Design and Construction of Clean Rooms

Clean rooms in cell-based products and bio-implants

International and national organizations monitor GMP rules and regulations that are required for safe and reproducible production of bio-implants and cell-based products used in clinical trials. One of the fundamental steps in this process is establishing an aseptic work environment. This environment is termed a clean room and is defined according to ISO as a room that is maintained with a low level of environmental pollutants, such as aerosol particles. Temperature, humidity and air pressure are tightly controlled in clean rooms.


Clean room standards and their applications

There are several standards for the establishment of clean rooms, including PICS-GMP, EU-GMP, US Pharmacopeia, ISO14644 and WHO-GMP. Observing these standards requires not only the engineering skills of clean room construction, but also an extensive knowledge of the process of manufacturing stem-cell products, which is fundamentally different from pharmacological products and biological drugs. At SABZ, we have an expert professional team with expertise in designing and establishing pharma plants and clean rooms as well as experts in the field of standard rules and regulations and quality management in the field of stem-cell products. Having such an interdisciplinary team is one of the unique features of our group that allow us to provide multifaceted, cost-effective services.


Consultation, design, and construction of clean rooms for cell and tissue-based products

Clean rooms are graded based on the count of particles according to different standards, such as GMP, ISO and 209E. Contrary to other standards, in GMP, the concentration of biological units is considered in the definition of cleanness instead of total particles.

At SABZ Corporation, we first identify the best available location for the construction of the cell therapy center and determine the manufacturing processes based on the intended products. After preliminary meetings with the scientific board of the customer institute, the first draft of the design documents and specifications will be prepared to be evaluated by the food and drug administration of the ministry of health. After obtaining the certifications, we start to set up the clean rooms and will adhere to quality control procedures. SABZ can also provide customers with consultations on benching, preparing lab supplies, and production management.