Optimisation of cleaning and changeover times in pharmaceutical production

Enhanced production systems

Production time in the pharmaceutical industry accounts for only one fifth of the total lead time. The remaining four fifths are spent on cleaning and preparing for new batches. Reconfiguration, i.e. converting external packings such as bags, barrels, cartons or big bags into internal bins, and central weighing are two of the most critical steps in bulk material handling. Cleaning and changeover times can be considerably reduced with the AZO modular technology to enhance the effectiveness and flexibility of the system.

Andreas Gehrig, Willi Weidmann

Orders which are received in the morning often have to be delivered the same day. Pharmaceutical producers are consequently under pressure to shorten conversion times. The trend today is towards fully automatic cleaning of all machines and apparatus involved in the production and manufacturing process. Several essential requirements need to be considered including easy handling of the equipment, in other words the modules must be light enough to be lifted by the operator reasonably effortlessly or handled conveniently by suitable lifting devices. Maximum weighing accuracy is equally important and all cross contamination must be excluded. Since the quantities of raw materials used each year and the number of weighing operations are enormous, the process has to be automated as far as possible.
Modular reconfiguration technology
Substances and active ingredients are supplied in different types of packings, which have to be dealt with efficiently by the manufacturer. The feeding hopper module that is used for bags and cartons starts aspiring as soon as the cover is opened, in order to ensure a dust-free product intake. A discharge unit for big bags can be integrated in the same basic module. This unit includes the big bag connection system with a self-adjusting frame, which docks the big bags dust-tight prior to emptying. In the case of substances with poor flow properties, the big bag stations can be equipped with a vibration unit. The containers are discharged via a module with an integrated, patented docking device which allows them to be docked dust-tight (Batchtainer). The containers are loaded onto the discharge module by means of a lifting vehicle. The container outlet has a dust-tight connection to the docking collar during this process. The butterfly valve is subsequently opened either manually or by a pneumatic rotary actuator and the container is discharged.
Cyclone screening for added safety
It is always advisable to integrate a cyclone screener, preferably the DA type, in the reconfiguration area. This screening technology enables contamination to be removed from the supplied substances and active ingredients. The advantage of this machine is that no additional dosing unit is necessary because it is equipped with two drives. This speeds up product changes as only one machine has to be cleaned. Another point in its favour is that the cyclone screener can be inspected and cleaned while it is still installed. Two extraction devices on the intake side and the screen basket side mean complete disassembly is only rarely necessary.
Modular technology in the central weighing area
After the raw materials have been supplied, the internal bins, e.g. barrels, Dositainers or Batchtainers, are weighed centrally. These bins are positioned on a floor scale and metered very precisely by the cyclone screener, which simultaneously serves as a dosing unit. The extremely constant dosing and screening flow facilitates unsurpassed accuracies. After reconfiguration, the bins are prepared for central weighing. Depending on the formula, a Batchtainer on a floor scale or an AGV moves underneath the dosing points and collects the exactly weighed components.
Short cleaning times
The modular system technology is designed for frequent product and batch changes that demand a high level of system flexibility. This requirement is fulfilled by the strictly modular design. All the functional units are mutually compatible. The modules are adapted to the bins and can be exchanged easily for fast and convenient product changeover. The parts, which are suitable for machine washing, are made entirely of chromium-nickel steel and can be cleaned manually or automatically in a cleaning cabin. The benefits of the AZO technology for cleaning work are immense. Each module can be removed from the system and exchanged for one that has already been cleaned, so that the manufacturing process is not slowed down unnecessarily. All the required energy (electrical power, compressed air and nitrogen supplies) is connected to the unitary energy column.
CIP for the discharge piping system
When a discharge piping system is spread across two floors, as is necessary in such cases, cleaning has to be as easy as possible, ideally with a CIP system (cleaning in place). The discharge pipe remains in place during CIP and only the vibration and dosing modules are removed from the centring station. A special lifting device with quick-acting clamps allows the lower part of the discharge pipe to be exchanged for a cleaning section. It is replaced for cleaning by a connection piece with a lateral outlet spigot, so that the cleaning agent in the upper part of the discharge pipe can flow out again and be carried off into the sewage system. The normal discharge pipe can be replaced just as easily after cleaning – quickly, safely and cheaply. The complete discharge piping system can be dismantled if necessary at longer intervals and cleaned thoroughly at a central cleaning point.
Flexible technology means excellent value for money
Considerable time savings can be achieved thanks to the easy and fast conversion to other bins. In the event of a shortage of raw materials, it is possible to switch to another supplier at any time. The specific characteristics of the raw materials can be influenced, for instance, by screening mod-ules or screening mills, lump breakers, discharge equipment or similar. The cost savings for buildings and building services should not be underestimated. Since it is not necessary to have a fixed discharge point for each type of packing, a considerable reduction in costs ensues. The modular technology can be easily installed by the operator in the pharmaceutical company owing to the plug-and-play principle, so that no special installation personnel are required. Numerous systems already installed have shown that in spite of the high initial outlay, the return on investment (ROI) is fast. Against the background of increased cost pressures, shorter production times and batch traceability, modular technology is set to become more and more popular in pharmaceutical manufacturing, offering a combination of maximum production reliability and operating economy.
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