What is a Sterile Injectable and How Are They Made?

Sterile injectables are increasingly important dosage forms and hence are critical to modern medicine, enabling the safe and effective delivery of life-saving drugs directly into the body.

Many modern medicines, such as biologics, conjugates, viral vector, oligonucleotides or cell therapy product could not be administered by other routes than injection or infusion.

However, producing sterile injectables requires a highly controlled environment, specialized expertise, and rigorous quality standards to ensure patient safety and adequate product qualify.

At ten23 health, we specialize in the development, manufacturing, and supply of high-quality sterile injectables. Our expertise and innovative approach ensure that these medicines reach patients safely and efficiently. But what exactly are sterile injectables, and how are they made?

Understanding Sterile Injectables

A sterile injectable, or better called “parenteral preparation” is a dosage form (drug product) designed for administration into the body via injection or infusion (or implant). Unlike oral medications, which pass through the digestive system, injectables must be free from microbial contamination (“sterile”) to prevent infections or adverse reactions.

Injectables are commonly delivered through different routes, such as intravenous (IV), intramuscular (IM), subcutaneous (SC) injections or infusions, or intravitreal (IVT) injections. Each method requires precise formulation and packaging to ensure stability and efficacy.

The Complex Process of Manufacturing Sterile Injectables

Manufacturing sterile injectables is one of the most complex and highly regulated processes in the pharmaceutical industry. At ten23 health, we consider the sterile drug product holistically, aiming to ensure adequate product from the start, with the end in mind.

The key stages include:

1. Formulation Development

Before (drug substance or drug product) production even begins, scientists design the injectable formulation, considering factors such as stability, usability (target injection forces and choice of delivery device and needles) and compatibility with primary packaging (e.g., syringes, cartridges or vials) and combination with potential delivery devices (e.g., autoinjectors, pens, on-body injectors). ten23 health's expertise ensures that drug formulations ensure both stability and patient or healthcare professional usability, anticipating potential risks and issues in later manufacturing and administration.

Check on our approach for Formulation Development here: Pharmaceutical Product Development | ten23 health

2. Aseptic Processing and Sterility Assurance

Sterile injectables require an environment completely free of microbial contamination. We achieve this through:

Adequately designed Cleanroom Facilities – Our GMP-certified production site in Visp operates under strict aseptic conditions.
Sterile Filtration – Drug formulations are filtered through ultra-fine membranes to remove any contaminants. Filters are carefully chosen based on formulation and product considerations.
Advanced Aseptic Filling – Using cutting-edge filling technologies, we ensure precision, can perform filling of highly viscous products, can fill ultra-low fill volumes (down to 0.2 and 0.1 mL) and with very minimal headspace (air bubble).

Read more on our approach for fill&finish here: Drug Product Manufacturing | ten23 health

3. Lyophilization (Freeze-Drying) for Stability

Many injectables, especially biologics, require lyophilization to extend shelf life. This process removes water from the formulation under low temperatures, preserving the drug’s integrity. ten23 health’s expertise in developing lyophilized products and lyophilization cycles ensures optimal stability and reconstitution performance. A key question however is: do you need to lyophilize? Lyophilizates are difficult to combine with devices, plus have various challenges related to usability (reconstitution).

4. Primary Packaging

Each injectable must be packaged in adequate Primary Packaging, to maintain sterility and protects against external contaminants. Primary Packaging can be vials, syringes or cartridges. Containers consist of glass or polymer. Stoppers are made of elastomers. Formulations need to be assessed on stability with relevant Primary Packaging, as well as on extractables/leachables. Containers exist both as ready-to-use (RTU) or bulk container versions. Latter must be washed and sterilized at a given sterile facility.

5. Visual Inspection

ten23 health employs state-of-the-art visual inspection systems to detect all kinds of defects, including visible particulates, ensuring compliance with all relevant regulations.

6. Regulatory Compliance and Quality Control

Sterile injectables must meet stringent global regulatory requirements. Our team ensures full compliance with EU, U.S. FDA, and international GMP guidelines, conducting rigorous quality control tests at every stage.

How ten23 health Supports Pharma and Biotech Companies

As a specialized CDMO, ten23 health provides pharmaceutical and biotech companies with tailored solutions for developing and manufacturing sterile injectables. Our expertise spans from early-stage formulation to full-scale GMP production, ensuring that each drug product is optimized for patient safety, ease of administration, and long-term stability.

What sets ten23 health apart?
✔ Patient-Centric Approach – We consider patient experience in formulation design and device selection.
✔ Sustainability Leadership – As a certified B Corp, we integrate environmentally responsible practices into our operations.
✔ Innovation and Expertise – Our team combines deep industry knowledge with cutting-edge technologies to advance sterile drug product development.

Partnering for the Future of Sterile Injectables

Sterile injectables are vital to global healthcare, and their production requires precision, expertise, and dedication to quality. At ten23 health, we are committed to supporting pharmaceutical companies in bringing these critical medicines to patients safely and efficiently and with adequate quality. Whether you need formulation support, aseptic processing, or lyophilization expertise, our team is ready to collaborate and drive success.

Interested in learning more? Contact us today to explore how we can support your sterile injectable projects. Submit us your inquiry via contact form – we are just one click away. Contact us with any questions! | ten23 health

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