Demonstration of process safety and reliability
Thread Content
AQ 3062-2025 \"Safety Management Specifications for Fine Chemical Enterprises\" requires that safety and reliability assessments be conducted when construction projects employ chemical process technologies that are used for the first time in China. It also provides a framework for preparing reports on such safety and reliability assessments. When the production processes involved in a construction project present any of the following situations, reaction safety risk assessments must be carried out, along with thermodynamic and kinetic tests and analyses: a) New processes or formulations that are used for the first time in China and put into industrial production, or those that are introduced from abroad for the first time without prior reaction safety risk assessment； b) Involving hazardous chemical processes or metal-organic synthesis reactions under key supervision (including Grignard reactions) ； c) Production safety accidents have occurred due to reaction process reasons. Furthermore, the \"Guidelines for Safety Risk Prevention and Control in Hazardous Chemical Production and Construction Projects\" (Emergency [2022] No. 52) states: 6.3.3 Demonstration of process technologies used for the first time. Demonstration of process technologies used for the first time: (1) Chemical process technologies used for the first time in China refer to: a) Products that are produced in China for the first time and involve chemical reaction processes ； b) Or the proposed process technology is a laboratory technology that is being pilot-scaled up or industrially applied for the first time in China ； c) Alternatively, the product is produced by other chemical enterprises in China; however, the process route, raw material route, or operational control method is being used in China for the first time ； d) Or introducing mature foreign production processes that are used for the first time in the country ； e) There are other domestic chemical enterprises that use the same process route to produce the same products, but there are significant changes in their production capacity and key production equipment (excluding an increase in the number of equipment units). (2) For chemical process projects that are being used in China for the first time, the construction unit shall prepare a report on the safety and reliability prior to the safety condition review, and submit it to relevant authorities for evaluation. 6.3.4 Reaction safety risk assessment (1) For batch and semi-batch fine chemical reactions involving hazardous chemical processes under key supervision and the synthesis of organometallic compounds (including Grignard reactions), a reaction safety risk assessment shall be conducted under any of the following circumstances: a) When a new process or formulation is used for the first time in industrial production ； b) New processes introduced from abroad for the first time, for which no reaction safety risk assessment has been conducted ； c) Changes occur in the existing process route, process parameters, or plant capacity (excluding the addition of more equipment units) ； d) Production safety accidents have occurred due to problems with the reaction process. (2) The safety risk assessment of the reaction should be conducted prior to the preparation of the feasibility study report. I still don’t understand this ordering... Must a reaction safety risk assessment be conducted for the initial process, and then based on that, must the process safety and reliability be demonstrated? The reaction safety risk assessment preliminarily determined the level of hazard associated with the production process? When conducting an argumentation on the safety and reliability of the process, what main points should be emphasized? Can different conclusions be drawn from the findings of a safety risk assessment?
Reaction risk assessment is only a part of the reliability demonstration. A reaction risk assessment must be conducted for the initial process demonstration. There is no order between them
“A reaction risk assessment must be conducted for the initial process demonstration. “There is no order between them” —— this statement is also hard to understand
Another issue: 1. There are other chemical enterprises in the country that use the same production process to manufacture the same products, but their production capacity and key production facilities (excluding an increase in the number of units) have undergone significant changes. ——How is it proven that there are significant changes in production capacity and production facilities? His production capacity and core equipment (if not standard) are considered trade secrets. Does changing the filtering format count? Does changing from bag filtration to candle filtration in pipelines constitute a significant change?
This post was last edited by hgsafety on 2026-7-5 16:07. First, the issue of the source of the process technology needs to be resolved. 1 Independent development: Since it’s definitely a new process, there’s no need to say more – proof of concept is certainly required. 2 Technology transfer: The technology provider should be required to explain any significant changes in the production capacity under the same process route; this way, there would be no issue of not being able to obtain information due to trade secrets. Next, consider what constitutes a major change. Some regions have established regulations regarding \"significant changes.\" For example, Tianjin stipulates that when moving from pilot-scale production to industrial-scale production, if the scaling factor for key production units involved in hazardous chemical processes that are under strict supervision exceeds 10 times (excluding cases where the number of equipment units increases), or if it exceeds 30 times for key production units in general reaction processes (again, excluding increases in the number of equipment units), further verification through industrial-scale testing is required. This data can be used as a reference to determine whether there are significant changes in production capacity. Finally, regarding the sequence of reaction risk assessment, it is usually carried out during the process development phase. During industrial production, a reaction risk assessment should be conducted again taking into account the specific conditions of the process, as cumulative changes may occur in actual operations. There can be differences between the data from the process development phase and those from actual production; for example, the material may be added in a single batch during development, but in actual production it is added in batches or gradually, which may reduce the risks. During the initial process demonstration, it is necessary to support the demonstration content based on the results of the reaction risk assessment. In summary, reaction risk assessment is a prerequisite for the initial process validation. Personal opinion, for reference only!