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. Sterility testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Tests for specified substances, and usp chapter 71 sterility tests. Sterility test method qualified the usp 71 sterility test is designed to check a specific number and volume of samples for sterility in both an aerobic recovery medium and an anaerobic recovery medium. Validating and implementing a rapid sterility testing method a.
Tga guidelines for sterility testing of therapeutic goods september 2006 page 4 of 36 7. However the usp 71 sterility test method presents the following limitations. The first is 21 cfr 211 and the second is the biologics 21 cfr 610. Usp, usp chapter 71, sterility us pharmacopeial con. Steris completes sterility testing to either usp ep or iso 11737 using membrane filtration, direct immersion inoculation or removal of. Testing conditions for medical devices, such as sutures, are outside the scope of the ich recommendation. Only content in usp relative to sterility tests will be the harmonized 71. The method for sterility testing described in usp chapter 71 already limits the repetition of tests to circumstances similar to those described in these amendments. The characteristics of a qa program include routine testing of sterile preparations. Identify microbiological tests used in managing the production of nonsterile drug products 3. Usp 34nf 29 exclusion from test the normative en iso 117372.
However, a satisfactory result only indicates that no con. Specific to pharmaceutical manufacturers, nelson labs provides routine usp and ep compendial tests for product sterility isolator, bacterial endotoxin, particulate analysis, antibiotic potency assays apa, antimicrobial preservative efficacy studies ape and microbial identification services. Tga guidelines for sterility testing of therapeutic goods september 2006 page 7 of 36 2. Comprehensive evaluation of compendial usp, bactalert. Annex 8r1 sterility test general chapter guidance for industry.
Understanding the role of sterility testing in compounding f. Pharmaceutical testing lab sterility testing usp 71. For additional quality assurance, a usp test can be run on products even if the test is not required by usp. Sterility of the product to be examined w he r e the na tur e o f the pr o duc t pe r m i ts. Sterility testing usp 71 medical device testing nova. Usp chapter sterility tests is internationally harmonized and describes two separate types of testsmembrane filtration and direct inoculation.
Tga guidelines for sterility testing of therapeutic goods september 2006 page 3 of 36 contents 1. 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. According to the international pharmacopeias usp 71, ep 2. This internationally harmonized test replaces the current method 3. Sterility test minimum sample requirements minimum number of articles to be tested in relation to the number of articles in the batch parenteral preparations not more than 100 containers 10% or 4 containers, whichever is greater more than 100 but not more than 500 containers 10 containers more than 500 containers 2% or 20 containers. Notification effective october 1, 2010, bioreliance will be discontinu. Our sterility testing services steris laboratories. Fluid thioglycollate medium continued interpretation of resultsor thioglycolic acid 0. Portions of this general chapter have been harmonized with the corresponding texts of the european pharmacopeia andor the japanese pharmacopeia. Usp and usp 71 must meet a sterility test before they are dispensed. Interpret sterility test results and assess sterility test limitations 4.
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 tests69 method the test is applied to substances, preparations, or articles which, according to the pharmacopeia, are required to be ster1. Following inoculation, the media is monitored for 14 days for visual signs of bacterial or fungal contamination. Usp 71 prescribes the sterility testing method used for pharmaceuticals and biologics. Usp 36 microbiological tests 71 sterility tests 71. The product to be examined complies with the test if resazurin sodium solution 1 in,fluorescence typical of mycoplasmas is not present. It is anticipated that, in the absence of these amendments, the majority of manufacturers would limit the repetition of sterility tests in order to comply with usp chapter 71. The pharmaceutical microbiology manual pmm evolved from the sterility analytical manual and is a supplement to the united states. Usp and usp must meet a sterility test before they are dispensed. Usp chapter 71 and iso 117372 im not familiar with usp 71 so i cant offer a specific judgement. Usp prescribes the sterility testing method used for pharmaceuticals and biologics. If growth is observed, this can be confirmed using. Focus laboratories can test product sterility through usp.
