ISO 14644: understand how Tecnotri can help with pharmaceutical regulation

07.02.2023

Pharmaceutical industries need to deal with different substances to create effective medicines. In this scenario, strict standards related to hygiene and safety are clearly required, so that there is no risk of contamination.

For this reason, the International Organization for Standardization (International Standard Organization) – the well-known ISO – establishes requirements that help companies achieve a high level of quality in their products.

Among the existing regulations is ISO 14644, which involves cleaning environments such as laboratories, precision testing rooms and manufacturing sites in the pharmaceutical segment. That’s what we’re going to talk about today! Continue reading, understand what this standard is and how Tecnotri can help your business adapt to it.

ISO 14644: what is it?

It defines limits for the amount of pollutants within a clean area, in addition to providing information for measurement, design and operation. Although not required by law, many countries include ISO 14644 as an official legal code.

In addition, by following this standard, organizations are able to guarantee suitable environments for the production of medicines and, thus, greater credibility in the market.

What are the main points of ISO 14644 and how is it divided?

ISO 14644-1 is divided into sections. Created in 1999, it established basic points to define the conditions of a clean environment. Part two of the regulation was released the following year and served to help companies measure particle concentrations, which includes guidance on accurate testing.

Throughout the 2000s, the standard was refined with the addition of new sections. Among the most important, we can highlight number four, which concerns the structure of environments, with definitions about ventilation, materials and layouts. The fifth version is focused on workers’ clothing.

How to comply with ISO 14644 with Tecnotri products?

In all areas of the pharmaceutical company, several aspects require control, such as temperature, humidity, lighting, air flows and, above all, hygiene, to avoid contamination.

Therefore, ISO 14644 aims to standardize operating processes. This involves cleaning the site, using specific clothing and footwear, and using appropriate equipment to store raw materials and medicines.

Tecnotri has a line of products ideal for the storage and transportation of pharmaceutical products, developed exclusively to serve the segment. As well as plastic pallets, rotomolded cages, cargo safes and plastic boxes are part of the portfolio.

Tecnotri products are also immune to external agents and withstand temperature variations from -35°C to 60°C, without suffering variations in weight and color. The company also has anengineering sector, to develop exclusive projects according to your needs.