Quality appraisal of pharmaceutical factory automation equipment

pharmaceutical factory automation equipment takes the collaboration of aseptic production and process compliance as the core principle. By optimizing cleanliness, temperature control accuracy and material traceability, it achieves sterility guarantee, process stability and data integrity of pharmaceutical production. It is widely used in the field of aseptic filling/packaging of sterile injections, solid preparations, biological preparations and medical devices. In aseptic filling, it is used for particle-free filling of vials/pre-filled syringes; in freeze-drying process, it meets the requirement of temperature control curve deviation ≤±1°C; in biopharmaceuticals, it ensures the dissolved oxygen/PH value control accuracy of cell culture tanks. Compared with general-purpose equipment, pharmaceutical factory automation equipment has features such as online cleaning/sterilization capabilities, material corrosion resistance, and electronic record audit tracking. It is the core equipment for GMP compliance production.

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

As GMP/EMA/FDA supervision becomes more stringent, related quality dispute cases have increased significantly. The judicial dispute focuses on:

1, performance index dispute: filling accuracy exceeds standard, sterilization verification fails;

2, material defects: tank welding roughness, silicone pipeline dissolution exceeds standard;

3, process issues: CIP coverage, freeze dryer plate temperature difference;

4, contract performance dispute: core modules (such as imported sterile isolators, electronic batch recording systems) are inconsistent with the technical agreement.

According to the characteristics of pharmaceutical factory automation equipment, common quality appraisal technical methods include:

1. Appearance inspection of the equipment

Check whether the appearance of the equipment is damaged, deformed, corroded, etc. Appearance problems may affect the normal operation of the equipment, and may also reflect the manufacturing process and usage of the equipment.

2, equipment performance test

In accordance with the requirements of the technical contract and industry standards, various performance indicators of the equipment are tested. For example, the production capacity, accuracy, stability, reliability of testing equipment, etc. Through performance testing, you can determine whether the equipment meets the requirements agreed in the contract.

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A biopharmaceutical company of the applicant signed a "Aseptic Filling Line Procurement Contract" with an equipment manufacturer of the respondent, agreeing on a filling accuracy of ±1%. After being put into production, the microbial contamination rate exceeded 0.5%, and the manufacturer argued that it was caused by operator intervention.

identification analysis results:

The quality analysis expert group discussed and comprehensively analyzed the relevant information, contract technical agreements, on-site inspection case materials and other data of "Pharmaceutical Factory Automation Equipment" and made the following quality analysis Analytical opinion:

The isolator HEPA leakage rate of the pharmaceutical factory automation equipment involved in the case is 0.05% (agreement ≤0.01%), the dynamic accuracy of the filling needle is ±2.5% (agreement ±1%); the CIP spray coverage rate is only 92% (agreement ≥95%), and the residual protein detection exceeds the standard by 3 times.

The appraisal conclusion determined that defects in equipment sealing and cleaning systems were the main causes of contamination.

Pharmaceutical factory automation equipment quality appraisal report should include:

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

2, equipment model involved, DQ/IQ/OQ/PQ files;

3, testing methods and equipment Checklist (such as particle counter, LC-MS);

4, detection data and failure correlation analysis (such as the impact of HEPA leakage on contamination rate);