In today’s pharmaceutical landscape, non-sterile liquids are more than just simple formulations. They are precision-crafted medical products with demanding regulatory, therapeutic, and commercial requirements. Whether you are launching an oral solution, expanding into disinfection products, or adapting a formulation for pediatric or geriatric use, the manufacturer you choose can either fast-track your success or become a bottleneck. Selecting the right CDMO is crucial for ensuring product quality, safety, and compliance.
So, what exactly are your options when it comes to non-sterile liquids? And how do you decide which CDMO is best equipped to handle the complexity of your project?
Let’s break down the major categories, challenges, and decision points and why more healthcare companies are trusting Adragos Pharma to bring their pharmaceutical products to life and serve their customers with high-quality non-sterile liquids.
The Role of Non-Sterile Liquids in Drug Development
Non-sterile liquids are used across a wide range of medical procedures, especially where full sterilization is not required but microbial safety still matters. Controlling bacteria is essential to prevent contamination in non-sterile liquids. Unlike sterile manufacturing, these formats are typically used for oral or topical drug administration, and must still meet stringent quality controls to prevent contamination and cross contamination.
They are also a core part of healthcare professionals’ everyday toolkit, from pediatric antibiotics and dermatology emulsions to antiseptic sprays and wound treatments.
How Non-Sterile Liquids Compare to Sterile Products
Non-sterile liquids and sterile products serve distinct roles in healthcare, each designed for specific applications and risk profiles. While sterile products are manufactured to be completely free of microorganisms, making them essential for clinical settings where the risk of infection is critical, such as injections, infusions, or direct contact with the bloodstream, non-sterile liquids are intended for situations where this same level of sterility is not required.
Non-sterile liquids, such as oral drops, nasal sprays, and certain wound care solutions, are formulated for use on the skin, in the mouth, or in other areas where the body’s natural barriers help prevent infection. These products are not manufactured to the same level of sterility as injectables or ophthalmic solutions, but they are still carefully controlled to minimize the presence of harmful microorganisms and avoid contamination. For example, oral drops and nasal sprays are effective for treating common conditions like coughs, colds, or minor wounds, where the risk of infection is lower and the product’s intended use does not demand absolute sterility.
In contrast, sterile products are designed for high-risk environments and applications, such as surgical procedures or direct administration into the bloodstream, where even minimal contamination could lead to serious infection. The manufacturing process for sterile products is far more stringent, involving aseptic technique and specialized facilities to ensure complete sterility.
Ultimately, non-sterile liquids are a practical and effective choice for many medical and consumer health applications. They provide reliable treatment options for skin care, wound management, and oral administration, without the added complexity and cost of sterile manufacturing, making them ideal for a wide range of products and situations.
The Main Types of Non-Sterile Liquid Formulations
Choosing the right format for your product is essential not just for therapeutic efficacy, but for market success. Here is a breakdown of the main types:
1. Oral Solutions: Clean, Clear, and Patient-Friendly
Oral solutions are liquid medications with dissolved APIs, favored for their ease of swallowing and quick absorption. They are common in pediatrics, geriatrics, and chronic care.
✅ Best for: Taste-masked formulations, precise dosing
✅ Challenges: Flavor integration, long-term stability, microbial control
✅ Packaging: Plastic or glass bottles, often with measuring caps or spoons. The choice of material for bottles and closures is crucial, as it affects product stability, compatibility, and safety.
This is where manufacturing precision matters. Consistency, homogeneity, and filtration systems must work flawlessly.
2. Oral Drops: Micro-Dosing with Maximum Control
Oral drops require low-volume, high-precision dosing, typically for infants or niche therapeutic areas. Because they are so concentrated, there is a fine line between efficacy and risk, making microbial integrity and dosing accuracy critical.
✅ Best for: Sensitive APIs, infant formulations, niche indications
✅ Packaging: Dropper bottles with calibrated closures
✅ Considerations: Avoiding leaks, ensuring stability, and selecting the right method to ensure both dosing accuracy and effective microbial control
For healthcare professionals, oral drops are essential tools but for manufacturers, they’re one of the most technically challenging formats in the production process.
3. Suspensions: When Solubility Is a Challenge
Sometimes, a drug doesn’t dissolve, so you suspend it. Suspensions are heterogeneous formulations where particles float in a liquid base. They are commonly used in wound care products or pediatric antibiotics. In many cases, suspensions require wetting agents to ensure that the particles are properly dispersed and do not clump together, highlighting the importance of the wet nature of these formulations.
✅ Best for: Poorly soluble drugs, taste-masked applications
✅ Risks: Sedimentation, inconsistent dosing
✅ Solution: Controlled particle sizing, homogenization, “shake-before-use” labeling
This is where compounding expertise shines: the margin for error is slim, and poorly handled suspensions can lead to dosing inaccuracies or microbial growth. Different methods for controlling particle size and preventing microbial contamination are essential to ensure the safety and effectiveness of suspensions.
