Pharmaceutical Production
Stringent demands for sterility in the production of patient cures
Medicinal products produced by the Pharmaceutical industry serve as the first and last lines of defense in patient care. Manufacturers require maximum uptime, performance and safeguards against microbial and particulate contamination to guarantee the efficacy of the lifesaving medicinal products produced from chemical and biological sources.
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.
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
Component & Equipment Processing
In biopharmaceutical production, GMP regulations require prevention of cross-contamination of components and equipment such as glass bottles, vials and machine parts that come in contact with the end product: the drug. The components must be thoroughly cleaned and sterilized at regular intervals, according to specific validated processes. Getinge’s portfolio of cGMP washers and sterilizers has been designed to help manufacturers ensure compliance with specific cGMP requirements and process demands.
Stopper & Closure Processing
Closures, rubber stoppers and plungers are a vital part of the drug administration system. Getinge equipment washes and sterilizes these stoppers and closures, and keeps them clean, sterile and dry. We offer a comprehensive system for process development and performance documentation.
Taking upstream bioprocessing to full-scale production
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
Terminal Sterilization
GMP regulations require that if a product can be terminally sterilized — without affecting the quality, safety or efficacy of the packaged products — it must be. Getinge sterilizers are designed to meet rigorous sterilization challenges of the most complex drug delivery systems. Our sterilization processes help you meet GMP regulations for all types of large volume and small volume parenteral packaging including ampoules, syringes, cartridges, IV bags, BFS containers, rigid glass, flexible containers and more.
Low Temperature Sterilization
A sterilization process must deliver safe, reliable and repeatable results. Each process and cycle must follow the validated customer requirements while maximizing throughput to minimize cost. Ethylene oxide (EO or EtO) can effectively sterilize at very low temperatures, making it the right choice for heat- and humidity-sensitive applications, including modern plastics and drug coated products.
Preventing contamination in the Life Science industry
In addition to pharmaceutical production, Getinge supports you with solutions for a safe and efficient workflow within your laboratory and biomedical research facility.
How can we support you?
Contact us for more information about our Pharmaceutical Production and
Research Laboratories solutions.