Ampac Fine Chemicals (AFC) is a leading U.S. contract manufacturer of active pharmaceutical ingredients and registered intermediates, and is a wholly-owned subsidiary of American Pacific Corporatio. AFC’s technology includes the development of energetic chemicals, cytotoxic chemicals and pharmaceutical fine chemicals. Its products are used in the development of pharmaceutical formulations for the treatment of diseases in cancer, antiviral and central nervous system therapeutic areas, among others. Because of the highly specialized nature of these products, they can be costly.
The use of pumps in AFC’s manufacturing processes is very important, and the precision of this equipment is critical to ensuring the consistent quality and integrity of the finished product. There are more than 80 air-operated diaphragm (AOD) pumps on site, pumping a variety of organic chemicals such as methylene chloride and ethyl acetates with abrasives. The operating environment and typical characteristics include:
During a plant visit conducted by W. L. Gore’s West Coast field sales manager and Gore’s authorized distributor Valley Rubber & Gasket Co. (Sacramento, CA), it was noticed that several AOD pumps were in the process of being rebuilt. For AFC, it is critically important that the AOD pumps be in perfect operating condition, since the intermediate batches being manufactured have such high market values. Any premature diaphragm failure – or worse, foreign particles generated by a faulty diaphragm – would be serious cause for concern for the plant’s O&M staff.
Naturally, equipment rebuilding was something maintenance personnel would prefer not to be doing, but it was a necessity. One AFC product utilizes methylene chloride and/or toluene at -10°F and has a coarse, gritty consistency. It turned out that the elastomers on the two-piece PTFE diaphragms that were previously used could not handle the cold temperatures and the abrasives – thus causing the diaphragms to fail within the first one or two manufacturing batches.
This problem had been persistent and serious enough that the Engineering and O&M teams were actually considering shifting to a completely different fluid transfer technology.
Changing to GORE™ ONE-UP® pump diaphragms was proposed as a solution that would allow AFC to continue to use the same Wilden® and Versamatic® brand pumps currently on line in the plant. ONE-UP® diaphragms have been engineered to provide long-life service in high-pressure pumping applications (head pressures of 250 psig [17 bars] or greater) involving corrosive or caustic media.
As it turned out, the recommended ONE-UP® diaphragms made with EPDM backings were perfectly suited to handle the media at the required low temperatures. Made from a proprietary design that is a considerable advancement over conventional PTFE materials, ONE-UP™ pump diaphragms are strong, deliver significantly longer service life, as well as provide greater flex life.
Moreover, the unique two-in-one construction of ONE-UP® pump diaphragms meant that installation was easier and faster – with the AFC maintenance crew no longer having to apply joint sealant on two diaphragms.
Before deciding to install GORE™ ONE-UP® pump diaphragms throughout the facility, tests were conducted on one pump. According to Dan Fischer, Site Maintenance Leader, the subsequent testing (and failure) of alternative diaphragm products resulted in the ONE-UP® diaphragms eventually being designated as the ones to be used on all AOD pumps handling all process fluids – not just the most difficult, coarse ones.
For AFC, the switch to GORE™ ONE-UP® pump diaphragms has resulted in several important improvements in plant efficiency, processing effectiveness and risk avoidance, including:
Moreover, quality control is a critical factor at pharmaceutical contract manufacturing plants such as Ampac Fine Chemicals. AFC must interface with FDA audit teams inspecting both procedures and paperwork. The fact that GORE™ ONE-UP® pump diaphragms are coded by lot number makes traceability much easier if this information is ever needed.