Our dedicated state-of-the-art sterilization facility provides API sterilization services through high-performance aseptic filtration, in complete compliance with cGMP standards. We can work with a large variety of products and offer different solutions to best suit your business needs.
Our sterilization facility utilizes highly-advanced technology for aseptic filtration, including isolators that are used throughout the entire process to ensure sterility and minimize the risk of contamination. Unlike other sterilization methods that can be invasive, this process is non-destructive and does not lead to degradation of the API.
You can either select our end-to-end solution for molecules within the Teva api portfolio, which includes API synthesis and sterilization. Or you can use our sterilization services as an outsourced step for other APIs.
Our facility can handle a large variety of products, including micronized APIs, and production volumes, ranging from a few kilograms up to a hundred kilograms. Our design of physical properties is meticulous.
Our microbiological lab monitors API sterility and the sterility of the facility itself, ensuring the API is free of any contaminants, as required by regulations.
We use dual packaging to ensure the sterility of the final API, which can be customized to meet individual equirements.
Our team has extensive experience in designing API physical properties, especially relating to sensitive products and complex formulations. Control and uniformity of particle size distribution are reached through robust, well-designed crystallization processes, as well as by micronization. A micronizer is integrated within the isolator system to ensure aseptic processing and safe handling of the material.
Our dedicated site has an excellent regulatory record. Stringent quality and safety considerations are incorporated throughout all aspects of the product lifecycle, in close coordination with national and international health authorities.
Interested in our sterile APIs or learning more about our sterilization services?