Dilution tank quality appraisal

dilute mixing tank takes the synergy of high-precision mixing and sterility control as the core principle. By optimizing the mixing uniformity, temperature control accuracy and sealing integrity, it achieves the synergy of liquid concentration deviation, microbial control and process stability. It is widely used in the fields of precision dispensing of biopharmaceuticals, chemical synthesis and food and beverages. In vaccine production, it is used for the aseptic mixing of adjuvants and antigens; in the field of macromolecule drugs, it meets the homogenization needs of high-viscosity solutions; in sterile preparations, it ensures that the microbial load reaches the standard before terminal sterilization. Compared with traditional liquid preparation tanks, dilute preparation tanks have the characteristics of excellent material biocompatibility, high online cleaning/sterilization efficiency and strong data traceability. They are the core equipment of GMP compliance production.

Zhongke Testing is a product quality appraisal service organization registered with the court. It can provide quality appraisal services for diluted tanks. It has a professional appraisal team and advanced instruments and equipment to provide fair and accurate appraisal results for the quality appraisal of diluted tanks.

As the supervision of the pharmaceutical industry becomes stricter, related quality dispute cases have increased significantly. The judicial dispute focuses on:

1, performance index dispute: mixing uniformity exceeds the standard, online sterilization temperature fluctuations;

2, material defects: tank inner wall roughness, sealing ring dissolution exceeds the standard;

3, process problems: dynamic balance deviation of stirring blades, leakage rate of sterile isolation valve;

4, contract performance dispute: core modules (such as magnetic stirring system, sterile respirator) are inconsistent with the technical agreement.

1. Appearance inspection

Visually inspect the overall appearance, weld quality, surface treatment, etc. of the diluted tank to see if there are any defects or non-compliance with requirements.

2. Material testing

conducts chemical composition analysis and mechanical property testing on the materials of the dilution tank to verify whether the materials meet the design requirements.

3. Performance test

The applicant, a pharmaceutical company, and the respondent, an equipment manufacturer, signed a "2000L dilute tank purchase contract", agreeing that the mixed CV value is ≤3%. Liquid stratification (CV value 12%) occurred during production, and the manufacturer argued that it was caused by differences in material properties.

Identification and analysis results:

The quality analysis expert team conducted relevant data on the "dilute preparation tank", contract technical agreement, on-site inspection case materials and other data After discussion and comprehensive technical analysis, the following quality analysis opinions were made:

The mixing blade design defect of the thin-mixing tank involved (Reynolds number is only 500, agreement ≥ 2000), resulting in laminar mixing failure; the tank weld roughness Ra 0.6μm (protocol ≤0.25μm), causing microbial retention; the magnetic driving torque is insufficient (actually measured 80% of the protocol value), and the rotation speed fluctuates by ±15%.

The appraisal conclusion determined that equipment design and material defects were the main causes of uneven mixing.

Dilute tank quality appraisal report should include:

1, appraisal purpose (such as process deviation attribution, GMP compliance verification) and reference standards;

2, involved equipment model, process parameters, verification records;

3, testing method and equipment list (such as laser Optical particle counter, LC-MS);

4, correlation analysis between detection data and failure (such as the impact of stirring Reynolds number on mixing efficiency);