Fda Approved Crushing And Screening Equipment ODM Manufacturer
1. HAPJE NGA PIKA E DIKIMIT
Are you managing a pharmaceutical, nutraceutike, or highpurity food processing operation where material size reduction is critical? The challenges of working with active pharmaceutical ingredients (API-të), eksipientë, and sensitive blends are unique and costly. Contamination risks can lead to entire batch rejections, resulting in hundreds of thousands in lost product and compliance violations. Inconsistent particle size distribution directly compromises tablet integrity, dissolution rates, and final product efficacy. Për më tepër, equipment that is difficult to clean and validate contributes to extended changeover downtime, reduktimin e xhiros së përgjithshme të impiantit. Aktualisht po përballeni:
How to achieve precise, repeatable particle sizing while maintaining absolute containment?
What steps are necessary to reduce crosscontamination risk and streamline FDA/GMP cleaning validation?
Which crushing and screening solutions can enhance yield while ensuring full audit trail compliance?
2. PËRMBLEDHJE E PRODUKTIT
This product line comprises FDAcompliant crushing and screening equipment engineered for stringent sanitary requirements in regulated industries. This includes cone mills, mullinj me çekiç, oscillating granulators, and vibratory sieves constructed to meet cGMP standards.
Rrjedha e punës operative:
1. Contained Feed: Material is introduced via sanitary connections or in a contained loading environment.
2. Precise Comminution: The crusher or mill reduces material within a sealed chamber using hygienic design principles.
3. Controlled Classification: Integrated or downstream screening ensures particles meet specified size distribution (p.sh., for direct compression or granulation).
4. Shkarkimi i përmbajtur: Finished material is discharged into intermediate bulk containers (IBCs) or process lines with minimal dust generation.
5. Vlerësuar CleaninPlace (CIP) / WashinPlace (WIP): Equipment is cleaned using documented procedures without disassembly.
Fusha e Aplikimit: Processing of APIs, eksipientë, granules, crystals, dried foods, and nutraceutical powders.
Kufizimet: Not designed for highly abrasive materials outside pharmaceutical/food specifications or for continuous 24/7 heavy mining/construction duty cycles.
3. TIPARET THEMELORE
Dizajn higjienik & Ndërtimi | Baza Teknike: cGMP principles per FDA 21 Pjesa CFR 211 | Përfitimi Operacional: Reduces contamination risk and simplifies cleaning validation | Ndikimi i ROI: Cuts batch changeover time by up to 40% and reduces cleaning labor costs
Full Containment Sealing | Baza Teknike: Advanced gasket materials (p.sh., FDAgrade silicone) and sealed bearing designs | Përfitimi Operacional: Contains potent compounds and prevents product loss or operator exposure | Ndikimi i ROI: Minimizes product giveaway and enhances operator safety compliance
QuickDisassembly Mechanisms | Baza Teknike: Clampbased (triclamp) or bolted connections with minimal tool requirements | Përfitimi Operacional: Allows for rapid inspection, mirëmbajtjen, and manual cleaning when required | Ndikimi i ROI: Increases equipment uptime and operational flexibility
CorrosionResistant Contact Surfaces | Baza Teknike: Electropolished 316L or highergrade stainless steel with Ra <0.8 Mm përfundimi i sipërfaqes | Përfitimi Operacional: Prevents material adhesion, inhibits bacterial harborage, and ensures product purity | Ndikimi i ROI: Extends equipment service life in corrosive environments and protects product integrity
Integrated Dust Control & CIP Systems | Baza Teknike: Engineered ports for vacuum connections or integrated spray ball systems for automated cleaning | Përfitimi Operacional: Controls airborne particulates at the source and enables reproducible cleaning cycles | Ndikimi i ROI: Lowers facility HVAC filtration load and provides documented compliance evidence
4. PËRPARËSITË KONKURRETARE
| Metrikë e performancës | Zgjidhja standarde e industrisë | This FDAApproved Crushing & Zgjidhja e shqyrtimit | Avantazhi (% Përmirësimi) |
| : | : | : | : |
| Koha e ndërrimit ndërmjet grupeve| 46 hours for manual teardown/clean/assembly| ≤2 hours with CIP/WIP capabilities| Deri në 60% më shpejt |
| Konsistenca e shpërndarjes së madhësisë së grimcave (RSD)| ±15% variance across batches| Controlled to within ±5% variance| ~67% more consistent |
| Surface Cleanliness Validation Pass Rate| ~85% pass rate on swab tests| >99% pass rate due to electropolished finishes| ~14% more reliable |
| Koha e ndërprerjes së mirëmbajtjes vjetore| 120150 hours/year for seal/bearing replacement| <80 hours/year with sealedforlife bearings| ~50% less downtime |
5. SPECIFIKIMET TEKNIKE
Kapaciteti/Vlerësimi: Models range from laboratory/pilotscale (550 kg/orë) to full productionscale (5003000 kg/orë).
