1. PAINPOINT DRIVEN OPENING

Are you managing a pharmaceutical, nutraceutical, or highpurity food processing plant where material consistency and regulatory compliance are nonnegotiable? The challenges of sourcing reliable crushing and screening equipment for FDAapproved applications are unique and costly. Contamination risks from equipment materials can lead to entire batch rejections, resulting in hundreds of thousands in lost product and remediation costs. Inconsistent particle size distribution from standard machinery creates formulation errors, impacting product efficacy and shelf stability. Furthermore, the difficulty of validating cleaning processes on complex equipment leads to excessive downtime for sanitation cycles. Are you questioning how to achieve guaranteed material purity, ensure full audit trail compliance for your size reduction process, and reduce operational risk? The solution requires equipment engineered from the ground up for regulated environments.

2. PRODUCT OVERVIEW

Our solution is a line of fully integrated FDAapproved crushing and screening equipment designed specifically for stringent hygienic processing. This system is constructed to meet FDA 21 CFR Part 177 standards for materials in contact with consumable products.

Operational Workflow:
1. Controlled Feed: Hygienicgrade feed systems introduce raw materials into the sealed processing loop.
2. Sanitary Comminution: Precision crushing or milling occurs within a fully polished, crevicefree chamber using compliant wear parts.
3. ClosedLoop Screening: Material is immediately transferred to an integrated, sanitary screener for precise classification without exposure.
4. Contained Discharge: Accepted and oversize fractions are discharged via validated sanitary valves into designated, clean containers or downstream processes.
5. CIP/SIP Ready: The entire system is designed for CleaninPlace (CIP) and SterilizeinPlace (SIP) protocols without disassembly.

Application Scope: Ideal for active pharmaceutical ingredients (APIs), excipients, vitamins, food additives, and highpurity cosmetic powders where product contact surface compliance is mandatory.

Limitations: This specialized equipment is not intended for standard mining or aggregate processing where hygienic standards are not required. Optimal performance is achieved with dry, powderbased materials; specific configurations are needed for wet or highly fatty substances.

3. CORE FEATURES

Hygienic Design & Material Compliance | Technical Basis: FDA 21 CFR Part 177 & EHEDG guidelines | Operational Benefit: Eliminates contamination risk at source, simplifies regulatory audits | ROI Impact: Avoids batch loss penalties and reduces quality assurance overhead by up to 30%

Fully Polished & CreviceFree Surfaces | Technical Basis: Electropolishing to Ra <0.8 µm internal surfaces | Operational Benefit: Prevents microbial harborage and enables rapid, effective cleaning | ROI Impact: Cuts sanitation downtime by up to 50% compared to standard industrial finishes

Sealed Processing Envelope with CIP/SIP | Technical Basis: Integrated spray ball system and validated cleaning protocols | Operational Benefit: Allows for automated cleaning without operator contact or reassembly errors | ROI Impact: Reduces labor costs for changeovers and ensures consistent cleaning validation

QuickChange ToolFree Access | Technical Basis: Sanitary clamp connections and captive fasteners | Operational Benefit: Enables rapid inspection, maintenance, and screen changes while maintaining system integrity | ROI Impact: Minimizes planned downtime by an average of 25%

Intelligent Vibration & Process Monitoring | Technical Basis: Integrated sensors tracking bearing temperature, vibration amplitude, and motor load | Operational Benefit: Provides predictive maintenance alerts and ensures consistent particle size output | ROI Impact: Prevents unplanned stoppages and reduces product giveaway from outofspec material

4. COMPETITIVE ADVANTAGES

| Performance Metric | Industry Standard Equipment | FDAApproved Crushing & Screening Solution | Advantage (% Improvement) |
| : | : | : | : |
| Batch Contamination Risk | ModerateHigh (Carbon steel, gaskets, poor cleanability) | Extremely Low (Compliant materials, polished surfaces) | Risk Reduction >95% |
| Average Cleaning Cycle Time| 48 hours (Manual teardown) | 12 hours (Validated CIP cycle) | Time Savings ~70% |
| Particle Size Consistency (RSD)| ±1015% variation common| ±5% or less variation achievable| Consistency Improvement >50% |
| Regulatory Documentation| Generic MOC certificates only| Full material traceability & validation support package| Audit Preparedness 100% |

