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Maker - Product Challenge

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In pharmaceutical and biotech manufacturing, ensuring sterility during the filling process of ready-to-use vials and syringes is critical. Challenges include minimizing contamination risk, achieving high filling accuracy, and adhering to cGMP (Current Good Manufacturing Practice) standards.
<h2>Automate precise and sterile filling operations</h2>
The Flex-Line™ by Comecer is a comprehensive solution that integrates a robotic filling system and an aseptic isolator. This system is specifically designed to handle and fill ready-to-use vials and prefilled syringes with high precision. The isolator ensures that the entire process occurs in a sterile environment, compliant with ISO5 / Grade A air quality standards, thanks to its laminar flow throughout the area. The filling system uses either peristaltic or volumetric piston pumps based on customer needs, ensuring high accuracy and minimal contamination risk. With integrated in-process control by load cells for statistical check weighing, the Flex-Line™ guarantees consistent and precise filling. Additionally, the system's design makes it versatile, allowing quick changeovers to accommodate different container types with minimal downtime. Suitable for R&D operations and pilot-scale sterile production, it features automatic or semi-automatic No-Touch-Transfer procedures to minimize human intervention.

Sterile robotic filling for ready-to-use vials and syringes

Automation

Filling lines are used extensively in all industries, such as food, pharmaceutical, chemical, and cosmetics, to accurately package different products into a container suitable for that product. Although the filling process is at the very end of the production line, it is no less important than the earlier steps. Last but not least, the idiom that dates back to 1382 when John Wyclif wrote the firste the laste, and the laste the firste, indicates just that the last things on a list are just as valuable as the previous ones. In this case, this idiom fits perfectly.

Filling

Industrial sterilization processes are employed in different industries to completely eliminate all living microorganisms from the final product. For instance, in food processing, sterilization equipment is used to produce a stable product with a long shelf-life by eradicating harmful bio-contaminants. Instead, in the medical field, sterilization technologies aim to prevent the transmission of microbes to patients by sterilizing all the tools and medical devices that come in contact with the patient. Most sterilization equipment, such as autoclaves, employs high-temperature pressurized steam to destroy bacteria and disinfect surfaces from spores. Other methods include radiation sterilization or using chemicals such as hydrogen peroxide for disinfection.

Sterilization

Weighing

liquid

Industrial

In pharmaceutical production, maintaining aseptic conditions during the preparation of infusion solutions, injectable products, and oral liquids is crucial. Traditional methods may not always provide the necessary control and efficiency, leading to possible contamination and quality issues.
<h2>Automates production, cleaning, and sterilization processes</h2>
The Sterile Preparation Dosage System from Austar is a state-of-the-art aseptic liquid preparation system tailored for various dosage forms, including infusion solutions, injectable products, eye drops, and oral liquids. Utilizing a 3D modular design, the system offers a compact and efficient layout. Key components, such as the tank, pump, heat exchanger, filter, valve, and pipe, are sourced from top-tier international and domestic brands to ensure high quality. The Siemens S7-1500 CPU series and TP1200 Comfort touch screen are used for PLC and HMI, optimizing the program design for stability and traceability in accordance with GAMP5 standards. The system supports automatic control of production, cleaning, and sterilization processes. Validation involves comprehensive activities and tests like risk assessment (RA), design qualification (DQ), installation qualification (IQ), and operation qualification (OQ) to ensure stable, high-quality production under various conditions.

Sterile liquid preparation system for pharmaceutical use

Industrial cleaning equipment is used to wash or disinfect machinery and the production/warehouse area. It may also be used to sterilize the product, equipment, tools, floor or work surfaces and to purify or clean the product by removing impurities. Choosing a suitable cleaning system depends on the type of product or equipment to be cleaned, the sensitivity of the product to heat, pressure, and chemicals, and the level of sterility desired.

Cleaning

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Sterile robotic filling for ready-to-use vials and syringes

Sterile liquid preparation system for pharmaceutical use

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