Parker Bioscience Filtration has come up with a solution to the danger of cross-contamination when bulk filling products and introduces the SciLog FD system.
‘Bulk ﬁlling generally implies filling 5 to 20 litre bags or containers with a product. Due to the high level of accuracy involved this is a process which involves several operators’, says Michael Matthijssen, technical manager at Biopharm BeNeLux Sales Company. ‘There is also a high risk of cross-contamination when manually filling in an open system. Bearing these factors in mind, Parker designed the SciLog FD system.’
FD stands for filter and dispense, the final stage of the bulk medication production process. It then needs to be packed, possibly frozen and shipped out. ‘That is when the value of your product is at its highest’, explains Matthijssen. ‘The SciPure FD is a completely closed and automated system which is able to fill with a high degree of accuracy and uses single-use flow paths and filling systems. The main advantage of this system is that it also prevents contamination.’
‘The system is highly efficient and cost-reducing at above thirty batches a year’
The system can be used with all liquid-based medicines, from antibodies for treating cancer to vaccines and gene therapies. Matthijssen: ‘It is a system which is highly effcient and cost-reducing at above thirty batches a year. It helps reduce errors and less manpower is required. Instead of three operators you only need one person to start up the system who is then free to focus on other jobs.’
Amongst other things, what makes the SciLog unique is that it is a simultaneous filter and dispenser step. ‘An integrity test is also incorporated in the filter’, says Matthijssen. ‘A very important addition is the product-recovery-step. This ensures the least possible hold-up volume by returning residual product to either the buffer or the discharge unit.’ The manifolds and container or bag systems are also provided with barcodes and all data is recorded.
‘We have incorporated two industry-standard container systems in our validation process. These are provided with a patented seal which is validated to -89°C’, says Matthijssen. ‘This means a minimal torque is maintained at -5 to -10 Nm during transport. We can also modify the containers to meet a customer’s requirements.’ Basically, all bags, containers, manifolds and flow paths can be incorporated. ‘It is in fact an open architect approach.’
Matthijssen concludes: ‘Our system meets the requirement to process everything within a closed system, and in doing so exclude as many risks as possible. By focusing on these risks and subsequently eliminating them we are now able to offer something quite unique with the SciLog FD system.’