Particle Counting Sampling Bottle PS-8011 by PULUODY

Overview

The PULUODY PS-8011 Particle Counting Sampling Bottle is a rigorously engineered container designed exclusively for quantitative liquid particle contamination analysis in hydraulic fluids, lubricants, aviation fuels, and other critical industrial media. Unlike generic laboratory bottles, the PS-8011 is manufactured under controlled cleanroom conditions (Class 100,000 per ISO 14644-1) and validated to meet the stringent cleanliness requirements of international standards including ISO 3722 (“Hydraulic fluid power — Validation of cleaning methods for sampling containers”), NAS 1638, and ISO 16232. Its core function is to eliminate background contamination during sample acquisition—ensuring that measured particle counts reflect only the intrinsic contamination level of the test fluid, not artifacts introduced by the sampling vessel. Constructed from high-borosilicate glass, the bottle exhibits exceptional thermal stability (up to 150 °C), chemical resistance to strong acids (e.g., sulfuric acid–potassium dichromate cleaning solutions), bases, and organic solvents—making it suitable for repeated sterilization cycles without degradation of optical clarity or dimensional integrity.

Key Features

• Ultra-low background contamination: Certified RCL (Residual Contamination Level) ≤15 particles ≥4 µm per 100 mL; achieves NAS 00–4 cleanliness grades per batch validation.
• AOQL (Average Outgoing Quality Limit) of 0.5%, verified per ISO 2859-1 sampling plans—ensuring statistical confidence in cleanliness consistency across production lots.
• Leak-proof design featuring externally threaded cap with integrated silicone O-ring seal and anti-drip lip geometry to prevent cross-contamination during transfer and storage.
• Optimized optical transparency and surface smoothness—minimizing particle adhesion and enabling reliable visual inspection and automated imaging-based verification.
• Available in standardized volumes (220 mL and 250 mL) with color-coded caps (blue, orange-yellow, pink) for traceable workflow segregation in multi-analyte or multi-shift laboratories.
• Fully automated manufacturing process ensures batch-to-batch reproducibility—critical for GLP/GMP-regulated environments where documentation of material provenance and processing history is mandatory.

Sample Compatibility & Compliance

The PS-8011 is validated for use with all major optical particle counters—including HIAC ROYCO 8000A, 8011, 8012, PODS, and PM4000 systems—as well as PALL HPCA-2, PCM400, PFC400, and SBSS/S40-series analyzers. It complies with the container specifications required by ASTM D6792 (Standard Practice for Liquid Particle Counting), ISO 4406:2017 (Fluids—Code system for contamination levels), and ISO 16232-4 (Road vehicles—Cleanliness of components—Part 4: Extraction of contaminants). Each lot undergoes independent verification by PUULODY’s accredited internal testing lab (PUULODY Analytical Testing Center, CNAS-certified scope) using calibrated reference suspensions traceable to NIST SRM 2806. Documentation includes full Certificate of Conformance (CoC), batch-specific RCL reports, and validation records aligned with FDA 21 CFR Part 11 data integrity expectations.

Software & Data Management

While the PS-8011 itself is a passive consumable, its integration into regulated workflows is supported by PULUODY’s TraceLink™ Digital Batch Record System—an optional cloud-enabled platform for electronic lot traceability. Users can scan QR codes on bottle labels to retrieve full manufacturing history: ultrasonic cleaning parameters, cleanroom environmental logs (temperature, humidity, particle counts), final rinse conductivity data, and sterility verification timestamps. This digital audit trail satisfies ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and facilitates compliance with ISO/IEC 17025 clause 7.7 (Sampling) and EU Annex 11 (Computerized Systems).

Applications

• Hydraulic system fluid monitoring per ISO 4406 and SAE AS4059 for aerospace and heavy machinery OEMs.
• Transformer oil and turbine lubricant cleanliness verification in power generation facilities (DL/T 427, DL/T 1096).
• Pharmaceutical process fluid sampling where particulate limits are defined by USP and .
• R&D validation of filtration efficiency and wear debris analysis in tribology labs.
• Calibration and verification of optical particle counters per ISO 21501-4 and ISO 11171.
• Field-deployed contamination control programs using portable counters (e.g., S40 series) requiring pre-validated, transport-stable sampling vessels.

FAQ

What does “RCL ≤15 particles/100 mL” mean in practice?
It specifies the maximum allowable number of residual particles ≥4 µm detected in a 100 mL volume of ultra-pure water used to rinse the bottle post-cleaning—verified via laser diffraction and/or light obscuration per ISO 11171.
Can the PS-8011 be autoclaved?
Yes—the borosilicate glass construction and O-ring material (FDA-grade silicone) support steam sterilization at 121 °C for 20 minutes; however, repeated autoclaving beyond 10 cycles may affect cap seal longevity and requires revalidation.
Is this bottle compatible with ISO 16232-C standards for automotive component cleanliness?
Yes—its certified NAS 00–4 grade meets the “Class A” requirement for extraction solvent containers specified in ISO 16232-3 and -4.
Do you provide lot-specific certificates of analysis (CoA)?
Yes—each shipment includes a signed CoA listing RCL results, AOQL verification, ISO 3722 conformance statement, and cleanroom processing log summary.
How is traceability maintained across production batches?
Each bottle bears a unique alphanumeric lot code laser-etched on the base; full manufacturing metadata is archived for ≥15 years per ISO/IEC 17025 retention requirements.