T/HIMIA 005-2024 Fully Automatic Capsule Filling Machine

Scope

Main Technical Content: I. Principles of Compilation 1. Scientific Principle: Based on scientific theories and methods, all technical indicators and requirements are fully verified through experiments and data analysis to ensure that the standard accurately reflects the essential characteristics and quality requirements of the equipment. 2. Advanced Principle: Combined with the latest technological developments in the industry, the standard ensures that technical requirements and performance indicators are forward-looking, helping enterprises improve their technical level and product competitiveness. 3. Practical Principle: Fully considering the actual production needs of enterprises, user requirements, and market supervision needs, the standard makes it feasible and easy to operate in production, inspection, and use. 4. Coordination Principle: Coordinate with relevant national laws and regulations, as well as existing national and industry standards to avoid conflicts and jointly build a complete standard system. II. Main Content Firstly, the standard clarifies the terminology and definitions of fully automatic capsule filling machines, providing a foundation for understanding and applying the standard. At the same time, it details the classification, marking, and basic parameters of the equipment to ensure its uniformity and comparability. Secondly, the standard specifies the basic requirements for the equipment, including design and R&D, materials and components, and process equipment. These requirements aim to ensure that the equipment design complies with Good Manufacturing Practice (GMP) for pharmaceutical production, that the materials and components used are safe and non-toxic, and that the process equipment is precise and reliable. In terms of technical requirements, the standard details the testing capabilities for key items such as appearance quality, performance requirements, safety and protection performance, and electrical safety, and

Development Information

Related Standards