High Quality Food Supplements & Medical Devices since 1987

Formulazioni all’avanguardia, materie prime innovative, tecnologie avanzate, produzione secondo standard farmaceutici e un team di professionisti

azienda-erbozeta

Erbozeta S.p.A. was established in 1987 in the ancient Republic of San Marino. The company produces and commercializes health products, such as food supplements and medical devices.

Founded as a commercial company and subsequently become a manufacturer, the company had a significant breakthrough in 2009 with inauguration of the new advanced production facility of 5200 square meters, developed to provide customers with the quality standards of pharmaceutical grade. The manufacturing site is currently under GMP certification for food supplements, while the management system is under ISO 9001 certification and ISO 13485.

From a single company, Erbozeta S.p.A. has become a group through the creation of new commercial companies: Pharmaluce since 2008, Logus Pharma since 2013 and two international branches: Erbozeta Austria since 2013 and Erbozeta Asia since 2015.

Erbozeta has expanded its business in more than 40 countries in the World, and today is a leading manufacturer of food supplements and medical devices at the national and international level.

Already present in 40 countries in the world

 

Expansion of the group into foreign markets started many years ago. Today ERBOZETA is present in Eastern and Central Europe, Southeast Asia, Middle East, Gulf, North African countries and former Soviet republic countries.
The company is increasing its presence in the World by participation in the important international exhibitions of the industry and building up new collaborations with distributors and local partners.
The group is continuously growing also thanks to Contract Manufacturing, that is an important part of our business activities.

Stability, Quality and Safety

A guarantee for the customer

  • Facility

    Our facility was designed to reduce the possible contamination from outside sources thanks to an air filtration and ventilation system. The security system prevents unauthorized personnel from accessing the building. Storage, manufacturing and packaging areas are entirely separated from each other.

  • ISO 8 Cleanrooms

    In these rooms temperature and humidity are constantly monitored and kept respectively at T=18 °C and RH <20%. The air filtering system is equipped with HEPA absolute filters with high retention efficacy.

  • Climatic Test Chambers

    Climatized wardrobes carry out stability tests on products: one is under standard conditions (25°C, RH 60%) and another is under “stress” conditions (40°C, RH 75%).
    In this way it is possible to follow and study the behavior of formulations during their shelf-life.

  • Equipment

    Maintenance team keeps all equipment functioning to a set of pre-determined quality standards. Equipment is regularly inspected and calibrated when required. Routine preventative machine maintenance is performed on a scheduled basis following written protocol.

  • Sanitation & Hygiene

    In accordance with cleaning procedures all the equipment is thoroughly cleaned and sanitized after every production run. These exhaustive line clean-ups are conducted and recorded in order to prevent any possibility of cross-contamination. Our hygiene program covers regulations for all workers that come in contact with materials or equipment used in production.

  • Manufacturing Controls

    When materials are received they are assigned a bar code so that to track electronically every future use, avoiding any human error

  • Storage of raw materials

    All the raw materials are properly received, stored, sampled and tested before being used in production.There is a warehouse for closed raw materials and another for open raw materials: all stored products are repackaged and internally numbered in lots to trace with certainty any subsequent picking of raw materials.

  • Electronic Weighing

    Our electronic weighing system, with related printing of an adhesive label for each just made weighing, guarantees absolute accurateness: if you do not dose an amount within the tolerance limits provided, the balance does not issue the label and does not allow the following weighing.

  • Fluidised-bed Granulation

    Powders are processed through fluidized-bed granulation: this process brings many advantages among which are an increase in mixture solubility, better compressibility and also homogeneous granulometry, thus preventing powder segregation, which can cause an inhomogeneous dose distribution of active ingredients.

  • Storage of finished products at controlled temperature and humidity

    The finished product warehouse is under controlled temperature and humidity (25° C and RH 60%): this system integrated into the entire production line monitors continuously temperature and humidity in the processing areas.

  • Highly-automated Packaging system

    The phases of primary and secondary packaging are highly automated: in this way the operator does not intervene directly on the product thus guaranteeing minimum contamination and maximum security.

  • Product testing

    All finished products are sent to certified laboratories for further testing depending on the customer’s requirements. The samples of all production lots are kept  in case further testing or quality checks are required. All quality documentation and records are signed, dated, and kept secure for the period of time required by regulations.

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