Introduction to Semi-Automatic Double-Head Capsule Filling Machine
2025-09-28
Introduction to Semi-Automatic Double-Head Capsule Filling Machine
In the pharmaceutical, nutraceutical, and herbal supplement industries, efficient and accurate capsule filling is a critical step in production. The Semi-Automatic Double-Head Capsule Filling Machine emerges as a cost-effective and high-performance solution, bridging the gap between manual filling and fully automatic lines. It is specifically designed to handle powder, granule, and small pellet formulations—with strict adherence to pharmaceutical GMP standards—making it ideal for small to medium-sized pharmaceutical production batches (e.g., clinical trial samples, specialty drug capsules).
Core Features and Working Principle
The machine’s defining advantage lies in its dual filling heads, which significantly boost output while maintaining pharmaceutical-grade precision. Its operation follows a streamlined, GMP-aligned process:
Capsule Loading: Empty hard capsules (size 00# to 5#, pharmaceutical-grade HPMC or gelatin) are manually loaded into a stainless steel 316L hopper (higher corrosion resistance than 304, suitable for pharmaceutical use). The machine then automatically separates capsule bodies and caps using adjustable vacuum suction (to avoid capsule damage, critical for pharmaceutical product integrity).
Dual-Head Filling: Two independent, dust-sealed filling stations simultaneously dispense pharmaceutical formulations (e.g., API powders, pre-blended granules) into the capsule bodies. Each station is equipped with a precision dosing auger (calibratable to ±1% accuracy for high-potency drugs) — this double-head design increases production efficiency by up to 50% compared to single-head models, while minimizing cross-contamination risks via isolated dosing channels.
Capsule Closing: After filling, the machine uses soft-pressure alignment to lock capsule caps onto bodies, avoiding content compression (critical for moisture-sensitive or friable pharmaceutical powders) and ensuring 100% sealing to prevent API leakage.
Unloading and Inspection: Finished capsules are discharged into a lint-free, FDA-approved collection tray (compatible with pharmaceutical inspection workflows, e.g., visual checks for empty/overfilled capsules).
In the pharmaceutical, nutraceutical, and herbal supplement industries, efficient and accurate capsule filling is a critical step in production. The Semi-Automatic Double-Head Capsule Filling Machine emerges as a cost-effective and high-performance solution, bridging the gap between manual filling and fully automatic lines. It is specifically designed to handle powder, granule, and small pellet formulations—with strict adherence to pharmaceutical GMP standards—making it ideal for small to medium-sized pharmaceutical production batches (e.g., clinical trial samples, specialty drug capsules).
Core Features and Working Principle
The machine’s defining advantage lies in its dual filling heads, which significantly boost output while maintaining pharmaceutical-grade precision. Its operation follows a streamlined, GMP-aligned process:
Capsule Loading: Empty hard capsules (size 00# to 5#, pharmaceutical-grade HPMC or gelatin) are manually loaded into a stainless steel 316L hopper (higher corrosion resistance than 304, suitable for pharmaceutical use). The machine then automatically separates capsule bodies and caps using adjustable vacuum suction (to avoid capsule damage, critical for pharmaceutical product integrity).
Dual-Head Filling: Two independent, dust-sealed filling stations simultaneously dispense pharmaceutical formulations (e.g., API powders, pre-blended granules) into the capsule bodies. Each station is equipped with a precision dosing auger (calibratable to ±1% accuracy for high-potency drugs) — this double-head design increases production efficiency by up to 50% compared to single-head models, while minimizing cross-contamination risks via isolated dosing channels.
Capsule Closing: After filling, the machine uses soft-pressure alignment to lock capsule caps onto bodies, avoiding content compression (critical for moisture-sensitive or friable pharmaceutical powders) and ensuring 100% sealing to prevent API leakage.
Unloading and Inspection: Finished capsules are discharged into a lint-free, FDA-approved collection tray (compatible with pharmaceutical inspection workflows, e.g., visual checks for empty/overfilled capsules).
| Parameter | Value |
|---|---|
| Capacity | 8,000 - 12,000 capsules/hour |
| Compatible Capsule Sizes | 00#, 0#, 1#, 2#, 3#, 4#, 5# (pharmaceutical-grade gelatin/HPMC) |
| Filling Accuracy | ±1% (for high-potency powders), ±2% (for standard pharmaceutical formulations) |
Advantages for Pharmaceutical Production Lines
GMP Compliance: All contact parts meet FDA/EMA standards; machine structure supports easy disassembly for cleaning (no hidden crevices where residues can accumulate).
High Precision: Calibratable dosing augers and vacuum control ensure consistent API dosage—critical for pharmaceutical products (avoids underdosing/overdosing risks).
Cost-Effective for Pharma Startups: Lower initial investment than fully automatic lines, while still meeting regulatory requirements (ideal for small-batch drugs or clinical supplies).
Cross-Contamination Prevention: Isolated filling channels, quick-change tooling (with cleaning validation documentation), and stainless steel surfaces minimize API residue transfer between batches.
