top of page

Integrated Overall Solution for Vial Sterile Lyophilization (part 1)

COVID-19 epidemic continues to spread in the globe, and over the past year, the number of newly confirmed COVID-19 cases overseas continued to increase, and the situation is still severe now. Appearance of the mutant strains will accelerate the spread speed of the epidemic. COVID-19 vaccine is the most important means for controlling the COVID-19 epidemic, and vaccination is being actively promoted worldwide. In order to improve procurement efficiency of COVID-19 vaccine manufacturers, and enable them to make batch production of COVID-19 vaccines as early as possible, TRUKING TECHNOLOGY put all its resources to complete equipment delivery of overall solution of vial compact line and other main production equipment in merely 30 days.

At present, 7 medical COVID-19 vaccines have been put into production using TRUKING equipment in China, including inactivated vaccine, adenovirus vector vaccine and recombinant proteinvaccine. Manufacturers of COVID-19 vaccines in China not only supply the vaccines to Chinese market, but also meet demands of overseas markets, thus having a great pressure in terms of Production capacity on the whole. For the COVID-19 vaccine filling production line supplied by TRUKING TECHNOLOGY to vaccine manufacturers in China, its production speed is up to above 500 pcs/min stably, thus having greatly relieved production capacity pressure of the vaccine manufacturers, therefore, in high-speed vaccine production line market in China, about above 80% Chinese vaccine manufactures select TRUKING as their strategic partner.

Characteristics of TRUKING vial compact line

  • Follow regulatory requirements of cGMP, EU-GMP and FDA

  • Excellent industrial aesthetic design, and good human-machine interface

  • Sterile design according to GMP concept, easy to clean, easy to operate and easy to maintain;

  • Flexible layout solution

  • Tool-free plug-in mold change parts that can be replaced quickly

  • Documentation system meet GAMP5 level, control system meets 21 CFR part 11

  • The batch record and batch report meet requirements of computerized system

Overall upgrading of equipment appearance

  • The complete line appearance with neat and uniform design which largely improves the appearance quality and aesthetic perception.

  • Optimize and improve poor appearance of all equipment, to improve aesthetic image of all equipment.

  • Add color printing acrylic board and lamp belt, to improve layering sense of the appearance on the whole.

Improvement of equipment performance

  • ISA88 program framework

The whole-line program is designed following OMAC (Organization of Mechanical Automation and Control) standard and adopting Siemens’ CPG (Consumer Package Goods) template based on OMAC PackML, which meets international unified industrial standard. All whole-line equipment adopts ISA88 architecture, standard communication interface, and unified mode management and equipment status management. It reduces spare parts for software and hardware and lowers the fault risk, to improve controllability of quality.

  • Pre-maintenance function of core parts

The whole line provides pre-maintenance function, makes operation statistics of key valves, motors and other key process parts, and gives early maintenance warning, to reduce production risk.

  • OEE (overall equipment effectiveness) analysis

Make statistics of six major equipment conditions which could cause loss: machine down-time, adjustment and setting time, idle time, speed drop, rejection rate, and startup damage.

Make real-time analysis of integrated benefit of each piece of equipment and operation efficiency of the whole line;

Help the users make reasonable overhauling, optimize production scheduling, and realize lean production.

  • The Vertical ultrasonic washing machine adopts automatic drainage technology for the first time, which realizes easy one-click drainage, thus having reduced the labor intensity and improved customer experience

  • Control of Water and air spraying time and circulation water temperature

Water and air spraying time of the vial washers can be controlled via formula directly, while circulating water temperature can be controlled by the upper and lower setting limits and the upper and lower alarm limits. When the temperature is below the lower setting limit, the Heater in the bottom water tank will start heating, while when the temperature is above the upper setting limit, the heater will stop heating; there is a certain value difference between the upper and lower setting limits and the upper and lower alarm limits, and the circulating water temperature shall be Controlled between the upper and lower alarm limits.

  • Washer high speed feeding technology for large size vials

The vial washers adopt brand-new single-row vial-feeding + parallel track spraying method, which has increased the vial washers’ large size via speed from 60pcs/min to 100pcs/min, and improved operation efficiency of the equipment by 67%.

  • Feedback technology for water-air joint control

This technology has resolved the washer spraying needle without block detection function problem. It will get accurate feedback of pressure from the pipeline with the pressure transmitter to know the flow condition inside the pipeline. Also, it can avoid the machine running without the control valve not open which will ultimately affect the cleaning efficiency. It achieves all the internal/external spraying's pressure detection.

