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.
Safe and efficient filling processes
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.
Getinge barrier isolation prevents product contamination and protects operators in aseptic filling processes. Isolator technology reduces the need for sterile conditions to the smallest possible working volume while allowing operation to take place in a class D clean room.
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.
High-speed nested syringe tub sterilization
Nested syringe tubs pose a challenge on high speed production lines. We have applied our vast experience in aseptic transfer techniques to develop an E-Beam system for rapid sterilization of the outer surfaces of the tub, allowing high speed lines to run at full capacity: 36,000 syringes per hour.
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.
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.
Keep protected during pharmacy preparations
Some drugs are toxic before being administered in their diluted form. Getinge’s barrier isolators keep the drug securely within a sterile barrier, protecting the staff and the environment, while simultaneously protecting the product from contamination.
Preventing contamination in the Life Science industry
In addition to biopharmaceutical production, Getinge support you with solutions for contamination prevention in biomedical research, medical device production and various laboratory applications.