Teva api division is adding a new capability to its industry-leading products and services: API sterilization
We are expanding our basket of services, and we are pleased to share with you a new service of sterilization service through aseptic filtration.
You are now able to rely on Teva api’s vast expertise, state of the art facilities and latest best-in-class resources to address your product formulation needs and achieve your goals. Sterilization provides another valuable solution that may factor into your consideration set when selecting an API supplier.
Sterilization capability designed for your needs
Teva api new facility is offering API sterilization using the aseptic filtration technique for production, quantities from a few kilograms to hundreds of kilograms. It will be able to support a wide variety of products with different characteristics (i.e. OHC levels, volumes).
We are able to sterilize materials from two sources:
1. For a molecule within Teva api portfolio, we can provide an end-to-end solution including API synthesis and its sterilization
2. Teva api can provide sterilization services for APIs from other sources
Aseptic filtration is a process where, under aseptic conditions, a dissolved API is filtered through a membrane to ensure the removal of all biological contamination.
Unlike other sterilization methods (like heat and gamma irradiation), it has significant advantages over other methods:
- It does not damage the API, which is essential for sensitive products
- It does not form new impurities during the sterilization process.
Dedicated facility producing quality results
Our scientific know-how and rigorous standards are incorporated in all aspects of our new manufacturing site Teva api Croatia. We chose to place the sterilization facility within one of our Croatian sites, which is one of our best manufacturing sites, with a good history of production. Clear from regulatory issues and approved by the FDA, this site is working with customers from around the world and is expert and knowledgeable in requirements for all markets, it is also cGMP certified.
The facility, which is built to comply with cGMP standards as well, has already reached operational readiness, with the first batches of sterilized products ready to ship in Dec 2019.
We were closely coordinating with the FDA and local regulatory authorities globally throughout construction, to ensure our facility is in compliance of regulatory requirements.
Stringent processes for sterility
Teva api’s sterilization facility is using dual packaging to ensure sterility of the final API, which can be configured to meet the customer’s requirements.
An on-site microbiological lab is monitoring API sterility and the sterility of the facility itself to ensure we use the best processes to avoid product contamination.
Download our API sterilization white paper now to discover how Teva api strives to provide an exceptional service and customer experience, along with advanced high quality API sterilization solution that can answer your needs.
Anticipating a need for aseptic filtration?
Contact us to find out how we can help. One of our account managers or customer experience experts will be happy to answer your questions and discuss your specific API sterilization needs.