INNOVATION | WE ARE INIBSA

State-of-the-art factory and facilities

Quality and innovation from start to finish. We demand the highest standards throughout the entire production process, from the analysis of the components to manufacturing, storage and distribution.

Manufacturing of small-volume sterile products and, more specifically, dental anaesthetic cartridges.
Independent rooms for the manufacturing of solutions and separate clean areas for product dosing.
Optical inspection, labelling and packaging equipment with the latest technology.

Plant equipment

Reactors: We have multiple manufacturing tanks for our filling lines.
Dosing lines, with washing machine, depyrogenation tunnel and filler. All of these are located in a separate laminar flow clean area with a grade B environment (according to the pharmaceutical cleanroom classification).
Optical inspection equipment to inspect all the dosed cartridges and guarantee that there are no foreign particles or bodies, as well as reject those that may have an aesthetic defect or are under-dosed. We employ state-of-the-art equipment and software with very high detection levels.
Labelling machines: Our cartridges are labeled using automatic labelling machines which not only apply the label containing the name and characteristics of the product, but that also allow us to print online the specific details for each product such as batch number and expiry date.
Packaging lines with equipment that allows the thermoforming, packaging into blisters, boxing and packing of the end product. They have control elements to guarantee the presence of all the units in the blister pack, ensure the insertion of the patient information leaflet, discard incomplete/broken units, and trace units/batches (track and trace) according to the current legislation in each of the different countries to which we export.

Laboratories

Own laboratories for microbiology (2016), physicochemical (2017) and materials. Equipped with the latest techniques and equipment.
They allow us to analyse all the components used to manufacture our medicines and to control processes and release batches.
Highest quality standards and compliance with the current legislation.

Logistics and supply

Our facilities and processes guarantee:

Product traceability.
Maintaining the right temperature conditions at all times: storage, transportation and delivery.
Preventing cross contamination.
A Customer Service team is there to guarantee the traceability of orders.
We have over 5,000 storage areas for raw materials, packaging material, semi-finished products and finished products.

Pharmaceutical development

We have a highly qualified team working on development and reformulation, always with the aim of improving the quality of our products.

Search for bibliographic information.
Selection of APIs and suppliers.
Reformulation of products to improve them, optimise them or comply with new regulations.
Galenic development.
Development of pharmaceutical analysis and validation methods.
Preparation of the product dossier with guarantees of international approval.
Design and manufacturing of pilot batches.
Generation or format of the information to complete the new product marketing dossier.

Regulatory services

We manage all the documentation required to obtain the necessary registrations in compliance with the regulatory framework, as well as to obtain the licences required to manufacture and market healthcare products and medicines for human use.