Critical Process Filtration Blog

The alcohol, low oxygen content, relatively low pH, hops extracts (alpha-acids) and dissolved carbon dioxide in beer inhibit the growth of pathogenic bacteria. That is why beer has been a safe drinking alternative for so many centuries. However, there are microorganisms that can survive and even thrive in beer and spoil the flavor and aroma of any good brew.

DEVELOPMENT, SCALE-UP, AND VALIDATION OF PHARMACEUTICAL FILTRATION PROCESSES Our Technical Service Team performs application testing for a wide variety of fluids from water to complex chemical solutions. No matter what industry the customer is part of, we carefully document our test results and make recommendations based on those results. We get it right the first time.  For pharmaceutical applications, whether removing particles from ingredients entering the plant or sterilizing parenteral products, the testing and documentation we routinely create help show the consistent performance required for validation of the process.

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?

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 to answer this question, we will detail the factors that impact the cost of filters in your market and why pharmaceutical companies should care.

   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.

Extractables and Leachables, these terms are a part of the manufacturing process of new medicines and other areas of such. These terms are very commonly misunderstood by one another and they both gave their distinct characteristics, which can be traced through the whole supply chain.  The definitions of these are not balanced. They overlap and have different utilization, and situations in the manufacturing process must be categorized to highlight the weight and necessity of both extractables and leachables.

While filter ratings are an important indication of how well the filter will remove particles of varying sizes from a fluid or gas, it is important to note that nominally rated filters from different manufacturers can have the same rating, but yield different results. The opposite is also true – nominally rated filters from different suppliers can have different ratings, yet yield the same result. Naturally, this can create confusion and impact your filter buying decisions. When these situations arise, we recommend that focusing on achieving the targeted performance of a filter over the rating will yield the best results. With that in mind, let’s start with differentiating between the two types of ratings that indicate pore size and efficiency in removing particulates -- Nominal and Absolute ratings.

A simpler integrity test for less critical applications is a Pressure Decay Test. This requires the same air (or nitrogen) source and an accurate pressure gauge but does not require a mass flow meter. This type of test can be performed before and after use and is sensitive enough to detect very small leaks.

Your process requires a sterile end product. To achieve this, you plan on installing a sterilizing filter. But with so many choices, how do you choose the best one? Some suppliers offer single layer membrane sterilizing filters. Others may offer filters with two layers of membrane, sometimes with different pore sizes (a larger pore size in front of the final sterilizing filter), or two layers of the identical material in the same pore size. Each plays a specific role in reaching your sterilizing requirements. This article will discuss the many factors in choosing a sterilizing filter and list our products that deliver targeted retention.

One of the first questions many customers ask when evaluating filtration solutions is, “how many filters will I need?” Getting to the correct answer requires consideration of many factors.