Projects / Pharmaceutical water
USP purified water for drug manufacturing at Betapharma
We designed, supplied, installed and commissioned the system that turns deep well water into purified water in accordance with the United States Pharmacopeia (USP) and Good Manufacturing Practices.
- ClientBetapharma
- Year2018
- SourceDeep well
- ScopeTurnkey project
USP purified waterUltrafiltration, double-pass osmosis and ozone
Well water turned into water for drug manufacturing
Betapharma needed water with very low salts, organic matter and microorganisms, and to be able to prove it at every audit.
- Dissolved saltsConductivity below the USP limit for purified water.
- Microbiological controlNo microbial growth in the treated and stored water.
- TraceabilityContinuous control and recording of critical parameters for Good Manufacturing Practices.
Purified water conductivityµS/cm at 25 °C, lower is purer
USP <645> sets a maximum of 1.3 µS/cm at 25 °C in the first stage of its conductivity test. The system operates with a margin below that limit.
- 110 m³/dayultrafiltration
- 21 m³/daydouble-pass reverse osmosis
- 1,000 Lstainless steel tank
- 1.0 µS/cmpurified water
Treatment train: from the well to purified water
Six stages that remove solids, colloids, salts and microorganisms, one after another.
- IntakeDeep well water stored in a cistern that regulates the feed.Regulating cistern
- Sediment filtrationRetains solids larger than 5 µm with an aluminosilicate filter media.Automatic backwash valve
- UltrafiltrationPhysical barrier against colloids, bacteria and organic matter.2 SPF 2860XP modules, 110 m³/day
- Intermediate storageFeeds the reverse osmosis in a stable, continuous way.1,000 L stainless steel tank
- Double-pass reverse osmosisThe second pass purifies the permeate again and brings salts down to pharmaceutical level.21 m³/day of purified water
- Ozone disinfectionContact tank that eliminates microorganisms and prevents their growth.Microbiological control
Installation, start-up and training
- Assembly of the control panel with PLC and touch screen.
- Testing and commissioning of each stage of the system.
- Training of plant staff in daily operation.
- PLC and touch screen
- Stainless steel panel
- Online conductivity and pH
- Dosing with digital pumps
- Status beacon and emergency stop
- Stainless steel sanitary piping
Turnkey, from design to training
Sanitron handled the entire project and left the plant staff ready to operate the system.
What Sanitron did
- Engineering and designTreatment train tailored to the well water.
- SupplyEquipment, membranes, electrical panel, PLC and touch screen.
- Electromechanical installationStainless steel frame and sanitary piping.
- Start-up and trainingTests, commissioning and plant staff training.
Results
- USP-compliant waterMeets the specifications for purified water for pharmaceutical use.
- Stable performanceEvery stage of the process runs in a stable, continuous way.
- Audit-readyAutomatic parameter logging supports GMP and inspections.
Does your plant need USP-compliant purified water?
We design and install purified water (PW) and water for injection (WFI) systems, with automation and local technical support.
Contact us
Office in EcuadorDe los Eucaliptos E8-70 y calle E9, Quito 170307
Phone+593 99 871 1330
+593 2 280 8126
Emailinfo@sanitronec.com
Office hoursMonday to Friday
9:00 a.m.–12:00 p.m. and 1:00–6:00 p.m.
Office in the United States9995 NW 9th St. Circle, Suite 3, Miami, FL 33172
+1 786 972 2008