Comecer, an isolation technology specialist for the pharmaceutical and nuclear medicine industries, has developed a state-of-the-art aseptic filling line.
This new filling line was designed specifically for RTM (Ready-To-Mix) syringes with double chamber stages and pharmaceutical vials.
The development of this isolated filling line by Comecer “represents a significant leap forward in pharmaceutical manufacturing,” the company said.
This new filling line was designed specifically for RTM (Ready-To-Mix) syringes with double chamber stages and pharmaceutical vials
“With its comprehensive and integrated approach, the line sets new standards in terms of efficiency, safety, and compliance with regulatory requirements,” Comecer continued.
“The meticulous design and state-of-the-art technology incorporated into each stage of the line reflect Comecer's dedication to delivering innovative solutions that meet the evolving needs of the pharmaceutical industry,” Comecer concluded.
The structure of the line
The complete line is meticulously designed to ensure the highest cleanliness and efficiency standards in pharmaceutical production.
The line is composed of several key stages, each dedicated to a specific part of the manufacturing process:
1. Washing and depyrogenation stage:
This initial stage is crucial for ensuring that the syringes and vials are thoroughly cleaned and free from pyrogens.
The washing and depyrogenation process uses advanced techniques to remove any contaminants that could compromise the safety and quality of the pharmaceutical products.
2. Liquid filling and stoppering chamber:
The next stage involves the precise filling of the syringes and vials with liquid pharmaceutical products.
This chamber is designed to maintain stringent aseptic conditions while accurately dispensing the required amount of liquid. Following the filling, the chamber also handles the stoppering of the vials and syringes.
3. Chamber for rack preparation for sterilisation:
After filling and stoppering, the products are prepared for sterilisation.
This chamber is specifically designed to handle the delicate process of rack preparation, ensuring that the products are correctly positioned and ready for the next sterilisation phase.
4. Chamber with two autoclaves for sterilisation:
Sterilisation is a critical step in pharmaceutical manufacturing. The chamber equipped with two autoclaves ensures that the products are sterilised effectively, eliminating any potential microbial contamination.
5. Chamber for rack unloading:
Post-sterilisation, the products are carefully unloaded from the racks.
This chamber is designed to handle the unloading process in a controlled environment to maintain the sterility of the products.
6. Powder-filling chamber:
For products that require powder filling, this dedicated chamber provides a precise and contamination-free environment for adding the pharmaceutical powder to the vials or syringes.
7. Chamber for final assembling and air washing:
The final assembly of the products is conducted in this chamber, mounting of needles for syringes and capping vials, along with an air washing process that ensures the removal of any residual particles or contaminants.
8. Stage for final packaging:
The last stage of the line is dedicated to the final packaging of the pharmaceutical products. This stage ensures that the products are securely and safely packaged, ready for distribution.