Gerresheimer adds primary packaging irradiation service

New offering includes surface finishing of plastic packaging for ophthalmology and rhinology products

Primary packaging for the pharmaceutical industry is produced in ISO class 7 and class 8 cleanrooms.
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Gerresheimer is expanding its range of services to include surface finishing of plastic packaging for ophthalmology and rhinology products with irradiation. As part of this move, the company is drawing on partnerships with selected certified partners.

Niels Düring, Global Executive Vice President Plastic Packaging, explained: “We want to make life easier for our customers when it comes to procuring their dropper bottles and, by treating our products with gamma radiation, we are adding in an important work step before filling."

Düring the company is relying on selected, recognised, and certified partners to achieve this. "The chosen partner companies have the requisite certification in accordance with ISO standards 11137, 11737, and 13004," he said.

Gerresheimer is assuming responsibility for handling this work step from start to finish, including transport to the irradiation company, monitoring and inspecting its work and delivering to the location specified by the customer.

The inspection processes also involve physically and chemically testing the product characteristics after irradiation. Gerresheimer regulates the validation and revalidation of the entire process, helping to reduce costs for the customer.

Gerresheimer’s range of ophthalmology and rhinology products encompasses bottles and dropper inserts made from low-density polyethylene (LDPE) with pump systems to match. Irradiation also ensures the products are germ-free.

As a specialist in plastic packaging for the pharmaceutical industry, Gerresheimer offers a wide range of packaging solutions for solid, liquid, and ophthalmological products.

All of the company’s primary packaging for the pharmaceutical industry is produced in ISO class 7 and class 8 cleanrooms at its plants in Vaerloese (Denmark) and Boleslawiec (Poland).

Low germ level to ISO standard irradiation

The population of viable microorganisms on the surface of a product and/or packaging is called the bioburden.

The bioburden is determined in accordance with ISO 11737. Raw materials, components, packaging, and medical products are all investigated to gather information about the germ composition and level of germ contamination before treatment. A stable bioburden guarantees a successful irradiation process.

Gerresheimer will be at booth 4C30 of CPhI Worldwide in Madrid on 9-11 October.

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