Safe Transport of Biopharmaceutical Substances

The biotechnology market is expanding continually, and the close cooperation between science and the rapid establishment of new markets frequently demands specific organisational procedures and marketing forms in the companies concerned. In many cases, the pharmaceutical companies spread the various production steps for their products between several facilities in one or more countries. In order to save costs, the substances are transported between these locations in a highly concentrated form. But safe transport can usually be ensured only if the easily spoilt biopharmaceutical products are frozen. For this, Zeta, a member of the Christ Water Technology Group, offers a hightech solution in the form of its Freeze & Thaw system.
The system comprises a Freezecontroller and Freezecontainer. The control unit regulates, monitors and documents the processes for freezing and thawing the substances. In addition, it can direct the cleaning and sanitisation (CIP/SIP) of the containers used for transport by parameterisation of the individual recipes. An integral component of the control unit in the Freezecontroller is the expansion vessel, which is filled with the silicone oil used as the heat transfer fluid. The automatically controlled fittings and valves permit blowing out of the double sleeve and the cooling coil and the pre-cooling of the Freezecontainer.
The Siemens S7 stored-program controller and the WinCC SCADA-visualisation system are responsible for controlling, operating, observing and documenting the processes. The data recording function includes alarm, event and log trending and provides an audit trail. The trend recording for the refrigerating machine also records the inlet, container and outlet temperatures, together with the differential pressure across the pump, the oil level in the expansion vessel and the volume flow rate of the heat transfer fluid.
The Zeta Freeze & Thaw system complies with the current requirements of GMP, FDA and the GAMP5 directive. Conformity with 21 CFR Part 11 and a comprehensive user management function also permit its flexible and safe use in the manufacture of biopharmaceutical products.