5. TECHNICAL SPECIFICATIONS

Capacity Range: From pilotscale systems at 50 kg/hr to full production lines exceeding 2,000 kg/hr.
Power Requirements: Configurable from standard 480V/3phase/60Hz industrial power to explosionproof (ATEX/XP) ratings as required.
Material Specifications: All product contact surfaces are 316L or highergrade stainless steel, electropolished internally to Ra <0.8 µm. Seals utilize FDAcompliant elastomers (e.g., EPDM, Silicone). External finish is beadblasted or electropolished.
Physical Dimensions: Modular designs adaptable to footprint constraints. Typical production unit footprint ranges from 10m² to 25m².
Environmental Operating Range: Ambient temperature operation from 10°C to 30°C recommended. Designed for humiditycontrolled environments typical of GMP facilities.

6. APPLICATION SCENARIOS

[Pharmaceutical API Milling] Challenge: A manufacturer of highpotency APIs faced crosscontamination risks during particle size reduction of different compounds using shared equipment with difficulttoclean surfaces.Solution: Implementation of a dedicated FDAapproved crushing and screening system with contained discharge and a validated CIP system.Results: Achieved a complete elimination of crosscontamination events, reduced cleaning validation time by 65%, and gained the flexibility to run multiple products in the same suite with reduced changeover quarantine time.

[Nutraceutical Powder Blending Prep] Challenge: A nutraceutical company experienced inconsistent bioavailability in final tablets due to variable excipient particle size from noncompliant crushers.Solution: Integration of a sanitary screening circuit postmilling to ensure all excipient material fell within a tight specification before entering blending.Results: Particle size distribution variation reduced from ±12% to ±4%, leading to a measured 15% improvement in tablet dissolution rate consistency and a significant reduction in customer quality complaints.

7. COMMERCIAL CONSIDERATIONS

Pricing Tiers:
Pilot/Development Systems: For R&D and smallbatch production.
Standard Production Line: Fully integrated crushing & screening units for established processes.
Custom Engineered Solutions: For complex multistage sizing or containment requirements.
Optional Features: Explosionproofing (ATEX), nitrogen inertion systems for oxygensensitive materials, advanced HMI with data logging for full audit trails, integrated metal detection.
Service Packages: Tiered plans offering from basic remote support up to comprehensive onsite planned maintenance programs including spare parts kits.
Financing Options: Capital lease agreements operating leases structured as monthly payments project financing available through partners

8.FAQ

1.Q What documentation is provided to prove FDA compliance?
A You receive formal Material Certificates of Compliance stating adherence tFDA regulations along with detailed material traceability documentation essential foGMP audits

2.Q Can this equipment be integrated into our existing process line?
A Yes these systems are designed fo modular integration We conduct a full review oyour current layout anmaterial flow tdesign compatible interfa ces anconveyance solutions

3.Q How does th eROI justify th epremium over standard industrial crushers?
A Th eprimary ROIdriver i sbatch security Avoiding even one major contamination related batch rejection ca noften cover asignificant portion o fthe investment Additional savings com efrom reduced downtime faster changeovers anlower validation costs

4.Q What i sthe typical lead time fro morder t ocommissioning?
A Fo rstandard production models lead times typically range fro m20 t o30 weeks depending onconfiguration Custom solutions require additional engineering time We provide detailed project timelines upon application review

5.Q Who handles installation an dvalidation support?
A Our team o fqualified engineers provides supervised installation an dstartup W eoffer validation support packages tha tcan include IOQ(I nstallation Qualification Operational Qualification protocol templates an donsite execution assistance

6.Q Are wear parts readily available an deasy t ochange?
A Yes Critical wear parts ar estocked fo rquick shipment Th eh ygienic design prioritizes toolfree o rsimple tool access fo rrapid replacement minimizing operational interruption

7.Q What training i sprovided fo roperators an dmaintenance staff?
A Comprehensive training i sprovided during commissioning covering safe operation routine maintenance sanitation procedures an dtroubleshooting Digital manuals an dvideo resources ar ealso supplied