UHS has its team of contamination engineering and hygiene specialists to provide design planning for clean rooms and contaminant-controlled rooms as per GMP, FDA, and ISO 14644-1 standards. Clean rooms are basically those areas which are under positive differential pressure as per USP 797 for IV compounding in a hospital’s internal pharmacy. Others can include cleanrooms for surgical areas with essential hygiene requirements, and cleanrooms for bone marrow transplants, stem cell banks, and cell therapy. They include generally all hospital clean rooms with high patient care, such as isolation rooms, ICUs and NICU rooms, as well as sterile storage rooms and vaccine storage (cold and cool) rooms. Contaminant controlled rooms have the same design as cleanrooms but with a negative differential pressure, as per USP 800 for hazardous rooms, chemotherapy preparation rooms, biosafety levels III and IV, laboratories, isolation rooms for Infectious diseases, and waste holding rooms. Our services include design and planning, validation of rooms, auditing, quality assurance, and developing SOPs for all work inside these specially classified areas. Our designs are based on the GMP/FDA classification A, B, C & D, or the European standards ISO8, ISO7, ISO 6, and ISO 5.
