Sterile injectables are essential components of the healthcare system, as they can help in the treatment of a wide range of conditions. Whether someone suffers from cancer, HIV/AIDS, or a different chronic condition, sterile injectables can provide them with therapeutic relief by administering medication directly into the bloodstream or tissues of the body.

Unlike pills, gels, or aerosols, injectables bypass the body’s natural defenses. While this is effective and better for long term use, it also requires extensive precautions throughout the manufacturing process to prevent product contamination. Therefore, a sterile manufacturing environment is required to ensure a process free of microorganisms, particulates, or other contaminants. Explore the essentials of sterile manufacturing for injectables, including aseptic processes, cleanroom technology, and fill-finish services in our post.

Sterile Manufacturing Protects Patients

Sterile manufacturing produces pharmaceuticals in environments free from microorganisms. The WHO allows an injectable to be classified as sterile once it has a probability of contamination with replicating organisms of less than one out of one million. Maintaining sterility requires a specialized process for manufacturing that is more advanced than what is used for other medical solutions.

The sterile manufacturing process is essential for maintaining the integrity of drug products, especially injectables, where a small microbial contamination can pose health risks for patients.

Key Components of Sterile Manufacturing

The FDA currently has regulations in place for CGMP, which includes requirements for creating sterile drugs and biological products. Different regulations feature different guidelines.

For example, 21 CFR 211.113(b) requires written procedures to prevent microbiological contamination and validation of sterilization processes. Additionally, the WHO also has GMP guidelines in place for clean areas, aseptic processing, and beyond.

Therefore, it is critical to maintain the following when producing injectables and other types of drugs:

• Aseptic manufacturing – Drug products are filled into sterile containers without exposing them to contamination.
• Terminal sterilization – This approach applies heat, chemicals, or radiation to sealed drugs, which eliminates microorganisms. The method is only used when the product’s formulation is able to withstand the treatments, ensuring sterility in the post-packaging process.
• Clean room technology – Clean rooms provide a controlled environment with minimized levels of airborne particles, microorganisms, and vapors from chemicals. These rooms have advanced air filtration, clean steam systems, and operational procedures that help to ensure that products within are free from contamination.

The Process for Fill Finish Services

Aseptic fill-finish is required because not all products can be sterilized after filling, especially since some cannot be sterilized after filling due to sensitivity to heat, radiation, or other terminal sterilization, which might negatively impact product effectiveness. This stage occurs at the end of manufacturing and is the most critical part of the injectable manufacturing process. Request the help of a CDMO to assist you in this process, and they will do the following:

• Filling – The drug is placed into the final product containers under controlled conditions and is performed in a cleanroom that controls the air quality, temperature, and humidity. In this part of the process, the equipment and packaging are also kept sterile for patient safety.
• Container closure – Just as the fill process is important to make sure everything is sterile, an appropriate closure must also be chosen to maintain the sterility and stability of the drug. Choose between a vial, syringe, ampoule, or something else – whatever is going to work best in your specific application.
• Quality control – A major part of the fill-finish process is rigorous quality control. It’s important to ensure that the product meets regulations, as proven by testing throughout the process. This includes environmental monitoring and testing the product at the end of the process to ensure that the final product is not only sterile, but also maintains efficiency.
• Labeling and packaging – When the product is filled and certified as sterile, the finished item will be labeled and packaged according to regulations and any established requirements.

As a reminder, it’s essential to work with a manufacturer that follows regulatory guidelines like GMP to ensure safety, efficacy, and quality.

Work with Oakwood Labs

Oakwood Labs has over 20 years of experience working with pharmaceutical firms of all sizes, so we know exactly what it takes to be an effective partner in creating sterile injectables. Our team is focused on achieving milestones within clearly defined deadlines and providing transparent communication throughout the entire manufacturing process. Additionally, we are ready to adapt at any point to ensure that your patient needs are met.

Learn about additional benefits of partnering with us:

• From R&D to formulation to GMP commercial manufacturing, we are fully equipped to help you
• We use microspheres in our injectables, a patented technology that facilitates tailored release from weeks up to one year
• Our scale-up process has lot-to-lot reproducibility, which means our formulations are reliable
• We operate in an FDA-approved aseptic GMP facility
• From proof of concept to clinical trials, we have a strong track record of success

Additionally, we perform work on a fixed-fee basis and carry it out using project management tools. A dedicated team is selected to work on your project once initiated, and each team includes formulation scientists, analytical chemists, and a project manager. We also host regular meetings to transparently report on progress, and we pride ourselves on our ability to accomplish your project goals.

Get Started Today

If you’ve been searching for a sterile manufacturer, Oakwood Labs is here to help. For more information or to ask any questions, be sure to reach out to our team. We’re ready to assist you.