Microbiological examination microbiological tests usp 31 the appropriate microorganism. In the united states pharmacopoeia, methods for sterility testing 71, microbial evaluation of clean rooms and pharmaceutical compoundingsterile. 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. Performing sterility testing using the two media to compliance as outlined per usp 71, 21cfr 610. Eliminated the entire discussion of sterility testing at the conclusion of the chapter. Quality control analytical methodslaboratory considerations of. Explain testing requirements based on usp microbiology test general chapters 2. Validating and implementing a rapid sterility testing method elodie muller traditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control laboratories are exploring more rapid testing methods. Testing conditions for medical devices, such as sutures. Sterility testing devices minimizing the risk of false positive and false negative results, the steritest neo system has been proven to be the most reliable filtration device available on the market. The population may vary depending on type and lot of growth medium, user technique and method employed. Sterility testing is a process control evaluation and a general indicator of microbiological quality of a product.
There are two different gmps describing sterility in the united states. Nova provides usp 71 sterility testing of pharmaceutical products, radiopharmaceuticals, medical devices and more. Given that testing for contamination is not a typical pharmacy task, we initially sought assistance from our microbiology lab. Method suitability report membrane filtration sterility. 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. Usp chapter 71 sterility tests in usp 30, the second paragraph of chapter 71 states the following. Pharmaceutical sterility testing usp 71 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. Meeting usp epcfr sterility testing requirements with a two media assay biologics safety testing. Sterility testing pumps our steritest symbio pumps are designed to integrate perfectly into all testing environments. We already had been sending samples to them, but the holding period and growth media used were not in line with usp 71 requirements for sterility testing. 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 71 sterility testing nova biologicals microbiological testing. For all product types, follow current usp methodology in, with the following additional. Testing the sterility of the filled final product is an essential and a decisive criterion for approving the release of a complete batch.
Equipment sterilisation details for the session should also be recorded in the comments section, including the autoclave used, the cycle number and the date of sterilisation. Today, usp chapter requires the use of two culture media, soybeancasein digest medium scdm and fluid thioglycollate medium ftm, and a 14day incubation period. Understanding usp 71 sterility tests and extending asp. Sterility test, and usp 71 sterility tests, can be used as interchangeable in the ich regions subject to the conditions detailed below. Introduction medical device sterility testing is an essential part of every sterilization validation. In order to fully comply with usp, a compounding facility producing sterile product must develop a formal quality assurance qa program. Pdf general difficulties associated with sterility test validation, practical. Chapter sterility tests as the prin ciple source used for sterility testing methods, including information on test. Sterility testing is required during the sterilization validation process as well as for routine release testing.
Detailed information on growth promotion tests is primarily described in usp chapter microbiological examination of nonsterile products. Because sterility testing is a very exacting procedure, where asepsis of the procedure must be ensured for a correct interpretation of results, it is important that personnel be properly trained and qualified. Us pharmacopoeia usp sterility tes t methods became harmonised with the publication of the. Compounding aseptic containment isolator caci a compounding aseptic isolator cai designed to provide worker protection from. Jan 30, 2019 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. Situations when 71 is unsuitable for product release testing sample size consideration. 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. How to establish growth promotion tests for pharmaceutical. According to the international pharmacopeias usp 71. Once the implementing a pharmacybased sterility testing program. 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.
Application of the test to parenteral preparations, ophthalmic and other noninjectable preparations required to comply with. U s pharmacopeia usp 71 sterility testing reference standards. Our sterility testing services sterility testing is carried out by our team of microbiological experts to verify the effectiveness of a sterilization process using iso117, iso115 or aseptic manufacture. 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. Keywords bactec, bactalert, bacteria, blood culture systems, fungi, product, sterility testing, usp, molds c.
