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1117 MICROBIOLOGICAL BEST LABORATORY PRACTICES

Printed on: Mon Mar 30 2020, 16:34:56 pmPrinted by: Deborah NishikawaOfficial Status: Currently Official on 30-Mar-2020 Official Date: Official Prior to 2013 Document Type: GENERAL CHAPTERDocId: 1_GUID-CE88236A-7EA2-4193-B62B-9638C88 BAFEA_1_en-USPrinted from: 2020 USPC 1117 MICROBIOLOGICAL best LABORATORY PRACTICES INTRODUCTIONGood LABORATORY PRACTICES in a microbiology LABORATORY consist of activities that depend on several principles: aseptic technique, control of media, control of test strains, operation and control of equipment, diligent recording and evaluation of data, and training of the LABORATORY staff. Because of the inherent risk of variability in microbiology data, reliability and reproducibility are dependent on the use of accepted methods and adherence to good LABORATORY PRACTICES . MEDIA PREPARATION AND QUALITY CONTROLM edia PreparationCulture media are the basis for most MICROBIOLOGICAL tests.

〈〈〈1117 〉〉〉〉MICROBIOLOGICAL BEST LABORATORY PRACTICES ... Storage of the media in the autoclave after the liquid cycle is ... Refrigerated purchased media should be allowed to warm up to ambient room temperature if it is to be checked for pH confirmation. A flat pH probe is recommended for agar surfaces, and an immersion probe is ...

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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).

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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

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

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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.

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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.

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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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STERILIZATION OF COMPENDIAL ARTICLES

latam-edu.usp.org

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.

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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.

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www.cdc.gov

Storage Best Practices for Refrigerated Vaccines–Fahrenheit (F) 1. Unpack vaccines immediately. VFC. 1. Place the vaccines in trays or containers for proper air flow. 2. Put vaccines that are first to expire in front. 3. Keep vaccines in original boxes with lids closed to prevent exposure to light. 4.

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Refrigerated Transportation Best Practices Guide

www.gcca.org

refrigerated transportation best practices guide 4 table of contents introduction 6 why a refrigerated transportation best practice guide?6 task force roster 7 pre-requisite programs and defined food safety procedures 7 1.1. appropriate equipment design and maintenance 8 1.2. vehicle and equipment storage 8 1.3. food safety procedures (fsp) 8 1.4. temperature …

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Temperature Monitoring Best Practices for Refrigerated …

www.cdc.gov

Best Practices. Refrigerated Vaccines. Too Cold! Take Action! Too Warm! Take Action! Within Range. 25˚ F 30˚ F 36˚ F 46˚ F 50˚ F. 40˚ F. Report out-of-range temperatures immediately! Never freeze refrigerated vaccines! Exception: MMR can be stored in refrigerator or freezer

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Temporary Food Facility (TFF) Application - Alameda …

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It’s best to remove any food particles or grease from the ... Ice may be used for cold storage of perishable foods if the ... chests or refrigerated trucks to maintain cold food items at or below 45˚ Fahrenheit. 14. Ice: Ice used to cool beverage. containers or to keep perishable.

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spoilage, food storage and food poisoning. An assessment of the food handling, safety, storage and hygiene practices by workers in Rwenzori and Mpanga tea estates revealed that: • Household ownership of food storage facilities varied with only 63% of …

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Administering Medication - United States Department of …

childcareta.acf.hhs.gov

, 3rd edition (CFOC3), is a collection of 686 national standards that represent best practices with respect to health and safety in early care and education settings. CFOC3 can help programs and providers implement CFOCB, understand rationale, and move to higher levels of quality in health and safety. CFOC3 is available at

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METRIC January 5, 2012 SUPERSEDING A-A-20143A January 5, …

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shells shall have at least one-third of the manufacturer’s stated “best by date” or “sell by date” remaining when accepted by the purchaser. 5.5.2 Extended shelf life. The Style D tortillas shall have a five year shelf life, from date of manufacture, when stored at …

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Insulated Metal Panels - All Weather Insulated Panels

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the best life cycle costs of any product available today. Erection speed is the key to many projects today. Higher installation rates can be achieved with insulated metal panels. Depending on job complexity and size, insulated metal panels can be erected at a rate of up to 5,000 sq. ft. per 8-hour shift by a four-man

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