PDF4PRO ⚡AMP

Modern search engine that looking for books and documents around the web

Example: confidence

660 〉〉 CONTAINERS—GLASS

Printed on: Fri Apr 03 2020, 16:41:29 pmPrinted by: Deborah NishikawaOfficial Status: Currently Official on 03-Apr-2020 Official Date: Official as of 1-May-2015 Document Type: GENERAL CHAPTERDocId: 1_GUID-67466D06-7 DCC-46C2-A61F-013D827120C6_1_en-USPrinte d from: 2020 USPC 660 containers glass DESCRIPTIONG lass containers for pharmaceutical use are intended to come into direct contact with pharmaceutical products. glass used for pharmaceutical containers is either borosilicate (neutral) glass or soda-lime-silica glass . Borosilicate glass contains significant amounts of boric oxide, aluminum oxide, and alkali and/or alkaline earth oxides in the glass network. Borosilicate glass has a high hydrolytic resistance and a high thermal shock resistance due to the chemical composition of the glass itself; it is classified as Type I glass . Soda-lime-silica glass is a silica glass containing alkaline metal oxides, mainly sodium oxide, and alkaline earth oxides, mainly calcium oxide, in the glass network.

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.

Fullscreen Download

Tags:

  Glass, Container, Containers glass

Information

Domain:

Source:

Link to this page:

Please notify us if you found a problem with this document:

Spam in document Broken preview Other abuse

Transcription of 660 〉〉 CONTAINERS—GLASS

Documents from same domain

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 …

  Precision, Potentiometric

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.

  Steam, Sterilization

Related documents

BRIEFING 660 Containers Glass,

www.usp.org

660 Containers—Glass, USP 40 page 534. The Packaging and Distribution Expert Committee is proposing the following revision to clarify the intent of the chapter and provide additional information to aid in the execution of the Surface Glass Test, Glass Grains Test, and Surface Etching Test. None of the

  Glass, Container, Containers glass

General chapter 3.2.1 Glass containers for pharmaceutical use

www.edqm.eu

glass containers for pharmaceutical use . 2004: Deletion of type IV glass from the scope. Hydrolytic resistance: Distinction of vials/ bottles and ampoules in the hydrolytic resistance test. Introduction of flame spectrometric method in the annex (Ph. Eur. 5.0) 2010: Alignment of limits for hydrolytic resistance test for glass grains with

  Pharmaceutical, Glass, Container, Glass containers for pharmaceutical use, 1 glass containers for pharmaceutical use

Manufacturer’s Marks and Other Logos on Glass Containers

sha.org

Manufacturer’s Marks on Glass Containers. First letter indicates the chapter (e.g. A = chapter on A logos) : name of section with chapter (e.g., American GW-Pitts is the section on the American Glass Works, Pittsburgh, PA. 5. Created Date:

  Glass, Other, Logo, Container, Manufacturers, Marks, Containers glass, Manufacturer s marks and other logos on glass containers

3.2.1. Glass containers for pharmaceutical use 01/2008 ...

www.biomed.co.th

Glass containers for pharmaceutical use 01/2008:30200 3.2. CONTAINERS A container for pharmaceutical use is an article that contains or is intended to contain a product and is, or may be, in direct contact with it. The closure is a part of the container.

  Glass, Container, Containers glass

Type I Glass for Pharmaceutical Containers: Technical ...

www.dcvmn.org

“When glass containers for pharmaceutical use are manufactured under stressed conditions (e.g. temperature time profile) and/or are placed in contact with particularly aggressive pharmaceutical preparations, they may give rise to delamination, i.e. the separation of the inner glass surface into

  Glass, Container, Containers glass

Holding Times and Containers - Eurofins Scientific

www.eurofinsus.com

D 24 hours 250 250-mL amber glass 4°C (no headspace) Carbon Dioxide RSK 175(M) 7; 40 2 × 40-mL VOA vials; 4°C (no headspace) Chemical Oxygen Demand (COD) SM 5220 D; 28 20; 250-mL glass H. 2. SO. 4 & 4°C Chloride EPA 300.0 / SM 4500-Cl. ...

  Glass, Container

Containers and Amounts - Teach-This.com

www.teach-this.com

a glass of water, orange juice, coke a can of coke, orange juice a carton of yoghurt, orange juice a jar of honey, marmalade a bunch of bananas a tube of tomato paste a box of crackers Activity Type Reading, matching and writing exercises Focus Containers and amounts Aim To match containers and amounts with food and drink items. Preparation

  Glass, Container

Material Safety Data Sheet WINDEX GLASS CLEANER (RTU)

www.kernair.org

WINDEX GLASS CLEANER (RTU) 90122 & 90135 & 90139 & 90940 & 94099 Industrial/Institutional: Cleaning product. 4/8/2003 4/8/2003 Material Safety Data Sheet Product Name Product Use Validation Date Print Date In Case of Emergency Section 1. Chemical Product and Company Identification Supersedes 10/21/2002. Health 0 0 1 Fire Hazard Reactivity ...

  Glass

Packaging Guidelines for Clinical Samples

www.fedex.com

watertight containers for liquid specimens with a positive closure such as a screw-on, snap-on or push-on lid, taped for an additional seal. If you place multiple fragile primary receptacles in a single secondary receptacle, they must be individually wrapped or separated to prevent contact between them. 2. Absorbent material.

  Container

Vaccine Storage and Handling Guidelines

www.health.gov.on.ca

View through glass doors Refrigerators Used for Vaccine Storage Purpose-built refrigerators • Purpose-built refrigerators are the preferred refrigerators for vaccine storage for health care providers and are required for vaccine storage at public health units. • It is recommended that …

  Glass

Related search queries

Containers Glass, Containers—Glass, Glass, 3.2.1 Glass containers for pharmaceutical use, Glass containers for pharmaceutical use, Manufacturer’s Marks and Other Logos on Glass Containers, Glass containers, Containers