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STERILITY TESTS - United States Pharmacopeia

Printed on: Mon Mar 30 2020, 16:39:24 pmPrinted by: Deborah NishikawaOfficial Status: Currently Official on 30-Mar-2020 Official Date: Official Prior to 2013 Document Type: GENERAL CHAPTERDocId: 1_GUID-481C30EA-8A49-4A77-9E81-D0CD7C533 498_1_en-USPrinted from: 2020 USPC 71 STERILITY TESTS Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia . Those portions that are not harmonized are marked with symbols ( ) to specify this Pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized.

Fluid Thioglycollate Medium is to be incubated at 30°–35°. For products containing a mercurial preservative that cannot be tested by the membrane filtration method, Fluid Thioglycollate Medium incubated at 20°–25° may be used instead of Soybean–Casein Digest Medium provided that it has been validated as described in Growth Promotion Test of Aerobes, Anaerobes, and …

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USP <71> Sterility Tests - United States Pharmacopeia

latam-edu.usp.org

The view from USP <1211> Sterilization and Sterility Assurance of Compendial Articles : 6 ... For products containing a mercurial preservative that cannot be tested by the ... Used for sterility testing of viscous products and for devices having tubes with small lumen.

  Product, Tests, Assurance, Sterility, Sterility assurance, Usp lt 71 gt sterility tests

USP <51> Antimicrobial Effectiveness Testing

latam-edu.usp.org

If the diluted product exhibits antimicrobial properties, specific neutralizers may need to be incorporated into the diluents or the recovery media. The ability of the procedure to measure preservative efficacy may be compromised if the method suitability requires significant dilution (10 −2 or 10 −3) as this will affect the measured recovery

  Testing, Effectiveness, Antimicrobial, Efficacy, Usp lt 51 gt antimicrobial effectiveness testing

1664 〉〉〉〉 ASSESSMENT OF DRUG PRODUCT …

latam-edu.usp.org

administration ports, overwraps, adminstration accessories, labels, cardboard boxes, and shrink wrap. A Primary Packaging Component is in direct contact or may come into direct contact with the product (e.g., IV bag). A Secondary Packaging Component is in direct contact with a primary packaging component and may provide additional protection

  Packaging, Shrink

659 PACKAGING AND STORAGE REQUIREMENTS

latam-edu.usp.org

Ancillary component:A component or entity that may come into contact with a Tertiary packaging component during the distribution, storage, and/or transportation of the packaged article (e.g., pallets, skids, and shrink wrap).

  Packaging, Shrink

1151 PHARMACEUTICAL DOSAGE FORMS

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Bioavailability (See also In Vitro and In Vivo Evaluation of Dosage Forms á1088ñ and Assessment of Solid Oral Drug Product Performance and Interchangeability, Bioavailability, Bioequivalence, and Dissolution á1090ñ.)Bioavailability is influenced by factors such as the

  Form, Solid, Dosage, Dosage forms

Module 08 USP 1115 Bioburden Control of Non-Sterile …

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Unlike aseptic processing for which facility requirements are generally uniform in specification and performance, nonsterile product manufacturing environments typically involve diverse products and microbial contamination control requirements. In general, liquid, cream, or ointment products require a greater level of

  Product, Control, Sterile, Aseptic, Bioburden, Bioburden control of non sterile

1117 MICROBIOLOGICAL BEST LABORATORY PRACTICES

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Whenever possible, sampling equipment should be loaded with its microbiological recovery media in the environment that is to be sampled. All testing in laboratories used for critical testing procedures, such as sterility testing of final dosage forms, bulk product, seed

  Microbiological, Sampling

1092 THE DISSOLUTION PROCEDURE: DEVELOPMENT AND …

latam-edu.usp.org

5.4 Precision 5.4.1 Repeatability of Analysis 5.4.2 Intermediate Precision/Ruggedness 5.4.3 Reproducibility 5.5 Robustness 5.6 Stability of Standard and Sample Solutions ... (such as dynamic solubility, potentiometric titration, or turbidity measurement methods). (USP …

  Precision, Potentiometric

STERILIZATION OF COMPENDIAL ARTICLES

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For steam and dry heat, the D-value is a function of temperature. In gas sterilization (ethylene oxide, ClO , or O ), D-values are a function of the chemical concentration, relative humidity, and temperature. Similarly, for liquid chemical sterilization the D-value is a function of the temperature and sterilant concentration.

  Steam, Sterilization

660 〉〉 CONTAINERS—GLASS

latam-edu.usp.org

glass containers will raise the hydrolytic resistance from a moderate to a high level, changing the classification of the glass to Type II. The following recommendations can be made as to the suitability of the glass type for containers for pharmaceutical products, based on the tests for hydrolytic resistance.

  Glass, Container, Containers glass

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The United States Pharmacopeia and Depyrogenation Introduction For many years chapters in the United States Pharmacopeia (USP) have made reference to depyrogenation. These chapters include <85> Bacterial Endotoxins Test (BET), 1 <797> Pharmaceutical Compounding of Sterile Preparations and the general information chapter,2 <1211> Sterility and

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