  • The ultrasonic washing machine adopts low-friction protection technology, which guarantees the vials without scratch at the out-feed station

  • The Sterilizing & drying tunnel assembles pipelines of the Conveyor belt and the surface cooler at the lower section of preheating zone to facilitate connection of the customer’s pipelines

  • Forced air compensation technology in high-temperature zone

KSZ1200 model forms forced air compensation by adding fan-filter system in the air compensation location, which is more convenient to regulate the pressure difference in high-temperature section; forced air compensation can increase exchange efficiency of internal humid and hot air, and enable a higher temperature rise efficiency of bottles; at the end of production, the inside of the tunnel cools faster than natural air compensation.

  • The sterilizing tunnel external cover with design to hidden the machine base frame and also convenient for the end client to do sealing to the floor after installation

  • The filling & stoppering machine before filling is available to configured with Pre-inspection technology

Before filling, the AR foreign-particle visual inspection system can detect glass particle fibers, black spots, white spots and other defects inside the vials effectively; For the abnormal vials, it will pass the machine without filling and stoppering automatically, so as to avoid waste of liquid medicine; it can also eliminate abnormal empty vials automatically.

1. Main testing contents and precision:

  • The glass size up to 0.5mm×0.5mm;

  • Hair and fiber size <50μm, the detecting precision is related with its color

  • For cracks at the bottom of the vial, the testing precision is related with the crack positions, depth and length

  • Other foreign particles which size is within the detectable range;

2. Production capacity: it matches with the washing, drying and filling production line (up to 600 pcs/min at the highest)

3. It is equipped with auto-rejecting function

4. It is equipped with counting, Data saving, testing report, three-level authoritarian and other functions.

  • Intelligent emptying and Smart tail-liquid filling technology

Filling technology has always been an important core part in filling production line of sterile injections, and high value-added injection drugs must meet high standards during the filling production process, as well as the stability and reliability requirement for filling precision. It is very important as for how to realize automatic calibration of filling amount in the production preparation stage with minimum or even zero liquid loss; how to guarantee non-drifting of the filling amount and realize process quality control of 100% filling amount during the filling production process; how to empty tail liquid with the minimum residue or even reduce the material loss to the amount of a vial in Empty Mode at the end of the filling production stage, however, for traditional filling technology, there will generally be tens and even a hundred of vials with non-conforming filling amount per batch, as well as filling vials with high value-added or multiple batches, causing the pharmaceutical enterprises to have a product value loss up to several millions yuan every year.

TRUKING TECHNOLOGY’s European Institute of R&D and Central Institute of R&D have gathered multi-disciplinary engineers such as mechanical engineers, automatic control engineers, CFD engineers, and AI engineers, etc., and they have achieved technological breakthrough upon accumulation and repeated verification of the joint researches in recent two years, and successfully developed near-zero-residue Smart Filling automatic emptying filling system and software technology, which can perfectly control minimization of liquid residue, and enable maximization of economic benefit of pharmaceutical enterprises.

In the production preparation stage, fluid dynamics model and AI technology are used to make automatic filling according to different conditions of each filling pump, and make calculation in combination with intelligent high-precision weighing system, and it can be configured with fluid-supplement filling technology to guarantee filling amount of each vial within acceptability limit. After a period of normal production, in case of alarm due to excessive low liquid level of the buffer tank, tail-liquid filling mode shall be enabled, and upon in-depth study and big data analysis, if the liquid in the buffer area becomes less and less, the filling amount will take on non-linear change, and by the unique tail-liquid filling technology, it can realize zero liquid residue in the buffer tank, dispenser, silicone tube and filling head of the whole filling system, as well as minimization of liquid residue in a perfect way.

TRUKING TECHNOLOGY’s Smart Filling-automatic emptying and tail-liquid filling technology breaks through technological bottleneck, and has become the unicorn technology for products of TRUKING TECHNOLOGY’s vials linkage line to compete with advanced products both at home and abroad, it can be used for filling of high-end bio-pharmaceuticals and other drugs, and can greatly improve automation and intelligence degree of the equipment, so as to improve economic benefit per single batch of production for high-end bio-pharmaceutical enterprises.

1. Solution for vibration influence factors / 2. Solution for laminar flow wind influence factors
1. Solution for vibration influence factors / 2. Solution for laminar flow wind influence factors
1. Solution for electrostatic influence factors / 2. Unique algorithm for online weighing process
1. Solution for electrostatic influence factors / 2. Unique algorithm for online weighing process

Anti-interference solution for extreme conditions
Anti-interference solution for extreme conditions


bottom of page