Usp 38 the united states pharmacopeia 1nf 33 the national formulary volume 4a by authority of the united states pharmacopeial convention prepared by the council of experts and its expert committees official from may 1, 2015 the designation on the cover of this publication, usp nf 2015, is for ease of identification only. Antimicrobial effectiveness must be demonstrated for multipledose topical and oral dosage forms and for other dosage forms such as ophthalmic, otic, nasal, irrigation, and dialysis fluids see pharmaceutical dosage forms 1151. Usp 39 published general chapter residual host cell protein measurement in biopharmaceuticals the official version can be found in the uspnf. Documentation should be on file demonstrating the quality of the required utilities such as steam, water, and air. Preservatives are antimicrobial ingredients that are added to aqueous product formulations to. The united states pharmacopeia usp was created nearly 200 years ago, dedicated to instilling trust where it matters most. United states pharmacopeia 39, national formulary 34 usp, general chapter 800, 2016 section 5. Settle plate exposure under unidirectional airflow and. Studies indicate that gowned humans slough particulate and microbial contamination at a rather consistent rate. This chapter is now specific to em of aseptic processing environments. Usp and its implications for measuring microbial recovery. Thermo scientific orion ph meter kits are part of a highquality ph test method designed to assist with compliance to usp.
Aug 19, 2016 by claudio denoya, phd, and gilberto dalmaso, phd, particle measuring systems. When it was revised and released in december 20, the title was shortened to balances, which clearly indicates the chapters major area of application. Those portions toxin is expressed in endotoxin units eu. Parenteral drug association pda by claudio denoya, phd, and gilberto dalmaso, phd, particle measuring systems the recently revised united states pharmacopoeia usp chapter 1116 microbiological control and monitoring of aseptic processing. Pda, pda comments on proposed revisions to usp chapter 1116, pda letter. Significant excursions excursions beyond approximately 15 cfu recovered from a single iso 5 sample, whether. Usp preservative challenge test microchem laboratory. The effectiveness of a disinfectant depends on its intrinsic biocidal activity, the concentration of the disinfectant, the contact time, the nature of the surface disinfected, the hardness of water used to dilute the disinfectant, the amount of organic materials present on the surface, and the type and the number of microorganisms present. No widely accepted standards for the various facility designs. Usp microbiological control and monitoring of aseptic. Environmental protection agency epa or the drinking. Feb 27, 2014 usp 36 chapter 1116 environment monitoring 1. The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from 1 microbial contamination nonsterility, 2. Limitations of microbial environmental monitoring methods in.
The following points on the conventional way to evaluate microbial contamination are discussed. Microbiological best laboratory practices general information usp 35 glassware or from prior materials used in the glassware. The use of colony growth, respect to the reference culture method and the alternate cellular morphology, differential staining, and key diagnostic pcr method after iso 57251 and 57252 2004 features to. The quality standards we develop help manufacturers deliver on their promises of safe products, while building confidence among healthcare. Usp 1116 and iso 14698 many life science industries base their em programs on usp 1116 microbiological control and monitoring of aseptic processing environments or iso 14698 cleanrooms and associated controlled environments biocontamination control. The guidance provided in this chapter and the monitoring. May 27, 2015 usp 1116 emphasizes that these specifications should be used only as a general guide due to the numerous variations on designs and operational use of cleanrooms. Combined index to usp 39 and nf 34 abacaacety i1 combined index to usp 39 and nf 34, including first supplement page citations refer to the pages of volumes 1, 2, 3, and 4 of usp 39nf 34 and its first supplement. Where equipment is the primary source of particulate matter, the resulting particulates are essentially all nonviable. The operational qualification stage is intended to confirm that the empty chamber functions within the.
In may 2012 the united states pharmacopeia usp, rev. The use of colony growth, respect to the reference culture method and the alternate cellular morphology, differential staining, and key diagnostic. Usp bioburden control of nonsterile drug substances. Chapter 1116 is arguably one of the most comprehensive informational chapters from the usp, and it is particularly challenging due to its proposal regarding measurement of microbial contamination based on contamination recovery rates crr rather than the conventional enumeration of colony forming units cfu. All modifications will become official on may 1, 2016 with usp 39 nf 34.
