Solutions for pharmaceutical companies

Solutions for pharmaceutical companies

Controlled quality water for production, washing, CIP/SIP, and auxiliary media – compliant with pharmacopoeial requirements and GMP principles.

For whom? For drug manufacturers, contract manufacturing organizations (CMO/CDMO), supplement producers, cosmetics manufacturers, and related products.We select the layout after analyzing processes, quality requirements, and documentation.

Schedule a free consultation Call: 883 020 044

Need a quick quote for the PW/WFI system?

Fill out a short form — we will call you back and propose solutions tailored toYour production facility.

Fill out the form Call: 883 020 044

Industry description

In pharmaceutical plants, water is one of the key media: used as an ingredient in products, for cleaning equipment and packaging, in CIP/SIP systems, in the production of pure steam, and asmedium auxiliaries in processes.

Depending on the application, purified water, highly purified water, or water for injection is required, meeting the requirements of the appropriate pharmacopoeia and GMP quality system.

After analyzing the URS, quality specifications, media diagrams, and required water class, we design a system (production + storage + distribution) that can be validated and maintained within specified parameter limits.

Most common water issues in pharmaceutical facilities

  • Unstable microbiological parameters or TOC in PW / WFI circuits
  • Biofilm issues in pipelines and tanks due to improper design or sanitation
  • Conductivity fluctuations exceeding specification limits
  • Too high costsexploitation resulting from mismatched technology or lack of modernization
  • Difficult validation and revalidation of the system due to lack of consistent documentation or monitoring
Rozwiązania uzdatniania wody dla zakładów farmaceutycznych
Infografika — uzdatnianie wody

What we offer

  • Purified water systems (PW) based on RO, exchangeof jonow, filtration, and UV, tailored to pharmaceutical requirements
  • Solutions for higher purity water (water for critical applications – depending on pharmacopoeial requirements and URS)
  • Designing storage and distribution (tanks, loops, circulation, sanitation) with the aim of reducing biofilm
  • Solutions for lower-grade process water (room cleaning, auxiliary media), to not"to burn out" PW/WFI
  • Installation, commissioning, support for qualification (IQ/OQ), and service with monitoring of key parameters

Your benefits

  • Stable water quality compliant with internal and pharmacopoeial requirements
  • Lower risk of quality deviations and production downtime due towater
  • Cost optimization of 1 m³ of purified water vs. off-the-shelf solutions
  • Easier validation, revalidation, and audits thanks to organized system documentation
  • Support for expanding production capacity without losing control over water quality

Micro-scenarios

  • Oral drug manufacturing: central PW system for solution preparation, equipment washing, and CIP, with a distribution loop in several production zones.
  • Contract manufacturing organization (CDMO): modernization of the existing purified water system, inclusion of new receivers, and improvement of parameter monitoring.
  • Supplement and cosmetic manufacturer: transition from technical water and supply of demineralized water in canisters.for your own purified water system, reducing operational costs.
  • Expansion of the plant: adding another loop or increasing the efficiency of the existing system while maintaining continuity of water supply to the ongoing production.

Do you need a stable PW/WFI system for production?

Send URS or mainBased on your assumptions, we will prepare a step-by-step proposal.

Fill out the form Call: 883 020 044

FAQ — frequently asked questions by pharmaceutical companies

Will the water system design comply with GMP requirements?
We design the system so that it can be validated within the quality system of the facility. We take into account the requirements arising from good manufacturing practices, pharmacopoeial guidelines, and internal quality procedures (e.g., URS, qualification IQ/OQ/PQ on the client's side).

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Is it possible to expand the system in the future?
Yes, already at the design stage.we consider the potential increase in production capacity. The system can be scaled (e.g., add loops, increase efficiency, integrate new receivers) while maintaining the continuity of the existing installation and control over water quality.

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What data is needed for the preliminary concept?
The following are useful: required water classes (e.g., for different zones/products), estimated profilesconsumption, media diagram, results of the feed water tests, information about the existing infrastructure (tanks, stations, technical rooms) and the main requirements of the URS or quality specifications for process and auxiliary water.

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Do you assist with system qualification documentation?
We can prepare the technical and operational documentation for the system, which will beformed the basis for the development of IQ/OQ/PQ plans on your side. We support quality teams in gathering data on the operating parameters, maintenance, and monitoring of the purified water system.

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What does the service and monitoring of water parameters look like?
We establish a schedule for inspections, replacement of consumables, and the method of monitoring key parameters (e.g.conductivity, TOC at selected points, microbiological parameters – in accordance with the internal procedures of the plant). We can prepare simple reports for the quality and maintenance departments.

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Can the water system also supply areas with lower requirements?
Yes, we often use a zoning approach: top-quality water for critical stages of the process and watertechnical / lower-class for cleaning rooms, auxiliary installations, or less sensitive applications. This allows for cost optimization while meeting the quality requirements of the main process.

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