Understanding usp 71 sterility tests and extending bud. 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. The testing method to be used for sterility testing is recommended in usp. Sterility the test is applied to substances, preparations or articles which, according to the pharmacopoeia, are required to be sterile.
This test is specific for the detection of aerobic organisms which have been exposed. This internationally harmonized test replaces the current method 3. 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. Usp sterility testing laboratory accugen laboratories.
Annex 8r1 sterility test general chapter guidance for. However, a satisfactory result only indicates that no contaminating microorganism has been found in the sample examined in the conditions of the test. 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. Japanese pharmacopoeia jp and united states pharmacopeia usp. Sterility testing membrane filtration sterility testing. Rapid sterility is an alternative test method to the us pharmacopeia usp general chapter, ph.
They may also produce pinpoints and filaments in the intercellular spaces. Examine method suitability and sampling requirements. The two media outlined in the usp, fda, ep and jp require ments are fluid thioglycollate ftmthio and soybeancasein digest scdmtsb usp, 21cfr 610. The test is applied to substances, preparations, or articles. Qc sterility testing of pharmaceuticals pacific biolabs. According to the usp in this sterility testing method products are filtered through 0. Usp chapter sterility tests in usp 30, the second paragraph of chapter states the following. Suitability of scanrdi as a rapid sterility testing method.
Sterility testing is required during the sterilization validation process as well as for routine release testing. Chapter sterility tests as the prin ciple source used for sterility. Seed the indicator cell culture at a suitable density ile. This time requirement is not suitable for shortlived products or those prepared for. Choose gibraltar labs for sterility testing by following methods.
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 thiogtest continued. Identify microbiological tests used in managing the production of nonsterile drug products 3. A typical sterility test has 14 full days of incubation and uses analyst observations to generate results, whereas a rapid sterility test is reduced to just five days of incubation a 64%. Interpret sterility test results and assess sterility test limitations 4. The test for sterility is carried out under aseptic conditions. These pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has been. Usp sterility tests represents the gold standard for sterility testing.
Sterility test, and usp sterility tests, can be used as interchangeable in the ich regions subject to the conditions detailed below. Usp and usp must meet a sterility test before they are dispensed. Method suitability report membrane filtration sterility test. Pharmaceutical testing lab sterility testing usp 71. Related tests qc sterility assurance microbiology sterility.
Comprehensive evaluation of compendial usp, bactalert. Focus laboratories can test product sterility through usp. Such sterility testing is usually carried out directly after the lot is manufactured as a final product quality control test. This article points out to the regulations guiding manufactured product sterility testing. The compendial usp sterility tests are growthbased and require at least a 14day incubation to yield results. 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. The only content in usp relative to sterility tests will be the harmonized 71. U s pharmacopeia usp 71 sterility testing reference standards. As a usp test, it is the official procedure for testing the sterility of pharmaceutical products usp 71. A harmonized standard for sterility test has been approved by the pharmacopeial discussion group pdg as described in its pdg signoff cover page. Tga guidelines for sterility testing of therapeutic goods. Usp chapter 71 and iso 117372 im not familiar with usp 71 so i cant offer a specific judgement. Compounding pharmacies and the usp sterility tests.
Usp prescribes the sterility testing method used for pharmaceuticals and biologics. 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. Usp chapter sterility tests is internationally harmonized and describes two separate types of testsmembrane filtration and direct inoculation. There are two different gmps describing sterility in the united states. Understanding the role of sterility testing in compounding f. Nova provides usp 71 sterility testing of pharmaceutical products, radiopharmaceuticals, medical devices and water.
For all product types, follow current usp methodology in, with the following additional. According to the international pharmacopeias usp, ep 2. For combination products, the iso radiation sterilization microbial methods 117372 1998 6 describes a sterility test which is a modification for the usp method. Validating and implementing a rapid sterility testing method a. New harmonization with international compendia and overview duration. Understanding usp 71 sterility tests and extending bud pages. All samples are prepared and plated in iso 5 hoods in iso 7 clean rooms, to eliminate laboratory contamination.
Institute of validation technology ivt, scott sutton, 20 6. Usp general chapter 62 microbiological examination of nonsterile products. The three methods of sterility testing are membrane filtration, direct transfer product immersion and product flush. Testing conditions for medical devices, such as sutures. The iso radiation sterilization microbial methods 117372 19984 describes a sterility test which is a modification for the usp method. Explain testing requirements based on usp microbiology test general chapters 2. Only content in usp relative to sterility tests will be the harmonized. The pharmaceutical microbiology manual pmm evolved from the sterility analytical manual and is a supplement to the united states. Thus, the challenge for rapid or alternate sterility tests is to demonstrate equivalence to usp 71.
