Parker Prädifa offers custom single-use systems (SUS), sealing and fluid handling components for biopharma laboratory and manufacturing applications, supporting customers from product design to finished devices, including regulatory matters, with a dedicated team of industry experts and ISO 13485 certified manufacturing locations in Europe.
Drawing on decades of experience in working with a wide variety of polymeric materials such as rubber, silicone, TPE and thermoplastics, Parker Prädifa is the ideal partner when it comes to supporting customers in developing new innovative products from conceptual designs or improving existing applications. Our engineering team utilizes advanced simulation technologies such as FEA (Finite Elements Analysis) and CFD (Computational Fluid Dynamics) to ensure short design cycles and maximum reliability even in early design stages.
Immunization against infectious diseases has a decades-long history in preventive healthcare and led to the development of a continually growing variety of vaccines and forms of delivery. The WHO reports that vaccines in various forms are currently available for inoculation against 25 different diseases – from cholera to yellow fever – and nearly the same number are in the pipeline.
The research, development and production of vaccines entails multiple challenges, particularly in terms of product and employee safety, and scale-up to ensure fast availability when and where needed. Therefore, vaccine manufacturers generally target ways of mitigating the risk of contamination, achieving greater production flexibility through appropriate scaling, as well as generally making manufacturing infrastructures leaner and more cost-competitive. Single-use technologies can help achieve these objectives.
Biologic drugs based on monoclonal antibodies (mAbs) and virus vectors have shown considerable effectiveness in combating diseases such as cancer, autoimmune diseases and rheumatoid arthritis and seen major growth over the past two decades. In turn, the growing demand for these biologic drugs requires higher efficiencies in both R&D and manufacturing.
Single-use technologies offer a wide range of benefits in terms of scalability, contamination risk mitigation, and reduction of time and money to be invested in the laboratory and production stages. For instance, by eliminating the need for repeated cleaning, development cycles can be shortened. In addition, single-use technologies serve to achieve a higher degree of flexibility in scaling and process design.
Blood derivatives have seen remarkable growth in recent years due to an increased incidence of diseases such as immunodeficiencies, hemophilia, and other bleeding disorders. Due to their high vulnerability to contamination, the production of blood derivatives is very complex, highly regulated, and closely monitored by national health authorities to ensure the safety of these critical drugs.
Therefore, mitigating the risk of contamination is one of the key objectives in blood derivative production. Single-use technologies provide a viable means of achieving this, for instance by eliminating the need for recurring specialized cleaning processes. This increases the safety of the production process and helps reduce costs.
Polymer-based single-use systems (SUS) from Parker Prädifa offer major benefits in biopharma production over conventional steel- and glass-based multi-use solutions: SUS can reduce the risk of leakage or malfunctions of container closure systems and thus mitigate the risk of contamination.
Through a wide range of available container sizes, a scalable production environment can be achieved. In addition, customizing SUS to meet the specific needs of the application environment and tailoring it to fit an existing, validated production framework has significant potential for cutting capital expenditures andoverall system costs.
The combination of Parker Prädifa’s long-standing experience in polymeric materials and certified clean-room production, knowledge of biopharma processes and validation procedures makes us an ideal partner to identify and maximize the potential of utilizing SUS in your manufacturing operations. Our experts can specifically assist you in:
- Developing customized solutions, tailored to perfectly fit your production environment
- Setting up a suitable validation procedure according to the safety level required by your specific SUS usage
As well as pharmaceutical production based on complex organic molecules, manufacturing of advanced biologic drugs and vaccines must ensure that in-process contamination risks are mitigated as effectively as possible.
Single-use systems (SUS) for up- and downstream processing in the pharmaceutical industry have become widely accepted in recent years due to their advantages in many operations, such as vaccine production. Parker Prädifa has extended its in-house overmolding technology and offers process engineering solutions specifically focused on these systems.
Parker Hannifin GmbH
Engineered Materials Group Europe