WFI and Purified Water System Contractor in South Carolina

Yes, across Greenville, Charleston, Columbia, Spartanburg and statewide: generation by either route, storage and distribution loops, sanitization systems, instrumentation and the full qualification package. We work with sites answering to FDA alone and with sites answering to a European parent as well.

Yes, in both jurisdictions now. USP has long accepted a process equivalent or superior to distillation. The European Pharmacopoeia permitted only distillation until monograph 0169 was revised effective 1 April 2017, which now allows purification equivalent to distillation, most commonly reverse osmosis combined with electrodeionization, ultrafiltration or nanofiltration.

It is far more energy efficient and produces excellent water, but it is not an equivalent system. Distillation is inherently self-sanitizing because nothing microbiological survives it. A membrane train’s microbial control is designed in rather than intrinsic, so the distribution loop, the sanitization regime and the monitoring have to be better.

Continuous circulation at velocity, no dead legs, a defined sanitization regime whether hot water, ozone or steam, and monitoring that would look like belt-and-braces on a distilled system. Where a still forgives a mediocre loop, a membrane train does not, which is the trade being made when the still is removed from the budget.

Hot distribution above 65 degrees Celsius is microbiologically self-protecting and costs energy continuously. Cold or ambient loops save that energy and transfer the risk to sanitization frequency and design quality. Membrane generation makes cold distribution more economically attractive, which is exactly why the loop design then has to be better.

Because so much of the state’s manufacturing base is European-owned. The South Carolina Department of Commerce reports over 160 German companies employing nearly 27,000 people in the state, with more than $4.1 billion of German capital investment since 2011, and France and other European countries add to that. Those sites frequently answer to two regulators.

If there is any prospect of European market access, acquisition by a European parent, or contract manufacturing for one, yes. Retrofitting a water system to satisfy a second regulator is far more expensive than specifying for it at the outset, and the qualification effort largely has to be repeated.

Design qualification against the user requirement specification, installation qualification covering materials, slopes, welds and instrumentation, operational qualification across the performance range, and performance qualification with an extended sampling program establishing control over time. The sampling phase is where schedules slip and is the least compressible part.

ASME BPE for materials and construction, orbital welding to AWS D18.1 with weld documentation retained, passivation to ASTM A967 after cleaning to ASTM A380, and monitoring of conductivity and total organic carbon per USP 643 and USP 645 where applicable. The WFI endotoxin limit is 0.25 EU/mL.

Use the form on this page or call 201-450-8280. Useful inputs are peak and average demand, which pharmacopoeias you must satisfy and whether product reaches Europe, feed water quality, whether the loop will run hot or cold, and what qualification documentation your quality organization expects.

The monograph for Water for Injections was revised to allow production by methods other than distillation, such as reverse osmosis coupled with other techniques, provided the process is validated and monitored. Before that, European WFI had to be distilled, while the USP had allowed membrane methods for longer.

To meet both monographs, which are now largely aligned on limits, and to satisfy both regulators' expectations for validation and monitoring. Where the two differ in detail, the stricter reading is applied.

Continuous monitoring of conductivity and total organic carbon, close attention to microbial control and endotoxin, and validated sanitisation, because a membrane system lacks the thermal barrier a still provides. Regulators expect a stronger control strategy for membrane WFI.

With a hydrophobic vent filter that is heated or integrity-tested, a spray device that keeps the tank's headspace and walls wetted, a rupture disc or relief, sanitary connections and no dead space at the outlet, so that the stored water stays at loop quality. The tank is part of the loop and is designed to the same standard.

Highly Purified Water was a European grade with WFI-like limits made by non-distillation methods; it was withdrawn from the European Pharmacopoeia once membrane WFI was permitted. Sites with older specifications referencing it update them to WFI.

The document stating what the water system has to deliver, in quality, quantity, points of use and regulatory expectation, written by the owner's engineering and quality organisation before design starts, and traced through the qualification afterward. A European parent expects to see it first, and it is the basis for every later acceptance.

Both accept 316L stainless with appropriate finish and passivation, orbital welds with documentation, and slope and drainability. ASME BPE is the usual reference in the US, and European sites accept it with their own additions on documentation.

Ozone dissolved in the storage tank and destroyed by ultraviolet before points of use provides continuous microbial control without heat. It requires ozone-compatible materials and validated destruction, and it is increasingly used where energy cost matters.

Warm feed water in summer raises RO productivity and microbial risk together, and the pretreatment and sanitisation regime are designed for the summer condition. Seasonal variation is covered in the performance qualification.

Industrial deionised water for painting and processing, which is a different specification and does not carry pharmacopoeial requirements. Where a site has both regulated and industrial water, they are separate systems.

By selecting conductivity and total organic carbon instruments that meet both compendia's requirements, calibrating them against traceable standards, and documenting the calibration and the system suitability tests each pharmacopoeia describes. The instruments have to satisfy the stricter of the two, and their records have to show it.

Material certificates, weld documentation, passivation records, calibration certificates, qualification reports and a monitoring plan, organised so that traceability from specification to installed system is complete. The structure is agreed before fabrication.

By ultrafiltration at the end of the generation train, by microbial control throughout, and by monitoring. The absence of a still means endotoxin control depends on the membrane stages and the sanitisation regime.

Sometimes, by adding ultrafiltration and additional membrane stages and by strengthening monitoring and sanitisation, if the existing loop design and materials support WFI. The assessment is done before committing.

Whether membrane WFI is acceptable to them, and what control strategy they expect for it. Settling that early decides the generation train, the loop design and the qualification scope.