- Case Study
- Strict regulatory requirements for sterile products in pharmaceutical and veterinary industry puts increasing pressure on CDMOs to ensure correct validation documentation and cleaning processes
- Piston pumps require complete disassembly and subsequent re-validation of the entire system, making them suboptimal for this application
- Flexicon worked with Labiana Pharmaceuticals and Labiana Life Sciences to facilitate the transition to peristaltic systems and optimise its sterile filling processes
The pharmaceutical and veterinary industries require high levels of validation of manufacturing and packaging processes to ensure sterility and prevent contamination. There is an increasing demand placed on the final fill/finish process of injectable and sterile products to ensure it meets cleaning validation requirements, with the correct documentation of the required quality standards in place. Where piston pumps are used, the required assembly, disassembly and subsequent validation of the entire system is complex and time consuming.
Experiencing these challenges, Labiana required an alternative fill/finish pump system for use in the manufacture of lyophilised and sterile medical products in human and animal healthcare. Labiana is a leading European Contract Development and Manufacturing Organisation (CDMO) based in Barcelona, Spain. The team at Labiana worked closely with fill/finish experts Flexicon, part of Watson-Marlow Fluid Technology Solutions (WMFTS) to replace its piston filling pumps with peristaltic pumps, designed to optimise filling accuracy while minimising assembly time and facilitating validation.
Closing the fluid path to eliminate contamination
Labiana Pharmaceuticals, which manufactures products for human health, required the replacement of four piston pumps in its packaging process. The Flexicon team replaced these with an MC12 controller and four Flexicon PD12I pumps designed for small volumes, from 0.6 ml to 50 ml. In one such operation, PD12I pumps are fitted with 3,2mm bore Accusil tubing to dose 10 ml volumes in the vial filling system.
Following this success, similar changes were implemented at Labiana’s Life Sciences arm where veterinary products are produced. The piston pumps of two different lines of packaging equipment have been replaced; each line is now equipped with one MC12 controller and three PD22I pumps, this time for larger volumes from 5 ml up to 500 ml, at a rate of 50 units per hour (with the three pumps working in parallel mode). For volumes up to 500 ml filling injectable animal health products, the pumps use 12,7 mm bore Pumpsil tubing and Flexicon filling nozzles with a non-drip valve.
Georgina Coll, Sales Engineer and Iberia Flexicon Product Manager, said, “The peristaltic design of these pumps means that the product only comes into contact with the tubes, Y connectors and nozzles, avoiding the risk of cross-contamination. We supply all these components with the necessary regulatory certification, and they are easily sterilisable as well as disposable, giving our customers the confidence that their products will be protected from contamination.”
PD22I pumps filling injectable animal health products into 500ml vials at a rate of 50 units/hour
PD12I pumps ready to dose 10ml volumes in the vial filling system
Concerns around metallic particle contamination have been raised for processing lines using piston pumps, which could cause very serious problems, especially in the production of injectable products. By switching to Flexicon peristaltic pumps, Labiana avoided these potential risks. The PD12 and PD22 pumps ensure that the pharmaceutical product is only in contact with the sterile, pre-assembled single-use fluid path which has FDA 21CFR177.2600 and USP Class VI certification.
Complete solution with 30 years’ experience
Flexicon peristaltic pumps offer improved accuracy and efficiency. Easy-to-use programmes allow simple doses calibration and adjustment, achieving optimal accuracy of 0.5% and avoiding costly overfilling. These adjustments can be made via changes only to the tubing dimension, avoiding time-consuming pump changes. Simple software allows rapid priming prior to the filling process, increasing overall speed and efficiency.
Furthermore, Flexicon pumps are ideal for integration into automatic high-speed filling or packaging equipment, giving Labiana flexibility to adapt in the future. Pumps are controlled via the MC12 which is remote to the pumps. Pumps can be placed close to the dispensing point and the controller installed in an ergonomically ideal position. The system is the product of over 30 years of experience, with its reliability and consistency backed by a 5-year warranty, providing the team at Labiana with confidence in their equipment.
Working collaboratively to deliver timely solutions
Sergio Jimenez, Engineering and Maintenance Director at Labiana Pharmaceuticals, said: “With the support of Georgina Coll and the rest of the WMFTS team, we were able to replace our piston pumps with Flexicon peristaltic pumps on time and without any issue. By understanding our needs completely, the team were able to recommend the perfect solution to remove the risk of cross-contamination and facilitate the validation process.”
Flexicon’s PD12 and PD22 are ideal for use in CDMO manufacturing, clinical trials, or production environments where filling various types of products is carried out in batches of different sizes. The pumps form part of a wide product portfolio which has proved Flexicon to be a leading global supplier of peristaltic filling systems.