Microbial characterization, identification, and strain typing general information usp 36. How to establish growth promotion tests for pharmaceutical. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists. Pharmaceutical compounding nonsterile preparations. The case for crr chapter emphasizes that if human operators are present, microbial contamination at some level is inevitable. 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. General chapter biological assay validation 2 is a companion chapter to three other proposed usp chapters pertaining to 3 bioassay. The value of k is the change in potential per unit change in ph and is theoretically 0. A tworow by twocolumn contingency table with microbial characterization. The united states pharmacopeia usp was created nearly 200 years ago, dedicated to instilling trust where it matters most.
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. Usp chapter pays special attention to the evaluation, provision and maintenance of air quality. Cfug, the total combined molds and yeasts count does not exceed 5x10. A suitable substance or mixture of substances to prevent the growth of microorganisms must be added to preparations intended for injection that are packaged in multipledose containers, regardless of the method of sterilization employed, unless one of the following conditions prevails. Usp general notices and requirements, or monographs. Must be downloaded with registration directly from. Microbial characterization, identification, and strain typing. Revision of usp chapter on environmental monitoring. United states pharmacopeia general chapter microbiological control and monitoring of aseptic processing environments, usp 35nf30 2012.
Since the official chapter was first published, and as part of a quality improvement plan for a usp chapter, both expert committee and comments from the public already have led to some. Usp 1116 microbiological control and aseptic processing environment monitoring. Usp general chapters and compounded monograph chapters. In the pharmaceutical industry, the united states pharmacopoeia usp set of standards for managing balances is widely recognized around the world. The types of chromatography useful in qualitative and quantitative analysis that are employed in the usp procedures are column, gas, paper, thinlayer, including highperformance thinlayer chromatography, and pressurized liquid chromatography commonly called highpressure or highperformance liquid chromatography. All equipment used for recording, monitoring, and maintaining temperatures and humidity conditions should be calibrated on a regular basis. The usp chapter is a general information chapter providing information and recommendations for environments where the risk of microbial contamination is controlled through aseptic processing.
This chapter provides background on the science and technology of temperature and humidity monitoring. Good storage and shipping practices1 internationally harmonized documents intended to assist. 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. The purpose of this chapter is to provide general information to guide and assist pharmacists in performing the necessary calculations when preparing or compounding any pharmaceutical article see pharmaceutical compoundingnonsterile preparations 795, pharmaceutical compoundingsterile preparations 797, and good compounding practices 1075 or when. Combined index to usp 40 and nf 35 abacaacety i1 combined index to usp 40 and nf 35, volumes 14. Mercury thermometers are typically used in the ranges from 0 to 50 with a precision of about 0. Usp microbiological control and monitoring of aseptic processing environments significant changes made to usp in late 2012 this chapter is now specific to em of aseptic processing environments sterile products, bulk sterile drug substances, sterile intermediates, excipients. Mix the lcystine, sodium chloride, dextrose, yeast extract, and pancreatic digest of casein with the purified water, and heat until solution is effected. For the purpose of this chapter, the date or time after which a csp shall not be stored or transported. Theyre what patients deserve and what usp strives to ensure across the globe through the development of public quality standards. Note some local regulations apply to mercurybased thermometers. 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. In may 2012, with the publication of the 35th edition of the united states pharmacopoeia usp, the chapter pertaining to the environmental monitoring of cleanrooms was updated. Unitofuse containers are reprocessed or repackaged as instructed by the manufacturer or as directed in the general test chapters containersglass 660 and containersplastics 661 or in the general information chapter packaging practicerepackaging a single solid oral drug product into a unitdose container 1146.
The shelf life of a drug is a function of the temperature and humidity conditions. The chapter provides a good discussion of how to evaluate these events for significance, a general input on methodology, and a glossary of terms. Use of antiseptics to disinfect hands has been shown to be more effective than soap and water in reducing the. Plasmabased techniques are heavily dependent on sample transport into the plasma, and because icpaes and icpms share the same sample introduction system, the means by which samples are prepared may be applicable to either. Usp 1094 capsulesdissolution testing and related quality attributes usp 2040 disintegration and dissolution of dietary supplements ep 2. 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. Usp 1116 and contamination recovery rates the microbiology.