Kërkesat për fuqi: Ndryshon sipas modelit; typical range from 3phase 5 HP (3.7 kW) te 30 HP (22 kW), compliant with IEC/NFPA standards.
Specifikimet e materialit: All product contact parts are constructed from certified 316L stainless steel; seals are FDAgrade silicone or PTFE; noncontact frames are powdercoated carbon steel.
Dimensionet fizike: Productionscale mill dimensions approximately 1.5m L x 1m W x 1.8m H; designed for integration into existing process lines.
Gama e funksionimit të mjedisit: Ambient temperature operation from 10°C to 35°C; lagështia relative deri në 60% jokondensuese.
6. Skenarët e APLIKIMIT
Pharmaceutical Tablet Production Line | Sfida: Inconsistent granule size from a legacy mill caused tablet weight variation exceeding USP limits (<±5%), leading to batch reprocessing. Zgjidhje: Implementation of an FDAapproved conical mill with integrated screen classification directly before the tablet press. Rezultatet: Particle size distribution variation reduced to ±3%, eliminating weight variationrelated rejects. Yield improved by an estimated 4%, representing significant annual savings on highvalue API.
Nutraceutical Powder Blending Facility | Sfida: Crosscontamination during changeovers between different botanical powders required extensive manual cleaning, causing production bottlenecks. Zgjidhje: Installation of multiple dedicated sanitary hammer mills with quickdisconnect screens and CIP capability for each major product line. Rezultatet: Changeover downtime decreased by 55%. Audit readiness improved with standardized CIP documentation logs.
7. KONSIDERATA TREGTARE
Nivelet e çmimeve: Pajisjet ofrohen në tre nivele kryesore:
Modeli standard i prodhimit: Includes base sanitary construction and core sizing functionality.
Validatable Package: Adds documentation packs (DQ/IQ/OQ protocols), extra surface finish certifications, and CIP integration ports.
Contained Potent Compound Package: Includes advanced sealing technology, split valve interfaces, and full containment verification testing.
Karakteristikat opsionale: Explosionproof motors (ATEX/US), integrated metal detection systems automated screen tensioning mechanisms custom mobile trolleys
Paketat e Shërbimit: Comprehensive annual maintenance contracts remote monitoring diagnostics training programs for operational staff
Opsionet e financimit: Capital lease operating lease rentaltoown programs available through accredited partners
8.FAQ
Q1 Is this equipment compatible with our existing pneumatic conveying system?
A1 Yes most models are designed with standardized sanitary flanges typically available in sizes that can interface via adapter plates Field data shows successful integration requires review of pressure drop specifications
Q2 What is the typical impact on our overall production line efficiency?
A2 Industry testing demonstrates that reducing size variation at the crushing stage improves downstream processes like blending tableting encapsulation Primary efficiency gains are measured in reduced rework rates higher batch yield
Q3 Are IQ/OQ protocols provided with the equipment?
A3 For Validatable Package purchases we supply comprehensive installation qualification operational qualification documentation templates These are designed as foundational documents your quality team can adapt
Q4 What are the lead times for standard production models?
A4 Lead times vary based on model complexity Current standard lead times range from weeks For fully customized configurations engineering timelines apply
Q5 How does the pricing structure account for optional features like CIP systems?
A5 Optional features are quoted as lineitem additions This modular approach allows you to specify only the capabilities required Commercial terms typically reflect this additive configuration
Q6 What material certifications are provided?
A6 We provide material test reports certifying grade stainless steel origin finish Electropolishing certificates detail surface roughness measurements essential for your technical files
Q7 Can you assist with implementation training for our operators?
A7 Yes we offer onsite training modules focused on safe operation sanitation procedures basic troubleshooting This training is often included within service package agreements
