Usp requirements for sterile and nonsterile preparations. This study shows that the bactec fx system is suboptimal for product sterility testing, and it provides strong data to support the use of bactalert testing at 32. Validating and implementing a rapid sterility testing method a. Testing conditions for medical devices, such as sutures, are outside the scope of the ich recommendation. Usp general chapter 62 microbiological examination of nonsterile products. Usp chapter 71 sterility tests in usp 30, the second paragraph of chapter 71 states the following. This internationally harmonized test replaces the current method 3. Usp chapter sterility tests is internationally harmonized and describes two separate types of testsmembrane filtration and direct inoculation. Usp 71 sterility tests applies to substances, preparations, or articles which, according to the pharmacopeia, are required to be sterile.
Table 3 specifies the number of articles to be tested based on the batch size and table 2 specifies the quantity to be tested. Growth promotion test and method validation usp sterility test contains two qualifying. Sterility test, and usp sterility tests, can be used as interchangeable in the ich regions. 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. Mycoplasmas produce pinpoints or filaments over the indicator cell cytoplasm. Usp chapter 71 and iso 117372 im not familiar with usp 71 so i cant offer a specific judgement.
Comprehensive evaluation of compendial usp, bactalert. Japanese pharmacopoeia jp and united states pharmacopeia usp. Milliflex rapid method for sterility testing demonstrated that it is a viable alternative to traditional sterility testing and reduces time to result from 14 to five days. 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. The only content in usp relative to sterility tests will be the harmonized 71. This chapter provides guidelines for the validation of isolator systems for use in sterility testing of compendial articles.
There are two different gmps describing sterility in the united states. The assay is a regulatory expectation that has been in existence for some time and is mentioned in fda warning letters. Test and general chapter sterility tests have been included, which harmonizes with general chapter. Quality control analytical methodslaboratory considerations.
Any modifications of or variations in sterility test procedures from those described under sterility tests 71 should be validated in the context of the entire sterility assurance program and are not intended to be methods alternative to those described in that chapter. Sterility testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Seed the indicator cell culture at a suitable density ile. Situations when is unsuitable for product release testing sample size consideration. The pharmaceutical microbiology manual pmm evolved from the sterility analytical manual and is a supplement to the united states. Usp chapter sterility tests in usp 30, the second paragraph of chapter states the following. United states pharmacopeia chapter 71 sterility tests thomas c.
Method suitability control studies for microbial testing. Usp prescribes the sterility testing method used for pharmaceuticals and biologics. Sterility tests69 method the test is applied to substances, preparations, or articles which, according to the pharmacopeia, are required to be ster1. Those portions that are not harmonized are marked with symbols to specify this fact. I wonder if their deliberations bear on the relationship between the two approaches, and in particular if the committee is on record as expressing an opinion about usp 71. The following procedures are applicable for determining whether a pharmacopeial article purporting to be sterile complies with the requirements set forth in the individual monograph with respect to the test for sterility. The sterility test must be validated to determine if a contamination could be isolated if one were present as well as to determine the sensitivity of the assay usp chapter sterility test.
Test design usp chapter 71 sterility tests is internationally harmonized and describes two. Pharmaceutical testing lab sterility testing usp 71. Usp chapter 71 contains two tables that describe sampling. U s pharmacopeia usp 71 sterility testing reference standards. Meeting uspepcfr sterility testing requirements with a. Compare the microscopic appearance of the test cultures with that of the negative and positive controls, examining for extranuclear fluorescence. The views and opinions presented are entirely my own. Sterility test, and usp sterility tests, can be used as interchangeable in the ich regions subject to the conditions detailed below. Tests storage and beyonduse dating maintaining sterility. In this method, portions of inprocess andor final release product with the inoculation volume being based on the batch size of the product, as defined in usp 71 are inoculated into portions of.
In this study, we demonstrated that all sda control plates grew mold within the acceptable 144h time frame, compared with only 43. Sterility tests microbiological tests usp 35 fluid thioglycollate medium is to be incubated at 3035. We can test sterile product in one day via a rapid scan rdi method and are proud to produce. Pdf practical approach to sterility testing researchgate. 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. Chapter sterility tests as the prin ciple source used for. Products, from usp chapter release test examples criteria sterility usp. Eliminated the entire discussion of sterility testing at the conclusion of the chapter. This chapter examines some practical approaches to sterility test method validation. Annex 8r1 sterility test general chapter guidance for. Usp allows for alternate tests for any compendial method so long as that alternate method is demonstrated to be at least equivalent to the standard. The tests for bacterial and fungal sterility are carried out on the same sample of the product to be examined. The purpose of this article is to describe united states pharmacopeia chapter. The only content in usp relative to sterility tests will be the harmonized.
Institute of validation technology ivt, scott sutton, 20 6. Pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized. Only content in usp relative to sterility tests will be the harmonized. Portions of this general chapter have been harmonized with the corresponding texts of the european pharmacopeia andor the japanese pharmacopeia.
