- Leading global pharmaceutical company
- Pharmaceutical product plant in Texas
- Operations in approximately 100 countries
The Filtration Situation
This 400,000 square foot facility, which produces pharmaceutical products for the eyes and skin, runs 24/7 in order to serve patients in 110 countries. Within this facility’s various types of cleanrooms there are necessarily strict air purity requirements, because of the direct effect that airborne contamination has on the quality of the products produced. Anything that could come into direct contact with these products creates the potential risk for contamination and costly unscheduled downtime.
The facility also had to deal with the changeout cost of the HEPA microglass filters they were using, if the filters became damaged in any way. Production had to be halted whenever a filter was damaged in order to ensure a sterile processing environment.
The costs of these changeouts added up significantly. For each filter changeout, costs included two labor hours of unplanned downtime, which could run into $250,000 an hour, as well as an average cost of $20,000 for documentation and meetings.
The AAF Flanders Solution
In 2014, AAF Flanders suggested that this facility test filter modules with ePTFE (expanded polytetrafluoroethylene) Filtration Technology in their cleanrooms. ePTFE is the first media of its type to be PAO compatible, with a higher PAO holding capacity than microglass. The strength of this media, 84 times the tensile strength of microglass, made it a very attractive option.
The TM-2TM filter module itself, which is entirely factory-sealed, has a lightweight aluminum body and is therefore easy to install. This module also comes in a variety of sizes and can simply be discarded when maximum design resistance has been reached.
After considering the flexibility and ease of installation with the TM-2 module, as well as the compelling features of the ePTFE media, the pharmaceutical facility decided to place an initial order of 25 TM-2 modules.
The MEGAcel II filter, which is composed of ePTFE media, is PAO compatible, has extremely low off-gassing of chemical components, and is the lowest pressure drop mini-pleat HEPA filter available. The resulting reduction in energy consumption adds up to significant savings.
Recognizing this, the facility has also placed an order for MEGAcel II filters to replace all of their microglass media throughout the plant. Elimination of detected leaks is expected to greatly reduce required documentation, increase cleanroom uptime, and optimize this facility’s clean air-related spending.