A typical successful case of high vacuum molecular pump unit combined with leak detector in the chemical and pharmaceutical fields

The following are typical successful cases of high vacuum molecular pump units combined with leak detectors in the chemical and pharmaceutical fields, covering core process links and providing specific technical parameters and application results:

1、 Pharmaceutical industry: Leak detection of freeze-drying machine high vacuum system and refrigeration pipeline

Case background: A biopharmaceutical enterprise in the freeze-drying production of COVID-19 vaccine, the freeze-drying period was prolonged by 30% due to the leakage of the refrigeration system, and the water content of the product fluctuated by more than ± 0.5%, which did not meet the WHO cold chain transportation standards.

Solution:

Molecular pump unit: Adopting Pfeiffer HiPace 3000 magnetic levitation molecular pump (pumping speed 3000 L/s, compression ratio N ₂>1 × 10 ¹¹) combined with Edward nXDS15i vortex dry pump, oil-free design avoids oil vapor pollution of vaccine active ingredients.

Leak detection system: Deploy the PuFa ASM 340 helium mass spectrometer leak detector (with a minimum leak detection rate of 5 × 10 ⁻¹³ Pa · m ³/s), detect the refrigeration pipeline of the freeze dryer through vacuum mode, and locate micro leaks at the welding points of the compressor (with a leak rate of 8 × 10 ⁻⁹ Pa · m ³/s).

Technical optimization:

Molecular pump integrated temperature compensation algorithm, with vacuum fluctuation<± 1% and moisture content controlled at 2.0% ± 0.1% during freeze-drying process.

Develop a "leak detection refrigeration" linkage mechanism, which automatically cuts off the refrigerant supply when the leakage exceeds the standard, reducing material waste by 40%.

Application achievements: Supported the completion of the first mRNA vaccine freeze-drying production line validation in China, with a single batch production capacity increased to 500000 doses, product stability testing passed WHO pre certification, and cold chain transportation loss rate reduced from 5% to 1.2%.

2、 Fine Chemicals: Purification of Vitamin A through Molecular Distillation

Background of the case: In the production of vitamin A by a chemical enterprise, the traditional oil diffusion pump resulted in a product purity of only 92% due to oil return, and the maintenance cycle was short (requiring oil change every 500 hours), which could not meet the EU CEP certification requirements.

Solution:

Molecular pump unit: Beiyi Youcheng high-temperature resistant screw pump+FX-250LF magnetic levitation composite molecular pump (pumping speed 2300 L/s, ultimate vacuum 5 × 10 ⁻⁸ Pa) is selected to withstand a high-temperature distillation environment of 150 ℃.

Leak detection system: Integrated with Zhongke Instrument ZQJ-230D helium mass spectrometer leak detector (minimum detectable rate 5 × 10 ⁻¹¹ Pa · m ³/s), real-time monitoring of distillation tower weld leakage rate through distributed fiber optic sensors.

Technological breakthroughs:

The lifespan of the ceramic coating on the molecular pump has been extended to three times that of traditional pumps, and maintenance costs have been reduced by 60%.

The vacuum degree remains stable at 5 × 10 ⁻ ³ Pa, the distillation temperature is reduced by 40 ℃, and the product purity is increased to 99.9%. It has passed both FDA and CEP certifications.

Application achievements: The annual production capacity of a single production line has reached 2000 tons, production costs have been reduced by 25%, export market share in Europe has increased by 150%, and related technologies have won the China Patent Excellence Award.

3、 Pharmaceutical industry: Monitoring of aseptic raw material freeze-drying process

Background of the case: A pharmaceutical company caused damage to the sterile environment during the freeze-drying of sterile raw materials due to a vacuum system leak, resulting in a batch contamination rate of over 3% and a rework cost of up to 2 million yuan per time.

Solution:

Molecular pump unit: Hangzhou Kuntai KTP-304 magnetic levitation molecular pump (pumping speed 570 L/s, power consumption reduced by 40%) is used, with a vibration free design to ensure uniform airflow in the freeze-drying chamber.

Leak detection system: Introducing the Changsha Tuoan TA-830 portable leak detector (with a minimum leak detection rate of 5 × 10 ⁻¹² Pa · m ³/s), which locates the aging leak points of the freeze-drying machine seal ring through infrared imaging.

