The reasons to spend lavishly on a high-end pharmaceutical water system are plentiful, with the most important being risk mitigation.  Upscale systems generally provide more features and benefits, a higher-degree of automation and on-line monitoring, more hygienic materials of construction, and state-of-the-art technologies.  These critical utility systems are often a vital component of a larger pharmaceutical or biotechnology development or manufacturing process, and system downtime can be very costly.

However, CAPEX budgets are finite and there may be instances where the price is just too high.  Let’s consider some options to reduce the upfront investment required for these systems.

1. Re-evaluate User Requirements: The design basis for system capacity involves evaluating all water users. This assessment helps determine whether the current capacities are precise or merely estimates, whether certain users might need a different or lower quality of water that could be provided more cost-effectively, and if usage patterns can be adjusted to reduce peak instantaneous demand on the system. To achieve this, consider staggering water-intensive tasks or rescheduling cleaning and sanitization activities to off-peak times.

2. Purchase Packaged or Bulk Waters: For smaller usage applications, pharmaceutical waters, including USP Purified Water and WFI, may be purchased.  These can be delivered in small volume packages (containers or bags), drums, or even larger totes.  

3. Explore Novel Technologies: Explore newer or lesser-known technologies that could provide comparable performance at a reduced cost. Since there are no specific manufacturing methods mandated for USP Purified Water or WFI, using alternative or unconventional technologies for producing pharmaceutical water is entirely acceptable, as long as they can consistently perform reliably and be validated.

4. Explore Standard Equipment:  Customization of any process equipment involves additional design and engineering work, increasing the price to the end-user.  Purchasing OEM standard products or systems is an option to provide a high quality system at the lowest price.  This option generally decreases equipment lead time, allowing for faster deliveries.  

5. Value Engineering and Design Optimization: Utilize risk assessment tools to pinpoint features that might not be critical for quality or compliance. While reducing CAPEX can generally lead to increased OPEX, this trade-off might be acceptable depending on budget constraints and cash flow considerations.   A few options to consider include:
   1. The use of grab sampling in lieu of online or in-line analytical monitoring
   2. Chemical (manual) sanitization as an option to heat or ozone (automated) sanitization
   3. Single use technology such as dead end filtration in place of backwashable or cross-flow filtration
   4. Portable exchange deionization rather than continuous electrodeionization
   5. The use of chemical injection as a replacement for other treatment processes or to increase the performance system components

6. Pre-Owned Equipment: Consider exploring used or refurbished equipment that has been tested and certified to meet industry standards. In a rapidly evolving industry, you may find high-quality pre-owned equipment available on the secondary market. Items made from stainless steel, like holding tanks, are often excellent candidates for reuse. Additionally, if you already have an existing system, investing in upgrades or enhancements could boost efficiency and performance without the need for a completely new purchase.

7. Explore Financing Options: There are numerous ways to finance capital purchases, including options directly from the OEM or through third-party leasing companies. You can explore various creative financing solutions such as build-own-operate, lease-to-own, pay-per-gallon, and other flexible arrangements available in the market.

8. Consult an Industry Expert: Reach out to an industry consultant that can help identify cost-saving opportunities or alternative solutions you might not have considered.

There are several areas where we advise against compromising on quality or the design, and attempting to reduce costs.These include:

• Process Configuration – A pharmaceutical water treatment system typically includes several different unit operations.  Eliminating certain processes can be detrimental to the performance of others and dramatically increase maintenance.  A common example is the elimination of pretreatment components which protect expensive downstream operations such as reverse osmosis or distillation units.  A sound, holistic strategy to contaminant removal is critical to long term successful operation.

• Undersizing Components – The capital costs savings for smaller or undersized equipment is generally not worth the savings.  Running equipment at the high-end of or outside of the design range will result in more cleanings, sanitizations, and consumable replacement.  

• cGMP Design – To ensure compliance with applicable cGMPs, there are specific requirements for design, maintenance, and monitoring. Adhering to these standards is mandatory for compendial water systems.

• Documentation and Validation – A sound, justifiable level of documentation, testing and verification required by regulatory agencies.  Retrospective efforts to generate or gather documentation and qualify equipment are difficult and expensive.

There are multiple strategies to lower the CapEx for a new pharmaceutical water system. While adhering to industry-specific design standards and GMP requirements is essential, there are still viable alternatives that can achieve the desired outcomes without compromising on quality. We recommend partnering with a design team, consultant, and/or OEM with industry experience to help assess and manage potential risks effectively.