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. The pharmaceutical microbiology manual pmm evolved from the sterility analytical manual and is a supplement to the united states pharmacopeia usp for pharmaceutical. 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. All samples are prepared and plated in iso 5 hoods in iso 7 clean rooms, to eliminate laboratory contamination. Usp requirements for sterile and nonsterile preparations. 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. U s pharmacopeia usp 71 sterility testing reference.
The test is applied to substances, preparations or articles which, according to the pharmacopoeia, are required to be sterile. 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. The methodology for the bioburden test is commonly modified from usp, usp sterility tests, and watertesting guidelines, such as usp water for pharmaceutical purposes. Quality control analytical methodslaboratory considerations of. Table 3 specifies the number of articles to be tested based on the batch size and table 2 specifies the quantity to be tested.
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. Compounding pharmacists face a unique challenge in the industry today. This internationally harmonized test replaces the current method 3. In this study, we demonstrated that all sda control plates grew mold within the acceptable 144h time frame, compared with only 43. Intermediate steps can and should be tested for sterility but usp chapter 71 was not written and is not intended for this purpose. 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. Usp revision process chapter revisions now official. Japanese pharmacopoeia jp and united states pharmacopeia usp. Related tests qc sterility assurance microbiology sterility.
Thus, the challenge for rapid or alternate sterility tests is to demonstrate equivalence to usp. Usp sterility testing definition culture media and. Sterility test, and usp sterility tests, can be used as interchangeable in the ich regions subject to the conditions detailed below. Usp 71 sterility tests represents the gold standard for sterility testing. Mar 22, 2016 sterility testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. We can test sterile product in one day via a rapid scan rdi method and are proud to produce. Those portions that are not harmonized are marked with symbols to specify this fact. Those chapters containing such strict requirements that may impact pharmacy compounding should be studied thoroughly by the appropriate united states pharmacopeia. The assay is a regulatory expectation that has been in existence for some time and is mentioned in fda warning letters. The purpose of this article is to describe united states pharmacopeia chapter. 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. However, a satisfactory result only indicates that no con. Chapter sterility tests as the prin ciple source used for. 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.
Negative mycoplasma direct and indirect culture method. Sterility testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. 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. Pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized. Sepoct 2007 veterinary compounding view all articles in issue. The first is 21 cfr 211 and the second is the biologics 21 cfr 610.
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. 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. Comprehensive evaluation of compendial usp, bactalert. Sterility tests microbiological tests usp 35 fluid thioglycollate medium is to be incubated at 3035.
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. There are two different gmps describing sterility in the united states. New harmonization with international compendia and overview duration. 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. Standards and best practices for cell, gene and tissue. 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. Situations when is unsuitable for product release testing sample size consideration. Only content in usp relative to sterility tests will be the harmonized 71. The product sterility cleanroom test is necessary for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms. This test is specific for the detection of aerobic organisms which have been exposed.
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. The only content in usp relative to sterility tests will be the harmonized 71. Method suitability control studies for microbial testing. Usp prescribes the sterility testing method used for pharmaceuticals and biologics. 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. Products, from usp chapter release test examples criteria sterility usp. Federal food, drug, and cosmetics act designates the uspnf as the official compendia for. Usp chapter sterility tests in usp 30, the second paragraph of chapter states the following. Sterility testing is required during the sterilization validation process as well as for routine release testing. Portions of this general chapter have been harmonized with the corresponding texts of the european pharmacopeia andor the japanese pharmacopeia. Usp chapter 71 contains two tables that describe sampling.
Usp chapter 71 sterility tests in usp 30, the second paragraph of chapter 71 states the following. Mycoplasmas produce pinpoints or filaments over the indicator cell cytoplasm. Test design usp chapter 71 sterility tests is internationally harmonized and describes two. 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. Annex 8r1 sterility test general chapter guidance for industry. The views and opinions presented are entirely my own. Nova provides usp 71 sterility testing of pharmaceutical products, radiopharmaceuticals, medical devices and water. Compare the microscopic appearance of the test cultures with that of the negative and positive controls, examining for extranuclear fluorescence. The sterility test usp section 71 is categorized under general requirements and is therefore a legal requirement. Testing conditions for medical devices, such as sutures, are outside the scope of the ich recommendation. Seed the indicator cell culture at a suitable density ile.
