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.
Discover how Getinge can support in contamination prevention for your specific application within the biopharmaceutical production space.
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.
API handling - Protection from highly toxic substances
Active Pharmaceutical Ingredients (APIs) and Highly Potent Active Pharmaceutical Ingredients (HPAPIs) may be highly toxic substances contained in a significant proportion of today’s drugs. Operators must be protected during preparation and formulation of drug products. Getinge helps protect staff and the environment through isolation technology and cleaning systems for the safe handling of APIs.
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 that meet the quality requirements of vaccine producers.