Legal Definition Standards for Pressure Vessels
Before determining whether a pharmaceutical plant’s compressed air system qualifies as a pressure vessel, it is first necessary to clarify the statutory criteria for defining a pressure vessel. According to the relevant safety technical codes for special equipment, a pressure vessel is generally understood to be a sealed device that contains gases or liquids and operates under a specified pressure. Its classification requires simultaneous fulfillment of the following core conditions:
- Work stress:The maximum working pressure is greater than or equal to the specified value (e.g., 0.1 MPa gauge pressure).
- Volume and Dimensions:The volume is greater than or equal to the specified value (e.g., 30 L), and the internal diameter is greater than or equal to the specified value (e.g., 150 mm).
- Medium properties:The service medium is gas, liquefied gas, or a liquid whose maximum working temperature is equal to or higher than its standard boiling point.
Only equipment that simultaneously meets the aforementioned conditions shall be subject to regulatory oversight as pressure vessels.
Equipment Composition of Pharmaceutical Compressed Air Systems
A pharmaceutical plant’s compressed air system is a complex engineering installation, primarily used to supply pneumatic equipment, instrumentation control, material handling, and packaging processes with a reliable source of compressed air. A complete system typically comprises the following core components:
- Air compressor:The system’s power source is responsible for compressing atmospheric air to the required pressure.
- Gas storage tank:It is used to store compressed air, stabilize system pressure, and reduce airflow pulsations.
- Purification equipment:Including refrigerated dryers, desiccant dryers, and multi-stage filters, these systems are designed to remove moisture, oil, and particulates from compressed air.
- Piping networks and valves:It is responsible for delivering treated, clean compressed air to all points of use.
Attribute determination of the system as a whole and its components
With regard to the question of whether a pharmaceutical plant’s compressed air system qualifies as a pressure vessel, it is necessary to distinguish between the concepts of the “system as a whole” and the “system components.”
System Overview:As an integrated process system, the compressed air system is not directly equivalent to a pressure vessel. It is a comprehensive utility network that encompasses power generation, storage, purification, and distribution.
System components:In this system,Gas storage tankIt is a typical pressure vessel. As long as its operating pressure, volume, and dimensions meet the statutory standards, it must be subject to strict regulatory control as a pressure vessel (special equipment). Furthermore, certain high-pressure pipelines, steam–water separators, or large filtration tanks within the system will also be classified as pressure vessels or pressure piping if their parameters simultaneously satisfy the criteria for pressure vessels.
Requirements for Pharmaceutical Company Compliance Management and Maintenance
Given that pharmaceutical compressed air systems incorporate components classified as pressure vessels, enterprises must strictly comply with relevant regulations governing special equipment in their day-to-day operations to ensure production safety and regulatory compliance.
- Equipment Registration and Inspection:Equipment such as gas storage tanks that fall under the category of pressure vessels must, before being put into service or within the prescribed time after commissioning, be registered with the special equipment safety supervision and administration authority and obtain a registration certificate. In addition, they are required to undergo statutory periodic inspections on a scheduled basis.
- Personnel Qualification Requirements:Personnel who operate and manage pressure vessels must undergo specialized training and obtain the relevant special equipment operator certificate before they are permitted to take up their posts.
- Daily Inspection and Maintenance:Enterprises shall establish and improve equipment safety management systems, conduct regular calibration of safety valves, pressure gauges, and other safety accessories to ensure their sensitivity and reliability. During normal operation, they must closely monitor operating parameters such as pressure and temperature and are strictly prohibited from operating beyond the specified temperature and pressure limits.
Defining the equipment attributes of each component in a pharmaceutical plant’s compressed air system is a prerequisite for implementing the safety production responsibility system. Enterprises should, based on the system’s actual design parameters, accurately identify pressure vessels and pressurized pipelines, thereby formulating scientific and compliant equipment management strategies.