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Microbe Investigations

September 3, 2024

Factors Influencing Cosmetic Shelf Life and The Role of USP 51 Testing

Factors Influencing Cosmetic Shelf Life and The Role of USP 51 Testing

Cosmetics /

For cosmetic products, it is of utmost importance to inhibit microbial contamination. To achieve sterility of the products, preservatives are added to inhibit microbial growth. How do we know that the preservatives are actually protecting the products from spoiling? How can manufacturers ensure that their products remain free from harmful microbes throughout their shelf life? […]

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How USP 61 Supports Regulatory Compliance for Pharmaceuticals

How USP 61 Supports Regulatory Compliance for Pharmaceuticals

Antibacterial Test /

The microbiological quality of the pharmaceutical product is one of the important aspects to be considered in a pharmaceutical company. Non-sterile products may be spoiled by microorganisms, which decreases their efficacy and harms patients due to contamination. The USP among other regulatory bodies sets certain standards or guidelines to support pharmaceutical companies in assuring the

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ISO and ASTM standards

Understanding the Differences Between ISO and ASTM Standards

Antimicrobial /

ISO and ASTM Standards Standardization is important as it assures quality, safety, and compliance in today’s regulated environments. The two dominant organizations that establish and publish standards to a worldwide community are the International Organization for Standardization (ISO) & The American Society for Testing and Materials (ASTM). These agencies share the commonality of standardization to

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sterility testing of parenteral products

How Sterility Testing of Parenteral Products is Performed

Antimicrobial /

Sterility testing is the most critical process in the production of parenteral products; essentially, it covers the assurance that the product is free from viable microorganisms and hence safe for administration to patients. These include parenteral drugs, intravenous solutions, and other sterile pharmaceutical formulations. Strict standards for the sterility of such products will protect against

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Comparative Analysis of USP 60, USP 61, and USP 62 Testing Standards

Comparative Analysis of USP 60, USP 61, and USP 62 Testing Standards

Antibacterial Test /

USP 60, USP 61, and USP 62 – Testing standards comparison Comparative analysis among the standards USP 60, USP 61 and USP 62 is indispensable, with each test targeting different microorganisms and serving different purposes in ensuring the safety of products. Understanding their differences through a testing standards comparison helps manufacturers identify which tests are

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Preservative Efficacy Testing: USP 51 Vs. PCPC

Preservative Efficacy Testing: USP 51 Vs. PCPC

Antimicrobial /

In industries like pharmaceuticals and personal care product manufacturing, preservative efficacy testing is an important test for ensuring the safety and quality of the product. Preservatives are added to products to prevent the growth of microorganisms that can cause severe infections if contaminated products are used. Two major standards for testing the effectiveness of preservatives

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challenge testing for cosmetics

What is Challenge Testing for Cosmetics?

Cosmetics /

In the cosmetics industry, safety and effectiveness are important aspects to be considered during the development of products. Consumers expect high-quality formulations and assurance that the products they apply to their skin are free from harmful microorganisms. This is where challenge testing for cosmetics comes into play.  Challenge testing, also known as preservative efficacy testing, 

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USP 62 and Its Relevance in the Cosmetic Industry

USP 62 and Its Relevance in the Cosmetic Industry

Cosmetics /

USP 62 was originally aimed at pharmaceuticals, but it has recently become more important in the cosmetics industry, where ensuring consumer safety and product quality is a top priority. In the manufacture of non-sterile products, assurance of the absence of harmful microorganisms is paramount. USP Chapter 62 has given elaborate guidelines for the microbiological examination

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