ASTM D 4169-14 is the current FDA approved consensus standard. The typical test regimen for medical device package testing is distribution cycle 13 (DC 13). The test intensity levels are most co
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Often in the microbial examination of products, physical issues occur that force adaptations to the sample preparation. Some of these challenges include viscosity, the need for mixing or blending to a
Significant product and package responses and interactions during shipment can be severe and may lead to package or product failure. Identification of critical frequencies and the nature of package stresses can aid in minimizing the effect of these occurrences.
Suitability Testing is integral to any Microbiological test system. Suitability testing demonstrates that the test system and methodology are suitable for the intended purpose and compatible with the
Controls, Validation, and Challenges of Bioburden Testing, Microbial Limits Testing, or Microbial Examination of Non-sterile products
AMRI’s Whitehouse Labs Division Bolsters its Impurity Testing Capacity with Additional Mass Spectrometeradmin 2018-10-10T13:22:25+00:00
(PRWEB) OCTOBER 08, 2018 Whitehouse Labs, a division of AMRI, has expanded impurity testing capacity in its Lebanon, NJ, facility with [...]
Booth #103 | October 8-9, 2018 | Orlando, FL
NETWORK WITH US AT CONTRACT PHARMA Scientific Expertise. Market-Leading Technology. Best-in-Class Solutions. AMRI, a global contract research and manufacturing organization, [...]