The principles and practices of lean manufacturing are widely used in industries across the globe to continuously improve processes, drive efficiencies and reduce costs.
Even in biopharmaceutical manufacturing where validation and regulatory requirements are high, lean can be used to improve processes, meaning more life-saving product can reach patients quickly.
Technology has been developed to support biopharmaceutical manufacturers, CMOs and CDMOs on their lean journey and at Parker we have worked closely with industry to develop a system that can improve operational efficiency, accuracy and safety.
Parker’s SciLog® FD System automates, standardizes and encloses final bulk filtration and dispense operations. It can support companies in addressing the eight wastes of lean: Transportation, inventory, motion, waiting, overprocessing, overproduction, defects, and safety.
As an automated, standardized and enclosed single-use system, it has many advantages over manual operations. It can increase efficiency, reduce process variation, protect the product and operator, and reduce risk.
Here is how the SciLog® FD System can help manufacturers tackle the eight wastes, and support them in implementing lean production strategies.
As the process takes place in a single, enclosed system, the movement of products and materials is reduced. The SciLog® FD System can combine two unit operations: the sterile filtration of bulk drug product and its dispense into bottles or bags. As both of these steps can be performed on one system, transport of material is reduced. Once dispensed into bags or bottles, the drug product can be easily transported for freezing or cold storage.
The use of the SciLog® FD System simplifies the supply chain, with the hardware and consumables, including single-use manifolds, designed together and available from a single source – Parker.
Using an automated system means that the motions associated with a manual operator – for instance operating pumps and valves – are removed from the process. All of the valves are controlled automatically, with intelligent feedback from the SciLog® single-use sensors which are part of the system.
Moving materials in a laminar air flow using aseptic technique can be challenging and has a high training requirement. Reducing the amount of movement of product through the use of a closed system reduces the risk of contaminated product. The SciLog® FD System allows recipe-driven processing, sampling and integrity testing — all taking place on the one enclosed automated system limiting unnecessary motion and associated risk.
As the SciLog® FD System is automated, it cuts down on an operator’s waiting time in between different stages of the process. This means that staff can be utilized more efficiently. For example, a recipe can be programmed to carry out an automated filter integrity test and, while this takes place, the operator can perform other activities such as checks or paperwork completion.
Time-consuming, and potentially inconstant tasks that would have been carried out manually are now automated. For instance, the SciLog® FD System generates automated batch records - an alternative to the operator having to complete forms manually (and reducing the risk of transcript error). There is also an integrated label printer with labels suited to cryogenic storage.
Manual fill can be inaccurate - and human error can lead to more product being transferred to a bottle than is required. Clearly this can have a significant impact on production and, given the high value of the product, can be financially damaging too. By automating the bulk fill process, costly inaccuracies can be avoided. In the SciLog® FD System, load cells located under receiving containers ensure direct measurement for high dispense accuracy.
An open process which relies on manual handling can result in contamination of a product and batch loss. Enclosing the process means that the product is protected and the risk of any contamination is greatly reduced. In addition, standardization and automation eliminate process variability and enables batch repeatability. Standardized, reliable programming ensures repeatability and control in the process.
As calibrated SciPres® single-use pressure sensors are included in the SciLog® FD System, operators can ensure that validated pressure limits are not exceeded, protecting the manifold and controlling the differential pressure over the filter.
Utilizing a fully enclosed process means the product is protected from contamination by the operator, but crucially also that the operator is protected from potentially highly potent molecules.
There are also additional advantages to using Parker’s SciLog® FD System which supports the application of lean in biopharmaceutical manufacturing. Standardization means that training is made simpler and easier, and by using a single-use system, change over times can be significantly reduced. The installation of manifolds in the system is quick and easy, again reducing labour costs and time spent on manual tasks.
This post was contributed by David Heaney, market development manager, Parker Bioscience Filtration, UK
Parker Bioscience Filtration specializes in automating and controlling bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively ensuring the quality of the final product. Visit www.parker.com/bioscience to find out more.