Har-Mark Pharmaceutical Cleanrooms

Activities in the pharmaceutical sector include the manufacturing and marketing of drugs, the study and creation of vaccines, and other research and development activities.

In this field, contamination control is absolutely vital, because it directly impacts people’s health and well-being.

For this reason, when manufacturing Clean Rooms for the pharmaceutical industry, Har-Mark pays meticulous attention to every single detail and scrupulously adheres to the relevant standards, which, in addition to ISO 14644, include GMP (acronym for Good Manufacturing Practice).

Classification

Cleanrooms are classified based on their level of cleanliness, typically determined by the number and size of particles allowed per cubic meter of air. They are usually classified on a scale from ISO Class 1 (cleanest) to ISO Class 9 (least clean).

International Standards

Pharmaceutical cleanrooms must adhere to strict regulations and guidelines established by regulatory authorities, such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance with Good Manufacturing Practices (GMP) is essential.

Thanks to our experience, know-how and expertise, we have gained the trust of pharmaceutical companies, who continue to work with us over time, entrusting us to create their Clean Rooms.

Characteristics of Clean Rooms for the Pharmaceutical Sector

All processes in the pharmaceutical sector require a sterile and decontaminated environment. The strict air contamination-control parameters and regulations governing Clean Rooms, as well as the certifications required, make these solutions ideal for manufacturing any type of pharmaceutical product.

Discover how Har-Mark can support in contamination prevention and upstream bioprocessing for your specific application within the biopharmaceutical production space.