Cleanroom Compatibility: Smooth exterior (no recesses for dust buildup) and low noise operation (≤65 dB) meet ISO 8 cleanroom environmental standards.
GMP Compliance: All contact parts meet FDA/EMA standards; machine structure supports easy disassembly for cleaning (no hidden crevices where residues can accumulate).
High Precision: Calibratable dosing augers and vacuum control ensure consistent API dosage—critical for pharmaceutical products (avoids underdosing/overdosing risks).
Cost-Effective for Pharma Startups: Lower initial investment than fully automatic lines, while still meeting regulatory requirements (ideal for small-batch drugs or clinical supplies).
Cross-Contamination Prevention: Isolated filling channels, quick-change tooling (with cleaning validation documentation), and stainless steel surfaces minimize API residue transfer between batches.
Cleanroom Compatibility: Smooth exterior (no recesses for dust buildup) and low noise operation (≤65 dB) meet ISO 8 cleanroom environmental standards.
Applications
Small-Batch Drug Production: Antibiotics, antiviral powders, and specialty pharmaceuticals (where large automatic lines are cost-prohibitive).
Clinical Trial Supplies: Flexible output for Phase I/II trials (5,000 - 20,000 capsules per batch) with strict dosage accuracy.
Controlled Substances: Enclosed filling chambers (optional) to comply with DEA regulations for narcotic or psychotropic drug handling.
Moisture-Sensitive Formulations: Optional nitrogen-purged hoppers to protect hygroscopic APIs (e.g., vitamins, certain antibiotics) during filling.
Maintenance and Care Guide
Proper maintenance is critical to sustaining GMP compliance, dosage accuracy, and equipment lifespan—especially in pharmaceutical environments where residue or equipment failure can lead to product recalls.
1. Daily Maintenance (Post-Production)
Complete Cleaning: Disassemble all contact parts (hoppers, dosing augers, filling chambers, collection trays) and clean with pharmaceutical-grade detergent (e.g., 0.5% sodium hypochlorite solution) followed by rinsing with purified water (USP Grade). Dry parts with lint-free, sterile wipes to prevent moisture buildup (a breeding ground for microbes).
Vacuum System Check: Inspect vacuum hoses for cracks or blockages (clogged hoses reduce capsule separation efficiency, leading to empty capsules). Clean the vacuum filter with compressed air (filtered to ISO 8 standards to avoid introducing dust into the cleanroom).
Lubrication (Food-Grade Only): Apply a thin layer of FDA-approved, pharmaceutical-grade lubricant (e.g., silicone-based) to moving parts (e.g., capsule closing mechanisms) — avoid over-lubrication, as excess oil can contaminate formulations.
Calibration Verification: Check dosing accuracy with a standard weight (e.g., 100 capsules filled with lactose) — record results in a logbook for regulatory compliance (required for FDA/EMA audits).
2. Weekly Maintenance
Tooling Inspection: Examine quick-change tooling (e.g., capsule size adapters) for wear or deformation (damaged tooling causes inconsistent capsule alignment, leading to leakage). Replace worn parts with GMP-certified spares (keep a inventory of critical parts, e.g., seals, augers).
PLC and Touchscreen Check: Verify that the PLC system retains parameter settings (password-protected) and that the touchscreen responds correctly (malfunctions can lead to incorrect dosing). Back up PLC data to a secure server (compliant with 21 CFR Part 11 for data integrity).
Electrical Safety Check: Inspect power cords and plugs for damage; test the emergency stop button (must cut power immediately to prevent accidents during batch production).
3. Monthly Maintenance
Deep Cleaning and Disinfection: Perform a full disassembly of non-sealed parts and disinfect with pharmaceutical-grade sanitizer (e.g., 70% isopropyl alcohol) — validate cleaning using a swab test (check for API residue, e.g., via HPLC, to confirm no cross-contamination).
Vacuum Pump Service: Drain condensation from the vacuum pump (moisture can corrode internal components) and replace the pump oil with pharmaceutical-grade oil (as per manufacturer specifications).
Belt Tension Adjustment: Inspect drive belts (for capsule transport) for slack or fraying — adjust tension to prevent slipping (slippage causes inconsistent filling speeds, leading to dosage variations).
4. Annual Maintenance (GMP-Required)
Full Calibration: Hire a certified technician to calibrate the dosing system, vacuum pressure, and PLC controls — obtain a calibration certificate (required for regulatory audits).
Mechanical Overhaul: Inspect all bearings, gears, and seals for wear; replace aging parts (e.g., silicone seals, which degrade over time and can shed particles into formulations).
Cleaning Validation Documentation: Update cleaning validation protocols (e.g., swab test methods, detergent compatibility) to reflect any changes in formulations (e.g., switching from a powder to a granule API).
Key Pharmaceutical-Specific Maintenance Notes
Logbook Requirements: Maintain a detailed maintenance log (digital or paper, with timestamp and operator signature) documenting all cleaning, lubrication, and calibration activities — this is mandatory for FDA/EMA inspections.
Spares Management: Store GMP-certified spare parts (e.g., 316L hoppers, FDA-approved seals) in a clean, labeled cabinet — avoid mixing spare parts with non-pharmaceutical equipment to prevent contamination.
