects

Taj Pharma adheres to:

  • ICH Q8/Q9/Q10 guidelines for pharmaceutical development and risk management.
  • 21 CFR Part 211 (US FDA), EU GMP, and WHO TRS for formulation and mixing validation.
  • Full equipment qualification (IQ/OQ/PQ) and process validation (PPQ) are performed for all commercial launches.

The formulation and mixing stage is where science meets precision engineering. At Taj Pharma, every batch undergoes rigorous development, blending, testing, and documentation to ensure that the fill material is consistent, stable, and bioavailable — forming the critical foundation for capsule quality and patient efficacy.


2. Shell Creation (Hard Gelatin Capsules)

Note: Taj Pharma generally procures pre-manufactured empty shells from GMP-certified suppliers for efficiency.

  • Shells are traditionally made by dipping stainless-steel pins into a gelatin solution at 45–50°C.
  • After gelling, they are dried, trimmed, and printed before supply.

3. Shell Creation (Soft Gelatin Capsules) – if in-house

  • Softgel formation via Rotary Die Encapsulation.
  • Two gelatin ribbons are fed from opposite sides and converge at the rotary die.
  • Drug fill material (oil-based or solution) is injected into the formed pocket.
  • Heat sealing is achieved as the capsule is formed.

Note: Taj Pharma primarily focuses on hard capsules; softgel capacity is managed through partner sites or upon specific project requests.


4. Capsule Filling (Core Step)

  • The automatic capsule filler separates capsule cap and body.
  • The lower body is filled with powder, granules, or pellets via dosing disks.
  • Capsules are rejoined, ejected, and sent to polishing unit.

Formulation Types Supported:

  • Single API powder
  • Pellet-filled (sustained-release)
  • Tablet-in-capsule (layered therapy)
  • Granules with coated particles
  • Herbal or nutraceutical blends

5. Sealing (Optional for Tamper Evidence)

  • Taj Pharma offers band sealing using gelatin banding solution.
  • For global markets, optional sealing ensures tamper-proof protection and enhanced stability.

6. Printing

  • Axial or radial printing for branding or identification.
  • UV or food-grade inks used as per pharmacopeial standards.
  • Options: logo, drug strength, batch ID, color coding.

7. Quality Control and In-Process Checks

Every batch undergoes rigorous QC as per ICH Q6A guidelines.

QC TestObjective
Weight VariationConsistency in fill quantity
Disintegration TimeBioavailability control
Content Uniformity (CU)Dose accuracy across batch
Microbial Load (for nutraceuticals)Safety assurance
Stability (Real Time & Accelerated)Shelf life validation
Dissolution ProfilingDrug release kinetics for IR or SR capsules
Moisture Content (LOD)Ensures storage and stability

8. Packaging and Labeling

  • Primary packaging: Blister packs (Alu-Alu / PVC-Alu), HDPE bottles, or strip packs.
  • Secondary packaging: Cartons with leaflet, serialized for traceability.
  • Labeling follows country-specific regulatory guidelines (US FDA, EU EMA, WHO, etc.)

Regulatory and Compliance Certifications

  • WHO-GMP Certified
  • ISO 9001:2015 and ISO 22000
  • PICS & EU-GMP audits underway (expected within 2025)
  • Follows 21 CFR Part 210/211, ICH guidelines, and local MOH norms

Capsule Product Categories Manufactured

SegmentCapsule Applications
AntibioticsAmoxicillin, Doxycycline, Cefixime
CNS & PsychiatryGabapentin, Pregabalin, Duloxetine
GastroenterologyEsomeprazole, Lansoprazole delayed-release
EndocrinologyThyroxine, Metformin XR pellets
NutraceuticalsOmega-3, Lycopene, Ginseng, Multivitamin blends
Antiviral / AntifungalItraconazole, Oseltamivir, Fluconazole

Excellence in Capsule Manufacturing

Taj Pharma’s capsule production integrates advanced automation, regulatory compliance, and formulation versatility to meet the global pharmaceutical industry’s expectations. Whether for conventional drugs, high-potency APIs, or nutraceuticals, the CT-150 capsule line ensures speed, precision, and reliability.