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Customer

Well known Global Pharma Company

Summary

The customer needed a highly customized, automated, aseptic filling, handling and packaging line for the containment of powder and liquid, capable of increasing production capacity of a cytotoxic drug. Initially we were asked to develop two separate machines so that on one  could produce the syringe line while  the second  could handle vials. Subsequently, the idea was to merge the two machines and make one end-to-end solution that could change formats in a short time from one format to another, quickly and efficiently.

Customer challenge

The customer’s existing equipment was outdated, contained several time-consuming, inefficient steps and was not Class A.

Much of their production process was carried out under laminar flow within highly classified areas, forcing cleanroom personnel to dress in full garbing and use personal protective equipment (the active drug ingredient is harmful if inhaled).

The client’s request was to close and automate the entire production process under grade A containment to solve the above problems and move towards regulatory compliance.

The client project

The complete line developed by Comecer and the ATS Life Science Group, was built in parallel for schedule efficiency (automation & isolation). The integrated project was FAT’d at Comecer and is meticulously designed to ensure the highest standards of cleanliness and efficiency in pharmaceutical production. The end-to-end fill finish 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 bulk 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 aseptic filling of the syringes with liquid pharmaceutical products. This chamber is designed to maintain stringent aseptic conditions while accurately dispensing the required amount of api. Following the filling, the chamber also handles the stoppering of syringes.
3. Chamber for Rack Preparation for Sterilization:After filling and stoppering, the products are prepared for sterilization. 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 sterilization phase.
4. Chamber with Two Large Autoclaves for Sterilization:Sterilization is a critical step in pharmaceutical manufacturing. The chamber equipped with two autoclaves ensures that the products are sterilized effectively, eliminating any potential microbial contamination.
5. Chamber for Rack Unloading:Post-sterilization, 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. This powder is extremely cytotoxic, requiring various precautions and isolator design features for OEB5 handling and filling.
7. Chamber for Final Assembling and Air Washing:The final assembly of the products is conducted in this chamber, needle assembly 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.