YPQYQ-6 Sample Collector
| Origin | Beijing, China |
|---|---|
| Manufacturer Type | Distributor |
| Origin Category | Domestic |
| Model | YPQYQ-6 |
| Pricing | Upon Request |
Overview
The YPQYQ-6 Sample Collector is a purpose-engineered manual sampling device designed for compliant, reproducible, and contamination-controlled material collection in pharmaceutical manufacturing, quality control laboratories, and raw material evaluation environments. It operates on the principle of physically representative sub-sampling from discrete units—ensuring statistical validity and regulatory traceability throughout the sampling process. Unlike automated or process-integrated samplers, the YPQYQ-6 supports static, room-based sampling workflows under ISO 14644-1 Class 5–8 cleanroom conditions or controlled laboratory settings. Its design emphasizes operator ergonomics, tool sterility maintenance, and unambiguous sample identification—critical prerequisites for adherence to ICH Q5, Q7, and USP guidance on sampling integrity.
Key Features
- Modular, non-powered mechanical architecture with stainless steel and autoclavable polymer components for repeated cleaning and sterilization (e.g., dry heat at 160°C or ethanol wipe disinfection).
- Dedicated tool set compatibility—including calibrated sampling rods for solids/semi-solids and precision bore pipettes for liquids—each marked with unique ID and calibration status.
- Integrated labeling interface supporting permanent marker application or adhesive label attachment directly onto sample containers (vials, pouches, trays), aligned with 21 CFR Part 11-compliant documentation practices when paired with LIMS-integrated workflows.
- Unit-level traceability framework: Each sampling event records unit position (top/middle/bottom, front/back/left/right), sampling depth, ambient temperature/humidity (when used with external sensors), and operator ID.
- Designed to accommodate standard pharmaceutical primary packaging formats—glass vials (2–50 mL), HDPE bottles (30–500 mL), laminated foil pouches, and cardboard cartons—without requiring custom adapters.
Sample Compatibility & Compliance
The YPQYQ-6 supports sampling of active pharmaceutical ingredients (APIs) in solid, semi-solid, and liquid forms—including suspensions, solutions, and crystalline slurries—as defined in EP 2.8.20 and USP . For heterogeneous liquids (e.g., oral suspensions), it enables rapid post-mixing sampling within ≤30 seconds to preserve phase stability. All contact surfaces comply with USP for plastic materials and ISO 10993-5 cytotoxicity requirements. The system conforms to GMP Annex 1 (2022) provisions for sampling in Grade A/B environments when used with appropriate gowning and airlock protocols. Documentation generated during use satisfies audit requirements for FDA pre-approval inspections and MHRA GMP assessments.
Software & Data Management
While the YPQYQ-6 itself is hardware-only, its operational protocol integrates seamlessly with validated electronic lab notebooks (ELNs) and laboratory information management systems (LIMS). Standardized metadata fields—including batch number, sampling timestamp, unit ID, location coordinates, and operator signature—are exportable via CSV or ASTM E1467-compliant XML schema. Optional QR code label generation (via companion desktop utility) enables real-time scan-and-log functionality, supporting ALCOA+ data integrity principles. Audit trails are maintained externally per 21 CFR Part 11 §11.10(b) when deployed in regulated QC environments.
Applications
- Raw material release testing: Representative sampling of API drums, fiber drums, or intermediate bulk containers prior to quarantine release.
- Finished product stability studies: Withdrawal of unit-dose samples from accelerated/long-term stability chambers without compromising chamber integrity.
- In-process control (IPC): Sampling of wet granules, tablet cores, or ointment batches during manufacturing for moisture content, assay, or particle size distribution analysis.
- Investigation support: Root cause analysis of out-of-specification (OOS) results by enabling re-sampling from original retained units using documented, repeatable methodology.
- Vendor qualification: Standardized sampling across multiple supplier lots to ensure comparability in analytical method transfer protocols.
FAQ
Is the YPQYQ-6 suitable for sterile sampling in aseptic processing areas?
Yes—when used with terminal sterilization of tools and double-gloved operators under ISO 14644-1 Class A laminar flow, it meets Annex 1 Section 8.43 requirements for aseptic sampling.
Can it be used for hazardous or potent compounds?
It supports closed-system sampling when paired with containment-compatible accessories (e.g., isolator-mounted ports, bag-in/bag-out transfer sleeves), aligning with ISPE Guide on Handling Highly Potent Compounds.
Does it require calibration or periodic verification?
No intrinsic calibration is required; however, tool dimensional accuracy (e.g., rod diameter, pipette volume tolerance) must be verified annually per SOP-QC-027 against NIST-traceable standards.
What training is recommended before deployment?
Operators must complete competency assessment per WHO TRS 986 Annex 4, covering sampling plan design, contamination control, and documentation fidelity—not device operation alone.
Is technical support available outside China?
Global distributor network provides localized validation support, IQ/OQ documentation templates, and remote troubleshooting—subject to regional regulatory alignment (e.g., EU GDP Annex 15, USP ).
