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

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

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

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

USP <51> Antimicrobial Effectiveness Testing

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 …

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

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

Annex 6 WHO good manufacturing practices for sterile ...

products. Batch-processing records and, in the case of aseptic processing, environmental quality records, should be examined in conjunction with the results of the sterility tests. The sterility test procedure should be validated for a given product. Pharmacopoe ial methods should be used for the validation and performance of the sterility test.

  Product, Sterility

Annex 2 WHO good practices for pharmaceutical …

— sterility testing; — detection, isolation, enumeration and identifi cation of microorganisms (bacteria, yeast and moulds) and testing for bacterial endotoxins in different materials (e.g. starting materials, water), products, surfaces, garments and the environment; and — assay using microorganisms as part of the test system.

  Product, Sterility

F0 a technical note - Fedegari

contents 1. essentials of moist heat sterilization kinetics 5 1.1. d-value or decimal decay time 7 1.2. sterility as "probable effect" of exposure time 7 1.3. z-value or temperature coefficient 9 1.4. f 0 or equivalent exposure time at 121°c 11 1.5. lethal rates 14 1.6. example of post-calculation of f 0 17 1.7. symbols and definitions used in sterilization technology 18

  Sterility

BRIEFING 797 Pharmaceutical Compounding—Sterile ...

BRIEFING 〈797〉 Pharmaceutical Compounding—Sterile Preparations, USP 41 page 6554 and PF 41(6) [Nov.–Dec. 2015]. Based on the number and significance of public comments received in response to the revision proposal published in PF 41(6), the USP Compounding Expert Committee is proposing to revise this chapter.