Name: Pharmaceutical-Grade Automated Checkweighers for cGMP Compliance
Brand: SMARTWEIGH INSTRUMENT CO.,LTD
SKU: Pharmaceutical-Grade Automated Checkweighers
Availability: InStock

Rumah Produk Automatic Checkweigher

Pharmaceutical-Grade Automated Checkweighers for cGMP Compliance

Detail produk:

Place of Origin:	CHINA
Model Number:	Pharmaceutical-Grade Automated Checkweighers

Syarat-syarat pembayaran & pengiriman:

Minimum Order Quantity:	1 set
Harga:	Bisa dinegosiasikan
Packaging Details:	Caron box
Delivery Time:	10-30days
Supply Ability:	2000 set per month

Kontak

Detil Deskripsi produk

Produk:	Checkweighers otomatis tingkat farmasi	Berat bobot:	0.1mg - 500g (dapat disesuaikan hingga 5kg untuk curah)
Keterbacaan:	0,1mg (model mikro-balance), 1mg (standar)	Ketepatan:	± 0,1mg hingga ± 5mg (tergantung pada model)
Kecepatan berat:	100-600 item/menit (kecepatan vs akurasi trade-off)	Standar Pengaturan:	FDA 21 CFR Bagian 11, EU GMP Annex 11, USP <41>, <905>, Who-GMP
Integritas data:	Alcoa+ Compliant, Tanda Tangan Elektronik, Jalur Audit	Paket validasi:	Dokumentasi IQ/OQ/PQ Termasuk (tersedia DQ)
Konstruksi material:	AISI 316L Stainless Steel, permukaan listrik	Peringkat Perlindungan:	IP65 (Standar), IP66 (Versi Cuci Tersedia)
Kebersihan:	Opsi CIP (bersih di tempat), tidak ada perangkap produk	Tipe penolakan:	Pusher pneumatik, servo-arm, atau pengalih konveyor
Akurasi penolakan:	± akurasi penentuan posisi 1mm	Kecepatan penolakan:	<50ms waktu respons
Penyimpanan data:	2+ tahun data aman (penyimpanan SSD yang dapat diperluas)	Format Laporan:	PDF, CSV, XML (21 CFR Bagian 11 sesuai)
Keterlacakan:	Barcode/QR/RFID Pemindaian terintegrasi	Protokol industri:	OPC UA, MQTT, MODBUS TCP/IP
Antarmuka jaringan:	Ethernet, Wi-Fi (Opsional), USB 3.0	Integrasi sistem:	SAP, WERUM PAS-X, SIEMENS SIMATIC, SISTEM PI
Menampilkan:	15 "layar sentuh (resistif, kompatibel sarung tangan)	Sistem Operasi:	Windows 10 IoT (terkunci) atau berbasis Linux
Akses pengguna:	Perlindungan kata sandi 5-level (operator ke admin)	Suhu operasi:	15 ° C hingga 30 ° C (59 ° F hingga 86 ° F) - Lingkungan Terkontrol
Kelembaban:	20% hingga 80% RH (non-kondensasi)	Perlindungan aliran udara:	Draft Shield Tersedia untuk Mikro-Weighing
Bobot kalibrasi:	NIST-Tracable (termasuk)	Kalibrasi otomatis:	Pemicu suhu atau berbasis waktu (dapat dikonfigurasi)
Interval kalibrasi:	Direkomendasikan setiap 6 bulan (lingkungan GMP)	Lebar Konveyor:	150-300mm (dapat disesuaikan)
Tinggi Infeed/Outfeed:	800-1000mm (dapat disesuaikan untuk mencocokkan garis)	Tapak:	1200mm (L) × 800mm (W) × 1500mm (h) (khas)
Menyoroti:	pharmaceutical-grade automated checkweighers , cGMP compliant checkweighers , automatic checking weigher

Pharmaceutical-Grade Automated Checkweighers for cGMP Compliance

Overview

Pharmaceutical-grade automated checkweighers are precision instruments designed to ensure accurate weight verification of tablets, capsules, vials, syringes, and other drug products in compliance with current Good Manufacturing Practices (cGMP). These systems integrate high-speed weighing, real-time data analytics, and full traceability to meet stringent regulatory requirements (FDA 21 CFR Part 11, EU GMP Annex 11, and USP <41>).

Key Features & Compliance Requirements

1. Ultra-High Precision Weighing

Weighing Range: 0.1mg - 500g (for tablets, capsules, powders, liquids).
Accuracy: ±0.1mg (micro-balance grade for low-dose formulations).
High-Speed Operation: Up to 600 items/minute (depending on product size).
Dynamic Weighing Compensation: Minimizes vibration & airflow interference.

