TECNinox Case History: Record Emulsion Plant

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Thanks to 40 years of engineering experience and highly qualified know-how, today TECNinox is able to build plants with high technological standards.

In the middle of the Food Valley, halfway between industrial districts of Milan and Bologna, TECNinox has its headquarter: a worldwide reference point for the design and construction of process plants for the production of drugs. TECNinox is a leading company in the supply of turn-key process plants for the formulation of products for the pharmaceutical, biotechnological and cosmetic sectors and for the production, storage and distribution of pure fluids. Each plant is built in compliance with the latest GEP, ASME, cGMP, GAMP and FDA regulations and can be customized in every part according to the customer’s needs. TECNinox ensures a constant presence to customers through an after-sales network with the supply of spare parts and assistance in a short time, through qualified personnel, with the aim of limiting the production downtime of the plants.

Over the years TECNinox has developed a large number of formulation plants for sterile product processes, not least a plant for the production of an anesthetic in the form of an emulsion. When we talk about emulsion we generally think of a plant that is easy to manage and build, because after all, it is a stable mixture over time of aqueous solution and oily solution treated with a high pressure homogenization. Actually, emulsion plants are not as trivial as one might imagine: the processing of aqueous nanoparticle suspensions for the administration of the drug and the related development of the process from an engineering point of view are difficult tasks, due to the specificities related to the nanometric size. The transition from the micrometric field to the nanometric field, in this specific case we speak of a fine emulsion in which the average diameter of the globules is less than 2 µm, is strictly necessary for specific applications in the pharmaceutical field and represents a real challenge. Several years of experience guarantee TECNinox a strong specialization and competence to review every detail and be able to cope with any type of process requirement.

THE SYSTEM STRUCTURE – Now let’s talk about the plant specifically: the formulation system is used for transfer, dissolution, preparation, emulsion, homogenization, filtration and storage of emulsion products in water before filling. It consists of three process rooms, two of which are for formulation – compounding rooms – and the other for storage – holding the room. In each of the two formulation rooms, the core activity of the process takes place: the oily solution contained in a 500L tank and the aqueous solution of a 2800L tank are mixed and, through sterile filtration lines, sent to a third 3000L tank. The resulting solution pass first through a high shear mixer, or pre-mixer, and then through a high pressure homogenizer (800 bar). In the latter, the raw product, forced to abrupt variations of energy capable of crushing the particles, is transformed into a homogeneous solution in all its parts. The obtained mixture is deposited in the third room, where there are four tanks of 3000L each, and then passes to two separate filling machines.

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THE KEY ROLE OF THE BLOCK VALVE SKID – The beating heart of the plant is in the block valves skid: a set of 60 valves able to transfer the product from each compounding tank to each holding tank and, consequently, indistinctly to one of the two filling machines attached; a not insignificant quality in a plant of such a capacity! The extremely complex matrix of sends and outputs has been managed with a block valve system that has the particularity of having the drains on board the skid. It is not an easy task to collect such a number of valves in just three drainage manifolds; it can, therefore, be said that the block valve skid is the pride of this plant both from an engineering point of view and in terms of sterility and cleanability.

EXTREMELY VERSATILE WASHING MANAGEMENT – The totally flexible and autonomous management of the washes, through the presence of two C.I.P. skids, is another important strength of this plant. The inclusion of an automated Clean in Place system, in addition to reducing the time of the washing phase, thus increasing production, maintains the quality of the system and the integrity of the system. In this specific case, thanks to a system of mix proof valves, the two different C.I.P. skids are able to reach any equipment present in the plant and carry out several washes at the same time.

INTEGRATED SOLUTION THAT GENERATES ADDED VALUE – An automatic control system supervises each process recipe: in this case, the plant is managed by 5 PLCs, two for the formulation units, one for the storage unit and two for the C.I.P. skids. This configuration allows a high degree of versatility: it is possible to perform several operations simultaneously on formulation platforms or one of these can be deactivated. The system allows us to monitor and record all the process parameters, both critical and non-critical, can guide the operator in every process operation and become a formulation batch displayed on the operator panel.

LAST, BUT NOT LEAST: THE TIMING – Thanks to the modular approach the duration of the design, construction and fine-tuning of the above mentioned plant has been reduced by 20% compared to a traditional approach. The easily transportable modules, which make up the process systems, are assembled and tested at the plant before being shipped to the customer.

The result obtained by TECNinox is an advanced and extremely customized emulsion plant, based on a deep knowledge of the production process acquired over years working in close contact with the customer, dialoguing with production operators, understanding their needs and always sharing advantages and potential problems.

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