Applicable Standards
- USP 51
- USP 61
- USP 62
- USP 63
- USP 71
Service Overview
Method Suitability, also known as Bacteriostasis and Fungistasis (B/F) is a required validation recommended annually to substantiate a sterility test. B/F testing confirms the absence of antimicrobial properties present on pharmaceutical products and medical devices. Without this validation, it is impossible to verify the sterility of your manufacturing process, as contaminants could be masked by the antimicrobial agents in the product.
For this reason, the United States Pharmacopeia (USP) and the U.S. Food and Drug Administration (FDA) require method suitability testing to ensure that standard operating procedures are appropriate. If changes are made in a pharmaceutical compound or a new product is needed, it is critical that method suitability as well as sterility testing is done to safeguard the health of customers and consumers.
By performing meticulous method suitability testing, our customers can be certain that their sterility testing is executed accurately and knowledgeably. Regardless of the facility or company, sterility testing is complex and requires a precise application for reliable results. Therefore, it is vital that testing is performed in order with regulatory standards and protocol. At Nelson Labs, we offer technical expertise accompanied by extensive proficiency in testing a wide range of products. By developing strict methods related to sterility testing in addition to our specialty glassware and equipment we can provide leading sterility testing throughout all steps of our product evaluation, as well as testing methods not offered by the rest of the industry. Namely, the ability to scale sterility testing to large volumes, allowing a sizeable advantage to the scope of product testing.