After incubation, where applicable, enumerate colonies to determine number of cfus obtained. Sterility testing usp 71 nova provides usp sterility testing of pharmaceuticals, radiopharmaceuticals, medical devices, and water. 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. Test design usp chapter 71 sterility tests is internationally harmonized and describes two separate types of tests membrane filtration and direct inoculation. Test design usp chapter 71 sterility tests is internationally harmonized and describes two. Pdf practical approach to sterility testing researchgate. Decrease cost of testing and storage space room temp batched medications with extended bud exceeding usp 797 continue to undergo usp 71 sterility testing csps quarantined 14 days until usp 71 sterility test is resulted designated quarantine area, optimal batch size forecasting. Sterility testing biosafety for biopharmaceuticals.
The test for sterility is carried out under aseptic conditions. 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 thiog test continued. Mar 22, 2016 sterility testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Understanding teh role of sterility testing in compounding. An additional series of assays that employ the use of four. Sterility tests microbiological tests usp 35 fluid thioglycollate medium is to be incubated at 3035. Download the sterility test pdg signoff cover pages. 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.
Sterility testing of the final product can be carried out either by the drug manufacturer or by a certified contract lab. A harmonized standard for sterility test has been approved by the pharmacopeial discussion group pdg as described in its pdg signoff cover page. Determining sterility involves the use of test material to inoculate media which supports microbial growth. Meeting uspepcfr sterility testing requirements with a two. As a result, while the concentration is standardised per. Tga guidelines for sterility testing of therapeutic goods. Sterility testing is a crucial step in quality control that must be taken to ensure the safety of products in the cosmetic, pharmaceutical, medical device, and diagnostic equipment industries. Today, usp chapter 71 requires the use of two culture media, soybeancasein digest medium scdm and fluid thioglycollate medium ftm, and a 14day incubation period. Usp chapter are referee tests in other words they are in place solely to. This test is performed according to the recommendations in usp general chapter 71, ansiaamiiso 117372, ep 2. Csp quality assurance testing advancing pharmacy roles. Seed the indicator cell culture at a suitable density ile.
Usp s revision of the standard for a sterility test has been approved by the pharmacopeial discussion group pdg. Usp 71 sterility tests and extending bud 2 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 do not. We can test sterile product in one day via a rapid scan rdi method and are proud to. The only content in usp relative to sterility tests will be the harmonized 71. Meeting uspepcfr sterility testing requirements with a. Usp numbered less than for example, the sterility test is. All samples are prepared and plated in iso 5 hoods in iso 7 clean rooms, to eliminate laboratory contamination. Microbial enumeration tests, usp chapter microbiological examination of nonsterile products. Federal register amendments to sterility test requirements. 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.
Microbiological examination microbiological tests usp 31 fatty productsdissolve in isopropyl myristate sterilized bygauze to prevent the patches from sticking together, and transfer filtration, or mix the product to be examined with the minimumthe patches to a suitable volume of the chosen diluent containing. This paper presents the general concepts and problems associated with sterility testing as well as the various testing methodologies. Japanese pharmacopoeia jp and united states pharmacopeia usp. U s pharmacopeia usp 71 sterility testing reference.
The pharmaceutical microbiology manual pmm evolved from the sterility analytical manual and is a supplement to the united states pharmacopeia usp for pharmaceutical. Implementing a pharmacybased sterility testing program u. Identify areas of pharmacy operations that require environmental monitoring. Qc sterility testing of pharmaceuticals pacific biolabs. Pdf sterility test is an established method for detecting the presence of viable forms of microorganisms in or on finished pharmaceutical products. The test is applied to substances, preparations or articles which, according to the pharmacopoeia, are required to be sterile. 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. These media detect anaerobic and aerobic bacteria as well as fungal contaminants. Usp 71 sterility tests represents the gold standard for sterility testing. Elodie muller is head of the microbiology laboratory at. For additional quality assurance, a usp 71 test can be run on products even if the test is not required by usp.
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