Filtration systems play a critical role in pharmaceutical manufacturing. Filters help ensure product purity by preserving the quality of APIs and optimising manufacturing processes.
Can you guarantee product purity?
Many drug manufacturers don’t realise that filters themselves can potentially adulterate the final product due to the materials they're made from. This is a serious risk that can negate life-saving medication, expose people to danger, and waste millions in revenue.
To help reduce risk, there's a wealth of documentation available with information about regulatory expectations or state-of-the-art contamination control, such as:
Yet despite so much literature, the advice is astoundingly vague. Not only is there no “out-of-the-box” for contamination control generally, but there’s also little guidance available for filters specifically. PDA Technical Report 26 is a highly regarded guidance document for pharmaceutical filtration operations that states: “chemical compatibility testing should be completed as part of the overall filter qualification package”. This guidance also fails to detail any specific methods or procedures for demonstrating compatibility.
And with the FDA issuing more warning letters every year (633 in 2020 compared to 482 in 2019), it’s clear that contamination control is a struggle for pharmaceutical companies.
How to ensure filters help, not hinder
According to ICH, anything that creates an impurity in an active drug product (API) is known as a degradation product. To make sure your filtration solution doesn’t become one, you need to consider two things:
- Correct material selection
- Consistency in delivery
Correct material selection
You need to make sure that the materials used to manufacture your filters are suitable for your application. It’s also important that the manufacturer you choose can supply validation guides to support their claims.
Validation guides provide data sets and qualification testing to support their suitability for pharmaceutical manufacturing. Without up-to-date validation guides, you can’t guarantee the safety of your filtration solution.
It’s important to remember that compatibility testing varies by application. You need to know how materials react in specific circumstances, depending on your manufacturing processes. What looks fine in room temperature testing may become compromised when higher temperatures are used.
Consistency in delivery
Exceptional service delivery is one of the key things to look for in a filter manufacturer. In practice, this means:
But, for pharmaceutical manufacturing, consistency of supply is particularly important. You need to trust that the filters you order on day 1 are the same quality and materials when you reorder new ones on day 100.
Experienced filter manufacturers have the controls you need
Established filter manufacturers understand the unique challenges faced by the pharmaceutical industry. They can bring their experience and expertise into your project to provide specific and relevant advice and guidance. They can supply the documentation, testing, and validation you need to ensure the suitability of your filters.
Industry experience also opens the door to the creation of bespoke filtration solutions that can help bring the latest pharmaceutical innovations to market.
Most importantly, experienced filter manufacturers add value while reducing risk:
Protecting your process
- Ensuring continuous operation of your plant
- Specifying the correct materials
Protecting your product
- Guaranteeing quality
- Validated filter performance
Protecting your people
- Ergonomic equipment design
- Isolating your operators from the process
Filtration in contamination control goes further than ensuring an effective product. When done well, with a partner you can trust, it provides more value to your entire organisation.
