Sterile API Manufacturing
Curia provides sterile APIs for over 300 clients in more than 30 countries around the world. Our customers trust us because of our excellent track record of regulatory compliance and quality assurance.
There are several different methods which can be used to sterilize APIs, such as the terminal ones that are heat (dry or wet) and radiation. Curia offers a technology that is used in situations where the terminal ones do not guarantee the stability of the API, neither a good impurity profile. This is the aseptic processing, working under closed systems design (as isolators) throughout the entire process to ensure sterility and to minimize the risk of contamination.
Curia is uniquely positioned to handle the most complicated challenges of manufacturing
With over 20 years of experience, Curia is here to help you identifying best conditions and parameters to perform Aseptic API sterilizing filtration, with three different manufacturing suites available, and following a four-step strategy for successful sterile API manufacturing:
Stage One: Dissolution and Sterile Filtration
- Sterile API manufacturing starts with sterilization of the product by dissolving the product to filter it through a sterile 0.22 microns filter. This is where selection of the filter is critical.
- Once the sterile filtration is finished, the integrity of the filter must be checked as part of the quality assurance process.
Stage Two: Crystallization
- This stage is critical to achieve the physical properties of the product, such as crystal shape, polymorphic and particle size.
- We have a variety of methods to achieve this, including adding anti-solvent where the product is not solvable, cooling (in cases where the solvability is different depending on the temperature), distillation of the dissolving solvent obtaining a saturated concentrator and using a sterile seeding.
Stage Three: Filtration and Drying
- The goal here is to separate the API from the solvent and dry the product to remove the voluntary impurities until we achieve the desired purification.
- At this stage, we are especially careful to avoid the degradation of the product from conditions such as temperature and moisture.
- Operations are carried out through isolator to avoid contact between people and the product.
Stage Four: Physical Treatment and Packaging
- If necessary, the dried material can be milled or micronized to reduce particle size.
- API is packaged according to the customer’s needs, using a range of customizable solutions.
Apart from the main process, we have secondary processes that we use to minimize risk in sterile API manufacturing. These include operator training to prevent contamination during handling, environmental monitoring to check all conditions and operations are right to assure the safety conditions, pressure cascade control to avoid contamination between rooms and particle control strategies to avoid foreign particles.
