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Comparison between USP 60 vs. USP 61 vs. USP 62

What is the U.S. Pharmacopeia (USP)?

The first Pharmacopeia originated in 15th century Italy and was a little book of drug formulas used to support pharmacists looking for quality control for drug therapy standards. The current U.S. Pharmacopeia (known as USP–NF) details over 4,500 pharmaceuticals, medical devices, dietary supplements, and other healthcare products. The U.S. Pharmacopeia was founded in 1820 and is over 200 years old. Develop USP reference standards used by manufacturers to test products to ensure they meet the published specifications and tests are performed via verified methods. The United States Food & Drug Administration (FDA) enforces USP standards under the law. The USP created these standards based on a combination of scientific evidence, empirical data, and public health concerns. These standards set purity, strength, quality, and identity standards for supplements, medicines, and other ingredients used in food or therapeutic purposes. The U.S. Pharmacopeia is a globally recognized organization that prevents poor-quality medicines and pharmaceuticals in the marketplace through publishing standards as well as laboratory quality control and pharmaceutical training. The U.S. Pharmacopeia standards are globally recognized as they bring together professionals from academia, health care, government, veterinary services, herbal medicine, pharmaceutical, and dietary supplement industries to produce the most up-to-date standards possible. This article covers USP 60 and USP 61 bioburden testing, USP 62 testing, USP growth promotion guidelines, pour plate method, surface spreading method, and much more!

USP 60 vs. USP 61

USP 60 and USP 61 are quite different. USP 60 details tests for growth promotion, inhibition, the indication of specific strains of a particular microorganism, and product testing of Burkholderia Cepacia Complex. On the other hand, USP 61 is a much larger document comprised of information on sample preparation, controls, and tests to quantify mesophilic bacteria and fungi. USP 61 is referenced in USP 60 for detailing the surface-spread method for bioburden testing and microbiological testing. USP 61 also describes other standard testing methods used for various bioburden and microbiological tests, including the pour-plate method, membrane filtration method, and most-probable-number method. USP 61 also details how to neutralize product or device samples with anti-bacterial effects before performing bioburden or microbiological tests. While USP 61 is referenced in USP 60, USP 60 is never referenced in USP 61. Additional information on USP 61, can be found in our article on microorganism recovery. Further, the distinctions between bioburden and microbiological testing can be found in our article on bioburden testing vs. microbiology testing

USP 60 vs. USP 62

The USP 60 and USP 62 standards are outlined similarly. However, neither document references the other. Both standards detail methods to detect specific types of microorganisms. Both also describe growth promotion tests, inhibition, the indication of particular strains of a specific microorganism, and product testing. However, USP 60 details tests for Burkholderia Cepacia Complex specifically. Thus, USP 60 covers the microorganisms Burkholderia cepacia, Burkholderia cenocepacia, and Burkholderia multivorans. In contrast, USP 62 covers Staphylococcus aureus (S. aureus), Escherichia coli (E. coli), Candida albicans (C. albicans), Salmonella enterica, Clostridium sporogenes, and Pseudomonas aeruginosa (P. aeruginosa). USP 60 also covers P. aeruginosa and S. aureus in the context of inhibition tests for Burkholderia Cepacia Complex.

USP 61 vs. USP 62

Like the USP 60 and USP 61 comparison, USP 61 and USP 62 are quite different. USP 62 covers tests for growth promotion, inhibition, in the presence of a product, and an indication of specific strains of Staphylococcus aureus (S. aureus), Escherichia coli (E. coli), Candida albicans (C. albicans), Salmonella enterica, Clostridium sporogenes, and Pseudomonas aeruginosa (P. aeruginosa). USP 61 is referenced in USP 62 for information on sample preparation, the surface-spread method, neutralizing anti-microbial activity, and microbial enumeration tests. As compared to USP 60 or USP 62, USP 61 contains the most extensive information on the preparation of different types of product samples (i.e., transdermal, oral, aerosolized, etc.). USP 61 testing methods (like the pour plate method) reference USP 62 for recommended solutions and media for the microorganisms covered in USP 62.

How do USP 60, USP 61, and USP 62 relate to regulatory testing?

Microorganism testing is vital to ensure products or devices that enter the human body do not cause illness upon consumption, administration, or use. Microbial tests at various stages of product or device manufacture are critical to verify product quality and ensure that sterilization processes are robust enough for the microbial load accumulated by a device or product experiences during manufacture, assembly, and packaging. These tests are essential to regularly perform quality control and risk management, especially if product manufacture, assembly, or packaging processes are modified or the location of manufacture, assembly, or packaging changes. If you are looking for bioburden acceptance criteria for a non-sterile pharmaceutical product, please see our article on USP 1111.

Ethide Labs is a contract testing organization that specializes in Bioburden Testing. Ethide Labs also offers Bacterial Endotoxin Testing, Environmental Monitoring, Sterilization Validations, Microbiology Testing, EO Residual Testing, Package Integrity Testing & Cytotoxicity Testing services for medical device companies and allied industries. Ethide is an ISO 13485 certified facility. 

References

USP Leadership. “What is a Pharmacopeia?” Quality Matters. 2014.

USP Leadership. “What is the U.S. Pharmacopeia?” Quality Matters. 2015.

United States Pharmacopeial Convention. <60> Microbiological Examination of Nonsterile Products- Tests for Burkholderia Cepacia Complex. Rockville, MD, USA. 2021. (USPC <60>)

United States Pharmacopeial Convention. <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. Rockville, MD, USA. 2021. (USPC <61>)

United States Pharmacopeial Convention. <62> Microbiological Examination Of Nonsterile Products: Tests For Specified Microorganisms. Rockville, MD, USA. 2021. (USP <62>)

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