Us pharmacopoeia usp sterility tes t methods became harmonised with the publication of the bp 2004, ph eur 5. The two media outlined in the usp, fda, ep and jp require ments are fluid thioglycollate ftmthio and soybeancasein digest scdmtsb usp 71, 21cfr 610. Eliminated the entire discussion of sterility testing at the conclusion of the chapter. The first is 21 cfr 211 and the second is the biologics 21 cfr 610. Meeting uspepcfr sterility testing requirements with a two. Mar 22, 2016 sterility testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. The only content in usp relative to sterility tests will be the harmonized. Usp 36 microbiological tests 71 sterility tests 71 fluid thioglycollate medium continued interpretation of results or thioglycolic acid 0. U s pharmacopeia usp 71 sterility testing reference.
Where sterility test media are to be used in the direct inoculation of the culture medium method under test for sterility of the product to be examined, modify the preparation of fluid thioglycollate medium and the soybeancasein digest medium as follows. Quality control analytical methodslaboratory considerations of. For additional quality assurance, a usp test can be run on products even if the test is not required by usp. Understanding teh role of sterility testing in compounding. Compare the microscopic appearance of the test cultures with that of the negative and positive controls, examining for extranuclear fluorescence.
Both methods use the same volume of compounded sterile. Those portions that are not harmonized are marked with symbols to specify this fact. Testing conditions for medical devices, such as sutures, are outside the scope of the ich recommendation. The sterility test usp section 71 is categorized under general requirements and is therefore a legal requirement. 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. Conclusion sterility testing delineated in usp is required for a significant number of csps routinely compounded under gcp as described by usp and usp. 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. Only content in usp relative to sterility tests will be the harmonized 71. Meeting uspepcfr sterility testing requirements with a. Sterility testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Bioreliance currently offers a panel of standard sterility as says that comply with us and eu requirements table 1. 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.
The procedural details may be the same with regard to media, inocula and handling of. Identify areas of pharmacy operations that require environmental monitoring. However, a satisfactory result only indicates that no con. In the course of sterility testing of products, sooner or later, you will come across a sterility test failure either real or falsepositive. Usp and usp 71 must meet a sterility test before they are dispensed. Usp 71 sterility tests represents the gold standard for sterility testing. Method suitability report membrane filtration sterility. Chili, ny 14514 page 5 of 5 sterility test method qualified the usp sterility test is designed to check a specific number and volume of samples for sterility in. This test is defined with detail in the usp and any modifications in. We can test sterile product in one day via a rapid scan rdi method and are proud to produce accurate, on time and cost. Mycoplasmas produce pinpoints or filaments over the indicator cell cytoplasm.
The sterility test usp section is categorized under general requirements and is therefore a legal requirement. 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. Direct transferimmersion sterility testing membrane filtrartion open system. The views and opinions presented are entirely my own.
One of the most important aspects of usp chapter is method suitability. 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. Sterility tests microbiological tests usp 35 fluid thioglycollate medium is to be incubated at 3035. Sterility tests69 method the test is applied to substances, preparations, or articles which, according to the pharmacopeia, are required to be ster1. Usp 71 sterility testing is widely used in both the medical device and pharmaceutical industries. Alternate sterility tests 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. 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. Sterility testing of manufactured products sterility. 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.
Sterility testing of the final product can be carried out either by the drug manufacturer or by a certified contract lab. For additional quality assurance, a usp 71 test can be run on products even if the test is not required by usp. There are different methods to test the sterility of the products. Usp chapter 71 usp71 5 remains the most common method used for product sterility testing in the biopharmaceutical industry in the united states. Today, usp chapter requires the use of two culture media, soybeancasein digest medium scdm and fluid thioglycollate medium ftm, and a 14day incubation period. Method suitability control studies for microbial testing. The compendial usp 71 sterility tests are growthbased and require at least a 14day incubation to yield results. To the containers of each medium, transfer aseptically a quantity of lactamase sufficient to inactivate the amount of antibiotic in the. Usp chapter are referee tests in other words they are in place solely to demonstrate conformance to qualities specified in the product monograph as. Sterility testing is a process control evaluation and a general indicator of microbiological quality of a product. Annex 8r1 sterility test general chapter guidance for industry.
The membrane filtration method is preferred, but the direct inoculation method is also detailed in the chapter. Membrane filtration sterility testing method is the method of choice for the filterable pharmaceutical products. 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. Usp chapter 71 sterility tests in usp 30, the second paragraph of chapter 71 states the following. Sterility test, and usp 71 sterility tests, can be used as interchangeable in the ich regions subject to the conditions detailed below.
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