Ensuring contamination-free and scalable processes while fulfilling the strictest compliance requirements
As a partner in pharmaceutical production, Getinge’s portfolio of Biopharmaceutical resources meets our customers’ unique challenges and strict compliance requirements while achieving high performance, maximum productivity and streamlined processes. We produce GMP washers, sterilizers, closure processing systems, isolators, sterile transfer systems and bioreactors systems to meet each facility’s specific needs.
Discover how Getinge can support in contamination prevention and upstream bioprocessing for your specific application within the biopharmaceutical production space.
Striving for the highest quality outcome from production processes
Biopharmaceutical production facilities are acutely concerned with maximizing uptime and performance while safeguarding against microbial and particulate contamination. Contamination can influence a drug’s active ingredient, excipient potency or its administered use, such as injection or infusion and can also negatively affect the patient’s health.
To ensure safety, all Biopharmaceutical production facilities must comply with strict regulations. These include Good Manufacturing Practices (cGMP) associated with production of the finished product, and Good Laboratory Practices (cGLP) associated with quality testing related to the product. Each process and cycle must follow validated customer requirements to deliver stable and repeatable results in the shortest time and at a minimum cost.
(Factory Acceptance Tests)
To support our customers we use remote FAT as an alternative approach to performing Factory Acceptance Tests.
Complementary to our physical Factory Acceptance Tests, we offer remote FAT to continue to support you even in times of (travel) restrictions.
Safe and efficient transfer
without breaking containment
Transfer material without breaking containment
The patented DPTE® transfer system enables the user to transfer toxic or aseptic components without breaking containment. The DPTE® system is based on the interaction of two separate units – "Alpha" and "Beta" – each fitted with a door, a lock and a sealing function.
Ensure reliable and safe sterility testing
Contamination of samples during sterility testing can be a costly problem, falsely indicating contamination when in fact there is none. These false-positive results require expensive investigation and rework. Getinge’s sterility testing isolators and patented DPTE® sterile transfer systems provide a safe and sterile self-contained environment for the most critical steps of the testing process.
Biocontainment in vaccine production
When working with live viruses, proper waste treatment is critical. Our experience with biomedical R&D has led to the development of sterilization systems with dedicated bio-decontamination processes including the DPTE® system that meet the quality requirements of vaccine producers. The DPTE® system is used for safe and efficient waste handling; there is no risk of sample or environmental contamination.
Validated cleaning and sterilization processes
Cultivation at large scale
After experiments and clinical trials, the next step is to scale up to production. Expansion of the cells is key to maximize production yield. Getinge offers Applikon bioreactor systems for the large-scale production of life-saving vaccines and first-rate medicines.
Protecting the integrity of sensitive goods and packaged products