We provide comprehensive support for the sterilization validation process.

16-Pallet Industrial Sterilization Line

Our sterilization line consists of a preconditioning chamber, a sterilization chamber, and two degassing chambers. The entire sterilization process is equipped with advanced control systems that ensure continuous monitoring and regulation of operating conditions within the chambers, such as:

• temperature,
• humidity,
• pressure,
• exposure time,
• ethylene oxide concentration.

The entire process is controlled by a validated SCADA computer system. Reports from each completed process are archived and made available upon the Client’s request.

Our Services:

Sterilization of medical devices
We ensure the highest level of cleanliness and safety by utilizing state-of-the-art sterilization technologies. Our processes comply with international standards and regulations, guaranteeing full protection for patients.

Sterilization of cosmetic products
Cleanliness is essential in the cosmetics industry. We provide sterilization services for packaging, tools, and cosmetic products to ensure their safe use by end users.

Other sterilization services upon request
Our sterilization services support the maintenance of the highest research and production standards, tailored to the specific needs of our Clients.

The core value of Margomed is the safety of products, an essential component of which is an effective sterilization process. We have over twenty years of experience in performing sterilization processes for medical devices and provide expert support throughout the validation process.

As a trusted partner in the field of sterilization, we offer:

• Effective and safe EO sterilization using a modern sterilization line,
• Low-temperature, vacuum-conducted sterilization, enabling the decontamination of materials that cannot be exposed to high temperatures,
• A highly effective process that does not alter the chemical bonds within the structures of materials used for sterilized products,
• Safety and repeatability of the process, confirmed through sterilization process validation.

Why Choose Us?

Professionalism and Experience
Our company employs highly qualified specialists with many years of experience in the field of sterilization. This expertise allows us to provide top-quality services tailored to the individual needs of our Clients.

Modern Technologies
We continuously invest in the latest sterilization technologies to ensure maximum effectiveness and safety throughout every process.

Individual Approach
We understand that every Client has unique requirements. That’s why we offer personalized solutions tailored to specific needs and expectations.

The sterilization service provided by Margomed covers the entire process — from receiving materials from the Client, through their storage under controlled conditions, to the sterilization process itself, which includes preconditioning, sterilization, degassing, quarantine, and storage, up to the point of product collection by the Client. Depending on individual needs, we can also assist in selecting suitable packaging materials.

We use a low-temperature sterilization method, in which ethylene oxide (EO) serves as the sterilizing agent. The sterilization process for each new product must be validated in accordance with PN-EN ISO 17665, and every stage must be closely supervised. Through validation and continuous monitoring of the physical parameters of the sterilization process — further verified by biological and chemical indicator readings — we ensure that the products are sterile and safe. After sterilization, each product achieves the required Sterility Assurance Level (SAL) of 10⁻⁶. Sterilization is classified as a special process, as its effectiveness cannot be directly verified by testing the final product. Therefore, the process must be validated and routinely monitored in accordance with established procedures.

All validation activities are carried out under strictly defined protocols that guarantee the highest standards of product and patient safety. Within the scope of validation, we provide our Clients with comprehensive support, offering our expert knowledge and long-standing experience at every stage.