Validation Testing

We provide GMP-compliant single-use fluid tubing technology to global biopharmaceutical clients. Compliance is ensured through continuously updated validation data and documentation. Our validation documentation integrates international pharmacopoeia standards such as USP and EP, and includes: 1) a quick-access validation summary guide; 2) a guide to materials for claiming compliance; and 3) a complete validation report (accessible only with authorization). This system supports clients in efficiently completing risk assessments and regulatory filings, and dynamically tracking the latest industry regulations.

FDA Drug Master File

Our independently developed platinum silicone tubing has successfully passed the US FDA Drug Master File (DMF) filing, filing number: 43250 (TYPE III). This marks another milestone breakthrough for the company in product quality, safety standards, and international compliance, providing global customers, especially high-end pharmaceutical and biotechnology companies, with a more secure supply chain option.

PreFluid Silicone Tube Biocompatibility Verification Checklist

Serial Number Validate project Regulations and Standards Serial Number Validate project Regulations and Standards
1 The appearance of solution S ISO17025 EP10.0(3.1.9) 19 Ignition residue ISO17025 USP43<661>
2 Acidity or alkalinity ISO17025 EP10.0(3.1.9) 20 Rubber products can be extracted ISO17025 FDA 21 CFR Part 177.2600
3 Relative density ISO17025 EP10.0(3.1.9) 21 Extractable research  BPOG 
4 Reducing substances ISO17025 EP10.0(3.1.9) 22 Bacterial endotoxin-interference test ISO-IEC 17025 USP<85> 
5 Substances soluble in hexane ISO17025 EP10.0(3.1.9) 23 Cytotoxicity ISO-IEC 17025 USP<87> 
6 Phenyl compounds ISO17025 EP10.0(3.1.9) 24 Intracutaneo us Reactivity ISO-IEC 17025  USP<88> 
7 Mineral oil ISO17025 EP10.0(3.1.9) 25 Acute Systemic Toxicity ISO-IEC 17025  USP<88> 
8 Volatile substances ISO17025 EP10.0(3.1.9) 26 USP Implantation ISO-IEC 17025  USP<88> 
9 Platinum ISO17025 EP10.0(3.1.9) 27 ISO L-929 Cell MEM Elution Assay ISO10993-5
10 Preparation of solution S ISO17025 USP2021<381> 28 ISO Intradermal reaction test in 3 rabbits (double immersion) ISO10993-23
11 Color ISO17025 USP2021<381> 29 ISO guinea pig maximum dose sensitization test (double extraction) ISO10993-10
12 Absorbance ISO17025 USP2021<381> 30 ISO Acute Systemic Toxicity Test (Double Extraction) ISO10993-11
13 Reducing substances ISO17025 USP2021<381> 31 ISO Material-Mediated Pyrogen Test (Salt Extraction)） ISO10993-11
14 Volatile sulfides ISO17025 USP2021<381> 32 ISO In Vitro Bacterial Reversion Mutation Assay: Dual Extract ISO10993-3
15 Ammonium ISO17025 USP2021<381> 33 ISO In Vitro Chromosomal Aberration Assay - Double Extract ISO10993-3
16 Heavy metal ISO17025 USP43<661> 34 ISO In Vitro Mouse Lymphoma Cell Assay: Double Extract ISO10993-3
17 Non-volatile residues ISO17025 USP43<661> 35 ASTM Hemolysis Test - Extraction Method ISO10993-4
18 Buffer capacity (This test is applied to ingredients that come into contact with oral liquids) ISO17025 USP43<661>