The recently revised united states pharmacopoeia usp chapter 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. Feb 07, 2017 white paper microbiological environmental monitoring data 1. The second purpose is to present examples of the charting of 1 microbial counts, 2 contamination recovery rates as suggested by usp 1116, and 3 instantaneous contamination rates using data taken from environmental monitoring programs of pharmaceuticals manufacturing facilities. Many life science industries base their em programs on usp microbiological control and monitoring of aseptic processing environments or iso 14698 cleanrooms and associated controlled environments biocontamination control. May 27, 2015 usp 1116 and its implications for measuring microbial recovery rates may 27, 2015 the recently revised united states pharmacopoeia usp chapter microbiological control and monitoring of aseptic processing environments includes a thorough description, definitions and guidance on microbiological control and monitoring in aseptic. Sep 30, 2015 environmental monitoring em generates a large amount of data. Usp 1116 and its implications for measuring microbial recovery rates may 27, 2015 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. White paper microbiological environmental monitoring data. Microbial characterization, identification, and strain typing. 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. Scribd is the worlds largest social reading and publishing site. Limitations of microbial environmental monitoring methods in.
Microbiological best laboratory practices general information usp 35 glassware or from prior materials used in the glassware. Microbiology controls environmental monitoring programs. How can we extract information from a mound of em data. Considerations for environmental and personnel monitoring t. The environment should be sampled during normal operations to allow for the collection of meaningful data. Settle plate exposure under unidirectional airflow and the effect of weight loss upon microbial. Uspnf establishes standards for medicines, food ingredients and dietary supplements. The proper role of environmental monitoring in aseptic processing. Usp and its implications for measuring microbial recovery rates 1 800 238 1801 page 1 of 8 the recently revised united states pharmacopoeia usp chapter microbial control and monitoring of aseptic processing environments includes a thorough description, definition and guidance on microbial. Can measure a variety of particle sizes, most commonly 0. Usp and its implications for measuring microbial recovery rates 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 environments includes a thorough description, definitions and.
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 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. Feb 27, 2014 usp 36 chapter 1116 environment monitoring 1. Usp 1116 microbiological control of aseptic processing environments and its implications source. Environmental monitoring program documented program, implemented through standard operating procedures, that describes in detail the procedures and methods used for monitoring particulates as well as microorganisms in controlled environments air, surface, personnel gear. Charting and evaluation of environmental microbial monitoring. The pharmaceutical microbiology manual pmm evolved from the sterility analytical manual and is a supplement to the united states pharmacopeia usp for pharmaceutical. Bd offers a complete line of top quality products to support your compliance with usp. United states pharmacopeia usp microbiological control and monitoring of aseptic processing environments approaches analysis of environmental monitoring em data in the aseptic core from a perspective of. 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. However, the details of a pharmacy em program are subject to some confusion in the current regulatory environment, leaving many to wonder what sample sites, testing frequency, and investigations. Usp 1116 and contamination recovery rates the microbiology. Nonviable particulate monitoring iso 14644, fed std209e, usp 1116 a calibrated laser particle counter used to sample a defined volume of air.
Pdf environmental monitoring usp chapter 1116 researchgate. The 2008 revision to the chapter added monitoring requirements as well as changes to the methodology and frequency for viable air. Recommendations from usp on contamination recovery rates by scott sutton, ph. Bd bbl sterile pack plated media are specifically designed to minimize the risk of false positive results and the introduction of contaminants into critical environments. Be media should be labeled properly with batch or lot num. Who recommended viables monitoring frequencies 15 2 the practice of air sampling at the start, middle, and end of filling operations provides better environmental monitoring and facilitates investigations related to filling batch release. Good laboratory practices in a microbiology laboratory consist of activities that depend on several principles. Usp bioburden control of nonsterile drug substances. This approach should be part of a general environmental monitoring strategy. Environmental microbial monitoring and analysis of data by qualified personnel will permit the status of control to be maintained in clean rooms and other controlled environments.