The following points on the conventional way to evaluate microbial contamination are discussed. Usp general chapter faqs usp general chapter education courses sign up for usp updates authorized reprint for individual use only. Usp current thinking general chapter microbiological control and monitoring of aseptic processing environments, recommends current thinking of ways to support microbiological control of aseptic environments, in particular clean rooms, restrictedaccess barrier systems rabs, and isolators used for aseptic processing. 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.
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. Chapter 1116 emphasizes that if human operators are present, microbial contamination at some level is inevitable. Procedures involve the use of various chemometric mathematical and statistical approaches with appropriate validation. Microbial characterization, identification, and strain typing general information table 4. Recommendations from usp on contamination recovery. Usp guidances on environmental control including related usp. Microbiological examination of nonsterile products. 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. Usp volunteers help shape the future of drug manufacturing. Microbiological best laboratory practices general information usp 35 glassware or from prior materials used in the glassware. The implementation of the following uspnf microbiology general chapters scheduled for august 1, 2007, has been postponed until may 1, 2009. The united states pharmacopeia usp chapter microbiological control and monitoring of aseptic processing environments describes growth promotion testing as a procedure used to demonstrate that media used in the microbiological environmental monitoring program, or in mediafill runs, are capable of supporting growth of indicator. Hands and surgical sites are disinfected in a hospital setting to reduce the resident flora and to remove transient flora e. Developing usp general chapter usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.
As we approach our 200th anniversary year in 2020, usp ceo ron. A limited number of uspnf items have microbial limits controls indicated as part of the monograph, but others do not. Like all general chapters numbered above, general chapter was informational. Usp and its implications for measuring microbial recovery rates 1 800 238 1801 page 3 of 8 7. Usp 1116 microbiological control of aseptic processing environments and its implications source. The current good manufacturingof a characteristic obtained by carrying out a specified test practice regulations 21 cfr 211.
In general, electronic model transfer is only recommended for another instrument of the same type and configuration. The quality standards we develop help manufacturers deliver on their promises of safe products, while building confidence among healthcare. Usp develops new standards related to sterilization and. Sample preparation is critical to the success of plasmabased analysis, and it is the first step in performing any analysis via icpaes or icpms. 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. Usp guidances on environmental control including related. The single calcudistribution practices for lated temperature at which the total amount of degrada tion over a particular period is equal to the. The section preservation, packaging, storage, and labeling under general notices and requirements provides definitions for storage conditions. Settle plate exposure under unidirectional airflow and. The date is determined from the date or time the preparation is compounded. It need not meet the requirement under smallvolume injections in the general test chapter particulate matter in. Pdf new guidance for environmental monitoring in cleanrooms. This chapter developed out of general chapter sterile products for home use, which took effect in usp 23 in 1995. This chapter includes discussions on 1 the classification of a clean room based on particulate count limits.
Studies indicate that gowned humans slough particulate and microbial contamination at a rather consistent rate. Usp and contamination recovery rates scott sutton abstract united states pharmacopeia usp 1116 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. Implications for longterm care and community pharmacies duration. Usp general chapter pharmaceutical compounding sterile preparations became official on january 1, 2004, in usp 27. 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. Dissolve the sodium thioglycollate or thioglycolic acid in the solution and, if necessary, add 1 n sodium hydroxide so that, after sterilization, the solution will have a ph of 7. The informal chapter of the usamerican pharmacopoeia usp, microbiological evaluation of clean rooms and other controlled. Microbiological best laboratory practices, usp is a living informational reference, which means that as the expert committee sees or hears of potential improvements, the chapter can be updated. It describes the available technologies and their performance characteristics, and it provides recommendations for verification and validation of performance. Alcohol thermometers may have a precision as good as 0. Those portions toxin is expressed in endotoxin units eu.
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