SAFEGUARDING CRITICAL OPERATIONS AT THIS PHARMACEUTICAL COMPANY

THE SITUATION

In addition to production areas, the company's research and product development lab air supply was filtered through ceiling-mounted HEPA filters constructed with industry standard glass fiber filter media. Each HEPA filter space in the facility had strict controls and procedures in place to limit damage to the sensitive room environment, equipment and products. However, the company experienced random filter failures due to leaks in the glass fiber filter media. Filter damage caused leaks which allowed unfiltered air into the critical space. Once detected, in addition to the filter replacement expense, leaks triggered time consuming and very expensive series of protocols, mostly documentation- and certification-oriented. Knowing that discovering damaged HEPA filters after installation was costly, the manufacturer was forced to closely inspect all new filters upon receipt and reject any that appeared damaged in shipping. Installation procedures were closely scrutinized and filters discarded if any possible harm was observed. If an installer’s hand was observed even touching the media, the filter was disposed. With these procedures, initial filter loss typically ranged between 5-10% – significantly less costly than replacement after installation. Despite the procedures, random filter failures still appeared after installation. While the causes were not always discernible, some damage to the filter’s glass fiber media likely occurred from inadvertent contact during regular room and equipment cleaning. Measures needed to be taken to maintain the integrity of the company's research projects and ad-dress the substantial time and money wasted with each damaged filter. 

THE ACTION

The company discussed the situation with Camfil and inquired about traditional glass fiber filter media. Camfil proposed the Megalam EnerGuard HEPA panel air filter with newly-developed polymer fiber media technology and particulate depth-loading capability for long product service life. Each individual filter was tested and certified to a minimum efficiency of 99.995% and specifically designed to be oil aerosol tolerant for life sciences applications.