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.