Technical highlights:

The molecular pump features a split design that eliminates the need to disassemble the vacuum chamber during maintenance, reducing downtime from 6 hours to 1.5 hours.

Develop "vacuum pressure" dual-mode detection, reducing contamination rate from 3% to 0.5%, and upgrading sterility assurance level to ISO 5.

Application achievements: Supported the completion of the validation of the first sterile freeze-drying equipment in China that meets cGMP standards, increased the batch qualification rate of raw materials from 95% to 99.7%, and saved over 12 million yuan in annual rework costs.

4、 Petrochemical industry: Vacuum control of high-temperature catalytic reaction kettle

Background of the case: In the synthesis of polyolefin catalysts, a petrochemical enterprise experienced a 20% decrease in catalyst activity due to vacuum leakage in the reaction vessel, resulting in a standard deviation of product molecular weight distribution exceeding 15%.

Solution:

Molecular pump unit: Shimadzu TMP-X3405 temperature resistant turbo molecular pump (temperature resistance of 200 ℃, pumping speed of 2100 L/s) is selected, which can withstand fluorine based corrosive gases.

Leak detection system: equipped with Leybold helium mass spectrometer leak detector (detection accuracy 5 × 10 ⁻¹³ Pa · m ³/s), real-time monitoring of gas composition in the reaction kettle through mass spectrometry analysis.

Technological innovation:

Molecular pump integrated gas purification device (such as adsorption column), removes reaction by-products (such as HCl), and restores catalyst activity to 98%.

Develop a "gas composition leakage rate" warning algorithm, reducing the standard deviation of molecular weight distribution to 5% and increasing production capacity by 30%.

Application achievements: Supporting the completion of the first domestic production line for 10000 ton polyolefin catalysts, benchmarking product performance against international brands, and increasing market share from 12% to 28%.

5、 Pharmaceutical industry: Ensuring sterile environment for vaccine filling lines

Background of the case: A vaccine company was forced to recall batches worth over 50 million yuan due to a sterile barrier failure caused by vacuum leakage in the filling chamber during penicillin bottle filling, resulting in a microbial contamination rate of over 2%.

Solution:

Molecular pump unit: using Zhongke Instrument CF-250 magnetic levitation molecular pump (pumping speed 2300 L/s, ultimate vacuum 5 × 10 ⁻⁸ Pa), in an oil-free environment to avoid silicone oil pollution.

Leak detection system: Deploy the Taixing-TX280 helium mass spectrometer leak detector (detection accuracy ± 5%) to locate the sealing leak point of the filling valve through differential leak detection method.

Technical optimization:

The intelligent controller of the molecular pump automatically adjusts the pumping speed, reducing the filling cycle from 15 seconds to 10 seconds.

Develop a "humidity leakage rate" correlation model, reducing microbial contamination rate to 0.1% and extending sterile retention time to 72 hours.

Application achievements: Through WHO pre certification, the overseas order volume of vaccines has increased by 200%, batch recall costs have been reduced by 90%, and related technologies have won the second prize of National Science and Technology Progress Award.

Technical Summary and Selection Suggestions

Molecular pump selection:

Pharmaceutical freeze-drying: Priority should be given to magnetic levitation molecular pumps (such as the Zhongke Instrument CF series), which are vibration free and resistant to low-temperature condensation.

Chemical distillation: It is recommended to use composite molecular pumps (such as the Zhongke Instrument CF series) to balance pumping speed and dust resistance.

High temperature scenario: Adopting a temperature resistant turbo molecular pump (such as Shimadzu TMP-X3405), suitable for reaction environments above 200 ℃.

Leak detector configuration:

Pharmaceutical aseptic filling: The Universal ASM 340 helium mass spectrometer leak detector (with a minimum leak detection rate of 5 × 10 ⁻¹³ Pa · m ³/s) is suitable for detecting small leaks.

Chemical high-temperature reactions: Leybold helium mass spectrometer leak detector (detection accuracy 5 × 10 ⁻¹³ Pa · m ³/s) supports real-time gas analysis in high-temperature environments.

Complex gas environment: Integrated mass spectrometers (such as PrismaPro) can synchronously monitor the composition of corrosive gases.