Fda Approved Limestone Mining ODM Manufacturer
1. PAINPOINT DRIVEN OPENING
Are you managing a limestone operation where inconsistent feed size, abrasive material, and stringent purity requirements for FDAapproved products are eroding your profitability? Operational challenges in this specialized sector directly impact compliance and the bottom line.
Contamination Risk: Noncompliant equipment materials or wear debris can introduce contaminants, risking batch rejection and regulatory scrutiny for your pharmaceutical or foodgrade calcium carbonate.
Inefficient Size Reduction: Standard crushers often struggle with the precise particle size distribution (PSD) required for highvalue applications, leading to excessive recrushing, energy waste, and offspec product.
Excessive Wear & Maintenance: The abrasive nature of limestone accelerates wear on standard machinery components, causing unplanned downtime, high parts replacement costs, and inconsistent product quality.
Dust Control Failures: Inadequate containment during processing creates environmental, health, and safety hazards, while also representing a direct loss of saleable product.
How do you ensure your processing line delivers the purity, consistency, and reliability demanded by FDAregulated supply chains while controlling operational costs? The solution lies in purposeengineered equipment designed for this exacting application.
2. PRODUCT OVERVIEW: FDAApproved Limestone Processing Plant
This is a modular, integrated processing system engineered for the primary and secondary crushing, screening, and material handling of limestone destined for FDAregulated applications. The plant is constructed using compliant materials and designed for closedcircuit operation to minimize contamination risk.
Operational Workflow:
1. Primary Crushing & PreScreening: Runofmine limestone is reduced by a heavyduty jaw crusher. An integrated prescreen removes fine material and foreign debris early in the process.
2. ClosedCircuit Secondary Crushing: Material is conveyed to a cone crusher operating in a closed loop with a sizing screen. This allows for precise control over the topsize product and immediate recirculation of oversize material.
3. Dedicated Fines Management & Dust Control: Generated fines are captured via an integrated baghouse filtration system with FDAcompliant filter media. Captured material is conveyed to dedicated silos as saleable product.
4. Clean Material Handling: All interprocess conveyors are fully enclosed with easyclean access points. Crusher cavities and contact points are lined with certified wear materials.
Application Scope & Limitations:
Scope: Ideal for producing crushed limestone aggregates and powders for pharmaceutical excipients (USP/EP grade), foodgrade calcium carbonate (FCC), dietary supplements, and other highpurity industrial fillers.
Limitations: System is designed for nonmetallic mineral processing. Feed rock must be within specified hardness (Mohs scale) and maximum feed size limits. Not suitable for highly moist or claybound material without predrying or washing modules.
3. CORE FEATURES
Certified Material Construction | Technical Basis: ASTM/ASMEgrade 304/316L stainless steel contact surfaces & FDAcompliant polymer liners | Operational Benefit: Eliminates risk of metallic contamination; ensures surface cleanability; meets audit requirements for traceable materials | ROI Impact: Reduces liability risk; prevents costly batch rejections; streamlines regulatory compliance documentation.
Precision ClosedCircuit Crushing | Technical Basis: Hydroset or similar hydraulic adjustment on secondary crusher paired with multideck sizing screens | Operational Benefit: Delivers tight control over Particle Size Distribution (PSD); minimizes generation of unwanted fines; allows quick adjustment for different product specs | ROI Impact: Increases yield of target fraction by up to 15%; reduces energy waste from overprocessing.
Integrated Containment & Dust Recovery | Technical Basis: Negative pressure design with PLCcontrolled pulsejet baghouse using foodgrade filter bags | Operational Benefit: Contains >99.9% of process dust at source; maintains clean plant environment; recovers valuable product | ROI Impact: Turns an environmental loss into revenue; significantly reduces housekeeping labor; mitigates silica exposure risks.
Advanced Wear Protection System | Technical Basis: Interchangeable liner panels made from highchrome white iron or ceramic composites in critical wear zones | Operational Benefit: Extends service intervals by 23x compared to standard manganese steel; maintains consistent cavity geometry for stable output | ROI Impact: Lowers costperton for wear parts; reduces frequency of disruptive maintenance shutdowns.
Centralized Process Control (PLC) | Technical Basis: Siemens/AllenBradley PLC with HMI touchscreen providing amperage monitoring, CSS tracking, and interlock controls | Operational Benefit: Gives operators realtime insight into plant performance; enables predictive maintenance alerts; allows repeatable setup for different products | ROI Impact: Optimizes throughput; reduces operator error; shortens changeover times between product grades.
