As pharmaceutical manufacturers attempt to balance productivity with greater assurance of patient safety, Alfa Laval has launched the CultureOne Maxi separation system
The pharmaceutical industry has recently observed a shift towards more flexible cell culture production systems. However, this has led the sector to rely on smaller facilities with single-use processing equipment, posing a major challenge to manufacturers designing process lines of this nature.
Ian Forrester, Business Unit Manager for Separation Systems at Alfa Laval, said: “Following the pandemic, pharmaceutical manufacturers are currently working more intensely than ever, while the importance of sterility in this setting has also been thrust under the spotlight. For this reason, there is a growing need for equipment that can ensure both productivity and effective sterility.
“Single-use technology – much like with syringes in a doctor’s office – will be key to addressing this challenge. By making use of disposable plastic components, we can ensure there is no cross-contamination between batches without the need for lengthy sterilisation.”
Stainless steel culture separators, which remain the current industry standard, limit operational time through the necessity for sterilisation between batches. This also incurs additional costs for chemicals, water and energy associated with cleaning in place (CIP) and steaming in place (SIP). Here, there may be scope for single-use technologies to address these challenges.
However, until recently, single-use centrifuges have only been available in batch processing formats, with waste material required to be manually ejected intermittently.
In an effort to address this charge, Alfa Laval launched the CultureOne range of premium separators in 2021. The integration of the unique TopStream™ feature allows solids to be discharged continually, allowing for continual operation of the centrifuge.
The latest development in this range is the CultureOne Maxi, which builds upon the platform of the original CultureOne Primo, raising its processing capacity from 200 L/h to 600 L/h.
During usage, the centrifuge reaches up to 5000 rpm, generating up to 12,000 g of force. The result is a short settling distance and large separation area, delivering biomass yields of up to 98%.
Thanks to Alfa Laval’s unique concept of hermetic design, cell cultures are treated gently to protect against lysis, allowing them to be recovered intact for later reprocessing if desired.
Ian continued: “Until recently, both stainless steel and single-use plastic centrifuges were subject to inefficiencies, either due to the need for sterilisation or the ejection of solids. By eliminating the need for these processes, the CultureOne centrifuge is able to function without interruption.”
The presterilised Spinsert, Alfa Laval’s unique separation insert technology, ensures that all product-contact parts are consumables, made of recyclable material and able to be disposed of after use.
Ian concluded: “Considering the current pressures upon the pharmaceutical industry, it is clear that wider scale adoption of single-use technologies will be key to adhering to revised sterility standards without negatively impacting productivity."
"Through the application of technologies such as the CultureOne Maxi, we can actively move towards better practice in the culture separation and wider pharmaceutical market.”