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Easy on the eye

Plants and processes for the production of ophthalmic medicines
Easy on the eye

Ophthalmic medicines are pharmaceutical products that are applied directly to the eyeball, conjunctiva or conjunctival sac. Sterility is a top priority in this sensitive area and strict compliance with the rigorous cGMP requirements for sterile pharmaceuticals a must. An American manufacturer of such medicines has trusted in FrymaKoruma processing equipment for the last five years.

The authors: Joachim Stoye Product Manager, Romaco FrymaKoruma Marco Schweizer Product Manager, Romaco FrymaKoruma

Seven years ago, it was Romaco’s US roadshow that originally convinced the pharmaceutical group. Orders followed for an annular gap bead mill and several Dinex vacuum processing units. In the course of the three-month round trip the FrymaKoruma crew took in 54 companies in 14 states, including New York, Florida, Texas, Illinois and Ohio. More than 65 tests were conducted during the travelling show.
The presentation of the CoBall annular gap bead mill convinced the American company, one of the world’s biggest manufacturers of ophthalmic products. The first mill of this type to be used for the sterile production of ophthalmic medicines was shipped to the USA in 2008. More orders for several Dinex vacuum processing units followed in its wake. A second Dinex 700 was installed in May this year and negotia-tions are currently taking place regarding the construction of further units. The various formulations for eye ointments, creams and drops were tested upfront at the FrymaKoruma ProTec process technology and training centre in Neuenburg. ProTec provides customers with a valuable opportunity to perform test series and optimise workflows. Thanks to the Dinex technology, the US pharmaceutical producer will in future be in a position to reduce its batch times by more than 90 %.
The overall concept of the FrymaKoruma vacuum processing units makes them ideal for sterile processes. Ophthalmic medicines are pharmaceutical products that are applied directly to the eyeball, conjunctiva or conjunctival sac. Strict compliance with the rigorous requirements of the cGMP (Current Good Manufacturing Practices) for sterile pharmaceuticals is therefore a must when these products are manufactured. The regulations concern both the machine itself and the manufacturing process. The system is sterilised by passing hot steam through the machine and then drying it. All product-contacted surfaces, piping and filters have to be absolutely sterile.
Precise temperature control
The product – in this case, the ophthalmic medicine – likewise has to be sterilised during the manufacturing process. All germs and microorganisms can be killed by selective heating. The normal values for in situ sterilisation are a constant 121 °C over a period of at least twelve minutes. Temperatures of 124 °C with a tolerance of ±2° over a minimum of 20 min are explicitly stipulated for the ophthalmic products in question. End-to-end monitoring of the process is essential in order to meet this requirement. Six independent measuring systems continuously monitor and control the temperature in the vessel, cover, bypass and other piping as well as in the sterile filter of the vacuum processing unit. Homogeneous temperature control of the product mass is achieved in this way under sterile conditions.
Thorough mixing is vital here. The scraper agitator on the inner wall of the vessel and the centrally mounted counter-rotating agitator distribute the product quickly and homogeneously, leading to extremely effective heat exchange. The double-walled pressure vessel ensures that the product is heated in line with sterility requirements. The formulation must not be allowed to overheat, however, or the active ingredients will be destroyed. This narrow temperature window represents a daunting technological challenge, yet the FrymaKoruma vacuum processing units can be relied on to master it without fail. The scalability of the Dinex series guarantees highly reproducible processes regardless of the product size.
Narrow particle size range
The CoBall mill is particularly suited for sterile applications involving wet grinding. This mill type is the system of choice when it comes to producing sub-micron particle sizes. When ophthalmic medications are manufactured, very small particles have to be produced within a closely toleranced range. Variations in size must be avoided as far as possible because they impair the quality of the product and create a potential risk of eye injuries. Due to its very narrow milling gap, the annular gap bead mill provides extremely homogeneous results.
The milling chamber is filled with beads made from wear-resistant ceramic materials. They move in a controlled way within the gap between the rotor and stator and are swirled around the milling space by an internal recirculation system. The product is milled by a combination of crushing, impact and cutting forces. The geometry of the process tool causes these milling forces to be input directly into the product. No additional aids such as pins, discs or other accelerating elements are required. The beads are separated from the product at the mill discharge by means of a dynamic sieve. Cleaning is fully automated in the form of CIP (cleaning in place) and SIP (sterilisation in place). During this process the beads can be cleaned without being removed from the milling chamber, saving time, energy and money.
Energy efficient heat exchange
The interior of the mill has additionally been optimised to facilitate cooling. The powerful milling forces result in high temperatures throughout the wet grinding process and these temperatures have to be controlled. The annular gap bead mill offers a very large heat exchange surface in relation to the volume of the milling chamber. The product temperature is regulated continuously by means of cooling ducts in the rotor, stator and mill cover, so that the system makes particularly efficient use of energy. The inlet temperature of the product can even be reduced during the milling process. Heat-sensitive ingredients can thus be processed gently and safely throughout.
The FrymaKoruma technologies simultaneously comply with the criteria of Blue Competence, the German Engineering Federation (VDMA) sustainability initiative, which aims to reduce the overall consumption of raw materials and energy during the production process.
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