Verification and Service

Single-use system can bring many advantages to Biopharmaceutical Enterprises, but for the sake of drug quality, efficiency and safety, it is necessary to study the impurities that may be introduced into pharmaceutical preparations in the process. Extractables / leachables may affect the quality and effectiveness of products. Therefore, it is recommended to evaluate the risk of precipitates / leachables in the system before establishing a single-use system (SUS) to evaluate the impact of the single-use system on drug quality, efficacy and safety.

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Under extreme conditions (such as organic solvent, extreme high temperature, ionic strength, pH, contact time, etc.), chemicals can be extracted from the process medium contact surface of single-use component materials. Extractable materials can characterize most (but not all) of the potential leachables in process media. < br / > leachables < br / > chemical substances that migrate from materials in contact with products or non-contact products into pharmaceutical products or process fluids under storage or conventional process conditio

Verification and Service

"A process validation scheme based on risk assessment and suitable for the specific production environment of customers, so as to provide customized risk assessment and validation services;

According to domestic and foreign E & L regulations and industry guidelines, such as USP, BPOG, ICH, etc., carry out relevant tests, including but not limited to standard extractable data service, process related extractable service, extractable service biocompatibility, etc., to ensure safety;

Risk assessment is carried out through product composition, surface area of product contact parts, temperature and contact time, compatibility of material structure, and similarity between components and final product;

A variety of standard analytical techniques, such as GC / ms-hs, GC / MS, HPLC / MS, ICP-MS, TOC, non volatile residue, FTIR, pH / conductivity, etc. "