The Role of Non-Sterile Liquid Solutions in the Pharmaceutical Industry

October 23, 2025
image of non sterile liquid solutions in adragos leipzig

In the ever-evolving pharmaceutical landscape, non-sterile liquid solutions have emerged as one of the most adaptable and efficient dosage forms available today. Unlike sterile preparations, these formulations do not require aseptic manufacturing conditions, yet they must maintain an exceptionally high level of quality, safety, and stability. For pharmaceutical companies seeking to expand or optimise their portfolios, non-sterile liquid solutions offer a powerful blend of convenience, versatility, and market potential.

At Adragos Leipzig, we specialise in the manufacturing of non-sterile liquid solutions for both human and veterinary use, operating as a trusted global CDMO partner. Our expertise spans from formulation to packaging, supported by a rigorous quality assurance system that meets the highest European and international regulatory standards.

Understanding the Science Behind Pharmaceutical Liquid Solutions

A liquid solution is a homogeneous mixture composed of a solute completely dissolved in a solvent, forming a stable and uniform product. In pharmaceutical applications, water often acts as the solvent, while the solute can be an active pharmaceutical ingredient (API), sugar, salt, or other excipients. These substances interact at a molecular level, forming hydrogen bonds and achieving an equilibrium that defines the physical properties and solubility of the formulation.

The role of water molecules in creating stable liquid solutions cannot be overstated. Through polar interactions, they enable the solute to remain evenly dissolved, ensuring accurate dosing and consistent therapeutic performance. In some cases, co-solvents such as ethanol or acetic acid are introduced to enhance solubility or modify the composition of the formulation.

When two substances are combined, for example a solute and solvent, their compatibility, temperature, and concentration determine whether the resulting mixture remains stable over time. For instance, a dilute solution containing sugar or salt in water exhibits predictable properties and minimal risk of crystallisation. Meanwhile, interactions with oxygen, nitrogen, or other gases can influence evaporation, oxidation, and shelf life, all of which must be tightly controlled during manufacturing.

The importance of understanding these forces and molecules lies at the heart of developing safe, high-quality liquid solutions. At Adragos Pharma, we apply our scientific expertise to ensure every solution we produce performs reliably from laboratory scale to commercial batch.

Advanced Manufacturing for Non-Sterile Liquid Solutions

Producing high-quality liquid solutions demands not only precise formulation but also sophisticated manufacturing technologies capable of maintaining batch consistency and preventing cross-contamination.

At our Leipzig site, Adragos Pharma runs three production lines, Dovema, Groninger, and Würschum, exclusively dedicated to non-sterile liquid solutions. Our equipment portfolio includes Becomix 15L, 250L, and 1200L mixers, as well as the EKATO-Mixer 4000L and Multi-Homo 500L systems, enabling batch sizes of up to 4,000 litres. This scalability allows us to support everything from early-phase clinical development to full commercial production.

Each process step is optimised for precision. APIs and excipients are dissolved under controlled temperature and agitation to achieve the desired concentration and volume. Our teams measure parameters such as pH, viscosity, and solubility to confirm that every batch exhibits the correct properties before packaging.

We handle a broad range of dosage forms, from solutions and drops to emulsions and suspensions, always ensuring that the liquid phase remains stable and miscible. Where immiscible components, such as oil and water, must coexist, our homogenisation systems create fine dispersions that remain stable across the product’s shelf life.

Quality Control and Stability Testing: Safeguarding the Integrity of Every Solution

Maintaining the stability of liquid solutions is a critical requirement for any pharmaceutical company. To ensure consistency, our Leipzig facility conducts comprehensive stability testing for climate zones II, IVa, and IVb, using alarm-controlled monitoring systems for temperature and humidity. These studies allow us to evaluate the influence of oxygen, nitrogen, and other gases on the dissolved state of the solute and on potential evaporation or degradation processes.

