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COVID-19 Resource Center

Healthcare professionals can find help and guidance on how to benefit from our offerings to treat your patients, as well as other practical information and advice.

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Biopharmaceutical Production

Stringent demands for sterility in the production of patient cures

Medicinal products produced by the Biopharmaceutical 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.  

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. Contamination 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.

Meeting common and highly specialized needs

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, and sterile transfer systems to meet each facility’s specific needs. 

Application areas

Discover how Getinge can support in contamination prevention  for your specific application within the biopharmaceutical production space.

Safe and efficient filling environment

It is critical to protect the product during the filling process. Getinge has equipment and systems for ensuring a safe and efficient filling process, maintaining sterility and preventing contamination.

Component and 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.   


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. 








Meeting GMP requirements in 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.

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.

Find out how Getinge's sterility testing isolators can ensure reliable test results

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 that meet the quality requirements of vaccine producers.

Learn more about decontamination of waste material in vaccine production

Preventing contamination in the Life Science industry

In addition to biopharmaceutical production, Getinge support you with solutions for contamination prevention in biomedical research, heat sensitive goods manufacturing and various laboratory applications.