The application of single-use disposable products within pharmaceutical process engineering has grown at a phenomenal rate over the past few years. The ability to have pre-prepared sterile production equipment that can be installed, run and disposed of quickly enables pharmaceutical manufacturers to produce fast, safe, and flexible batch production. Reaction times are faster for production, equipment is already sterile so no cleaning is required and production can begin immediately and safely.
After completing a batch, significantly less time is needed to replace the single-use disposable products than is required for cleaning and sterilisation processes (CIP/SIP) in a conventional stainless steel plant. This reduces not only the investment costs of such a plant, but also eliminates the time-consuming cleaning validation of the piping system components which is no longer required for Single Use systems.
Single-use processes are safer due to the reduced risk of cross contamination and other influencing factors such as costly cleaning. Contract Manufacturing Organizations (CMOs) can also benefit from using a single-use plant. If they are commissioned by large companies to produce smaller than normal quantities of a product, or to produce products within a short period of time, they can now respond flexibly to customers’ needs and specifications. In the manufacture of small batch sizes up to approx. 2000 liters, which are also often required in research and pilot production systems, single-use equipment is increasingly being used.
Single-use processes and technology are undoubtedly making an important contribution in helping to overcome global challenges in the healthcare sector, particularly in controlling the rapid spread of infectious diseases and in the case of pandemics where time lost is critical. Single-use plants allow for new biopharmaceuticals and vaccines to be brought to the market faster.
Born from a need for an aseptic valve to use in a Single-Use plant, GEMÜ has developed the world's first Single-Use diaphragm valve (GEMÜ SUMONDO). The diaphragm valve body is easily connected and disconnected from the actuator. The diaphragm is ultrasonically welded within the body which then hermetically separates the working medium from the environment and the actuator. The medium remains closed o? from the environment by the internal welded diaphragm not only during operation, but also after removing the valve body. The body materials are cleanroom produced and double bagged. When built into tubing assemblies they can be sterilized through gamma irradiation and GEMÜ SUMONDO is therefore Flowpath ready.
GEMÜ SUMONDO has a panel mount actuator that remains in the plant ready for the next batch with optional positioner for flow control. Using a tried and tested actuator design from GEMÜ aseptic valves, the actuator can also transmit feedback as required to ensure complete monitoring of the controlled system. A SUMONDO version with a mini GEMÜ 1434 digital positioner lets the process modulate the flows through the valve using a PLC and 4-20mA control, making the GEMÜ SUMONDO even more versatile. Pharmaceutical processes in particular will be made easier to document, reproduce and validate thanks to the ability to send feedback to the plant control system. The increased levels of automation also mean that the systems are less susceptible to faults.