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When was the last time you examined your API filtration process?
Many pharmaceutical companies are reluctant to change their processes. API production is inherently high-risk. Purity, safety, time, and money are all at stake. Quality managers often rely on tried and tested processes – and none want to be responsible for a change that could jeopardise the operation.
As a result, API filtration processes stay the same for years, sometimes decades. But every process can always be better. And while they remain stagnant, technology and methodologies evolve, creating a widening gap between how efficient a process is and how efficient it could be.
However, if you work with an experienced filtration partner, there’s no reason to fear process change. In this article, you’ll see how the right partner can save you time and money, make your operations safer, and minimise risk – often in ways you might not have realised.
The challenges of managing risk in API production are unique. With any process change, you must protect three Ps:
The purity of your final product is paramount
Every step of your operation needs to be efficient and cost-effective
Your people must be isolated from the potent chemicals they handle
A filtration partner with industry experience will understand these challenges. And they’ll use their expertise to ensure every improvement they make minimises risks to all three.
A critical part of API production is eliminating ‘specks’ – solids such as loose carbon and debris – from the product.
To guarantee the purity of your final product, you need pharmaceutical filters designed to remove specks effectively. And you need a way to keep an eye on the solution to ensure there aren’t any problems, such as a breakdown of carbon, that could cause bigger issues downstream.
However, many pharmaceutical companies use stainless steel filter housings for API production. You can’t see into steel filter housings, which means you can’t spot specks until they reach the end of the process. The solution then must be reprocessed, which is extremely costly and causes significant delays.
A filter manufacturer protects your product and process by providing filters that remove specks, encased in stainless steel housing that incorporates a 360-degree sight glass that’s designed for pharmaceutical industries. This allows you to monitor the upstream process in real-time, identify issues such as carbon breakdown early, take preventative measures to address them, and stop significant time and money from being wasted.
Colour reduction for APIs is in frequent demand. But conventional decolourisation methods can be messy and time-consuming.
The typical process is to add bulk quantities of powdered activated carbon into reaction tanks. This absorbs colour from the product and is filtered out later. However, cleaning up after this process can take up to eight hours. And with multipurpose production facilities in ever-increasing demand, time is limited.
A pharmaceutical filter manufacturer can protect your process by streamlining it with a carbon block cartridge filter. This gives you a high surface area of active carbon in the convenience of a cartridge.
Some of the ways that a carbon block can improve your process include:
Filter validation can often seem like a barrier to process improvement. But if you work with the right filtration partner, it doesn’t have to be.
When you change or upgrade your systems, your partner can arrange and carry out any testing required. They’ll give you the paperwork you need to prepare for upcoming audits. So, you can make your processes safer, faster, and more cost-efficient, and rest easy knowing that you can prove your filters are fully validated.
A common misconception is that a filter housing is nothing more than a tin that holds the filter. Filters are often seen as the only important part of the filtration system, as they have the most direct effect on product quality.
As a result, many pharmaceutical companies make the mistake of buying their housings as cheaply as possible. And some filter manufacturers, failing to see the value or profit in housings, will outsource the manufacture of their housings to save costs.
However, if you choose generic housing designs, you’ll need to design your systems and processes around the housing, rather than the housing fitting your specific requirements.
An experienced filtration partner will work with you to create specific, quality housings that will protect your process and make it more efficient. Be aware: if you choose a filter partner who outsources the manufacturing of their housings, you won’t benefit from the flexibility and fast lead times you get from a partner offering a bespoke, in-house service.
Limiting operator exposure to the chemicals used in the API process is critical.
If they’re exposed to chemicals when changing filter cartridges, they could be seriously injured.
A filter manufacturer with experience in the pharmaceutical industry understands the risk and can provide filter solutions designed to protect your people.
Contained filter systems seal the filter within plastic bags, securing it and any process fluids. Your filtration partner can also provide bags that are compatible with the volatile fluids used in API manufacturing, helping to protect your process.
The design of bag housings often requires operators to lift out the bag vertically when changing filter cartridges – which is neither the safest nor the most efficient approach. Your filtration partner can provide inclined housing to allow operators to extract them at an angle. This makes cartridge changeouts simpler and less risky.
Multi-round housings can come equipped with hydraulic lids. These automatically lift the bag and cartridge to the top of the housing. Operators don’t have to reach in as far to change out cartridges, minimising the risk of injury.
API production involves working with solvents that can be highly explosive. Solvents flowing through polymeric filters can sometimes generate static electricity. There is a risk that they could spark and cause an explosion, leading to significant damage and injury.
An experienced filtration partner will protect your environment and your people by providing grounded, ATEX-approved housings that don’t build up static electricity.
Choosing the correct base material is critical for any system that filters aggressive chemicals and solvents.
For example, a substance often used in API production is 37% hydrochloric acid (HCL). This chemical will eat away at most materials and cause considerable damage to systems over time. If your filter housing isn’t designed with compatible materials it will start to degrade, which means you’ll have to replace it frequently.
An experienced filtration partner will protect your process by offering solutions made from materials that are compatible with the substances you work with.
For example, tantaline housings feature a surface made of pure Tantalum metal. This is one of the very few materials on the market that is fully compatible with the 37% HCL solution. Because it’s more resistant to corrosion compared to nickel alloys, it will last much longer, saving you money.
Fluoropolymer coatings can also be applied either in powder or liquid form for added protection. This coating is 50-100 microns thick and offers superb chemical resistance.
A global pharmaceutical corporation required 100 filter housings for a significant expansion of their API manufacturing plant in Singapore.
Not just any housings – they had to be custom-designed for their process and compliant with strict health and safety regulations. And every housing had to be designed by the manufacturer in-house for consistency, so outsourcing was out of the question.
With our extensive experience of working with clients in the pharmaceutical industry, we have the know-how and resources to start projects like this straight away.
Our expert team designed bespoke housings to fit around the client’s existing vents, drains, and welding. The design of the housings protects operators when managing hazardous chemicals. The entire project was managed and delivered in-house, with no subcontractors involved in any important processes.
Our bespoke housings:
The housings are ATEX-approved and minimise operator exposure
Designed around the client’s process, the housings are quick and simple to install
We designed the housings to last longer, and be resistant to a wide range of substances
To improve your filtration process while minimising risk, you need a filtration partner that:
That’s exactly what Amazon Filters offers with our unique Fit 4 Purpose (F4P) model.
We perform a hands-on analysis of your filter specification, so we can introduce equivalent filters that meet your process requirements practically and cost-effectively.
With our five-step model, we:
To find out more about our F4P model and discover how we can support you with improving your API process, get in touch today.
For over 35 years, our team of experts has designed, manufactured, and installed innovative filtration solutions for businesses worldwide.
Today, we’re one of the world’s leading filter manufacturers supported by years of industry knowledge, we deliver high-quality, reliable, and accredited filtration solutions to your exact specifications.
We help you focus on producing high-quality products and services, and worry less about the filtration process.