Environmental monitoring guidance, background to usp, main changes and debates method limitations, incident rates, frequencies of monitoring, locations of. Pharmaceutical compoundingste rile preparations introduction the objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from 1. Environmental monitoring is usually performed by person. Particle counts are recorded as the number of particles per volume of air sampled. Nonviable particulate monitoring iso 14644, fed std209e, usp a calibrated laser particle counter used to sample a defined volume of air. Environmental microbial monitoring and analysis of data by qualified. Additional mention is given to personnel and their garbing and gloving, along with aseptic technique, all of which are part of environmental monitoring.
Feb 04, 20 listen as william stuart, rph gives his notations regarding recent regulatory changes affecting compounding pharmacies as a result of the recent meningitis outbreak, as well as information gained. Environmental monitoring guidance, background to usp, main changes and debates method limitations, incident rates. Usp chapter pays special attention to the evaluation, provision and maintenance of air quality. 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. Environmental monitoring guidance, background to usp 1116, main changes and debates method limitations, incident rates, frequencies of monitoring, locations of monitoring, other. Taking full advantage of microbiological environmental monitoring data last update. The second edition of bergeys manual represented a ma deposition in. Usp 1116 microbiological control of aseptic processing. Effective environmental monitoring microbiology network. Focus laboratories has over 20 years of providing cleanroom environmental monitoring testing and consultation services. Trending of the em data is one way that fda recommends extracting the.
Pharmaceutical compoundingsterile preparations 1 change to read. Trending in the environmental monitoring program american. Usp 1116 microbiological control and monitoring of aseptic processing environments usp 1115 bioburden control of nonsterile drug substances and products fda aseptic processing guideline eu annex 1 japan aseptic processing guide and jp aami tir 52 environmental monitoring for the manufacture of terminally. Gibraltar laboratories starts out with creating a protocol that describes the locations and specifications with respect to airborne viable and nonviable particulates and surface. Usp 1116 microbiological control and aseptic processing environment monitoring. Usp 1116 environmental monitoring sterilization microbiology. Recommendations from usp on contamination recovery rates. Usp guidances on environmental control including related. Pdf new guidance for environmental monitoring in cleanrooms. Usp and cgmps agree that compounding personnel represent the impact of usp on environmental monitoring comprehensive monitoring is essential both usp and cgmps require concentrated em efforts to ensure the facility is maintained in a manner that does not adversely affect the quality and safety of csps. General chapter usp establishes best practices and regulations for the production of compounded sterile preparations. As manual interventions during operation increase, and as the potential for. Environmental control and monitoring of nonsterile processes either range from nonexistent to parallel programs to aseptic processing data generated from some programs may be of little value for the control of the microbiological quality of nonsterile environments in which the product is manufactured mestrandrea consulting. Usp 1116 microbiological control and aseptic processing.
Clean operations practical application of rapid the usp in usp 35nf 30, now entitled microbiological control and monitoring of aseptic processing environments. Usp guidances on environmental control including related usp. Cleanroom environmental monitoring usp 797 microbial. Microbial characterization, identification, and strain typing general information table 4. Eu 04 usp annex 1 fda 1116 aseptic core a environment monitoring is incapable of. The program includes sampling sites, frequency of sampling, and.
Even relatively small programs can generate hundreds of data points, however, raw data is not useful until it has been analyzed and yields information. Cleanroom em usp 1116 and iso microbiological monitoring of. A tworow by twocolumn contingency table with microbial characterization. Usp guidances on environmental control including related usp, fda. Apr 20, 2018 environmental monitoring em program requirements are currently described in the 21 code of federal regulation cfr 211. Usp suggests using percent contamination recovery rate as the. 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 contamination recovery rates while noting a need to improve em data analysis. The use of colony growth, respect to the reference culture method and the alternate cellular morphology, differential staining, and key diagnostic. A microbiological control and monitoring of aseptic. Environmental monitoring is a critical component of a companys overall activity. Recommendations from usp on contamination recovery. 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.