Put in commission in February 2008. The shop's capacity is 10 billion IU per year, which allows to satisfy 100% of Russia's demand for insulin preparations.

The production site design was examined for compliance with European GMP requirements by UK specialists.

The equipment has been purchased in Germany, from companies which supply similar equipment to the world's biggest insulin manufacturers - Novo-Nordisk, Eli Lili, Sanofi-Aventis.

The bottling line (made in Germany) has a unique design; it operates in an automatic mode and requires only monitoring the process. Bottles and cartridges are washed, rinsed, sterilized, filled and sealed without any human intervention. This kind of automation makes it possible to fully protect insulin preparations from any environmental effects and a human factor. Additionally, once filling is over, the filling line can be automatically rinsed and sterilized too.

The insulin solution preparation zone is fully computerized; people can affect the process only by installing appropriate programs. The zone has been designed and manufactured by a German company's specialists possessing unique experience in this field. 

The inspection machines, which are made in Japan and Italy, are able to examine each bottle and cartridge for mechanical impurities.

Since human insulins cannot withstand high temperatures and cannot be sterilized in an autoclave, the project provides for aseptic adding of the drugs.

Clean zones (A grade) have been designed and built in such a way that not a single microorganism is allowed per cubic meter of the production area air. In these zones, the supplied air is constantly monitored for purity.

Before filling, all insulin preparations are sterilized by means of the double sterilizing filtration. And only solutions which are already sterile are poured into sterile bottles or cartridges.

Using multiple methods to protect a drug from environmental and human exposure makes it possible to produce high-quality and safe recombinant and analog insulins.

The workshop's product range:

• Rosinsulin R (solution);
• Rosinsulin S (Suspension);
• Rosinsulin M (mixed);
• Rosinsulin aspart;
• Insulin glargine.

The preparations come:

• in cartridges (3 ml)
• in bottles (5 ml)
• in disposable pre-filled syringe pens (3 ml)

Rosinsulin® disposable pre-filled syringe pens have been designed for administering Rosinsulin P, Rosinsulin C, Rosinsulin M, Rosinsulin aspart, Insulin glargine insulin products.

Using disposable pre-filled syringe pens allows the patient to:

• make the insulin injection procedure comfortable and easy;
• inject high, medium and small doses of insulin accurately;
• avoid the problem of injecting an inaccurate dose due to gradual wear of a syringe pen;
• absolutely strictly follow the treatment regimen

Manual instructions for ComfortPen ROSINSULIN syringe pen