This chapter provides guidelines for the validation of isolator systems for use in sterility testing of compendial articles. Meeting uspepcfr sterility testing requirements with a. Download the sterility test pdg signoff cover pages. Growth promotion test and method validation usp sterility test contains two qualifying. Tests storage and beyonduse dating maintaining 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. Usp provides guidance on this in chapter validation of microbial recovery from phar. Understanding the role of sterility testing in compounding. 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.
Eliminated the entire discussion of sterility testing at the conclusion of the chapter. Usp sterility tests represents the gold standard for sterility testing. Sterility the test is applied to substances, preparations or articles which, according to the pharmacopoeia, are required to be sterile. The pharmaceutical microbiology manual pmm evolved from the sterility analytical manual and is a supplement to the united states. This chapter examines some practical approaches to sterility test method validation. Understanding teh role of sterility testing in compounding.
Annex 8r1 sterility test general chapter guidance for. A harmonized standard for sterility test has been approved by the pharmacopeial discussion group pdg as described in its pdg signoff cover page. This test is performed according to the recommendations in usp general chapter 71, ansiaamiiso 117372, ep 2. A discussion of united states pharmacopeia chapter 71 sterility tests. The iso radiation sterilization microbial methods 117372 19984 describes a sterility test which is a modification for the usp method. 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. Usp chapter 71 and iso 117372 im not familiar with usp 71 so i cant offer a specific judgement. Focus laboratories can test product sterility through usp. Inprocess bioburden testing of pharmaceuticals the story. 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. Test and general chapter sterility tests have been included, which harmonizes with general chapter. Sterility test, and usp sterility tests, can be used as interchangeable in the ich regions. United states pharmacopeia chapter 71 sterility tests thomas c.
Test design usp chapter sterility tests is internationally harmonized and describes two. Portions of this general chapter have been harmonized with the. 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. The only content in usp relative to sterility tests will be the harmonized. Pdf general difficulties associated with sterility test validation. Meeting uspepcfr sterility testing requirements with a two. U s pharmacopeia usp 71 sterility testing reference standards. 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.
Understanding usp 71 sterility tests and extending bud. 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. Pharmaceutical testing lab sterility testing usp 71. Quality control analytical methodslaboratory considerations. Usp 71 sterility tests applies to substances, preparations, or articles which, according to the pharmacopeia, are required to be sterile.
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. The tests for bacterial and fungal sterility are carried out on the same sample of the product to be examined. 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. Usp chapter sterility tests is internationally harmonized and describes two separate types of testsmembrane filtration and direct inoculation. Biological reactivity tests, in vivo and sterility 17 safety concerns with gene therapy products. Institute of validation technology ivt, scott sutton, 20 6. 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. Product quality tests common to parenteral dosage forms which are consist of 2 parts.
Understanding usp 71 sterility tests and extending bud pages. Microbiological examination microbiological tests usp 31 the appropriate microorganism. Usp chapter are referee tests in other words they are in place solely to demonstrate conformance to qualities specified in the product monograph as. However, a satisfactory result only indicates that no contaminating microorganism has been found in the sample examined in the conditions of the test. One of the most important aspects of usp chapter is method suitability.
Thus, the challenge for rapid or alternate sterility tests is to demonstrate equivalence to usp 71. United states pharmacopeia usp chapter sterility tests as the principle source used for sterility testing methods, including information on test procedures and media. Usp general chapter 62 microbiological examination of nonsterile products. Glp assay number gmp assay number assay description media. Understanding the role of sterility testing in compounding f.
When the volume or the quantity in a single container is. Only content in usp relative to sterility tests will be the harmonized. 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. Sterility tests69 method the test is applied to substances, preparations, or articles which, according to the pharmacopeia, are required to be ster1.
234 1450 408 1107 1492 868 766 207 289 83 969 1298 781 174 1377 577 1408 1540 727 461 219 1306 1393 1387 766 775 1424 835 649 1296 553 1450 52 1237 272 282 96 113 300 1023 273 90 387 610 6 1022