Understand the Equipment Implications of Biotechnology

Bioprocessing places different demands on pumps, valves and seals.

By Bill Newton, Flowserve Corporation

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Most pumps can be steamed-in-place if they are designed in accordance with appropriate standards (e.g., ASME BPE Design and Manufacturing standards, 3A sanitary standards, DIN EN 12462 Biotechnology, GMP regulations and FDA regulations). These guidelines cover areas such as appropriate surface finish, materials of construction and fabrication, not only for pumps but also for valves and for seals. Adequate steam flow is required to maintain saturated steam within the pump being sterilized — so to enhance steam flow, pumps should provide a means for removal of the condensate formed as the steam cools. For proper sterilization to occur, this condensate must be removed from the pump quickly, to prevent formation of cold spots that may encourage bacterial growth. Therefore, when the pump must be self-draining, a tangential bottom drain is provided.

Surface finish in wetted areas of pumps intended for biotechnology applications is critical because of the requirement to preserve hygienic or sanitary conditions. Thus, all product contact surfaces must be free of cracks, crevices and occlusions that could harbor and promote bacterial growth. In addition, the surfaces should not have abrupt changes in morphology, which can entrap particles by molecular adhesion. For homogeneous pore-free surfaces, forged or cold-rolled stainless steel is preferred. By contrast, sand casting and even investment casting can't provide the quality of surface finish required. Where cast pumps are used in biotechnology applications (e.g., because of flow/head constraints of the forged/cold-rolled equivalents), the wetted surfaces usually are electropolished. This is an additional process that adds to the cost; because of the variability of quality and surface finish of sand castings, only the highest quality sand-cast volutes should have further treatment. Low ferrite content (less than 5%) also is important because an iron film (so-called "rouging") can develop over stainless steel when steam is used as the sterilizing agent.

Diaphragm valves by the nature of their design don't trap media — an advantage for biotechnology applications because it minimizes contamination or cross-contamination and facilitates system cleanup. Moreover, by using compliant materials such as polytetrafluoroethylene with an ethylene propylene rubber backing for the diaphragm, this type of valve can withstand sanitizing and sterilizing procedures. However, for operations such as fermentation, full-bore ball or butterfly valves are favored because they eliminate the risk of catastrophic seat failure and have superior flow characteristics. As with pumps, the preferred option is forged (rather than cast) material with tightly controlled chemistry and electropolishing where appropriate (e.g., in fine chemicals manufacture) to minimize contaminant buildup. Passivation (i.e., formation of iron and chromium oxides on metal surfaces) can further improve chemical resistance to biofilm buildup in vulnerable areas.

Joints between valve bodies and the connecting pipework are a potential "dead zone" where stagnant water can pool and provide a breeding ground for microorganisms. Therefore, it's important that the inside diameter of the valve exactly matches that of the pipework. Valve seats should be made from fluoropolymer derivatives to allow bubble-tight shutoff, even under high cycle conditions.

Agitation ensures the adequate mixing of nutrient and inoculum. The agitator usually consists of paddles mounted on a shaft that passes through the wall of the fermentation vessel and is attached to an electric motor. Choosing the correct seal for the mixer shaft is crucial because it must provide a barrier to ensure sterility is maintained following steam cleaning. Biofuels producers and other bioprocessors increasingly are specifying pharmaceutical-grade seals. These typically are dual cartridge seals that don't require threading or porting; this configuration minimizes opportunities for bacteria to settle out and multiply. As with pumps and valves, electropolishing and passivation of the wetted surfaces of the seal can reduce bacterial growth and potential carryover of contaminants.

Fine chemicals derived by biotechnology often have high purity requirements. In such cases, it's important to avoid any seal-wear residue (arising from a soft carbon face running against a harder face) that may contaminate the fermentation process. Specifying sanitary seals or using non-contacting full-fluid film, gas or liquid seals can prevent such contamination. With this type of arrangement, to ensure compatibility with the product, special consideration must be given to the type of barrier gas or liquid used.

The increasing use of biotechnology by chemical companies poses equipment challenges that will require concerted development effort, particularly by pump manufacturers.

Current sanitary/hygienic designs must be scaled up to meet the higher flow rates demanded of commercial-scale operations. On the other hand, pump and valve producers that use traditional casting methods must address problems of how to maintain sterility while keeping prices competitive or perhaps must perfect alternative methods of manufacture. The stakes are high, and failure to tackle these issues could result in lost opportunity and significant reduction in market share. The challenge is to be able to adapt the solutions developed for low-quantity batch-type operations, as in the pharmaceutical sector, to the high-volume continuous-operation requirements of the bulk chemical industry.

BILL NEWTON is Newark, U.K.-based strategic marketing manager (chemical industry) for Flowserve, a global manufacturer of pumps, valves and seals. E-mail him at bnewton@flowserve.com.

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