The manufacture of products based on small-molecule Active Pharmaceutical Ingredients (API) remains critical to global healthcare. The manufacturing landscape is also full of challenges and opportunities. This is due to emerging international markets and rapidly evolving social, economic, regulatory and environmental expectations.
Pall Life Sciences, with its range of products and services is well positioned to help Active Pharmaceutical Ingredient customers in all stages of development and manufacturing optimization. This part of the site is dedicated to chemical processing of small molecules - if your interest is biomolecule products produced by fermentation or cell culture, you will find relevant information in our Biotechnology, Vaccine or Plasma sections. You may also find relevant information on final processing in our Formulation and Filling section.
- Cost reductions can be required due to increased competition, including generic suppliers, as patents expire
- Process changes may be required as new products and formulations are developed in response to changing market conditions
- Regulatory agencies continue to develop guidelines and global standards for Good Manufacturing Practices (GMP)
- Environmental factors may also drive process changes
- Higher-potency active products may require greater attention to containment to meet safety and GMP requirements
We have many years' experience helping our clients respond to changing demands or to bring new products and processes to success in the following ways:
Range of Active Pharmaceutical Ingredient Products
Our offerings include by far the widest range of filtration technologies available. All these products have highly defined and consistent, reproducible removal ratings and performance. Choosing the right filter gives not only the right economy but also reduced risk of added contamination due to release of particle or extractables. This means that working with Pall offers an unparalleled capability to find the right balance between filter protection, filter size and filter throughput economy in different liquids and gases. Applications may range from particulate control to bioburden control and strict sterility assurance. We have a wide range of experience in areas such as crystallization and catalyst removal and specialized containment or in advising on housing compatibility, safety regulations and electrostatic protection where needed.
Available Technical Services
Our Technical Services
teams are on hand to advise on issues such as housing design, compatibility, extractables and operator training and ensure that the best products and practices are applied. Our Validation and Certification programs, including ‘P’ Grade and ‘Q’ Grade documentation with cartridge filters, mean that appropriate regulatory standards can always be applied for cost-effective processes.
Other Technologies and Packages
Besides the complete filtration offering, Pall is also the leading supplier of a number of other technologies and packages which have been developed to meet Active Pharmaceutical Ingredient demands: