Pharmaceutical Clean Plant and Water System Verification

The production of pharmaceutical and sterile medical devices must be carried out in a clean production environment, and the plant should be rationally arranged according to the production process and the required air cleanliness level. Clean workshop and main facilities should be verified or confirmed before production, and regular inspections should be carried out to ensure the correct operation of the environmental system. In addition, the water system is crucial to the quality of process water, and its verification work also directly or indirectly affects the quality of the product.

In order to ensure that product quality meets aseptic standards, enterprises should regularly verify and confirm the purification facilities and water systems of the plant to ensure that the products are produced in a clean area that meets the requirements. The process of verification and confirmation should be throughout the entire product life cycle.

STEMart provides different levels of air conditioning system, clean room environment and water system performance verification services to demonstrate that clean room and water systems can continue to meet standards under normal operating methods and process conditions.

Service Items

• Clean plant facilities and system verification
  • Suspended particle
  • Floating bacteria
  • Settling bacteria
  • Surface bacteria
  • Temperature and humidity
  • Illuminance
  • Noise
  • Airflow detection
• Water system verification
  • Purified water (properties, pH, nitrate, nitrite, ammonia, conductivity, total organic carbon, easy oxides, nonvolatile matter, heavy metals, microbial limits, etc.)
  • Water for injection (properties, pH, nitrate, nitrite, ammonia, conductivity, total organic carbon, easy oxides, nonvolatile matter, heavy metals, cellular endotoxins, microbial limits, etc.)

For more information about our pharmaceutical clean plant and water system verification services, please contact us.