Production of ultrapure water for the pharmaceutical industry

Ultrapure water for an international pharmaceutical company

MEGA company is a leading supplier of advanced environmentally friendly solutions for the sustainable use of water resources. We design complex turnkey solutions according to customer needs.

Our customers include a major international pharmaceutical company for which MEGA has built a new ultrapure water treatment plant. The entire project was delivered to Pharma standard quality. The basic functional elements of the technology were 2 units of three-stage reverse osmosis (RO) and 2 units of MPure™ 36 electrodeionization (EDI) modules to produce ultrapure water. The output is water with a quality of max. 1 µS/cm.

Customer needs

With the planned growth in pharmaceutical production volumes, the customer was faced with the challenge of increasing the supply of ultrapure water for his production.

The water source used comes from an underground borehole that has a limited capacity. The existing water treatment technology based on a combination of nanofiltration (NF), and two-stage RO provided a system yield of 50% and was no longer capable of producing the required amount of water.

Challenge

The MEGA technologists were faced with the following challenge:

• Limited water resource capacity.
• Increasing of ultrapure water production by 40%.
• Pre-treatment of groundwater with pre-filtration (20 µm) and UV disinfection.
• Yield value (savings) of at least 70%.
• 24/7 continuous operation mode.
• Complication to deal with the small space of 7×6×3 m, (L×W×H), as the customer required to place the complete technology in the existing, very limited, space.

The increase in the capacity of pharmaceutical production required an increase in the nominal production of ultrapure water to 14 m³/h, while it was necessary to devise a regulation of the production of this water, in the range from 50 to 100%, as the customer has a smaller volume of storage tanks but needs water for production all the time. All this must be backed up, i.e., in a two-line arrangement. Fully automated operation is a requirement.

Our solution

The technology supplied by MEGA was designed to combine a three-stage RO with membranes that have the highest solute retention and 2 EDI MPure™ 36 modules, which in this combination provide a system-wide recovery of 77%.

As this is a water treatment plant for the pharmaceutical industry, it is essential to comply with the Pharma standard for the production and distribution of ultrapure water. For this reason, AISI 316 L stainless steel is used for the entire process line, for the pure side of the technology in the Ra 0.5 electropolishing treatment (technology from the permeate side RO onwards).

The entire production is automated, and the design is built in a 1+1 arrangement to ensure continuous operation in 24/7 mode.

How to achieve flow regulation?

The proposed RO + EDI system for demineralised water production currently produces between 7-14 m³/hr at the required capacity to meet the customer's requirement for production regulation between 50-100%.

As the RO technology is not very controllable, the MEGA technologists came up with a simple yet ingenious idea. Excess-produced water will be mixed back at the input. This solution fulfils the needs of the customer, who accepted even a slight increase in energy consumption associated with it.

Results

The ultrapure water production system supplied by MEGA operates 24 hours a day, 7 days a week and is fully automatic.

RO Outputs:

• Minimum guaranteed RO yield 80% (82-83).
• Permeate max. 10 µS/cm (4-4.5).
• Flexible permeate flow control system from 50 to 100%.
• Dosing of (antiscalant) NaOH to remove carbon dioxide is prior to RO.
• Waste stream = concentrate of 20 % RO inlet volume.
• RO input is groundwater 590 µS/cm.

• Minimum guaranteed EDI yield 97%.
• Output is a diluate of max. 1 µS/cm.
• Zero chemical consumption.
• Waste streams = concentrate + electrode solution (together both streams are 3% of input volume).
• EDI input is permeate from RO max. 10 µS/cm.

Customer service

We initially assembled the unit at MEGA's production facilities, where we verified its functionality under customer supervision using drinking water. Subsequently, we installed the technological unit on site and put it into operation, first in a test mode for drinking water and then in a test mode with connection to groundwater from a borehole. After verifying the functionality of the technology and debugging the communication of all control elements with the client's control system, the entire technology was decontaminated according to Pharma standards with subsequent complete CIP cleaning before being put into the standard production process. MEGA provides long-term contract service for the installed technology.

Benefits for the client

The installation of MEGA's reverse osmosis and electrodeionisation technology has had a significant positive impact on the existing production process. By streamlining and upgrading the process of producing ultrapure water, the customer can essentially double the amount of water for his needs without having to find a water source. This also has a positive impact on the environment.