Equipment cleaning is becoming a popular issue for many reasons. On one hand, the pharmaceutical industry is turning more and more to highly potent active pharmaceutical ingredients: about 50% of New Chemical Entities in the pipeline are highly active, and according to IMS Health, expected growth rate for this market segment is between 12% and 16%, well ahead of the 3-4% of the general pharmaceutical market. At the same time, regulations for operator and environmental safety are becoming more stringent.
Conversely the pharmaceutical industry is facing a general downward pressure on costs: the opportunity represented by emerging markets, government healthcare cost-containment measures in western countries, together with the growing competition of generics, are all driving forces of this market trend. Translated to the manufacturing process, this means lower capital asset expenditure and also waste minimisation, inventory reduction and just-in-time production, improvement of equipment productivity and effectiveness.
Reduction of equipment down times for change over and cleaning are critical in order to improve production efficiency. According to the product and process characteristics different solutions can be implemented:
- CIP (Clean-In-Place): cleaning of a piece of equipment without preliminary disassembling: the different cleaning phases are controlled by an automated programme thus achieving a reproducible cleaning.
- WIP (Wash-In-Place): sequence of automated and manual operations.
- WET: binding dust within the machine manually, followed by manual clean-finishing.
IMA has been the first tablet press producer to launch on the market a machine fitted with a complete Clean-In-Place system. On the Comprima series of tablet presses, some preliminary manual operation is necessary to take out the tooling and to fit the cleaning devices, but once the cleaning cycle is started the different phases are carried out in a completely automatic sequence up to the final rinsing and drying, so that at the end the machine is clean and ready to start a new production batch. Detergents and washing phases can be adjusted according to the products, and different cleaning recipes can be stored in the computer and recalled by the operator, allowing reproducible results.
When Comprima was launched to the market in 1995, its Clean-In-Place system was a revolutionary innovation, as at that time the cleaning of tableting machines was a manual and extremely laborious job. In fact, the innovation of the Comprima created a need and raised the bar for the standards of technology.
The IMA Kilian Synthesis was launched to the market in 2002, and incorporated some of the main design concepts of the Comprima, including the complete separation between the compression and mechanical areas. This feature extends the life of cam and tooling and results in black spot free tablets, and is essential as far as cleaning is concerned, because it limits the area contaminated by powder (and therefore to be washed). By enclosing the processing area to a well-defined space, the Synthesis presses of the WIP version can be fitted with a Wash-In-Place system, where different levels of automation of the cleaning phases are possible. As no mechanical or electrical device/part is wetted or washed, no re-lubrication of cams or rollers is required, nor any special attention is necessary before restarting a new production batch.
Spray nozzles are located at defined points of the process area and inside the aspiration tube, guaranteeing the complete washing of all contaminated parts and yet requiring only a minimum of water. The process area is prearranged for easy water discharge: the base plate is inclined so that water runs directly into the drain. There is no mechanical gearbox mounted on the stainless steel force feeder, so this unit can be easily washed without the danger of water or detergent penetration. The process area has been designed for an optional flooding. This way all product contact parts are already washed inside the machine (with water/detergent). As it is possible to rotate the turret during the flooding, washing results are extremely good: the flooding increases the washing results particularly for the fill-shoe and the bellows.
When working with highly active products, WIP and CIP systems can be improved to prevent any direct contact between the operator and the product, and avoid the necessity of Personal Protection Equipment. IMA Active has been supplying equipment for contained processing of Highly Active Pharmaceutical Ingredients since 1996, and today has over 70 installations worldwide for dispensing, handling, granulation, tableting, capsule filling and coating, both for production and R&D, reaching an Occupational Exposure Level lower than 1μg/m³.
Fourteen years of design, in cooperation with our customers, has gained IMA Active an expertise and a range of available and proven technical solutions which is unrivalled in the marketplace. This includes the use of isolators, Rapid Transfer Ports, Glove Ports, as well as block and bleed valves protecting purified water supply, ductwork for tubing and drainage and many other technical devices: all of this can make the investment for these kind of installations quite high.
To meet the growing demand of a cost-effective approach, the latest IMA Kilian development is represented by the WET system. Again it is the limited area contaminated by the product that is the basis for this clever solution, developed with the aim of reducing time and operations involved in cleaning the press, containing capital expenditure and improving operator protection, but with a minimum extra investment when compared to a standard, manually cleaned press.
Dust binding is the key concept of the design: the Synthesis WET presses are fitted with spray guns, incorporated in the window flaps and/or to the product feeder through the product hopper and fill shoe. Spray guns use minimal water consumption and water supply is easily achieved by means of a male/female quick connection. The WET systems prevents operators coming into contact with airborne hazardous material and make the final cleaning an easy and quick operation.
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