INSIGHTS ON QUALITY CONTROL
Fits Like A Glove: Particle Size Analysis For Latex Glove Production
There are many factors affecting the chemical and mechanical properties of latex gloves. In this application report we use zeta potential measurements and two different particle sizing techniques (dynamic light scattering and laser diffraction) to characterize synthetic latex dispersions as well as a vulcanization accelerator.
Customized Auto-Sampling With Xsample 530 Sample Changer For Vials
The Xsample 530 sample changer for all DMA Generation M instruments and Lovis M/ME viscometers automatically fills samples from up to 71 vials in one unattended run.
Common Fume Hood Containment Problems
While there are “bad” fume hoods, anything wrong with the entire system (exhaust fan, ductwork, building configuration, regulative dampers) may cause a lack of containment in a hood.
Moisture Headspace Analysis For Efficient Scaleup Of Freeze Drying Capacity And Validation
A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations. Activity involved a scale up of freeze-drying capacity from 14 m2 to 28 m2. With the application of non-destructive feadspace moisture analysis small scale proof of concept studies were used to minimize project risk and the number of full-scale runs in the freeze-drying validation process.
The Definitive Guide To Particle Sizing
This paper provides an introduction to particle sizing comparing six widely used techniques, explaining how they work and what this means in terms of strengths and limitations.
Test Method Migration Considerations For CCIT
In this webinar you will learn about important and critical considerations when shifting to a new or different inspection test method. Also covered is how to assess the test method accuracy, information, data analysis and how to carefully define method transfer objectives for each application. Site-to-site transfer of test methods will also be discussed in this presentation.
New Method To Quantify Redispersion Potential Of Al Salts In Vaccines
Adjuvants such as aluminum salt (Alum) are commonly added to vaccines to enhance their immune responses. A resulting sediment can be more or less compact and difficult to redisperse depending on the strength of the bonds between particles. In this note, we propose a rapid evaluation method (less than 30 minutes) of the sediment redispersibility.
Risk Mitigation Of Parenteral Packaging With Container Closure Integrity
Parenteral delivery systems are the highest risk packaging application concerning container closure integrity. Leaks that register in the single micron range can introduce a threat of bacterial ingress.
Evaluating The Container Closure Integrity Of A Vial Using Headspace Gas Ingress Methods
To ensure patient safety, pharmaceutical products must be kept properly packaged prior to use. Proper packaging prevents ingress of contaminants. Unfortunately, these contaminants are not always visible to the human eye and container closure integrity (CCI) tests must be performed to ensure the package has not been compromised. One way to test for proper CCI is to analyze the headspace gas composition of the vial.
QUALITY CONTROL SOLUTIONS
Rotational Viscometer: ViscoQC
Developed for a wide range of applications, ViscoQC 300 ensures the quality of your substance – from almost any fluid to semi-solid samples – by delivering fully traceable viscosity results with a Peltier device for the most precise sample temperature control – right at your fingertips.
High-Risk Package Integrity Testing Systems
The ongoing R&D of PTI continues to build a powerful set of leading-edge inspection technologies that will bring patented and unique solutions to high risk packaging applications. There is continuous development in the field of creating new test methods for container closure integrity, seal integrity testing and package integrity testing.
NuAire In-VitroCell™ ES Model NU-5710
Model NU-5710 is a CO2 incubator that utilizes heating elements that surround the growth chamber on five sides. An independent door heater helps maintain temperature uniformity and reduce condensation. This direct heat model offers optimal cell growth conditions by producing humidity levels up to 95% and precisely controlling CO2 gas and temperature levels while minimizing potential contamination.
Measure the refractive index and concentration of liquids, gels and solids using laboratory refractometers from Anton Paar – the universally applicable and user-friendly Abbemat series. Simply take your pick depending on the accuracy, temperature range and level of automation you require - you can be sure to find a digital refractometer model to suit your application and budget.
HPAPI Package Inspection Enclosure
The HPAPI Package Inspection Suite is designed to provide personnel and product protection down to a respiratory exposure of at least 100 micrograms per cubic meter air (100 ug/m3). Package inspection operations involve manipulation of highly potent pharmaceutical ingredients (HPAPI), such as fentanyl.