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STERILIZATION OF COMPENDIAL ARTICLES

Printed on: Mon Mar 30 2020, 16:40:49 pmPrinted by: Deborah NishikawaOfficial Status: Currently Official on 30-Mar-2020 Official Date: Official as of 1-Aug-2013 Document Type: GENERAL CHAPTERDocId: 1_GUID-ECD53800-853C-40EB-9E08-F125CF4C9 99B_1_en-USPrinted from: 2020 USPC 1229 STERILIZATION OF COMPENDIAL ARTICLES BACKGROUND AND SCOPEThis general information chapter provides an overview of the concepts and principles involved in STERILIZATION (by various modes) of COMPENDIAL ARTICLES that must be sterile. It includes information about supportive STERILIZATION processes utilized in their preparation. More detailed recommendations are presented in specific information chapters for each STERILIZATION mode: Steam STERILIZATION by Direct Contact Moist Heat STERILIZATION of Aqueous Liquids Monitoring of Bioburden Sterilizing Filtration of Liquids Biological Indicators for STERILIZATION Liquid Phase STERILIZATION Gaseous St

The most sophisticated integrators are radiation dosimeters that are so accurate and robust that their use has displaced the use of biological indicators for the validation of radiation sterilization. Additional detail about integrators and indicators can be

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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

latam-edu.usp.org

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 …

latam-edu.usp.org

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

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

1117 MICROBIOLOGICAL BEST LABORATORY PRACTICES

latam-edu.usp.org

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

71 〉〉〉〉 STERILITY TESTS

latam-edu.usp.org

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

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 …

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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 Deadly Van Allen Belts? - NASA

www.nasa.gov

Note: According to radiation dosimeters carried by Apollo astronauts, their total dosage for the entire trip to the moon and return was not more than 2 Rads over 6 days. The total dosage for the trip is only 16 Rads in 68.1 minutes. Because 68.1 minutes is equal to 1.13

  Belt, Radiation, Allen, Ansas, Deadly, Dosimeter, Radiation dosimeters, The deadly van allen belts

Billing and Coding Guidelines for Radiation Oncology ...

downloads.cms.gov

utilized for measuring and monitoring can include thermoluminescent dosimeters (TLD), solid state diode probes, special dosimetry probes, or film dosimeters. The physician must specify the type of special dosimetry. When special dosimetry is employed, the usual frequency will vary from one to six, consistent with the number of dose calculations.

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Radiation Safety relating to veterinary medicine and ...

www.vmb.ca.gov

thermolumnescent dosimeters (TLD), pocket dosimeters, and ring or wrist badges [see CFR Section 20.1003 and CCR Section 30100 (m)]. Film and TLD badges are the most commonly used radiation monitoring devices by the veterinary profession. Personnel monitors may be performed either on a monthly or quarterly basis.

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General Accreditation Guidance - NATA

nata.com.au

dosimeters 2 IEC 61672-3 for sound level meters On use Compare against acoustic calibrator or pistonphone Spectrophotometers and spectroradiometers 6 Wavelength accuracy, bandpass, absorbance, stray light error, linearity of response, repeatability and matching of cells On use A blank and at least 2 points on the

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user guide - Instadose

amp.instadose.com

The “ADD BADGES” section is used for instadose dosimeters only. Begin by clicking [Add badges] in the “QUICKMENU” field. The following screen will open. From this screen you can use the different search criteria to locate instadose badges within your account to manage.

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