In the pharmaceutical industry, filtration and separation steps are essential. When the appropriate filters are used, they ensure that end-of-line products (primarily medicines) are sufficiently purified and safe for patients, while also optimizing the production process and limiting losses of active molecules or raw materials.
The use of filters: a technological challenge
Filtration requirements in the pharmaceutical industry concern not only the steps directly involved in the manufacture of active pharmaceutical ingredients (APIs) but also the production and operation of utilities (gases, liquids, and steam), clean-in-place and sterilize-in-place systems, compressed air systems, and packaging processes.
The temperature and pressure conditions along the production line are sometimes extreme, and the compounds involved may be highly corrosive, viscous, or extremely fragile. At every stage, the technological challenges are therefore numerous in order to obtain safe raw materials, utilities, or finished products within reasonable timeframes and at controlled cost.
On top of this specification come stringent regulatory constraints. From research and development through to final production, the pharmaceutical industry must comply with demanding quality standards. This creates additional challenges for the implementation of filters and filtration housings, the filter bodies that make up the filtration process throughout product manufacturing.
For example, the use of pharmaceutical waters, which come into direct (manufacture of ophthalmic solutions, injectable solutions in particular) or indirect contact with the product that will be administered to the patient, is highly regulated. Their production and distribution are governed by strict standards, specific to each country, aimed at guaranteeing their physico-chemical and microbiological properties.
To learn more about the regulatory constraints related to pharmaceutical-grade water and the associated filtration solutions, read the following article on the blog:
What are the regulatory constraints on the quality of water for pharmaceutical use?
Expert advice
Special attention must be paid to the filtration of endotoxins present in pharmaceutical-grade water systems. Particularly dangerous for the human body, endotoxins can be removed using filters made with hollow-fiber membranes.
To learn more about endotoxin filtration, read the article on the blog:
“How to remove endotoxins from pharmaceutical-grade water?”
The filters, filter housings, or filtration skids supplied to the pharmaceutical industry must also be fully traceable, notably through an individual batch number, and the filters must be manufactured in a cleanroom.
Filtration applications in the pharmaceutical sector
In the pharmaceutical industry, filters are used in particular for:
- Filtration of compounds produced by microbial culture, such as antibiotics
- Solvent filtration for API production
- Sterile gas filtration used for pressure equalization along the production line or as a bacterial barrier during storage
- Vent filtration on autoclaves, to protect the product from external contamination
- Clarification and pre-filtration to remove solid impurities, undissolved powders, and particles, which determine the final product quality and protect downstream equipment
- Steam filtration, used for example for equipment disinfection
- Sterile gas filtration for fermentation and aeration agitators
- Preparation of sterile water used for drug dilution and dissolution
- Reduction of particle or bacterial load upstream of the final sterilizing filtration
- Sterile filtration of the final product, ensuring its biological safety
- Sterilization of packaging, for example through vacuum sterile filtration
Expert advice
Activated carbon is used to remove colored impurities produced in the reactor during the synthesis of active pharmaceutical ingredients. Rather than adding powdered carbon directly into the reactor before filtration, it is preferable to use activated carbon filters or lenticular modules equipped with an activated carbon medium.
To learn more about activated carbon filters, read our blog article:
“Why use activated carbon filters in API production?”
Contact a filtration expert
We are at your service
Our experts place their knowledge and expertise at your disposal for liquid filtration, air and gas filtration, decontamination, and separation technologies.
