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Our production sites in Hornstein and Vienna are EU-GMP and EN ISO 13485 and EU-MDR-compliant. All manufacturing processes are vetted by the quality control department and monitored by the quality assurance department. This enables us to guarantee the highest product quality and ensure compliance with GMP guidelines and ISO standards.

EXPERTISE Our core business is dedicated to sterile and non-sterile liquids (with the exception of injectables) in the form of nasal spray, throat spray, eye drops and vials. As such, we are able to handle the most varied product properties (e.g. aqueous, oily, alcoholic or viscous liquids).

TECHNOLOGY The aseptic filling of liquids is a complex technological process, the requirements of which we have been fulfilling successfully for decades. This expertise is reflected in sophisticated process definitions and modern batch documentation. Our facilities are state of the art, regulation-compliant and are equipped to handle complex process requirements and establish valid processes.

Our staff receives continuous and comprehensive hygiene and monitoring training. In order to guarantee the highest level of quality, our bottling and packaging lines are equipped with a fully automatic 100% control system for the bottling quantities and IPC camera control systems for process monitoring.

CAPACITIES For aseptics, we currently have the capacity to process approx. 12 million packs per year. MoNo’s versatility truely comes into its own when it comes to batch sizes: in addition to GMP-compliant bottling of very small quantities, pilot batches and stability batches, we can, of course, also process large-scale orders. Anything between 30 l and 1,000 l is possible with MoNo. We also operate a GMP-compliant bottling area for small and very small batches A/B in order to process pilot and scale-up batches.

When it comes to sterile products, we offer a wide range of plastic and glass primary containers for different applications in sizes ranging from 10 ml to 30 ml:

When selecting raw materials, we adhere to the most stringent requirements and, as such, exclusively partner with GMP and ISO-certified suppliers. Our quality assurance and quality control systems guarantee suitable raw materials being used for production without fail.

If you are interested to take advantage of our services, please contact:
projects@mono.co.at
phone: +43-(0)1-330 0671-0

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