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Related Concept Videos

Testing Water Quality01:14

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When the quality of water for concrete preparation is uncertain, its impact on the setting time of cement and compressive strength of mortar is assessed by comparison with de-ionized or distilled water benchmarks. American Society for Testing and Materials (ASTM) C1602 requires the setting times to be within 90 minutes of the control, British Standard (BS) 3146:1980 allows a 30-minute variance in the initial setting, while British Standards European Norm (BS EN) 1008 specifies initial setting...
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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
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A complete procedure to test a claim about population standard deviation or population variance is explained here.
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The rebound hammer test, also known as the Schmidt hammer test, is a non-destructive technique for evaluating the hardness of concrete and, indirectly, the strength of concrete. It operates on the principle that the rebound of a spring-driven mass from a concrete surface correlates to the surface's hardness. The device comprises a mass within a tubular housing, a spring mechanism, and a plunger that strikes the concrete. Upon release, the energy imparted to the mass by the spring causes it...
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The soundness of cement refers to the ability of cement paste to retain its volume after setting. Unsound cement can lead to expansion and structural damage due to the presence of free lime, magnesia, and calcium sulfate. Free lime hydrates very slowly, expanding and causing unsoundness, which is difficult to detect because it intercrystallizes with other compounds. Magnesia also reacts with water, forming crystals that can disrupt the cement's structure. Calcium sulfate can create...
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Validating Container Closure Integrity with Statistically Based Tests.

Daniel Coleman1, Tony Pourmohamad2, Yenny Webb Vargas1

  • 1Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA 94080, USA; and.

PDA Journal of Pharmaceutical Science and Technology
|May 15, 2021
PubMed
Summary
This summary is machine-generated.

New statistical tests improve vial seal quality assessment. These methods use continuous helium leak data for more efficient, smaller sample size testing of non-integral container closures.

Keywords:
Rule of 3left-censored datalower limit of validation (LLOV)one-failure testone-sided confidence intervalsignificance leveltype 1 errorzero-failure test

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Area of Science:

  • Pharmaceutical Manufacturing
  • Quality Control
  • Analytical Chemistry

Background:

  • Vial capping processes are critical for drug product integrity.
  • Ensuring low rates of leaky vials (non-integral container closures) is essential.
  • Traditional binary (leaky/not leaky) tests can be sample-intensive.

Purpose of the Study:

  • To propose novel statistically-based testing procedures for vial capping.
  • To demonstrate acceptably low rates of failed seals using these new methods.
  • To improve efficiency in detecting leaky vials.

Main Methods:

  • Development of a zero-failure test and a one-failure test.
  • Utilizing the standard helium-leak test method for continuous measurements.
  • Incorporating left-censored data (measurements below validation limits).

Main Results:

  • Proposed tests achieve similar conclusions to binary tests with significantly smaller sample sizes.
  • The methods effectively handle continuous helium leak measurements.
  • All measurements below the lower limit of validation can be accommodated.

Conclusions:

  • Statistically-based tests offer a more efficient approach to assessing vial seal quality.
  • Continuous leak measurements provide richer data than binary assessments.
  • These methods enhance the reliability and efficiency of pharmaceutical packaging quality control.