Powder flow tester manual powder flow tester tap density tester usp 1 and 2 peristaltic pumps variable speed series counter fch series precision dispensing pump. Strength and stability testing for compounded preparationsi usp. Moreover, simultaneous toctnb measurements can be carried out, leading to a higher information content of the analysis. Usp needs to incorporate safety concepts into its discussions about food ingredients and dietary supplements. Gas adsorption the surface area of powdered materials can be measured by adsorption of. In addition, while it is clear that no single and simple test method can adequately characterize the flow properties of pharmaceutical powders, this. Usp apparatus 4 flow through method primer the flowthrough method usp apparatus 4, designed to test the dissolution character istics of a wide range of dosage fontis, is becom ing incrensingly popular alllong the pharmaceutical hi erarchy. Rick schnatz, pharmd, manager compounding and healthcare standards, us pharmacopeial convention, 12601 twinbrook parkway, rockville. Powder flow tester manual powder flow tester tap density tester usp 1 and 2 peristaltic pumps variable speed series counter fch series precision dispensing pump cassette pumps cascade head pump ceramic piston pump.
Usp xxiinf xvii 1990 644645, united states pharmacopeia convention, inc. Usp needs to think about modernization in terms of complete systems and implementation of qualitybydesign qbd in addition to individual standards. Strength and stability testing for compounded preparationsi. Sodium hydroxide, pellets, nf is used as a ph adjusting agent. The reagent equivalency factor, the recommended titration volume, buret size, and amount of standard to. Since there was no web posting at the time of signoff of this chapter, all previous pdg signoffs and stage 6 postings are summarized as below. The complete and current version of the participant manual is available free of charge on the usp website at. In addition, while it is clear that no single and simple test method can adequately characterise the flow properties of pharmaceutical powders, this chapter.
Making sure you have uptodate information chapter 4 the usp convention process. For smallvolume parenterals less than 25 ml in volume, the contents of 10 or more units are combined in a cleaned container to obtain a volume of not less than 25 ml. Wassgren 20 nj center for engineered particulates microscopy size measures can get particle shape simultaneously. The advantage of the combustion method is its high oxidation potential, especially for samples containing particulate matter.
Some minor discrepancies are still found in details of the respective monographs. Our experts are happy to find or develop a solution tailored to. Drained angle of repose is determined by allowing an excess quantity of material positioned above a fixed diameter base to drain from the container. November 29, 2006 demystifying the standardssetting process. Mathematical correlation between physical data and microbial effect is extremely poor. Usp and contamination recovery rates scott sutton abstract united states pharmacopeia usp microbio logical control and monitoring of aseptic processing environments approaches analysis of environmen tal monitoring em data in the aseptic core from a perspective of contamination recovery rates while. We therefore conducted measurement of a potassium hydrogen phthalate solution with a 0.
Laboratories that have the capability of performing d value assays could conduct a d value determination using one of the three methods cited in the general test chapter biological indicatorsresistance performance tests 55 and in the appropriate usp monographs for specific biological indicators. The first documented concept of the flowthrough cell. It contains sections that describe 14 of the 40 functional categories identi. General chapter will apply to drug products currently in the usp nf. Flow properties of powders and bulk solids page 2 k h v 1 typical values of k are between 0. Structure of ep and usp and their enforcement additional pharmacopoeias around the world japan, china, india, int. Relative retention packaging and storagepreserve in tight containers. In the case of this book, it is the opinion of the author that the terms required to interpret the united states pharmacopeia usp and the national formulary nf and understand their processes is more appropriately placed upfront in the volume. Where sigma product or stock numbers are specified, equivalent reagents may be substituted. Light scattering other automatic particlesize measuring instrument employs the light scattering principle. Usp a harmonized standard for powder flow has been approved by the pharmacopeial discussion group pdg as described in its pdg signoff cover page.
Procedureallow an excess of powder to flow through. Chapter 1 the glossary of terms is usually included at the end of a manuscript. United state pharmacopeia usp 30 national formulary nf 25 by. It has been incorporated into several international pharl11lcopoeias. Flow properties and corresponding angles of repose1 flow property angle of repose degrees excellent 2530 good 35 fair aid not needed 3640. While usp class vi certification is not required for pharmaceutical processing, many pharmaceutical customers seeking iso9000 certification have requested it. The retention time for propylene glycol is 4 min1,2propanediol 57556. Usp needs to lead discussions on biologies and biosimilars. Mass of a substance that passes through a given surface per unit time. Usp apparatus 3 online dissolution systems 8 station with syringe pump 14 station with syringe pump onoffline dissolution systems. The test is carried out under conditions limiting particulate matter, preferably in a laminar flow cabinet. Biological indicators may also be used to evaluate the capability of processes used to decontaminate isolators or aseptic cleanroom environments. Sotax flyer ce 7smart usp 4 euro 12seitig teknokroma. The pf1 powder flow tester has been specifically designed for standardized testing in full compliance with pharmacopeia requirements as laid down in usp.
United state pharmacopeia usp 32 national formulary nf 27 by us pharmacopoeial convention. Mass flow rate is the easier of the methods, but it biases the results in favor of highdensity materials. Navigate our instrument portfolio according to applicable standards and norms or contact us directly. One unit is equivalent to one nf unit as determined by the method described in usp xxiinf xvii combined edition, p. Pharmaceutical companies are beginning to refer to the usp 429 test as a guideline when using laser diffraction for particle size analysis. Significant excursions excursions beyond approximately 15 cfu recovered from a. Cohesionflow characterization using several powder testers dave. United states pharmacopeia 38na tional formulary 33. Proposed new usp general information chapter, excipient. It needs to go beyond developing new general chapters for usp nf.
