Homepage » Pharma »

Revolution is progress

Rotating spray balls in the CIP process
Revolution is progress

The suitability of static spray balls in validated cleaning processes for bio- pharmaceutical plants is not unlimited. RotaCIP is a CIP lance equipped with a spray ball, which rotates due to the force of the CIP fluid. The rotation, and thus the cleaning intensity, can be verified by means of sensors. The dynamic principle of the RotaCIP system renders the CIP process more efficient, faster and safer than the static concept of old-fashioned spray balls.

Dr. Karin Koller

Cleaning a biopharmaceutical plant is not merely a necessary evil on which no thoughts are wasted. It is an integral part of the process. Cleaning removes not only media components and cell debris but also residues of the active ingredient produced, metabolites and auxiliary substances. In multipurpose plants even the slightest contamination of a previous batch can make the entire product in the current batch unusable. Cross contaminations, especially with active ingredients and allergens, must be avoided at all costs to ensure product safety.
Validation has top priority during the development of the cleaning process for a biopharmaceutical plant. Hard-to-clean areas in the reactor have to be identified for this purpose. The suitability of the cleaning agents for removing all residues from the production process must be tested. The removability of the cleaning agents is also an important factor. Absolute cleanliness is verified by means of swab and rinse tests. Toxicity, environmental impact, water consumption and heating expenses have to be evaluated in this context. It is advisable to prepare a detailed risk analysis at this stage.
Not only the nature of the cleaning agents has to be considered, but also the equipment and process management. Although fully automated CIP systems are an expensive initial investment, their operational costs are comparatively low due to the lower chemical and water consumption. Less time is required for automated cleaning than for other cleaning techniques because all the components have already been mounted to the plant and the cleaning process can seamlessly follow the production process. An automated CIP system consists of mixing tanks for the cleaning agents, probes, pumps, elaborate piping systems, valves, a complex controller and various other components. The spray ball that is necessary for both automated and manual CIP systems appears to be a relatively straightforward technical part. It is often taken for granted and its suitability for the process is not evaluated extensively.
Additional spray balls
Even simple bioreactors for standard fermentations are equipped with many built-in components, such as baffles, an aeration tube, an agitator and probes. If these are only sprayed from above during cleaning with a simple spray ball, spray shadows can form. The affected areas of the vessel are insufficiently cleaned. Product carry-over and contamination with media components are the result. In severe cases pockets of dirt may form, where microorganisms survive sterilisation. These externally acquired microorganisms start to grow during cultivation, contaminate the fermenter and cause the entire production batch to be wasted. This problem is eliminated if two or – depending on the vessel size – more static spray balls are used. Especially in combination with a CIP valve that sprays the built-in components from below, spray shadows become a thing of the past.
The use of two or more static spray balls could, however, give rise to an entirely different set of problems. This method must not be employed if the water pressure of the cleaning and rinse solutions is not sufficiently high, since this pressure is evenly distributed to all spray balls during the cleaning process. Insufficient pressure of the CIP solutions reduces the range of each ball and absolute cleanliness can no longer be ensured. Even if the CIP system can be supplied with adequate water pressure, several spray balls are not necessarily the optimum solution for the process in question because they may use up too much space, resources and energy.
Limitations of static spray balls
The fermenter lid is always fitted with dosing systems for media and corrective agents as well as inlet and exhaust air filters and probes. The space for additional components is limited and further decreased if the reactor is equipped with a top drive or a foamkill system. The cavity inside the fermenter lid is often insufficient for several spray balls. Other equipment must be removed prior to each cleaning process to make room for the balls. This could even involve opening the fermenter lid. The time and effort necessary to do this – a lifting device is required as a minimum or possibly a crane for large reactors – annihilates all the advantages of the CIP process, endangers personnel and is costly.
In addition, static spray balls have spray characteristics that could put the entire cleaning process at risk. The cleaning so- lution only hits the vessel interior with the intended pressure through the bore holes in the balls. Since the spray balls are static, the local impact of the cleaning solution always occurs at the same points. The areas in between are merely rinsed rather than actively cleaned with mechanical force. Cleaning with static spray balls is therefore very time-consuming. If all areas of the vessel interior – and especially those that are hardest to clean – were to be sprayed actively, both the application times for the cleaning agents and the rinse times could be reduced. The bore holes in the spray balls are relatively small and can be obstructed by insufficiently dissolved particles of the cleaning agent. If these holes become clogged, the vessel is not adequately cleaned in the areas concerned. There is no way to determine exactly when this happens and the cleaning efficiency starts to deteriorate.
Rotation is the solution
If the spray ball rotates on a static lance, the problem of local spraying is reduced but that of spray shadows remains. If both the spray ball and the lance are in motion, both problems are overcome. The spray ceases to hit the vessel in the same tiny, distinct areas. The range of the cleaning agent is increased and all areas within it are actively sprayed. An extra mechanical component is added to the cleaning process by the rotation itself. This shortens the cleaning time, reduces the consumption of chemicals and gets rid of spray shadows. Only one spray ball is required instead of several.
Bioengineering developed the RotaCIP lance with rotating spray ball with the aim of rendering the cleaning process safer, faster and more environmentally compatible. RotaCIP is mounted in the reactor lid or a side port, where it effectively supports the cleaning process. It remains in the reactor during cultivation and can be fully integrated into an automated cleaning process. The spray ball, which is located at the end of a curved pipe, is driven by the force of the CIP solution and rotates along a horizontal plane. Uniform spraying of the reactor interior is assured. No spray shad-ows occur. The RotaCIP has a modular structure and can be individually adapted to the vessel geometry. The material and design comply with all the usual sterile and hygienic regulations. The rotation is started by means of a bearing and is therefore not only hygienic but also virtually maintenance-free.
With conventional spray balls there is no way of telling whether they are working correctly or whether they are even working at all. The RotaCIP’s rotation can be monitored by a sensor. It is thus possible to document at any time during the CIP process whether the spray ball is rotating correctly and spraying the vessel interior with sufficient water pressure.
All Whitepaper

All whitepapers of our industry pages

Current Whitepaper

New filtration technology for highly corrosive media


Industrie.de Infoservice
Vielen Dank für Ihre Bestellung!
Sie erhalten in Kürze eine Bestätigung per E-Mail.
Von Ihnen ausgesucht:
Weitere Informationen gewünscht?
Einfach neue Dokumente auswählen
und zuletzt Adresse eingeben.
Wie funktioniert der Industrie.de Infoservice?
Zur Hilfeseite »
Ihre Adresse:














Die Konradin Verlag Robert Kohlhammer GmbH erhebt, verarbeitet und nutzt die Daten, die der Nutzer bei der Registrierung zum Industrie.de Infoservice freiwillig zur Verfügung stellt, zum Zwecke der Erfüllung dieses Nutzungsverhältnisses. Der Nutzer erhält damit Zugang zu den Dokumenten des Industrie.de Infoservice.
AGB
datenschutz-online@konradin.de