Requirements for cleanrooms in the formulation workshop

Article Summary:
Pharmaceutical formulation cleanrooms ensure drug safety by controlling contamination through strict cleanliness levels (A-D), precise temperature (18-26°C) and humidity (45%-65%) control, and effective personnel and material flow management. Key measures include HEPA filtration, positive pressure, separated pathways, specialized gowning, corrosion-resistant equipment, and adherence to standardized procedures.

The cleanrooms in the formulation workshop are the core areas of pharmaceutical production. Their primary requirement is to create a controlled environment to minimize the risk of contamination from microorganisms, dust particles, and the like, ensuring the safety and efficacy of the medicines. Below, DERSION will take you through the requirements for formulation workshop cleanrooms.

First, cleanliness classification is a basic requirement. Depending on the drug dosage form and the different risks associated with process operations, the clean areas in the formulation workshop can be divided into four grades: A, B, C, and D. For high-risk sterile drug production, the core areas (such as filling lines) must achieve Grade A cleanliness with unidirectional airflow, and the surrounding environment must meet Grade B cleanliness; non-sterile formulation production is typically carried out in Grade C or D clean environments. Formulation workshop cleanrooms achieve this through efficient air filtration systems, such as HEPA high-efficiency filters, and strict pressure differential control (usually maintaining a positive pressure of 10–15 Pa) to prevent contaminants from lower-grade areas entering.

Second, temperature and humidity parameters of the formulation workshop cleanrooms must be controlled. Appropriate temperature and humidity prevent drugs from absorbing moisture, caking, or cracking, and ensure the physical and chemical stability of the products. They also support normal operation of production equipment and reduce equipment failures caused by environmental factors. Therefore, the temperature in formulation workshop cleanrooms is typically maintained at 18–26°C, with relative humidity usually at 45%–65% RH; maintaining specific temperature and humidity both ensures operator comfort and provides a suitable environment for the stability of certain drugs.

Next, personnel and logistics management are key to preventing cross-contamination in formulation workshop cleanrooms. Reasonable personnel and material purification procedures must be designed, such as using buffer rooms and air showers, donning dedicated cleanroom garments, and following strict cleaning and disinfection procedures. Personnel routes and material/logistics routes should be designed separately to avoid cross-traffic. All equipment should be made of low-shedding, corrosion-resistant materials, and equipment surfaces must be easy to clean and disinfect.

Finally, strict standardized management is an indispensable part of formulation workshop cleanrooms. All operations must follow detailed standard operating procedures, and personnel must undergo continuous training to collectively maintain the dust-free and sterile cleanliness requirements of the formulation workshop cleanrooms.