4. COMPETITIVE ADVANTAGES
| Performance Metric | Industry Standard Solution | FDAApproved Limestone Plant Solution | Advantage (% Improvement) |
| : | : | : | : |
| Product Purity Assurance| Carbon steel contact parts with potential corrosion/contamination| Certified stainless steel & compliant liners at all product contact points| Risk mitigation from material traceability & cleanability |
| Target Fraction Yield (% of 20 mesh +100 mesh)| ~6575% due to open circuit or basic crushing circuits| 8085% through optimized closedcircuit crushing & screening| +15% average yield increase |
| Wear Life in Critical Zones (Hours)| 8001,200 hours on standard manganese steel| 2,4003,000 hours with composite liner systems| +150% extended service life |
| Process Dust Emission (mg/Nm³)| <50 mg/Nm³ with standard baghouse| 80% reduction in particulate emission |
| Energy Efficiency (kWh/Ton)| Varies widely based on circuit design| Field data shows 1012% reduction through optimized load sharing & reduced recirculating load| 1012% lower specific energy consumption |
5. TECHNICAL SPECIFICATIONS
Capacity Range: Configurable from 50 to 400 Tons Per Hour (TPH), depending on feed size and target product gradation.
Power Requirements: Total connected load from 250 kW to 1.2 MW. Plant requires 480V/3Phase/60Hz power supply (other voltages available).
Material Specifications: All productcontact surfaces are ASTM A240 Grade 316L Stainless Steel or FDAcompliant polyurethane/ceramic liners. Structural steel is primed and painted with industrial epoxy coating.
Physical Dimensions (Typical Setup): Modular design. A 150 TPH plant footprint is approximately 30m (L) x 15m (W) x 12m (H).
Environmental Operating Range: Designed for ambient temperatures from 20°C to +45°C. Electrical components rated for IP65 protection against dust and water ingress.
6. APPLICATION SCENARIOS
Pharmaceutical Excipient Production | Challenge: A specialty minerals producer needed to supply USPgrade calcium carbonate but their existing plant used carbon steel screens and conveyors, creating iron oxide contamination risk during wear. Audits identified this as a critical nonconformance.| Solution: Implementation of a turnkey secondary crushing & screening module from our FDAapproved limestone plant line, featuring allstainless contact surfaces and a dedicated fines recovery system.| Results: Achieved full compliance with supplier quality agreements. Contaminationrelated batch rejections fell to zero within the first year of operation. The recovered ultrafine fraction opened a new revenue stream.
FoodGrade Calcium Carbonate Expansion | Challenge: A processor aiming to enter the FCC market required a new production line that could guarantee cleanliness while achieving a very specific coarse granule profile (+16 mesh 40 mesh) at high throughput.| Solution: A complete primarytotertiary processing plant was installed, emphasizing precision screening stages and total dust containment per food manufacturing facility standards.| Results: The plant consistently met the stringent granule specification with <5% variance, securing longterm contracts with major food additives distributors. Dust emissions remained below internal hygiene benchmarks.
7 COMMERCIAL CONSIDERATIONS
Pricing Tiers: Systems are configured modularly.
Base Configuration: Secondary crushing/screening module with standard dust control.
Enhanced Configuration: Full primary+secondary circuit with advanced PLC controls and extended wear packages.
Turnkey Configuration: Complete system including civil engineering support, installation supervision, commissioning, and operator training.
Optional Features: Metal detection systems at feed point; automated grease lubrication systems; remote monitoring telematics package; acoustic enclosures for noise suppression.
Service Packages: Annual inspection contracts; guaranteed spare parts availability programs (e.g., 24/48hour delivery); onsite rotor rebuild services.
Financing Options: Equipment leasing through thirdparty partners; rentaltoown programs available for qualifying projects; milestonebased project financing can be structured for large turnkey installations.
8 FAQ
1. What documentation do you provide to support FDA compliance?
We provide full Material Certificates (Mill Test Reports) for all stainlesssteel components used in product contact areas , along with Declarations of Conformity stating construction follows current Good Manufacturing Practice (cGMP) principles relevant to equipment design.
2. How does this system integrate with our existing quarry primary crusher or downstream milling circuit?
The plants are designed as skidmounted modules with standardized conveyor interfaces . Our engineering team conducts a frontend review of your existing layout feed points discharge requirements , ensuring compatibility .
3.What is the expected impact on our overall plant availability?
By design , key components feature extended wear life . Industry data from similar installations shows planned maintenance intervals can be extended by approximately onethird , contributing positively to overall equipment effectiveness OEE .
4.Are performance guarantees offered?
Yes . We offer guaranteed throughput capacity based on agreedupon feed material specifications , along with guaranteed maximum dust emission levels . These are formalized in the sales contract .
5.What operator training is included?
Comprehensive training is provided covering normal operation , safety procedures , basic troubleshooting ,and preventative maintenance tasks . Training occurs both at commissioning onsite .
6.Can we produce multiple different product grades on this system?
Yes . The closedcircuit design allows adjustment via crusher setting changes screen cloth changes . Changeover procedures typically take one shift crew .
7.Do you offer ongoing technical support after commissioning?
Support includes access phone email technical assistance lifetime access updated documentation drawings optional remote diagnostic support via telematics package


