Products > Biopharmaceutical Equipment: Safety/Lab

Isolators

Pharmaceutical Isolators. Isolators are cabinets or workstations that environmentally separate the user or technician from the product being handled. With minor differences in design, some isolators protect the user from the product and others protect the product form the user or the external environment. Those protecting the user may have controlled negative pressure, filters on all gas exhaust, integrated hepa filters, and closed cleaning systems. Those protecting the product may have controlled positive pressure, multiple inlet filters, inert gas systems, humidity and temperature control,and closed cleaning systems. Interaction between user and product is usually through robotic devices or impermeable gloves that are attached to and protrude through the isolator bulkhead.

Things to Consider When Purchasing This Product:

GMP grade A as defined in GMP reference PICS GMP Guide 2002, Agency approvals, Exterior dimensions, Capacity, Internal dimensions, Tough hygienic construction, Surfaces resistant to corrosion and cleaning agents, Quick change glove system, Transfer devices, Electrical sockets for use inside workzone, Work surface dished to contain spills, Work surface free from crevices and with radiused corners, Lockable casters on frame, Fan variable speed, Sound power from sound sources < 65dB(A) at one meter, Filtration double in line safe change HEPA filters on both inlet and outlet, Filter size, Airflow unidirectional Grade A downflow at 0.3 to 0.6 meters per second, Air change rate 1800 per hour in the workzone, Airflow must sweep entire controlled workspace with no standing vortices or stagnant areas, Preferable to exhaust air from isolator to outdoors, Recirculation option needs to consider impact on sited room air quality, Negative air pressure with gradient -70 to -100 pascals, Air leak rate < 0.5% volume/hour as ISO 14655-7 for the isolator, Vibration < 0.005mm RMS amplitude in center of work surface between 20 to 20000Hz when isolator is operational, Control panel alarms audible and visual for low air flow/high or low internal pressure/filter blocked or damaged, Visual displays for air flow and internal pressure and HEPA filter pressure drop for each filter, Enclosed lighting units for 750 to 1000 lux at work level, DOP test port on eacdh HEPA filter, Heat gain < 4 to 6C above ambient, Glove leak tester built-in, Control unit failsafe, Maintenance service, Spare parts availability, Instrumentation with calibration certificates traceable to standards, Re-calibration schedule, Validation procedure, Training for users