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Pharmaceutical-Grade Automated Checkweighers for cGMP Compliance

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Pharmaceutical-Grade Automated Checkweighers for cGMP Compliance

Model Number : Pharmaceutical-Grade Automated Checkweighers

Place of Origin : CHINA

MOQ : 1 set

Price : Negotiation

Supply Ability : 2000 set per month

Delivery Time : 10-30days

Packaging Details : Caron box

Product : Pharmaceutical-Grade Automated Checkweighers

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)

Cleanability : CIP (Clean-in-Place) options, no product traps

Rejection Type : Pneumatic pusher, servo-arm, or conveyor diverter

Rejection Accuracy : ±1mm positioning accuracy

Rejection Speed : <50ms response time

Data Storage : 2+ years of secure data (expandable SSD storage)

Report Formats : PDF, CSV, XML (21 CFR Part 11 compliant)

Traceability : Barcode/QR/RFID scanning integrated

Industry Protocols : OPC UA, MQTT, Modbus TCP/IP

Network Interfaces : Ethernet, Wi-Fi (optional), USB 3.0

System Integration : SAP, Werum PAS-X, Siemens SIMATIC, PI System

Display : 15" touchscreen (resistive, glove-compatible)

Operating System : Windows 10 IoT (locked down) or Linux-based

User Access : 5-level password protection (operator to admin)

Operating Temperature : 15°C to 30°C (59°F to 86°F) - controlled environments

Humidity : 20% to 80% RH (non-condensing)

Airflow Protection : Draft shield available for micro-weighing

Calibration Weights : NIST-traceable (included)

Auto-Calibration : Temperature-triggered or time-based (configurable)

Calibration Interval : Recommended every 6 months (GMP environments)

Conveyor Width : 150-300mm (customizable)

Infeed/Outfeed Height : 800-1000mm (adjustable to match line)

Footprint : 1200mm (L) × 800mm (W) × 1500mm (H) (typical)

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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)

Pharmaceutical-Grade Automated Checkweighers for cGMP Compliance

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