Within the pharmaceutical industry, strict requirements on air purity levels are necessary because of the direct effect that airborne contamination has on the quality of the pharmaceutical products. Anything that could come into direct contact with a pharmaceutical product is a potential risk toward contamination. Especially for aseptically prepared parenteral medicine (such as injectables and infusions), no contamination can be allowed, otherwise severe harm or life-threatening health risks to the patient can result.
The Air Inside These Facilities Can Contain:
- Molds, spores, pollens
- Carbon monoxide, radon, volatile organic compounds (VOCs)
- Bacteria, viruses, and byproducts
- Vehicle engine exhaust, exhaust from industrial plants
- Asbestos, clays, elemental particles, and man-made fibers
Extensive Studies Show:
- Up to 65% of energy spending at a pharma facility is related to moving air
- 77% of production downtime can be attributed to failures of equipment and environmental problems
The time it takes to address a filter leak:
- Five to ten minutes planned time for an experienced team to scan a filter
- At least two labor hours unplanned downtime to remove, replace, and retest a leaking filter
- Loss from a single microglass filter leak:
- $250,000+/hr (two hours of unplanned downtime)
- $20,000 (documentation and meetings)
- Total Cost: $520,000+
- $3,000 to $20,000 documentation costs associated with a single filter leak
Balancing High Level Protection with Total Cost of Ownership
Clean air is not possible without a carefully selected and reliably functioning air filtration system. The performance of installed air filters, whether terminal filters or prefilters, directly determines how effectively harmful contaminants are prevented from entering the airstream in process environments. However, if the air filter selection process does not also consider the lifetime operating costs of a given product, facilities could be exposed to unnecessary risks and expenses.
Air in critical areas should always be supplied at the terminal stage by HEPA filtered unidirectional airflow, preceded by sequential prefiltration steps. Leak-free and high filtration efficiency performance of the HEPA filter is vital for ensuring that air purity is optimized, the pressure differentials between rooms are met, and healthy working conditions are achieved.
A thorough air filter audit of your HVAC Systems is the first step that AAF takes in order to provide you with professional guidance and analysis for cost savings and risk reduction. By conducting this audit, we will be able to understand your current state and then utilize TCO Diagnostic,® an advanced analytical software tool, to identify how you can improve air quality, energy savings, and operational flexibility while reducing risk and total cost of ownership.