MICROBIOLOGICAL VALIDATIONS AND QUALIFICATIONS

In the domain of microbiology, the process by which it is proven by laboratory tests that a method’s performance characteristics satisfy the needs of the intended application is known as microbiological validations and qualifications. Finding out whether the sample being tested has any inherent anti-microbial qualities and whether the incubation and growth conditions can recover any microorganisms that may be present to an acceptable level is one of the most crucial goals of microbiological tests. Assessment standards for a microbiological test are as follows, according to Microbiological Validations and Qualifications:

Specificity: The capacity of a technology to distinguish or quantify a variety of microorganisms in the presence of additional substances or bacteria is known as specificity..

Precision: Precision is the closeness of agreement between a series of test results or the variation in a
series of test results, when a method is applied repeatedly to multiple samples.

Accuracy: The degree of agreement between the measured value and the “real” or anticipated measure or reaction over the test’s whole range is known as accuracy..

Range: Range is the interval between the highest and lowest microbial count values for which the process has been shown to be accurate, linear, and precise.

Limit of Detection: Under the specified experimental conditions, this is the smallest number of microorganisms that can be identified but not necessarily measured (as in a low-level challenge).

Limit of Determination: This is the lowest level of the sample where the microbial content can be precisely and quantitatively quantified.

Limits of Quantification: Typically, three or more replicates over the range are used to determine.

Linearity: This is the capacity to obtain outcomes that are inversely correlated with the concentration of microorganisms within a specified range..

1. Culture Suspension Validation
2. Performance Qualification Protocol of HPHV Steam Sterilizer
3. Performance Qualification Report for HPHV Steam Sterilizer
4. Bacterial Endotoxin Test Product Validation
5. Disinfectant Validation Protocol and Report
6. Steam Sterilization using Autoclave for Porous and Non porous loads
7. Protocol for Evaluation of Sanitation Solution (By mopping method)
8. Drain Time Study Protocol for collected Water Samples
9. Performance Qualification Protocol for Dynamic Pass Box
10. Performance Qualification Report for Dynamic Pass Box
11. Antibacterial Antifungal Efficacy Test
12. Testing Methodology of Biological Indicators
13. Effectiveness of Antimicrobial Preservatives
14. Efficacy of Fumigation
15. Disinfectant Validation Protocol
16. Efficacy Evaluation of Disinfectants & Sanitizing Agents
17. Sterility Method Validation
18. Sterility Method Validation Report
19. Protocol for Determination of Effectiveness of 70% IPA after storage period of 7 Days
20. Validation Protocol for Evaluation of sample size for Microbiological Analysis of Purified Water
21. Validation Report for Evaluation of sample size for Microbiological Analysis of Purified Water
22. Comparative Study of Media for Microbiological Limit Test of Water
23. Drain Time Study for Water Samples
24. Evaluation of Sample size for Microbiological Analysis of Purified Water
25. General Study Protocol for Development of Environmental and Water Isolates
26. Protocol cum Report for Comparative Study of Media for Microbiological Limit Test of Water
27. Design Qualification for Check Weigher Machine
28. Protocol for Disinfectant Efficacy & Challenge Validation
29. Fogging Validation Protocol for Microbiology Lab
30. Fogging Validation Report for Microbiology Lab
31. Protocol for Disinfectant Validation of 70% IPA
32. Report for Disinfectant Validation of 70% IPA