General chapter biological assay validation 2 is a companion chapter to three other proposed usp chapters pertaining to 3 bioassay. I2 acetyalumi combined index to usp 39 and nf 34 acetyltriethyl citrate, 7141 isoproterenol sulfate inhalation, 4420 alfuzosin hydrochloride, 2371 nacetyltyrosine, 6448 lidocaine topical, 4560 extendedrelease tablets, 2372 nacetylltyrosine ethyl ester, 2085 metaproterenol sulfate inhalation, 4757 alginates assay. A mode of processing pharmaceutical and medical products that involves the separate sterilization of the product and of the. Some dosage forms of drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation e. The recently revised united states pharmacopoeia usp chapter 1116 microbiological control and monitoring of aseptic processing environments includes a. A balancing quantity of cations, such as sodium ion, is. The use of colony growth, respect to the reference culture method and the alternate cellular morphology, differential staining, and key diagnostic pcr method after iso 57251 and 57252 2004 features to characterize a laboratory. Use these solutions to prepare the standard response line. Usp suggests that microbial recoveries should be identified at a rate sufficient. Be media should be labeled properly with batch or lot numsure that the cleaning process removes debris and foreignbers, preparation and expiration dates, and media identifica. For more information on how to access the usp nf click here.
For biological indicator for dryheat sterilization, paper carrier, preheat the unit to temperature, and equilibrate the heat chamber. Usp 39 s2 revisions to informational chapter water for pharmaceutical purposes joe manfredi gmp systems, inc. This index is repeated in its entirety in each volume. Usp 1116 and its implications for measuring microbial recovery rates 1 800 238 1801 page 3 of 8 7. Open the access door or port, and place the holder s in the chamber, close the access door or port, and continue to operate the apparatus. Nf more than 4500 monographs the uspnf is the official authority fdaenforceable standards. Chapter 1116 emphasizes that if human operators are present, microbial contamination at some level is inevitable. It is not possible to clearly distinguish between background. Settle plate exposure under unidirectional airflow and the effect of weight loss upon microbial. For example, the accuracy of the assays of heparin sodium and vitamin b 12 activity, as well as the pyrogen and total organic carbon tests, are particularly dependent upon scrupulously.
Cleanroom em usp 1116 and iso microbiological monitoring. Usp 39 1116 studies indicate that gowned humans slough particulate and microbial contamination at a rather consistent rate. Microbial characterization, identification, and strain typing general information usp 36. Portions of this general chapter have been harmonizedtions in the package leaflet and on the label for preparation with the corresponding texts of the european pharmacoand storage of the standard endotoxin stock solution. So far, the usp chapter 41 was entitled weights and balances. To ensure adherence to certain minimal chemical and microbiological quality standards, water used in the production of drug substances or as source or feed water for the preparation of the various types of purified waters must meet the requirements of the national primary drinking water regulations npdwr 40 cfr 141 issued by the u. Microbial characterization, identification, and strain typing.
It need not meet the requirement under smallvolume injections in the general test chapter particulate matter in. This chapter includes discussions on 1 the classification of a clean room based on. Recommendations from usp on contamination recovery rates. Usp chapters and implementation strategy kahkashan zaidi, ph. Usp bioburden control of nonsterile drug substances and products. Commence timing the heat exposure when the chamber temperature returns. Chapter proposes a new way to look at microbiological data by adopting crr as percentage value of maximum allowed contaminated. Operational intentions vary much more widely than in aseptic processing. Usp guidances on environmental control including related.
Usp 39 published general chapter residual host cell protein measurement in biopharmaceuticals the official version can be found in the usp nf. Alcohol thermometers may have a precision as good as 0. Hands and surgical sites are disinfected in a hospital setting to reduce the resident flora and to remove transient flora e. Reorganized existing chapter to group similar topics together, eliminate redundancies, and clarify requirements. Sterile water for irrigation sterile water for irrigation see usp monograph is water for injection packaged and sterilized in singledose containers of larger than 1 l in size that allows rapid delivery of its contents. Revisions to chapter include the introduction of compendial standards for packaging desiccants. Each worksheet then lists the monographs and general chapters with affected references. Usp 1116 emphasizes that these specifications should be used only as a general guide due to the numerous variations on designs and operational use of cleanrooms. A tworow by twocolumn contingency table with microbial characterization. Much like a preservative challenge screen, it is used to evaluate the effect of preservatives in cosmetics, personal care products, and drug products. The conductivity of the ubiquitous chloride ion at the theoretical endpoint concentration of 0. As manual interventions during operation increase, and as the potential for.
