Tailin Biotech Sterile Sampling Bottles QYP Series
| Brand | Tailin Biotech |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Manufacturer |
| Product Origin | Domestic (China) |
| Model | QYP Series Sterile Sampling Bottles |
| Pricing | Available Upon Request |
Overview
The Tailin Biotech Sterile Sampling Bottles QYP Series are single-use, gamma-irradiated containers engineered for microbiological water quality analysis—specifically for the detection and enumeration of total coliforms, thermotolerant (fecal) coliforms, and Escherichia coli using enzyme substrate-based methods (e.g., IDEXX Colilert®, Chromocult®, or equivalent EPA-approved assays). These bottles operate on the principle of membrane filtration-compatible liquid-phase sampling and serve as integral components in standardized presence/absence and most-probable-number (MPN) testing protocols. Designed for field and laboratory use, the QYP Series ensures sample integrity from collection through incubation by eliminating pre-sampling contamination risks associated with reusable or inadequately sterilized vessels. Their application aligns with regulatory frameworks including US EPA Method 1603, ISO 9308-1:2014, and EN ISO 9308-2:2013 for coliform and E. coli detection in drinking water, surface water, wastewater, and recreational water sources.
Key Features
- Gamma irradiation sterilization validated per ISO 11137-1:2015, achieving a Sterility Assurance Level (SAL) ≤ 10−3, ensuring consistent microbial sterility prior to use.
- Integrated 10 mg sodium thiosulfate (Na2S2O3) tablet or powder formulation to neutralize residual chlorine and chloramines commonly present in treated water supplies—critical for preserving target microorganisms during transport and storage.
- Precisely molded volume indicators (calibration lines) at 100 mL and 250 mL positions, enabling accurate volumetric sampling without auxiliary measuring devices—reducing operator variability and supporting GLP-compliant documentation.
- High-clarity polyethylene terephthalate (PET) or low-density polyethylene (LDPE) construction offering optimal optical transparency for visual confirmation of enzymatic colorimetric or fluorometric reactions post-incubation.
- Leak-resistant screw-cap design with tamper-evident seal, compliant with ICH Q5C stability requirements for container-closure integrity under standard ambient transport conditions.
Sample Compatibility & Compliance
The QYP Series is compatible with all major commercially available enzyme substrate reagents requiring defined sample volumes (e.g., 100 mL or 250 mL aliquots). It supports both qualitative (presence/absence) and quantitative (MPN) interpretations per ASTM D6162–22 and ISO 9308-1 Annex A. The bottles meet material biocompatibility requirements outlined in USP and , and their manufacturing process adheres to ISO 13485:2016 quality management standards for medical device-associated consumables. While not classified as an in vitro diagnostic (IVD) device under EU IVDR, they are routinely deployed in laboratories operating under ISO/IEC 17025:2017 accreditation scopes for environmental microbiology testing.
Software & Data Management
As a passive sampling consumable, the QYP Series does not incorporate embedded electronics or firmware. However, its standardized dimensions, batch-coded labeling (including lot number and expiration date), and traceable sterilization documentation integrate seamlessly into LIMS environments (e.g., Thermo Fisher SampleManager, LabVantage) via barcode scanning. Each production lot undergoes full sterilization validation reporting—including dose mapping, bioburden testing, and SAL verification—available upon request for audit readiness under FDA 21 CFR Part 11 and EU Annex 11 compliance workflows.
Applications
- Routine monitoring of municipal drinking water distribution systems per WHO Guidelines for Drinking-water Quality and national regulatory mandates.
- Compliance testing of bottled water, spring water, and beverage process water under FDA 21 CFR Part 129 and NSF/ANSI Standard 60.
- Environmental surveillance of wastewater effluents, stormwater runoff, and aquaculture intake points per EPA NPDES permit requirements.
- Field-based rapid assessment in disaster response scenarios where portable, ready-to-use sterile containers minimize cold-chain dependency.
- Research-grade sampling for microbial source tracking (MST) studies involving host-specific genetic markers (e.g., Bacteroides HF183).
FAQ
Are QYP Series bottles suitable for cold chain transport of samples?
Yes—bottles maintain structural integrity and seal performance between −20 °C and +40 °C; however, freezing is not recommended due to potential crystallization-induced stress on PET walls.
What is the shelf life post-sterilization?
Validated shelf life is 24 months from manufacture date when stored unopened in dry, dark, ambient conditions (15–25 °C, RH ≤ 60%).
Can these bottles be autoclaved again after opening?
No—autoclaving is strictly prohibited. Re-sterilization compromises material integrity and invalidates the certified SAL. Use only as supplied, single-use.
Do QYP bottles comply with ISO 8573-7 for compressed air microbiological sampling?
No—they are designed exclusively for aqueous environmental matrices. For compressed air applications, refer to ISO 8573-7–compliant impingers or membrane filter cassettes.
Is lot-specific sterilization validation data provided with each shipment?
Yes—Certificate of Conformance (CoC) and sterilization dossier (including dose audit reports) are available upon request and referenced via batch number on product labeling.