2. cGMP & Regulatory Compliance

FDA 21 CFR Part 11: Electronic signatures, audit trails, data integrity (ALCOA+ principles). Role-based access control (RBAC) for operators & QA personnel.
EU GMP Annex 11: Validation documents (IQ/OQ/PQ) included. Secure data storage with automatic backups.
USP <41> & <1251>: Meets pharmacopeial standards for weight variation testing.

3. Hygienic & Contamination-Free Design

Stainless Steel (AISI 316L) Construction: Corrosion-resistant, easy to clean.
IP65/IP66 Enclosure: Protects against dust, moisture, and washdowns.
No Product Contact Zones: Smooth surfaces with minimal crevices for GMP compliance.

4. Automated Rejection & Sorting

Rejection Mechanisms: Pneumatic pushers (for blister packs). Servo-driven arms (for vials & bottles). Conveyor diverters (for bulk sorting).
Closed-Loop Feedback: Adjusts filling machines in real-time to minimize giveaway.

5. Real-Time Data Analytics & Traceability

Statistical Process Control (SPC): Monitors Cp/Cpk trends for process capability. Alerts for OOS (Out-of-Spec) deviations.
Batch Reporting & Electronic Records: Generates PDF/CSV/XML reports with timestamps. Barcode/QR/RFID scanning for full track-and-trace.
Cloud & MES Integration: Syncs with Siemens SIMATIC, Werum PAS-X, or SAP.

Applications in Pharmaceutical Manufacturing

Tablet & Capsule Production - Ensures dosage uniformity (USP <905>)

Lyophilized Vials & Injectables - Checks fill weight before sealing

Blister Packs & Sachets - Verifies individual unit weights

Powder & Granule Filling - Prevents under/overfilling in bottles

Conclusion

Pharmaceutical-grade automated checkweighers are mission-critical for ensuring drug safety, regulatory compliance, and operational efficiency. By combining micro-precision weighing, full traceability, and cGMP-compliant software, these systems help manufacturers avoid costly recalls and maintain 100% batch accountability.

Parameter	Specifications
Weighing Range	0.1mg - 500g (customizable up to 5kg for bulk)
Readability	0.1mg (micro-balance models), 1mg (standard)
Accuracy	±0.1mg to ±5mg (depending on model)
Weighing Speed	100-600 items/minute (speed vs. accuracy trade-off)
Regulatory Standards	FDA 21 CFR Part 11, EU GMP Annex 11, USP <41>, <905>, WHO-GMP
Data Integrity	ALCOA+ compliant, electronic signatures, audit trails
Validation Package	IQ/OQ/PQ documentation included (DQ available)
Material Construction	AISI 316L stainless steel, electropolished surfaces
Protection Rating	IP65 (standard), IP66 (washdown versions available)

Label:

Kontak Person: Mrs. Shirley

Tel: +86-15851932889

Faks: 86-519-68781609

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C35 AdvancedLine Checkweigher for Ultimate Production Efficiency

Produk: Timbangan Cek AdvancedLine C35

Aplikasi Inspeksi: Kelengkapan Periksa Kontrol Berat Badan

Industri: Komponen logam, plastik dan elektronik kimia, makanan & minuman

Penimbangan akurasi: dari ± 0,01 g

Checkweigher Combinations with Vision Systems

Produk: Kombinasi periksa lebih tinggi dengan sistem penglihatan

Kamera: 2-8X Industri CMOS (5-20MP)

Optik: Lensa telecentric (perbesaran 0,1-0,5x)

penerangan: Array LED multi-sudut (RGB/W/UV/IR)

Industrial Weight Checkers Ensuring Product Compliance & Accuracy

Produk: Pemeriksa Berat Badan Industri

Lebar sabuk: 150-800mm (dapat disesuaikan)

Bahan sabuk: PU, PVC, atau logam yang terdeteksi

Kecepatan sabuk: 5-120 m/menit (dikendalikan servo)

Checkweigher Integration in Packaging Lines

Produk: Integrasi Checkweigher di jalur pengemasan

Lebar Konveyor: 200–1200mm

Sinkronisasi kecepatan sabuk: 5–120 m/menit

Jarak produk: Min. 50mm di antara item

Precision Checkweighers for Automotive Component Manufacturing

Produk: Presisi Checkweighers untuk pembuatan komponen otomotif

Berat bobot: 0,01g - 20kg (konfigurasi modular tersedia)

Keterbacaan: 0,001g (model mikro) hingga 0,1g (tugas berat)

Ketepatan: ± 0,005g (0-100g) hingga ± 0,2g (5-20kg)

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