- Environment
fully loaded with the microorganisms. In environment some organisms are
pathogenic and some organisms are non- pathogenic.
- Manufacturing
area or any critical area monitor regularly in different methods like
passive air sampling, Active air sampling, surface monitoring and
personnel monitoring.
- Environment isolates are the microorganisms which we isolate from the environment like Air, Water, personnel….etc.
- Identification of environment isolate very important and mentioned in different guidelines (USP General chapter 1116,EU GMP,WHO-GMP and PIC/S).
- These environmental isolates are main source of the product contamination.
- Use full of investigation of source of contamination in pharmaceutical product.
- To be prove the these organism also testing the supported to nutrient media.
- Culture library should be maintained.
- Culture library could be easily traced and if any previous history out come.
- Every new isolate found should be investigated and possible source.
- As per pharmacopoeia and different regulatory guideline microorganism should be identify up to species level.
- Different instrument and methods are available for the identification of microorganism up to species level.
- DNA sequencing one of the best.
- For example in case of identification of A.niger and A.brasiliensis both have same morphology on media plate but very small difference is there. So, DNA sequencing is the best method to identify closely related microorganisms up to species level. Once environment isolate identified then we can give right direction to the investigation and could identify root cause.
- Every new isolate cross check the support to the media (GPT test) and kill the Disinfectant (Disinfectant validation).
- So, identification of environment isolate is very important and major tool in investigation
Examples:
Environmental monitoring isolates:
1. Micrococcus luteus
2. Staphylococcus arlettae
3. Staphylococcus matgatae
4. Staphylococcus warnerii
5. Kocouria rhizophila
6. Rhodococcus
Corynebacteriodes
7. Kocouria varians
Water Monitoring isolates:
1. Staphylococcus arlettae
2. Bacillus megaterium
