Equipment certifications are performed on most manufacturing, testing and production equipment to verify that the equipment is operating within the specifications defined in the production process.
Performing the certification on a daily routine
Performing the certification on a routine basis provides documented verification that equipment is meeting the specified requirements and is vital in maintaining confidence in quality assurance programs.
ICM SI engineering is skilled in providing me with equipment certification on Biological Safety Cabinets (BSC), Laminar Flow HEPA Workstations, Fume Hoods, compounding isolators and other equipment that has specific user requirements.
ICM SI engineering is highly trained and usually assist me with testing, repairs and qualifications of equipment to the manufacturing specifications and the applicable standards.
THE ENVIRONMENT CHECKS:
HEPA Filter Integrity
HEPA Filter velocity
Airflow Visualization
Viable Air Sampling
Viable surface Sampling
Temperature and Humidity uniformity
IQ/OQ/PQ