Advanced ChemTech offers essential support through various services, including terminal sterilization.
Advanced ChemTech is proud to handle all aspects of parenteral dosage forms in Louisville. This includes peptides, solutions, suspensions, and lyophilized products. The unique internal processes work to reduce line loss while increasing efficiencies.
With over two decades of experience with Gamma irradiation terminal sterilization and suspension handling, clients receive optimal sterility throughout the entire pharmaceutical manufacturing process. Our facilities deliver the capability of vial terminal sterilization from 2 mL to 100 mL.
Several benefits are possible when investing in terminal sterilization.
It is a well-understood mechanism that delivers practical microbicidal effects.
The process has documented, published, and accepted methods for setting and using appropriate dosages to achieve the desired sterility level.
It eliminates the need for complete sterile manufacturing because appropriate cleanroom classes aren’t needed for equipment maintenance or validation. This advantage often reduces or avoids the time and monetary costs.
The turn time for this process is rapid, adding no excess heat or moisture to the product to ensure sterility occurs.
The low minimum doses have seen rapid expansion in recent years as technology development in this sector has increased. When working with Advanced ChemTech, clients receive support for products that are not filtered effectively while ensuring no residuals remain. It’s an adaptable process that even works with small volume items through special handling operations.
Sterilization’s purpose is to deliver an efficient drug product to patients that are usable at the highest safety levels. With terminal sterilization, the item receives sterilization during its final packaging phase or in its assembled form. These steps significantly reduce sterility risks, validated with a Sterility Assurance Level (SAL) lower than 10-6. It can be calculated, validated, and controlled to ensure safety margin incorporation.
Aseptic processing, an alternative to terminal sterilization, is also provided by Advanced ChemTech. This effort maintains material sterility from assembled components that have already received sterilization support. It relies on several factors to prevent recontamination, all met by the company’s cGMP facility.
Advanced ChemTech specializes in the analytical method and manufacturing process, providing fill batch capacities of up to 15,000 units. This structure allows for smaller-scale projects that don’t meet the minimum vial requirements of other companies, ensuring the preferred outcome is still achievable.
New clients are currently being accepted. More information is available at https://Advanced ChemTech.com/.
About Advanced ChemTech
Based in Louisville, Kentucky, Advanced ChemTech provides various fine chemicals to the research and pharmaceutical market. These chemicals vary massively, including amino acids, peptides, resins, reagents, and more. We are Leaders in instrumentation, and provide TETRAS™, a state-of-the-art synthesizer for peptide synthesis.
Advanced ChemTech has all the chemicals you need, whether for pharmaceutical research or the market, or perhaps a school science project, required re-stock for a commercial entity, or other requirements. Whatever you need, the Chemtech team is here to help you; you can even read their newly released blog for free information and advice. To find out more information about the team and their processes, you can also reach out via https://www.advancedchemtech.com/contact/