API production is inherently high-risk. You’ve got to preserve the quality of your final product. Get it wrong, and the consequences could be catastrophic. At the same time, you need to ensure your people and environments aren’t exposed to the potent chemicals they’re handling throughout the process.
Filtration plays a pivotal role in ensuring that API production runs safely and smoothly. That’s why it’s important to work with a filter manufacturer that understands the unique challenges of the pharmaceutical sector and can help you reduce risk at every stage.
When producing APIs, you must protect your three Ps:
A highly experienced filtration partner will use their expertise to minimise the risk to all three.
Many pharmaceutical companies don’t know that filter housings can be a risk to the API production process. If they aren’t made from the correct materials, they corrode and contaminate the final product. The wrong filter housing could not only ruin potentially life-saving drugs, but also waste millions in revenue.
An experienced filtration partner understands the unique challenges of chemical synthesis. They will work with you to develop bespoke filter housings that will resist corrosion and protect the purity of your product. Using 3D modelling techniques, they can visualise new designs and evaluate them to ensure they meet the latest standards for the best quality.
By developing bespoke housings, your filtration partner isn’t just protecting your product, but your process too. Because these filters resist corrosion, they minimise the risk of system shutdowns and the need for filter changeouts. This means less downtime and reduced costs.
If you want to enhance your process, a filtration partner can help you with that too by making validation as easy as possible. They’ll work with you to create and arrange the right tests for extractables and provide reports ready for any future audits. You’ll have all the documentation you need to prove your filters are suitable for your process.
Keeping your employees and environment isolated from the process is crucial to managing risk in API production. If an operator comes into contact with highly aggressive chemicals and compounds, they could be seriously harmed.
An experienced filtration partner understands these risks. They will help protect your people and your business with bespoke filtration equipment that’s ergonomically designed to be as safe as possible without sacrificing quality. For example, gloved systems where the filter is fully contained within the system enable operators to change out cartridges easily, without exposing themselves or the environment to potent substances.
A lot can go wrong in API production. The risks range from ruined products and lost revenue to employees being seriously harmed.
When filters are such a core part of the production process, you need to work with a filtration partner that takes reducing risk extremely seriously. Make sure your partner has the expertise to protect your product, process, and people at every step.