A Primer on HPLC Flowmeters

High performance liquid chromatography – HPLC – is very often the method of choice for analyzing pharmaceutical compounds starting with R&D and continuing into manufacturing.  Among other things it is used to

  • Check candidate drugs for purity
  • Monitor changes in pharmaceutical intermediates during chemical synthesis scale up
  • Test the stability and dissolution of formulations in development and
  • Support quality control in final drug products

Identifying an analyte by HPLC is based on accurate and reproducible column retention time as it passes through an HPLC system.  Reproducible retention time is critical and depends on uniform, reproducible HPLC pump flow rates.  A leak developing or other malfunction in the HPLC system will result in analysis errors.  Obviously, then, continuous testing is necessary to insure that the HPLC system is properly calibrated.  This is called operational qualification. OQ starts before the HPLC system is put into use and as part of ongoing system … Read the rest

How Ultrasonic Cavitation Bubbles Scrub

Pardon us for the take-off on a well-advertised household cleaner.  We have many posts describing how the implosion of cavitation bubbles in an ultrasonic cleaner solution removes contaminants from wetted surfaces. Here we’ll take a look at what happens at the bubble/surface interface in an ultrasonic cleaner.

Airless Bubbles

Let’s start by saying that unlike the household cleaner bubbles cavitation bubbles have no “air” inside.  Instead they have a vacuum.  The nitty-gritty of how is not as important as what happens.

Except to say in brief, cavitation bubbles are created by ultrasonic transducers bonded to the bottom and/or sides of the ultrasonic cleaner tank.  The generator-driven transducers cause a vibration on the tank surface to produce sound waves in the cleaning solution.  This causes compression and expansion in the liquid leading to cavitation bubbles that implode violently and produce shock waves radiating from the site of the collapse.

What is … Read the rest

Hot Weather Precautions for Laboratory Refrigerators

Unprecedented heat waves across much of the country place strains on laboratory refrigerators and laboratory freezers even if they are in air conditioned research labs and medical facilities.  Power cutbacks and power failures due to excessive strain on the power grid and electrical storms should be anticipated by lab personnel. Provision should be made to protect costly or rare biological samples, vaccines, and other temperature-sensitive pharmaceuticals and products.

10 Tips on Proper Lab Fridge and Lab Freezer Operation

Your organization should have standard operating procedures for stocking and maintaining laboratory refrigerators and freezers.  These are especially important when atmospheric conditions could lead to sub-par performance.  Here are some useful tips to help ensure content protection in medical grade refrigerators and freezers during the dog days of summer.  Or anytime for that matter. They are not listed in order of importance because all are important.

  1. Minimize access to the units.  Every
Read the rest

How to Calibrate a Moisture Balance

Laboratory-scale moisture analyzers use halogen or infrared heaters as part of a procedure to determine moisture content in products to ensure they are in compliance with federal or industry regulations.  As with all precision analytical scales and balances accuracy is a paramount requirement for a moisture analyzer.

In the case of moisture analyzers, two calibration processes must be performed: one for weighing accuracy and one for temperature accuracy.

Why Moisture Analyzers Must be Calibrated

It takes very little in the way of disturbances to impact the accuracy of a moisture analyzer balance.  For example, the effect of gravity is not the same everywhere on Earth, meaning that newly purchased analyzers must be calibrated on location before being used.

Moreover, changing environmental conditions in the laboratory or wherever moisture analyzers are used can impact accuracy, as can moving a unit to another location, even if it’s only to another worktable.   The … Read the rest

Density Determination Kit Helps in Accurate Analysis

Determining the density of a solid or liquid is easier and more accurate when using a density determination kit with an analytical balance.  Analytical balances such as the Kern ABS, AES and ABT models available from Tovatech can be programmed to work in concert with density determination sets, showing the density directly on the analytical balance liquid crystal display.

These density determination kits work on the buoyancy method, based on Archimedes’ Principle and recognized for a high degree of accuracy. As an example, 10 cm3 glass plummet is used for measuring the density liquids, giving a resolution of 0.0001 g/cm3.  The density is determined from the weight of the plummet in air and its weight in the liquid being measured.

For solids, the density is the ratio of the object’s weight in air and its volume.  Volume is determined by the buoyancy of the sample when immersed … Read the rest

How to Prepare a Sample for a Moisture Analyzer

Moisture content in a wide variety of products is an essential indicator of product quality – so essential that in many cases moisture content is regulated by government authorities. Google “moisture content regulations” and see for yourself.  A useful if not essential tool to comply with these regulations is a moisture analyzer or moisture balance.

Elegant in design and simple in principle, a moisture analyzer replaces cumbersome drying ovens with a halogen heater mounted on a precision scale.  The difference in sample weight before and after drying determines the moisture content of what is being tested.  But while the principle is simple, correctly operating a moisture balance requires careful sample preparation and programming consistent with the product being analyzed.… Read the rest

Primer on Laboratory Refrigerator & Equipment Validation

A controlled environment is critical to maintaining the potency and safety of pharmaceutical products across a supply chain stretching between R&D laboratories, manufacturing facilities, transportation and storage at healthcare facilities.  Examples of controlled environments include laboratory refrigerators, laboratory freezers, blood bank refrigerators, chromatography refrigerators, laboratory incubators, stability chambers and temperature test chambers.

Equipment such as this as manufactured by Norlake Scientific and offered by Tovatech is designed and constructed to comply with standards developed and promulgated by the FDA, the AABB, the Red Cross and other agencies.  Once the equipment is purchased, however, the facility operator assumes the responsibility of assuring it is installed and maintained according to FDA and related guidelines.… Read the rest

Get the Most from Your Moisture Analyzer

The slang phrase “you’re all wet” is generally not taken as a compliment – signifying instead that “you are wrong.”   Wetness can also be wrongness when too much moisture is contained in products such as plastics, fabrics and wood chips. Laws define the maximum moisture content in applications including food processing and pharmaceutical manufacturing. Correct moisture content positively impacts processing results and overall product quality across a wide range of industries.… Read the rest

Maintenance Tips for Your Ultrasonic Cleaner

To get the most from your investment in an ultrasonic cleaner you should avoid practices that degrade performance.  But because mistakes occur you also need to know how to remedy situations that may arise due to improper use, or in the case of cavitation erosion postpone its onset.

A question we get here at Tovatech is how to avoid rust films on ultrasonic cleaning tanks. Elma ultrasonic cleaners have stainless steel tanks, which under normal conditions do not rust.  Instead, rust films are introduced as a deposit either from ferrous products being cleaned or from tap water used in the tank.  Rust stains can be avoided by regularly cleaning the tank surface using a suitable cleaning solution such as elma clean 60 or 215 to remove deposits before they have the opportunity to stain the tank surface.  If stains are present, an alternative is to operate the cleaner in a … Read the rest