Pharmaceutical machinery and equipment quality appraisal

Pharmaceutical equipment refers to various equipment and machinery required in the drug production and preparation process, mainly including material handling equipment, mixing equipment, drying equipment, conveying equipment, filling and packaging equipment, etc. These equipment provide stable and reliable production environment and process conditions, ensuring efficient, safe and controllable pharmaceutical production.
pharmaceutical equipment is widely used in pharmaceutical, chemical, food and other industries. Its main uses include material handling, mixing equipment, drying equipment, conveying equipment, filling and packaging equipment.
Zhongke Testing and Appraisal Institute can provide quality appraisal services for pharmaceutical machinery such as crushers, slicers, medicine frying machines, decoction machines, tablet presses, pill making machines, multi-functional extraction tanks, liquid storage tanks, liquid preparation tanks, decompression drying ovens, tilting reactors, etc., and make accurate identifications in terms of product design analysis, load analysis and product quality analysis.

1. API equipment: including reactors, separators, dryers, etc., used for synthesis and extraction of APIs.
2. Preparation equipment: used to produce tablets, capsules, injections and other pharmaceuticals in different dosage forms, including tablet presses, capsule filling machines, injection production lines, etc.
3. Packaging equipment: used for packaging and labeling of pharmaceuticals, including automatic packaging machines, label printers, etc.
4. Storage and transportation equipment: used for the storage and transportation of drugs, including refrigerated trucks, cold storage, etc.
5. Quality control equipment: used for quality testing and control of pharmaceuticals, including laboratory equipment, testing instruments, etc.

GB/T 28671-2012 Pharmaceutical Machinery (Equipment) Verification Guidelines
GB/T 42354-2023 Pharmaceutical Machinery (Equipment) Material Selection Guidelines
GB/T 36035-2018 Pharmaceutical Machinery General Requirements for Electrical Safety
GB/T 36036-2018 Guidelines for verification of cleaning and sterilization of pharmaceutical machinery (equipment)
GB/Z 42540-2023 Technical guide for sealing of pharmaceutical equipment Solid preparations
GB 37823-2019 Emission standards for atmospheric pollutants in the pharmaceutical industry
GB/T 36030-2018 General technical requirements for in-place cleaning and sterilization of pharmaceutical machinery (equipment)
GB 28670-2012 General Principles for Implementing Good Manufacturing Practices for Pharmaceutical Machinery (Equipment)

A complete set of system equipment such as a continuous countercurrent extraction unit, a disc dryer, a three-effect concentrator and a scraped film concentrator purchased by a technology company from a pharmaceutical machinery company failed to meet the technical requirements stipulated in the agreement after repeated debugging, so it appealed to the court.
Our company was entrusted by the court to undertake the quality analysis of the "pharmaceutical machinery" involved in this case.
appraisal analysis results: The
quality analysis expert group discussed and comprehensively technical analyzed the relevant information, on-site investigation and inspection conditions, and inspection and testing data of the "pharmaceutical machinery" involved in the case, and made the following quality analysis opinions:
The "pharmaceutical machinery" involved in the case has quality defects.