One of the most important aspects of usp chapter is method suitability. Inprocess bioburden testing of pharmaceuticals the story. When the volume or the quantity in a single container is. It is apparent that the quality assurance program of a compounding pharmacy cannot adhere to the strict requirements of some of the general chapters in the united states pharmacopeia. Usp chapter 71 are referee tests in other words they are in place solely to demonstrate conformance to qualities specified in the product monograph as described in the current national formulary nf the other part of the book. U s pharmacopeia usp 71 sterility testing reference. Usp revision process chapter revisions now official. Compounding pharmacists face a unique challenge in the industry today. Annex 8r1 sterility test general chapter guidance for industry.
Understanding the role of sterility testing in compounding f. 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. This test is specific for the detection of aerobic organisms which have been exposed. Portions of this general chapter have been harmonized with the. Federal food, drug, and cosmetics act designates the uspnf as the official compendia for. A fresh look at usp validation of alternative microbiological methods and how the revised chapter compares with pda tr33 and the proposed revision to ph.
Jan 30, 2019 usp chapter 71 usp 71 remains the most common method used for product sterility testing in the biopharmaceutical industry in the united states. Pharmaceutical sterility testing usp sterility testing of sterile pharmaceuticals is an important part of gmp microbiology, and is used to ensure that pharmaceutical and biopharmaceutical therapeutics are actually sterile and safe for human use. Thus, the challenge for rapid or alternate sterility tests is to demonstrate equivalence to usp 71. Thus, the challenge for rapid or alternate sterility tests is to demonstrate equivalence to usp. New harmonization with international compendia and overview duration. The test is applied to substances, preparations or articles which, according to the pharmacopoeia, are required to be sterile.
Biological reactivity tests, in vivo and sterility 17 safety concerns with gene therapy products. The sterility test usp section 71 is categorized under general requirements and is therefore a legal requirement. Intermediate steps can and should be tested for sterility but usp chapter 71 was not written and is not intended for this purpose. Negative mycoplasma direct and indirect culture method. Usp chapter are referee tests in other words they are in place solely to demonstrate conformance to qualities specified in the product monograph as.
Incubate at the specified temperaized, then it is to be assumed that the inhibited microorganism will ture for a period of time within the range specified in the test. Sterility testing is required during the sterilization validation process as well as for routine release testing. Usp sterility testing definition culture media and. P o r ti o ns o f thi s ge ne r a l c ha pte r ha v e be e n ha r m o ni z e d w i th the c o r r e s po ndi ng te x ts o f the eur o pe a n.
United states pharmacopeia scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines usps drug standards are enforceable in the united states by the food and drug administration the u. Sterility testing is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms. This test is performed according to the recommendations in usp general chapter 71, ansiaamiiso 117372, ep 2. Kupiec, phd analytical research laboratories oklahoma city, oklahoma abstract it is apparent that the quality assurance program of a compounding pharmacy cannot adhere to the strict requirements of some of the general chapters in the united states pharmacopeia. Quality control analytical methodslaboratory considerations of. Test design usp chapter sterility tests is internationally harmonized and describes two. Product quality tests common to parenteral dosage forms which are consist of 2 parts. Standards and best practices for cell, gene and tissue. Related tests qc sterility assurance microbiology sterility. Usp 71 sterility tests represents the gold standard for sterility testing. Pdf general difficulties associated with sterility test validation. Sterility the test is applied to substances, preparations or articles which, according to the pharmacopoeia, are required to be sterile.
The iso radiation sterilization microbial methods 117372 19984 describes a sterility test which is a modification for the usp method. Usp chapter are referee tests in other words they are in place solely to demonstrate conformance to qualities specified in the product monograph as described in the current national. Usp sterility tests represents the gold standard for sterility testing. Understanding usp 71 sterility tests and extending bud. Meeting uspepcfr sterility testing requirements with a two. Microbiological examination microbiological tests usp 31 the appropriate microorganism. Understanding usp 71 sterility tests and extending bud pages. Those chapters containing such strict requirements that may impact pharmacy compounding should be studied thoroughly by the appropriate united states pharmacopeia.
The first is 21 cfr 211 and the second is the biologics 21 cfr 610. United states pharmacopeia usp chapter sterility tests as the principle source used for sterility testing methods, including information on test procedures and media. Nova provides usp 71 sterility testing of pharmaceutical products, radiopharmaceuticals, medical devices and water. However, a satisfactory result only indicates that no contaminating microorganism has been found in the sample examined in the conditions of the test.
Sepoct 2007 veterinary compounding view all articles in issue. Focus laboratories can test product sterility through usp. Kastango, mba, rph, fashp clinical iq, llc july 10, 20 disclaimer although i am an expert consultant to the usp, i am speaking today in my individual capacity and not as a member of the committee or as a usp representative. It is apparent that the quality assurance program of a compounding pharmacy cannot adhere to the strict requirements of some of the general chapters in the united states. Mar 22, 2016 sterility testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. They may also produce pinpoints and filaments in the intercellular spaces. In accordance with usps rules and procedures of the council of experts rules, and except as provided in section 7. Understanding teh role of sterility testing in compounding. By common consensus, the 21 cfr 211 cgmp looks to the compendial sterility tests, while 21 cfr 610 describes a separate test in 21 cfr 610. However, a satisfactory result only indicates that no con. Note in the context of this chapter, sterilized refers to an item or surface that has been subjected to a process that eliminates viable bioburden.
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