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Related Concept Videos

Testing Water Quality01:14

Testing Water Quality

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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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Quality of Water01:19

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In concrete preparation, the quality of water is paramount as it affects the strength and durability of the concrete. Potable water is usually preferred; however, it must not have excessive sodium or potassium to prevent compromising the concrete's integrity. Water quality is typically evaluated based on impurities such as dissolved solids, chlorides, and sulfates, and its pH value is ideally between 6 and 8. Even slightly acidic natural water may be acceptable unless it contains harmful...
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Permeability of Concrete01:25

Permeability of Concrete

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Permeability in the context of concrete refers to how easily liquids or gases can pass through the material. This quality is crucial for assessing the water-tightness and durability of concrete structures and their resistance to chemical attacks. Concrete permeability can be determined through comparative laboratory tests. These tests typically involve sealing a concrete specimen from the sides, applying water pressure to the top surface with pressure, and measuring the amount of water passing...
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Cleaning, disinfection, and sterilization are the methods that help to break the infection chain and prevent disease.
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
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Concrete members with a small surface-to-volume ratio are cured by oiling and moistening the forms before casting the concrete member. These forms can be left in place for a prolonged period to prevent moisture loss, and can be wetted if made of a material suitable for wetting. If the forms are removed early, the concrete member is moistened and covered with polythene sheets to maintain moisture. For large horizontal concrete surfaces exposed to dry weather, a temporary covering is suspended...
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Classification of Systems-I

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Linearity is a system property characterized by a direct input-output relationship, combining homogeneity and additivity.
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How to Qualify Container Closure Systems for Intended Use, Part 1.

Amy A Kim1, Matthew R Gehrmann1, James McCaw1

  • 1West Pharmaceutical Services Inc, Exton, Pennsylvania.

International Journal of Pharmaceutical Compounding
|November 22, 2019
PubMed
Summary
This summary is machine-generated.

Outsourcing facilities must qualify container closure systems for drug product stability and integrity to meet U.S. Food and Drug Administration regulations. Proper qualification ensures systems are fit-for-purpose throughout the drug product

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Affairs
  • Drug Product Quality

Background:

  • Outsourcing facilities operate under stringent U.S. Food and Drug Administration (FDA) regulations, mirroring those for drug manufacturers.
  • Achieving and maintaining 503B status requires adherence to evolving regulatory standards.
  • Container closure systems are critical components that must ensure drug product stability and integrity.

Purpose of the Study:

  • To address the essential process of qualifying container closure systems for intended use.
  • To provide guidance on ensuring container closure integrity for outsourcing facilities.
  • To highlight the importance of fit-for-purpose container closure systems in maintaining drug quality.

Main Methods:

  • This article focuses on the qualification of container closure systems regarding integrity.
  • It emphasizes the need for systems to be suitable for in-use conditions.
  • The discussion is framed within the context of drug product stability and shelf-life.

Main Results:

  • Container closure systems must be rigorously qualified to ensure they protect drug products.
  • Integrity qualification is a key step in meeting regulatory expectations for outsourcing facilities.
  • Fit-for-purpose systems are essential for maintaining drug product quality under various storage conditions.

Conclusions:

  • Qualifying container closure systems for integrity is a critical regulatory requirement for 503B outsourcing facilities.
  • Ensuring systems are fit-for-purpose supports drug product stability and shelf-life.
  • This article serves as a foundational guide, with component selection discussed in a subsequent part.