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Specifications:
| Application | Particle size distribution |
| Storage Temperature | Room Temperature |
| Product Type | Service |
| Product Brand | FRITSCH GmbH |
| Product Grade | Analytical grade |
The FRITSCH ANALYSETTE™ 3 Certification & IQ/OQ Documentation package provides comprehensive support for instrument validation, compliance, and quality assurance in regulated laboratory environments.
Designed to meet international standards, these certification services and documentation tools enable laboratories to verify performance, ensure traceability, and maintain compliance with ISO and quality management systems.
From inspection certificates for the sieve shaker and test sieves to IQ/OQ qualification documentation, this offering ensures that your ANALYSETTE™ 3 system operates within validated parameters and is fully prepared for audits and regulatory requirements.
Key Features
-
Certified Compliance Support
- Inspection certificates in accordance with EN 10204
- Supports compliance with ISO 3310-1 for test sieves
-
Comprehensive Instrument Qualification
- IQ (Installation Qualification) documentation
- OQ (Operational Qualification) documentation
- Structured questionnaire format for systematic validation
-
Flexible Implementation Options
- Documentation can be completed by LabMart during installation
- Or independently by the customer’s QA/QC team
-
Traceability & Audit Readiness
- Ensures proper documentation of instrument performance
- Supports regulatory audits and quality inspections
-
System-Wide Validation
- Covers both sieve shaker and test sieves
- Ensures complete workflow compliance
Product Variants & Specifications
A. Inspection Certificates
| Order No. | Description | Standard |
|---|---|---|
| 96.0010.00 | Inspection certificate 3.1 EN 10204 for ANALYSETTE™ 3 PRO | EN 10204 |
| 31.0900.00 | Inspection certificate 3.1 EN 10204 for test sieves | ISO 3310-1 |
B. IQ/OQ Documentation
| Order No. | Description | Implementation |
|---|---|---|
| 96.0200.00 | IQ/OQ documentation for ANALYSETTE™ 3 PRO | Implementation not included |
| 96.0100.00 | IQ/OQ documentation for ANALYSETTE™ 3 | Implementation not included |
Applications
- Pharmaceutical and biotechnology laboratories
- Food and environmental testing facilities
- Quality control and assurance laboratories
- Academic and research institutions
- Regulated laboratories operating under ISO, GLP, or GMP standards
Compliance & Standards
- EN 10204 (Inspection Certificate 3.1) – Material and product conformity
- ISO 3310-1 – Test sieve specifications and verification
- Supports ISO 9001, GLP, GMP quality management systems
Unique Advantages
- Ensures full regulatory compliance and audit readiness
- Structured qualification process for consistent validation
- Supports both instrument and accessory certification
- Flexible execution with or without LabMart support
- Reduces risk of non-compliance and operational errors
LabMart Implementation Advantage
When delivered as part of a LabMart installation package, this certification and documentation ensures:
- Immediate qualification upon commissioning
- Reduced workload for internal QA/QC teams
- Proper documentation aligned with international standards
- Faster approval for regulated laboratory operations
The FRITSCH ANALYSETTE™ 3 Certification & IQ/OQ Documentation package is essential for laboratories requiring validated, compliant, and traceable particle size analysis workflows.
By combining inspection certification and structured qualification documentation, it ensures that your ANALYSETTE™ 3 system is fully compliant, audit-ready, and optimized for regulated environments.
- Type: Inspection certificate, EN 10204 3.1 for ANALYSETTE™ 3 PRO Inspection certificate, EN 10204 3.1 / ISO 3310-1 for test sieves IQ/OQ documentation, questionnaire format for ANALYSETTE™ 3 PRO IQ/OQ documentation, questionnaire format for ANALYSETTE™ 3