4. Emulsions: Blending Oil and Water, the Right Way
Emulsions combine oil and water with stabilizers, but keeping the mix stable over months (or years) is no small feat. If an emulsion loses its stability, it becomes compromised, which can affect safety and efficacy. Therefore, it is essential to formulate durable emulsions that can withstand storage and handling. Used in topical or oral formats, emulsions are ideal for delivering lipophilic or hydrophilic APIs in a smooth, patient-friendly product.
✅ Use cases: Dermatology, oral lipophilic drugs, medical device adjuncts
✅ Formats: O/W and W/O emulsions, glass or plastic bottles
✅ Key concerns: Droplet size, phase separation, preservative compatibility
Perfecting emulsions involves real science, from emulsifier selection to sterile compounding techniques (where applicable) and understanding how they behave under stress.
5. Disinfectants: Safety, Compliance, and Scale
Disinfection products are a world of their own. Often alcohol-based and flammable, they require special facilities, ATEX-compliant processes, and packaging expertise to ensure both efficacy and safety.
✅ Formats: Liquids or sprays in 25 ml to 1,000 ml bottles
✅ Considerations: Volatility, regulatory classification (drug or biocide)
✅ Applications: Surface sterilization, wound cleaning, healthcare use
Used by healthcare workers, patients, and even institutions aligned with World Health Organization protocols, these products need high throughput without sacrificing GMP compliance. Maintaining a reliable supply of disinfectants is essential for healthcare and institutional needs to ensure safety and operational continuity.
The Manufacturing Process for Non-Sterile Liquids
The production process of non-sterile liquids is a carefully controlled procedure designed to ensure product safety, stability, and quality without the need for full sterility. It begins with precise compounding, where active ingredients are blended to achieve the desired consistency, therapeutic effect, and shelf-life. This step is critical for ensuring that oral solutions, drops, emulsions, and ointments deliver consistent results with every dose.
Once formulated, non-sterile liquids are packaged in containers such as glass bottles or specialized plastic bottles, chosen for their ability to maintain product stability and prevent contamination. The packaging process is engineered to minimize the risk of cross contamination, with facilities and equipment designed to keep the product free from unwanted microorganisms and environmental contaminants.
Quality control is a cornerstone of non-sterile liquid manufacturing. Each batch undergoes rigorous testing to confirm that it meets established safety and efficacy standards. This includes checks for microbial content, physical stability, and packaging integrity. Facilities like those operated by Adragos in Leipzig and Halden are purpose-built for the production of non-sterile liquids, following EU-GMP guidelines to ensure every product is manufactured to the highest standards for medical and healthcare applications.
Non-sterile liquids are versatile and practical alternatives to sterile products in many situations. They are used not only as oral solutions and drops, but also as wound dressings, skin cleansers, and topical ointments, offering flexible solutions for a variety of medical and consumer needs. By focusing on robust formulation, secure medical device packaging, and stringent quality control, manufacturers can deliver non-sterile liquids that are safe, effective, and ideally suited to their intended applications in both healthcare and pharmaceutical products.
Why Adragos Pharma Is the Partner You’re Looking For
With the two manufacturing facilities in Germany (Leipzig) and Norway (Halden), Adragos Pharma offers full-service CDMO capabilities for non-sterile liquids, from R&D and pharmacy compounding to commercial-scale production.
Here’s what makes us different:
Specialized Facilities
- Leipzig: Oral solutions, drops, suspensions, emulsions (up to 4,000L)
- Halden: High-volume disinfectants (up to 5,300L, ATEX-compliant)
Regulatory Confidence
- EU-GMP certified
- Compliant with medical device and biocide regulations
- End-to-end packaging and serialization
Whether you are launching a pediatric suspension or scaling up a portfolio of hospital disinfectants, we make the complex simple — and the difficult achievable.
Every format, API, and use case in the non-sterile liquid space presents a unique challenge. Choosing a partner that understands the different types of formulations, the medical context, and the production process, from medical grade packaging to pharmacy compounding needs, is the only way to ensure long-term success.
At Adragos, we do not just manufacture. We collaborate, solve problems, and help your product make the leap from idea to shelf safely, efficiently, and at scale.
FAQs about Non-Sterile Liquids
What are non-sterile liquids?
Non-sterile liquids are pharmaceutical or healthcare formulations that do not require complete sterility but must meet strict microbial quality standards to ensure safety during use.
What are examples of non-sterile?
Examples include oral solutions, suspensions, emulsions, oral drops, and disinfectants. They are commonly used in medical settings, consumer health, and daily wound care. Non-sterile dressings are often used for covering minor wounds where sterility is not critical. In wound care, non-sterile swabs may be used to absorb blood and exudate during cleaning and dressing changes.
What are sterile liquids?
Sterile liquids are formulations that must be completely free from microorganisms, typically used in injectables, ophthalmic solutions, or surgical procedures. Their production involves sterile manufacturing, aseptic technique, and specialized environments. Sterile liquids must be free from contaminants such as bacteria, fungi, and viruses to ensure patient safety.
What are non-sterile items?
Non-sterile items include non sterile gloves, face masks, topical medications, and some medical devices. These are typically used in lower-risk settings or where sterilization is not essential to function or safety. When using non-sterile items, proper handling and storage are important to prevent cross contamination.
