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Model Number : Compliant Automated Checkweighing Solutions for Regulated Industries
Place of Origin : CHINA
MOQ : 1 set
Price : Negotiation
Supply Ability : 2000 set per month
Delivery Time : 10-30days
Packaging Details : Caron box
Product : Compliant Automated Checkweighing Solutions for Regulated Industries
Weighing Range : 0.01g-5kg
Accuracy : ±0.05% of reading
Data Integrity : ALCOA
Audit Trail : Blockchain-encrypted
Contact Materials : 316L SS, FDA elastomers
Surface Finish : Ra ≤0.8μm
Cleanability : CIP/SIP capable
GMP Classification : Grade A/B
Access Control : Role-based (5+ tiers)
Data Retention : 10+ years
Electronic Signatures : Two-factor auth
Feature : FDA 21 CFR Part 11
Material Tracking : RFID/UHF tagging
Environmental Monitoring : Particle counters
Cleaning Validation : Swab test documentation
Regulatory Reporting : eCTD submission ready
Data Recording : Local storage
User Access : Single level
Change Tracking : Manual logs
Compliant Automated Checkweighing Solutions for Regulated Industries
The core of any compliant system is its verifiable accuracy. This is achieved through:
Legal for Trade (LFT) Certification: Many countries require checkweighers to be certified as "legal for trade"
by a recognized metrology organization (e.g., OIML, NIST). This certification confirms that the system meets strict standards for precision and reliability, making it suitable for weighing products sold by weight.
High-Resolution Weighing Technology: Compliant systems use advanced load cell and weighing algorithms to provide high-resolution measurements, often down to a fraction of a gram. This ensures that even small deviations from the target weight are detected.
Robust Calibration and Verification: The system must be easy to calibrate using certified test weights.
The software should guide operators through the process and log every calibration event, creating a clear
audit trail.
Regulatory bodies like the FDA (Food and Drug Administration) demand complete data integrity. Compliant checkweighers are designed to meet these requirements:
21 CFR Part 11 Compliance: In the pharmaceutical and food industries, this is a critical standard. It
requires electronic records and signatures to be trustworthy and reliable. Compliant checkweighers offer secure, timestamped data logs that prevent unauthorized changes and create an unalterable history of every product weighed.
Detailed Reporting: The system must generate comprehensive reports, including statistics on weight distribution, standard deviation, and the number of accepted and rejected products. These reports are essential for quality control and regulatory audits.
Traceability: Each product's weight data can be linked to a specific batch or lot number, providing full traceability from the production line to the end consumer.
Specifications:
Parameter | Specification |
Weighing Range | 0.01g-5kg |
Accuracy | ±0.05% of reading |
Data Integrity | ALCOA |
Audit Trail | Immutable blockchain |
Contact Materials | 316L SS, FDA elastomers |
Surface Finish | Ra ≤0.8μm |
Cleanability | CIP/SIP capable |
GMP Classification | Grade A/B |
Access Control | Role-based (5+ tiers) |
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Compliant Automated Checkweighing Solutions for Regulated Industries Images |