Our quality control laboratories perform routine analytics on raw materials, intermediates, and finished goods. We analyse solid and liquid substances for purity, ions, and residual solvents, and we develop and validate analytical methods using HPLC, GC, UV-VIS, and titration. Microbiological testing of non-sterile liquid solutions ensures compliance with pharmacopoeial limits for TAMC and TYMC, maintaining patient safety and product quality.

Every solution produced is subject to strict quality assurance governed by EU-GMP, AMG, and our internal QA Committee. Activities such as risk-based qualification, supplier evaluation, PQRs, and annual Quality Management Reviews (QMR) demonstrate our commitment to operational excellence. Our validated digital systems, ERP-GUS, Perfact, and Seritrack, ensure full traceability throughout the manufacturing lifecycle.

Regulatory Compliance and Risk Management

The pharmaceutical industry demands robust systems to manage risk, traceability, and data integrity, especially in non-sterile liquid solutions manufacturing. At Adragos Leipzig, our operations are fully compliant with both National/EU regulatory standards and GMP certifications for human and veterinary products.

We apply risk-based cross-contamination management and regular self-inspections to maintain the highest safety standards. Through paper-based documentation supported by validated electronic tools, every solution is produced, reviewed, and released under a transparent and auditable framework.

By combining technological precision with scientific insight, we ensure that our liquid solutions processes are not only compliant but also continuously improving to meet evolving client expectations.

Why Adragos Leipzig Is the Partner of Choice for Non-Sterile Liquid Solutions

Selecting the right CDMO partner for non-sterile liquid solutions is a strategic decision that can directly influence product success. Pharmaceutical clients must determine whether their manufacturing partner can offer scalability, regulatory expertise, and scientific innovation, all under one roof.

Adragos Pharma’s services are designed to meet those exact needs. We are capable of managing complex formulations, including polar and hydrocarbon-based solvents, and can adapt form and composition according to market or therapeutic requirements. Our facilities operate under the highest European standards, providing our clients with peace of mind, regulatory compliance, and reliable timelines.

We understand that every project is unique. Whether developing a sugar-free oral solution, an oil-based emulsion, or a dilute solution requiring sensitive pH control, our teams bring the ability and flexibility to deliver outstanding results. The positive outcomes we have achieved for numerous clients demonstrate why Adragos Pharma continues to be the preferred partner for high-quality liquid solutions manufacturing.

The pharmaceutical industry’s focus on patient-centric design and flexible dosing options continues to fuel the growth of non-sterile liquid solutions. Their adaptability, stability, and dosing accuracy make them an indispensable dosage form for the future.

At Adragos Leipzig, we recognise the importance of each component, from water quality to solvent selection, in achieving the desired therapeutic effect. Our integrated service model, advanced equipment, and commitment to regulatory excellence make us the ideal partner for companies submitting new products or optimising existing formulations.

If your organisation is exploring new opportunities in non-sterile liquid solutions, we invite you to contact Adragos Pharma today and learn how our expertise can elevate your next pharmaceutical project.

FAQs About Liquid Solutions

1. Which are examples of liquid solutions?

Common examples include oral syrups, saline solutions, ethanol-water mixtures, sugar syrups, and oil-in-water emulsions, each a homogeneous mixture of solute and solvent designed for specific therapeutic applications.

2. What is the liquid solution?

A liquid solution is a uniform mixture where a solute (such as a drug or salt) is completely dissolved in a solvent (often water), forming one continuous phase with consistent properties throughout.

3. What are 10 examples of a solution?

Ten examples include saline solution, glucose solution, ethanol-water blend, acetic acid in water, sugar syrup, oil-in-water emulsion, iodine tincture, oxygen in water, nitrogen in air, and carbon dioxide in beverages.

4. What are 10 examples of liquids?

Water, ethanol, oil, acetic acid, mercury, petroleum, glycerol, ice (when melted), air-saturated water, and other liquids used in pharmaceutical formulation all serve as examples of liquids used across industries.

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