Maintaining Buffer Areas In Sterile Facilities

Buffer areas are spaces within the manufacturing facility that are kept sterile at all times. They are known as ISO 7 or class 10,000, and must adhere to set standards of excellent air quality.

To prevent any contamination by microbial life or other unidentified particles, a HVAC system is required to maintain the buffer at a positive air pressure, with a differential air pressure of around 10-20 pascals. Around the buffer area, the surrounding areas must be kept at ISO 7 (10,000) or ISO 8 (class 100,000).

According to the USP Pharmaceutical Compounding, any non-essential equipment or objects must not be placed within the buffer area. Examples include computers and printers, storage cabinets, and any unneeded apparatus. Entrance to the buffer areas should be restricted to only authorized personnel who have received proper training on the use of buffer areas.

Buffer areas should not contain any sources of water such as sinks or drains, however an eye washer is permitted in case of emergencies. The eye washer should be cleaned and disinfected according to the company’s guidelines.

Any objects placed inside the buffer area must be validated by the company to ensure they do not pose a risk of contaminating the sterile area. The quality of the environment should always be monitored within the buffer area. Finally, the area should be inspected at least every six months to ensure that standards are maintained and proper guidelines are followed.