A member of our GMP for Dietary Supplements group recently inquired about positive air pressure requirements for dietary supplement manufacturing facilities. The short answer is no, there are no specific requirements and there’s no minimum for differentiating pressure (DP) for a supplement manufacturing facility. The only applicable regulation for facilities is Section 111.20 which states that “any physical plant you use in the manufacture, packaging, labeling, or
holding of dietary supplements must: (a) Be suitable in size,
construction, and design to facilitate maintenance, cleaning, and
sanitizing operations”. Basically, as long as the facility is clean and designed to prevent contamination and mix-ups, you should be in compliance.
From a quality standpoint, however, it never hurts go a step further. DP is relative. You may have a more pressing need to control the environment if:
- The facility has low air pressure, but the warehouse doors are often left open causing variation in temperature or air flow.
- The nature of the materials being used have an inherent risk of contamination. Dusts and powders can absorb moisture form the air, join with bacteria and ultimately contaminate a product.
This can be achieved with the use of ventilation systems, dust extraction systems air locks and HEPA HVAC systems. While not formally required, these systems are used by supplement manufacturers using quality has a competitive edge.