- Identification of environment isolates very important and mentioned in different guidelines.(USP General chapter 1116, EU GMP, WHO-GMP and PIC/S).
- A lot of microorganisms are found in the air and water of pharmaceutical manufacturing area.
- These organisms some of these may be pathogenic and non pathogenic.
- Pathogenic organisms harmful for the products and humans, these should be addressed and monitored frequently.
- These environmental Isolates are main source of the product contamination.
- Use full of investigation of source of contamination in pharmaceutical product.
- Every new isolate found should be investigate and possible source.
- Once In-house isolates are identified, it's important to have a complete information (Library) of the organisms. Likes characteristics, photographs,Type of of identification tests and Identification results, source of possible contamination.
- In-house library should be maintained and updated regularly must be reliable and accurate.
- In-house library could be easily traced and if any previous history out come.
- These In-house isolates presence and using MLT validation, Disinfectant validation and sterility validation and to be prove these organisms also testing the supported to nutrient media.
As per USP
- A successful environmental control program includes an appropriate level of identification of the flora obtained by sampling.
- A knowledge of the flora in controlled environments aids in determining the usual microbial flora anticipated for the facility and in evaluating the effectiveness of the cleaning and sanitization procedures, methods, agents, and recovery methods.
- The information gathered by an identification program can be useful in the investigation of the source of contamination, especially when recommended detection frequencies are exceeded.
- Identification of isolates from critical and immediately adjacent areas should take precedence over identification of microorganisms from noncritical areas.
- Identification methods should be verified, and ready-to-use kits should be qualified for their intended purpose.
