When a process does not perform as expected, asking the question “what changed” is the best place to start. For over 20 years we have been helping customers find the culprit in their filtration process when suddenly results go awry. A robust, professionally designed filtration system will work the same way, every day, until something changes. Intentional changes are easy to figure out, but what happens when something changes in the process and no one is aware until a batch is compromised? That’s a critical point for process review and troubleshooting. Here are the top questions we ask in determining "what changed" so we can help get your operation back on track.
Most Commonly Asked Filtration Question Series You’ve sanitized your system. You have sterilizing grade filters installed at key points in your process. Your bioburden measurements are low but you still have endotoxin issues. What’s going on?
If you’re using filtration to remove bacteria from your process, integrity testing will provide you with data to ensure product quality. Did you know you can perform integrity testing in-house without the huge expense of buying commercial equipment?
Most Commonly Asked Filtration Question Series The risks of not using vent filters on holding and mixing tanks are real. And costly. Unfortunately, we usually hear from a company after they've experienced serious issues because they did not install vent filters. So, this article is written for those not yet using vent filters on their tanks. It will address the most common issues/questions we're asked on this topic with the hope of sparing you a process headache you don't need. Many processes require the use of tanks for holding ingredients to be added into the process, mixing of ingredients, or to hold the final product pending final filtration and filling. During the course of normal operations these tanks will be filled and emptied many times.
Most Commonly Asked Filtration Question Series Integrity Testing is a requirement of suppliers selling absolute rated membrane cartridge filters for microbial reduction or removal of yeast and mold. Test results are validated to remove specific organisms and a certificate is included with each product proving the quality of the filter. In addition to vendor testing, manufacturers in different industries perform their own Integrity Tests for critical processes. In pharmaceutical and bioprocessing, industry regulations call for Integrity Testing at prescribed intervals in a process. In the Food & Beverage industry, although not mandatory, Integrity Testing is a strategic move in assuring product safety and quality. Today we'll discuss the need and steps for in-process integrity testing.
Most Commonly Asked Filtration Question Series In every process the final filter plays the most critical role in assuring that your filtrate meets expectations and requirements. It is typically the most expensive filter as well. The useful life span of a final filter will determine your change out schedule and impact your filtration costs. But what if you could extend the life of your final filters, improve process efficiency and lower filtration costs? With the right Prefiltration strategy you can. We've been helping process teams since 1998 by offering real business and technical filtration solutions that achieve our customers' goals. Critical Process Filtration is a mid-sized filter manufacturer that has designed and shipped millions of filters to hundreds of companies producing pharmaceuticals, food, chemicals, electronics, medical supplies and more. We have complied the most commonly asked questions and situations that most filtration operations experience. Today we'll explore Prefiltration and how it impacts process efficiency and costs.
When comparing pharmaceutical filters, you're likely to find a wide variation in pricing. You may find yourself wondering -- what's the real difference between them? How can one sterilizing filter cost $500 and its equivalent cost $200? And in the case of a larger size, one can cost $1,000 while its equivalent costs $500. As a manufacturer of process filters for over 20 years, Critical Process Filtration, Inc. competes with large, well known filtration companies and is a supplier to many distributors. We have been asked how our filters, delivering the same performance, can be so much less expensive than our larger competitors. Visually, sterilizing cartridge filters with pleated PES (polyethersulphone) membrane and polypropylene support media and hardware look pretty much the same from manufacturer to manufacturer. The end cap or cage designs may vary to differentiate between manufacturers, but that's not the reason for the drastic cost differences. Comparing product specifications between suppliers shows that all sterilizing filters are integrity tested, with very similar diffusion and flow specifications. They are also validated to ensure the integrity test correlates to bacteria removal. So, if they look the same, and perform the same, what accounts for pricing differences of 50% or more? To try answering this question, we will detail the factors that impact the cost of filters in your market and why pharmaceutical companies should care.
It happens. Unfortunately, more often than anyone would like. You are about to process a new batch of fluids or adjust the current load and inventory status reports show that only half of the filters needed are in stock. Your next regular delivery is two months out. A phone call to your vendor reveals they can expedite your next order and it will arrive in six weeks. What do you do? You jump into crisis management mode, determined to figure out – how else can we get filters delivered fast? The answer to that question is now driving your business goal for that batch or shall we say, the cart is now leading the horse. In this article we will discuss options for improving delivery strategies and putting the horse back in the lead.