Aseptic preparations include injections directly injected into the body or non-gastrointestinal preparations directly applied to the wound or mucosa. Due to the special administration site of this type of preparation, the quality and safety risk of aseptic preparation is significantly higher than that of other types of preparation, and the sterility of the final product must be guaranteed. For liposome injections, sterility checks, and endotoxin analysis are also necessary tests for quality control. CD Formulation is capable of providing customers with comprehensive sterility and endotoxin testing services.

Why Conduct Injectable Liposome Sterility and Endotoxin Testing?

With the progress of science and technology, the method of sterility examination of liposome injection has become more and more scientific and accurate, which better guarantees the safety of patients. At present, many rapid sterility testing methods are also gradually emerging, which will be a trend. But both the new and old methods have limitations: neither sampling nor testing can fully guarantee detection of potential microbes. Therefore, we should pay more attention to the whole process of aseptic control of drug production to ensure the aseptic quality attribute of drugs.

Fig. 1 Endotoxin of Gram-negative bacteria. (Marcano R, et al., 2021)

Our Services for Injectable Liposome Sterility and Endotoxin Testing

Injectable Liposome Sterility Testing

Sterility testing is performed for pharmaceutical products that necessitate sterility, such as injectables, implants, and bandages. The examination is carried out under aseptic conditions to identify any viable microorganisms. We provide analytical techniques, including thin-film filtration and direct inoculation, to assist our clients in conducting sterility testing on liposome injectables, encompassing method development.

Injectable Liposome Endotoxin Testing

We offer a variety of endotoxin tests, including animal-based tests(e.g. gel method and photometric method) and artificial recombinant methods. In addition, we can provide method development and validation services.

Fig. 2 Workflow of injectable liposome sterility and endotoxin testing. (CD Formulation)

Our Platforms for Injectable Liposome Sterility and Endotoxin Testing

Our Key Advantages in Injectable Liposome Sterility and Endotoxin Testing

• Advanced Facilities. Advanced analytical technologies and facilities to customers to offer cutting-edge services. Sterility testing is provided in Class 1000 clean rooms (ISO 6/B) and Class 100 laminar flow enclosures (ISO 5/A). It also serves the healthcare, pharmaceutical, medical device and cell therapy industries.
• Pharmacopeia standards are available. We comply with pharmacopeia requirements and adopt strict testing methods to ensure that manufacturers' products are safe to market. Applicable Standards: USP <85>, USP <161>, USP <797>, AAMI ST72, EP 2.6.14, JP 4.01, USP <71>, etc.
• Rapid and efficient. We support simultaneous testing of multiple samples to ensure efficient testing.

Published Data

CD Formulation has formulated a sterility and endotoxin testing service for injectable liposomes. If you need any kind of assistance, please contact us immediately.