71 〉〉〉〉 STERILITY TESTS

of the test. Modify the conditions in order to eliminate the antimicrobial activity, and repeat the Method Suitability Test. This method suitability is performed (a) when the test for sterility has to be carried out on a new product; and (b) whenever there is a change in the experimental conditions of the test.

  Tests, Activity, Antimicrobial, Antimicrobial activity

1664 〉〉〉〉 ASSESSMENT OF DRUG PRODUCT …

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

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

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 …

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

USP <71> Sterility Tests - United States Pharmacopeia

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

1117 MICROBIOLOGICAL BEST LABORATORY PRACTICES

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 …

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

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

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

5.1.3. EFFICACY OF ANTIMICROBIAL PRESERVATION

Efficacy of antimicrobial preservation suspensions may be presented in sealed ampoules. Biological indicators are prepared in such a way that they can be stored under defined conditions; an expiry date is set. Micro-organisms of the same bacterial species as the bacteria used to manufacture the biological indicators may be inoculated

  Preservation, Antimicrobial, Efficacy, Efficacy of antimicrobial preservation

GUIDELINE FOR STABILITY DATA

(e.g., Efficacy of Antimicrobial Preservation of the BP or Antimicrobial Preservative Effectiveness Test of the USP) and by performing chemical assays for the preservatives during the regular stability testing schedules. If a lack of or low levels are found, testing for sterility should be carried out. iv) Dissolution testing

  Preservation, Antimicrobial, Efficacy, Efficacy of antimicrobial preservation

2.6.12. MICROBIOLOGICAL EXAMINATION OF NON-STERILE ...

the test forEfficacy of antimicrobial preservation(5.1.3) as described in the Pharmacopoeia. They may furthermore be used for monitoring raw material quality and may be used in association with guidelines on Microbiological quality of pharmaceutical preparations(5.1.4). When used for such purposes, for example by a manufacturer for raw

  Preservation, Antimicrobial, Of antimicrobial preservation

2.6.12. MICROBIOLOGICAL EXAMINATION OF NON-STERILE ...

the test forEfficacy of antimicrobial preservation(5.1.3)as described in the Pharmacopoeia. They may furthermore be used for monitoring raw material quality and may be used in association with guidelines on microbiological quality (5.1.4). When used for such purposes, for example by a manufacturer for raw materials and/or finished product

  Preservation, Antimicrobial, Of antimicrobial preservation

propionic acid - Agricultural Marketing Service

preservation as a mold inhibitor. It is used in shipping and storage and is applied either as a solution or on ... The undissociated form of propionic acid is essential to the antimicrobial activity. It can penetrate the ... In 1991, Higgins and Brinkhaus conducted a study to determine the relative efficacy of eight organic acids (propionic ...

  Services, Agricultural, Marketing, Preservation, Antimicrobial, Efficacy, Agricultural marketing service

Microcare Personal Care Ingredients 0718 - Cosmer

Microcare® BDP Liquid blend of phenoxyethanol and organic acids for gentle preservation ... Microcare® Emollient AEHX A blend which improves the antimicrobial efficacy of traditional preservative systems thereby reducing susceptibility of cosmetic products to microorganisms

  Ingredients, Care, Personal, Preservation, Antimicrobial, 1870, Efficacy, Antimicrobial efficacy, Microcare personal care ingredients 0718, Microcare

General Chapter Injections Correction - USP-NF

therapeutic efficacy or with the responses to the specified assaysmore than 1 L are labeled to indicate that the contents are not in- ... tices and Antimicrobial Effectiveness Testing 〈51〉). remains uncovered for its full length or circumference to permit in- ... the section Preservation, Packaging, Storage, and Labeling of the

  General, Chapter, Preservation, Antimicrobial, Injection, Efficacy, General chapter injections

5.1.4. MICROBIOLOGICAL QUALITY OF PHARMACEUTICAL …

5.1.4. Microbiological quality of pharmaceutical preparations EUROPEAN PHARMACOPOEIA 6.0 B. Herbal medicinal products to which boiling water is not added before use. — Total viable aerobic count (2.6.12).Not more than 105 bacteria and not more than 104 fungi per gram or per millilitre. —Notmorethan103 enterobacteria and certain other gram-negative bacteria per gram …