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How is Cell Culture Used in Bio-Process?

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What is Cell Culture? Cell culture is the growth of plant or animal cells in special containers and in controlled conditions. In the bio-pharmaceutical process space, cell culture is ubiquitous and used for a variety of applications, such as developing drugs, vaccines, bio-markers and in personalized medicine where we can study the effects of a particular treatment on a patient at an individual or group level. Cell culture is highly regarded for its reproducibility. and because living cells can act… Read More »

What is Tangential Flow Filtration (TFF) and Where is it Used?

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  What is Tangential flow filtration? Tangential flow filtration (TFF), also known as Cross-flow filtration, is a process of separation widely used in bio-pharmaceutical and food industries. It is different from other filtration systems in that the fluid is passed parallel to the filter, rather than being pushed through a membrane perpendicularly which can clog the filter media. This method is preferred for its continuous filtration and reproducible performance. The particles that pass through the membrane, the permeate, are put… Read More »

USP Class VI Testing

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What is USP Class Testing? USP Class testing is one of the most common methods of testing to determine bio-compatibility of materials. There are six classes, VI being the most rigorous. Class VI testing is aimed to certify that there are no harmful reactions or long-term bodily effects caused by chemicals that leach out of plastic materials. USP Class Testing standards are determined by the United States Pharmacopeia and National Formulary (USP-NF), the organization responsible for the quality and safety… Read More »

WFI Basics and Sampling Methods

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What is Water For Injection (WFI)? Water For Injection is a solvent that is used for the manufacture of injection drugs. It can be used as an excipient as well as the final cleaning rinse agent for Bulk Active Pharmaceutical Ingredient (API) or in a Bulk Pharmaceutical Chemical (BPC) preparation. Types of Water For Injection USP WFI – USP WFI is the material used to make Bacteriostatic and Sterile WFI. It is not the finished product, therefore, it needs to go… Read More »

Differences Between Cleanroom Classes

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What is a Cleanroom? A cleanroom is a space in which the number of contaminants in the air per unit of volume, such as dust and other airborne microbes sized between 0.1µm and 5µm, are controlled to decrease chances of contamination. These particles are controlled by a high efficiency particulate air (HEPA), which filters the air before entering the cleanroom, and it is changed multiple times per hour, according to the class of the cleanroom, as established by the International… Read More »

How to Determine Tubing Burst Pressure and Working Pressure

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  How to determine the pressure rating of tubing? To ensure that your desired tubing is fit for your needs, one must understand how pressure ratings affect different materials. If the material is chosen for inappropriate use, it can burst at the most inconvenient time; however, this can be prevented by using Barlow’s formula, which shows the theoretical maximum operating pressure of a tube by using its tensile strength at yield (maximum pressure at which there is no permanent damage)… Read More »

Choosing Tri-Clamp Fittings for Your Application

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Tri-clamps are one of the most common types of pipe connections in the food, beverage, biotech, and pharmaceutical industries. This type of connection consists of a gasket compressed between two tri-clamp ferrules or flanges which are mechanically compressed in place with a clamp. Tri-clamp fittings are available in a variety of sizes, can be constructed from either steel or plastic, and can be either permanent or temporary. The clamp itself also comes in a variety of designs for ease of… Read More »

How do we Achieve Exacting Tolerances with Plastic Tubing? Lasers.

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For many critical applications, it is essential that plastic tubing is produced within strict dimensional tolerance limits. Spatial measurements of a tube, such as inside diameter (ID), outside diameter (OD), wall thickness, concentricity, and overall length all play separate roles in ensuring a tube performs up to intended standards. For example, Peristaltic-pump tubing is especially susceptible to performance flaws when tubing is manufactured out of specification. The following are three common instruments employed for measuring tubing dimensions: pin gauges, comparators,… Read More »

So, which is better, Platinum or Peroxide?

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Silicone tubing has many beneficial properties and has been utilized in medical and pharmaceutical applications for over 50 years. It is made from silicone polymers that are extruded then crosslinked and “cured” in to solid form using an assortment of curing methods. The two most common of these methods are platinum-catalyzed addition polymerization (platinum curing) [see Figure A] or peroxide-initiated free-radical polymerization (peroxide curing) [see Figure B]. Platinum-cured silicone tubing is widely accepted in applications where purity is a concern,… Read More »

Single-Use Pressure Sensor – New Alternative!

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  Our team at TBL is extremely proud to launch our aSURE™ instrument fitting, which was developed to provide a sterile barrier where disposable manifolds and tubing assemblies are used on hybrid single-use process equipment. Fixed or tethered pressure-monitoring devices provide extremely high accuracy and are often hard-wired into a central control panel. The aSURE™ instrument fitting provides a practical means of providing a sterile barrier on a complex manifold set, and provides a barrier without the need to have… Read More »