Changeover Protocol: When switching between formulations (especially different APIs), follow a documented changeover process: disassemble, clean, swab test, and air-dry parts before reloading — retain swab test results for at least 5 years (per GMP guidelines).
In summary, this machine balances pharmaceutical-grade precision, GMP compliance, and operational efficiency—making it a reliable choice for pharmaceutical manufacturers seeking to optimize small-to-medium ba
Small-Batch Drug Production: Antibiotics, antiviral powders, and specialty pharmaceuticals (where large automatic lines are cost-prohibitive).
Clinical Trial Supplies: Flexible output for Phase I/II trials (5,000 - 20,000 capsules per batch) with strict dosage accuracy.
Controlled Substances: Enclosed filling chambers (optional) to comply with DEA regulations for narcotic or psychotropic drug handling.
Moisture-Sensitive Formulations: Optional nitrogen-purged hoppers to protect hygroscopic APIs (e.g., vitamins, certain antibiotics) during filling.
Maintenance and Care Guide
Proper maintenance is critical to sustaining GMP compliance, dosage accuracy, and equipment lifespan—especially in pharmaceutical environments where residue or equipment failure can lead to product recalls.
1. Daily Maintenance (Post-Production)
Complete Cleaning: Disassemble all contact parts (hoppers, dosing augers, filling chambers, collection trays) and clean with pharmaceutical-grade detergent (e.g., 0.5% sodium hypochlorite solution) followed by rinsing with purified water (USP Grade). Dry parts with lint-free, sterile wipes to prevent moisture buildup (a breeding ground for microbes).
Vacuum System Check: Inspect vacuum hoses for cracks or blockages (clogged hoses reduce capsule separation efficiency, leading to empty capsules). Clean the vacuum filter with compressed air (filtered to ISO 8 standards to avoid introducing dust into the cleanroom).
Lubrication (Food-Grade Only): Apply a thin layer of FDA-approved, pharmaceutical-grade lubricant (e.g., silicone-based) to moving parts (e.g., capsule closing mechanisms) — avoid over-lubrication, as excess oil can contaminate formulations.
Calibration Verification: Check dosing accuracy with a standard weight (e.g., 100 capsules filled with lactose) — record results in a logbook for regulatory compliance (required for FDA/EMA audits).
2. Weekly Maintenance
Tooling Inspection: Examine quick-change tooling (e.g., capsule size adapters) for wear or deformation (damaged tooling causes inconsistent capsule alignment, leading to leakage). Replace worn parts with GMP-certified spares (keep a inventory of critical parts, e.g., seals, augers).
PLC and Touchscreen Check: Verify that the PLC system retains parameter settings (password-protected) and that the touchscreen responds correctly (malfunctions can lead to incorrect dosing). Back up PLC data to a secure server (compliant with 21 CFR Part 11 for data integrity).
Electrical Safety Check: Inspect power cords and plugs for damage; test the emergency stop button (must cut power immediately to prevent accidents during batch production).
3. Monthly Maintenance
Deep Cleaning and Disinfection: Perform a full disassembly of non-sealed parts and disinfect with pharmaceutical-grade sanitizer (e.g., 70% isopropyl alcohol) — validate cleaning using a swab test (check for API residue, e.g., via HPLC, to confirm no cross-contamination).
Vacuum Pump Service: Drain condensation from the vacuum pump (moisture can corrode internal components) and replace the pump oil with pharmaceutical-grade oil (as per manufacturer specifications).
Belt Tension Adjustment: Inspect drive belts (for capsule transport) for slack or fraying — adjust tension to prevent slipping (slippage causes inconsistent filling speeds, leading to dosage variations).
4. Annual Maintenance (GMP-Required)
Full Calibration: Hire a certified technician to calibrate the dosing system, vacuum pressure, and PLC controls — obtain a calibration certificate (required for regulatory audits).
Mechanical Overhaul: Inspect all bearings, gears, and seals for wear; replace aging parts (e.g., silicone seals, which degrade over time and can shed particles into formulations).
Cleaning Validation Documentation: Update cleaning validation protocols (e.g., swab test methods, detergent compatibility) to reflect any changes in formulations (e.g., switching from a powder to a granule API).
Key Pharmaceutical-Specific Maintenance Notes
Logbook Requirements: Maintain a detailed maintenance log (digital or paper, with timestamp and operator signature) documenting all cleaning, lubrication, and calibration activities — this is mandatory for FDA/EMA inspections.
Spares Management: Store GMP-certified spare parts (e.g., 316L hoppers, FDA-approved seals) in a clean, labeled cabinet — avoid mixing spare parts with non-pharmaceutical equipment to prevent contamination.
Changeover Protocol: When switching between formulations (especially different APIs), follow a documented changeover process: disassemble, clean, swab test, and air-dry parts before reloading — retain swab test results for at least 5 years (per GMP guidelines).
In summary, this machine balances pharmaceutical-grade precision, GMP compliance, and operational efficiency—making it a reliable choice for pharmaceutical manufacturers seeking to optimize small-to-medium ba
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