The multiple barrier mechanism designed in the injection water preparation system can effectively prevent heat source reactions and microbial contamination, ensuring that the produced drugs will not cause adverse reactions due to water quality issues, thereby improving the safety and stability of the drugs. This is particularly important for biological products in high-risk dosage forms. Stable water supply and accurate temperature control reduce unplanned downtime, making the production process smoother and more efficient. Continuous and stable water supply capacity also means that it can support large-scale continuous production and reduce unit costs.
Modern injection water equipment generally integrates energy-saving technology and intelligent control systems, which can reduce energy consumption and minimize the consumption of natural resources while ensuring performance. This not only helps companies achieve their green production goals, but also aligns with the trend of sustainable development. It can be quickly adjusted according to different production needs, whether it is changing water production or modifying water quality parameters, which makes it flexible in responding to market changes and diversified production tasks.
Steps for using the injection water preparation system:
1. Confirm production demand and raw material water quality
-Determine the amount of water to be prepared: Based on the actual needs of this production, specify the amount of injection water that needs to be prepared.
-Check the conductivity of the raw material water: Ensure that the conductivity of the purified water used as raw material is less than 2.0S/cm, which is an important prerequisite for ensuring the subsequent distillation effect and product quality.
2. Start the system and monitor the operating parameters
-Hanging status sign: Hang the "Running" status sign on the injection water system to indicate that the system is running.
-Operate the equipment according to standard procedures: Prepare the multi effect distilled water machine according to the Standard Procedure for Multi effect Distilled Water Machine (SOP). During this process, it is necessary to closely monitor the temperature of the produced water, which should not be lower than 90 ℃. Because the appropriate temperature helps to remove harmful substances such as impurities and microorganisms, ensuring the quality of injection water.
3. Quality inspection
-According to the pharmacopoeia regulations, multiple key indicators of the prepared injection water are tested, including properties, pH value, nitrate, nitrite, ammonia, heavy metals, total organic carbon (TOC), easily oxidizable substances, non-volatile substances, conductivity, as well as bacterial endotoxins and microbial limits, based on the pharmacopoeia of the People's Republic of China and relevant enterprise quality standards. These testing items cover various factors that may affect the quality and safety of drugs to ensure that injection water meets pharmaceutical requirements.
4. UV lamp management (if any)
-Regularly verify the cumulative operating time: The cumulative operating time of the ultraviolet lamp should be verified and counted once per shift. When the cumulative usage time of the ultraviolet lamp reaches a certain number of hours or the ultraviolet intensity decays to 70% of the initial intensity, it should be replaced in a timely manner. UV lamps play a role in sterilization and disinfection in the system, and their performance directly affects the microbial indicators of injection water.