A controlled environment room is a modular environment in which the following environmental factors are kept stable and under control; airborne particulates test, air filter leak test, air changes per hour, microbiology, differential pressure, air flow temperature, relative humidity, light test, noise test, etc.
SmartCal carries out the validation of controlled environment rooms for a variety of reasons most attractive to ensure that the facility, design, equipment, and environment function together as a system to meet defined international / national standards or regulatory requirements such as the USP797, CETA, ISO14644, ASHRAE 170, ISO14698, etc.
SmartCal performs the validation of all the following types of locations and rooms:
- Inpatient Pharmacy Sterile Preparation Center (IV Clean Rooms) Validation:
SmartCal performs an outstanding comprehensive validation of all the zones that are included in the Sterile Preparation Center not limited to the IV preparation zone, buffer zone, ante zone (support zone), air lock zone, gowning zone and hazardous drug zone.
The tests that are performed for this section are according to the international standards USP797, ISO14644, ASHRAE 170, EN12469 and ISO14698.
- Operating Theaters, Central Sterile Services Department Clean Rooms And Clean Rooms Validation:
SmartCal performs a legitimate comprehensive validation for all types of operating theaters along with central sterile services departments packing area, storage area, etc. and any clean room
The tests that are performed for this section are according to the international standards ISO14644, ASHRAE 170, EN12469 and ISO14698.
- Negative Airborne Infection Isolation Rooms Validation:
SmartCal performs an outstanding comprehensive validation of all types of negative airborne infection isolation rooms such as that for patients that suffer from transmittable respiratory diseases like tuberculosis (TB).
The tests that are performed for this section are according to the international standards ASHRAE 170 and EN12469.
- Positive Protective Environment Room Validation:
SmartCal performs a comprehensive validation for all types of positive protective environment rooms. These are hospital rooms designed to protect a high-risk immunocompromised patient from human and environmental airborne pathogens. These are positive pressure rooms intended to keep patients safe during recovery from cancer treatment or stem-cell transplant.
The tests that are performed for this section are according to the international standards ISO14644, ASHRAE 170, EN12469 and ISO14698.
SmartCal has the total capability to perform all the following tests, each with it’s respective international standard:
- Ceiling HEPA/ULPA Filter Leak Test (Integrity Test).
- Airborne Particle Counting.
- Air Change Per Hour (ACPH) Test.
- Differential Pressure Test.
- Airflow Visualization Studies (Smoke Test).
- Light Intensity Test.
- Noise Level Test.
- Temperature Test.
- Humidity Test.
- Volatile Organic Compound (VOC) Test.
- Microbiology Air Sampling Test.
- Fingerprint Hand Sampling Test.
- Media-Fill Test.
- Others....