General chapter pharmaceutical compounding sterile. Comparative evaluation of flow for pharmaceutical powders and granules article pdf available in aaps pharmscitech 91. Wassgren 20 nj center for engineered particulates microscopy size measures. United state pharmacopeia usp 32 national formulary nf 27. Now in the sepoct 2014 usp pharmacopeial forum for public comment. System suitability can be verified by using the usp particle count rs.
Usp will apply general chapters and to monographs via general notices provision 5. Includes free cd rom using the new usp nf print with interactive presentation. Flow properties of powders and bulk solids dietmar schulze1 in order to compare and optimize powders regarding flowability and to design powder handling equipment like silos, feeders, and flow promoting devices, it is necessary to know the mechanical properties the socalled flow properties. Supplements are included in the price and will be issued in february and june 2007. Usp 911 viscosity capillary viscometer methods products by standard safe footing. The usp specifies the use of an instrument capable of toc quantitation below 0. The cdrom version is also available isbn 1889788511. United states pharmacopeia usp and the european pharmacopeia ep 2. Very carefully wash the glassware and filtration equipment used, except for the membrane filters, with a warm detergent solution, and rinse with. This stimuli article presents draft general information chapter excipient performance h1059i prepared by the usp excipient general chapters expert committee. The flowthrough apparatus is currently monographed in usp, ph. Annex vi of and equipment, and international peace institute.
The revision of the united states pharmacopoeia usp general chapter elastomeric closures for injection dating from may 2009 harmonised it with the european pharmacopoeia ph. Dealing with different compendial methods 1415 may 2019, barcelona, spain mr ms title, first name, surname company department important. Usp apparatus 4 flow terry through method primer sollix. Usp 911 viscosity capillary viscometer methods anton paar. Parenteral drug association pda by claudio denoya, phd, and gilberto dalmaso, phd, particle measuring systems the recently revised united states pharmacopoeia usp chapter microbiological control and monitoring of aseptic processing. In the case of this book, it is the opinion of the author that the terms required to interpret the united states pharmacopeia usp and the national formulary nf and understand their processes is more appropriately placed upfront in. Teflon pfa fluoroadditives in applications regulated by the. Apr 11, 2014 united state pharmacopeia usp 32 national formulary nf 27 by us pharmacopoeial convention. History of usp apparatus 4 and the flowthrough cell. Method ib residual titration principlesee the information given in the section principle under method ia. Usp packaging storage and distribution expert committee. For largevolume parenterals, single units are tested. It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. Xii monograph high performance liquid chromatography hplc is a method of gel column chromatography where the mobile phase is a fluid moving through a.
Formation of a cone of powder on the fixed diameter base allows determination of the drained angle of repose. Demystifying the standardssetting process of the usp nf. Pdf comparative evaluation of flow for pharmaceutical. Defined physical parameters have proven problematic. Which standards and norms do you need to comply with. A vibrator is occasionally attached to facilitate flow from the container. Dynamic angle of repose is determined by filling a cylinder with a clear, flat cover on one end and rotating it at a specified speed. It needs to go beyond developing new general chapters for uspnf. General pharmacopoeia monograph highperformance gpm. The flow through cell design of the usp apparatus 4 is a more practical approach to dealing with microspheres, liposomes, stents, and other novel dosage forms. The principles and requirements for these applications are described under sterilization and sterility assurance of compendial articles 1211. Nf more than 4500 monographs the usp nf is the official authority fdaenforceable standards.
All spectrum chemical nf products are manufactured, packaged and stored under current good manufacturing practices cgmp per 21cfr part 211 in fda registered and inspected f. The uspnf is a combination of two official compendia, the united states pharmacopeia usp and the national formulary nf. The paddlebasket system is described in usp, the european, the japanese and many other pharmacopoeias. Uspnf sf in which s is the volume, in ml, of the reagent consumed in the second titration. Learning the language of the usp chapter 2 brief history of the united states pharmacopeianational formulary chapter 3 usp publications. Who harmonisation of ep, usp, jp ep, usp testing for organic impurities implementation of ich q3d differences and similarities analytical instrument qualification according to ep and usp. In the residual titration, excess reagent is added to the test specimen, sufficient time is allowed for the. Significant excursions excursions beyond approximately 15 cfu recovered from a single iso 5 sample, whether. Usp testing was done to support use of these fluoropolymers in pharmaceutical processing and food processing applications. Powder flow 801 a slope of 1, passing through the origin. The flowability tester bep2 from copley provides a range of options for testing pharmaceutical powders including three of the four.
General chapter will apply to drug products currently in the uspnf. Settle plate exposure under unidirectional airflow and the effect of weight loss upon microbial. Teflon pfa fluoroadditives in applications regulated by. Knowledge of flow properties of a powder or bulk is necessary to design bulk solid handling equipment so that no flow problems flow obstruction, segregation, irregular flow, flooding, etc occur. This information is excerpted from the participant manuals for the verification programs. This can be performed either in solution or in the dry powder state. Determination of flow properties of powders authorstream. Usp microbiological control of aseptic processing environments and its implications source. Defining the 5 year revision cycle chapter 5 the standard setting process. Includes free cd rom using the new uspnf print with interactive presentation.
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