Usp 1116 microbiological control and monitoring of aseptic processing. Microbial characterization, identification, and strain typing general information table 4. Usp, usp 1116 microbial control and monitoring of environments used for the manufacture of healthcare. They also stress that, in many cases, the magnitude of 2012 mpn usp usp. In december 2014, a new version of usp officially went into effect. For biological indicator for dryheat sterilization, paper carrier, use an apparatus of known thermodynamic characteristics that has been validated for compliance with the requirements for safety 1 and performance, 2 that consists of a sterilizing chamber equipped with a means of heating the contained air, preferably electrically rather than gas fired, and that has adequate. Chapter 1116 is arguably one of the most comprehensive informational chapters from the usp, and it is. United states pharmacopeia usp 1116 microbiological control and monitoring of aseptic processing environments approaches analysis of environmental monitoring em data in the aseptic core from a perspective of. As discussed below in validation of temperature and humidity monitoring devices, it is not possible to calibrate an individual chemical tti because the test is, by the nature of the device, necessarily destructive.
Usp 1094 capsulesdissolution testing and related quality attributes usp 2040 disintegration and dissolution of dietary supplements ep 2. A limited number of usp nf items have microbial limits controls indicated as part of the monograph, but. The second edition of bergeys manual represented a ma deposition. Usp guidances on environmental control including related usp.
The recently revised united states pharmacopoeia usp chapter 1116 microbiological control and monitoring of aseptic processing environments includes a thorough description, definitions and guidance on microbiological control and monitoring in aseptic processing environments 1. Examples of designs for hazardous drug compounding areas, 2016. Pdf microbiological control and monitoring of cleanrooms. For the purposes of this chapter, csps include any of the following. Usp 1116 microbiological control and aseptic processing environment monitoring. Nf more than 4500 monographs the usp nf is the official authority fdaenforceable standards. We provide testing for auxiliary packaging components in accordance with all requirements and revisions to current usp chapters. By claudio denoya, phd, and gilberto dalmaso, phd, particle measuring systems. This version of is part of the second supplement to usp 37nf 32. The case for crr chapter 1116 emphasizes that if human operators are present, microbial contamination at some level is inevitable.
Usp 39, nf 34 general chapter operator protection from. It is proposed to revise this chapter to improve clarity, respond to stakeholder input, and reflect new science. Strains of the test microorganisms suitable for use in for products containing a mercurial preservative that cannot the growth promotion test and the method suitability be tested by the membrane filtration method, fluid thiogtest continued. Chemical timetemperature indicators are relatively inexpensive and may be customized for a wide range of applications. Usp 1116 microbiological control of aseptic processing. For more information on how to access the uspnf click here. The recently revised united states pharmacopoeia us p chapter 1116 microbial control and monitoring of aseptic processing environments chapter 1116 is arguably one of the most comprehensive informational chapters from the usp, and it is particularly challenging due to its proposal. Usp, usp 1116 microbiological evaluation of clean rooms and other controlled environments. Usp and its implications for measuring microbial recovery rates. This chapter provides tests to demonstrate the effectiveness of antimicrobial protection. Recommendations from usp on contamination recovery. There were significant problems right from the onset.
The usp chapter 51 preservative challenge test is the most common method used to gauge preservative effectiveness. United states pharmacopeia 39, national formulary 34 usp, general chapter 800, section 2. Usp 1116 microbiological control of aseptic processing environments and its implications source. Usp was first proposed in 1991 to add a new general information chapter on the evaluation and classification of clean rooms and clean zones for. Mercury thermometers are typically used in the ranges from 0 to 50 with a precision of about 0. Heavy metals deletion date o jan 1, 2018 publish omission of general chapter o published in usp 38nf 33 with an official date of december 1, 2015. Like usp 1116 they note that most data are zero from these areas, and this makes any type of data analysis difficult. A list of the monographs and general chapters that will be modified can be found here.