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  • A workshop for finished dosage forms of genetically engineered human insulin

A workshop for finished dosage forms of genetically engineered human insulin

инсулин

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 genetically engineered insulins.

The workshop's product range:

  • Rosinsulin R (solution);
  • Rosinsulin S (Suspension);
  • Rosinsulin M (mixed);

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 and Rosinsulin M 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

Quality

Quality, safety and efficacy of medicines are «Medsitntez» plant's top priorities.

Знак GMP

The Quality Director's service structure, which includes the quality control and assurance departments, is in full compliance with GMP standards.

The core staff was trained at Bayer AG in Leverkusen and Berlin. All plant employees were trained in GMP requirements at special training organizations or at the enterprise itself.

The plant has the МС ISO 9001:2015 quality control system in place.

Quality control of finished products is carried out in the plant's laboratories accredited by Roszdravnadzor and FMBA of the Russian Federation.

  • Sterile boxing laboratory of the workshop for the production of infusion solutions2.jpg
    Sterile boxing laboratory of the workshop for the production of infusion solutions2.jpg

The Medsintez plant’s awards:

A prize of the Russian Government

for achieving significant results in terms of quality and services, as well as for the implementation of highly effective management techniques (2007)

A prize of the Commonwealth of Independent States

for achievements in the field of product and service quality (2009)

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Torgovaya 15, Novouralsk, Sverdlovsk region, Russia, 624130

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