The pharmaceutical manufacturing unit is a facility where staff and supplies can be used repeatedly to complete various activities. Results from environmental monitoring reveal details about the room's physical arrangement, the operation of the HVAC system, gowning customs, employee hygiene, equipment, and cleaning procedures. Environmental monitoring is a key part of any pharmaceutical, biotechnology-produced, or medical device-controlled process to demonstrate that the microbial particulate level of all clean-room air and work surfaces is at acceptable levels. It is also regulation-driven. Microorganisms are used to classify particulate particle levels, microbial diversity, and ecosystem health.
Published in | International Journal of Microbiology and Biotechnology (Volume 10, Issue 3) |
DOI | 10.11648/j.ijmb.20251003.14 |
Page(s) | 102-110 |
Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
Copyright |
Copyright © The Author(s), 2025. Published by Science Publishing Group |
Environmental Monitoring, Biochemical Reaction, Microbial Contamination, Sterilization
Serial NO. | Area Room | Frequency | Acceptance criteria | Different Pressure (Pascal). | |
---|---|---|---|---|---|
Temp. | R.H. | ||||
1 | Change room I (L0014) | Twice in day | 23± 2°C | NMT 60% | NLT-15 Pascal |
2 | Change room II (L0014 A) | Twice in day | 23± 2°C | NMT 60% | NLT-15 Pascal |
3 | Change room III (L0014 B) | Twice in day | 23± 2°C | NMT 60% | NLT-15 Pascal |
4 | Core Area (L0014 C) | Twice in day | 23± 2°C | NMT 60% | NLT-15 Pascal |
5 | Inoculation Area (L0014 D) | Twice in day | 23± 2°C | NMT 60% | NLT-15 Pascal |
6 | Cooling zone (L0014 E) | Twice in day | 23± 2°C | NMT 60% | NLT-15 Pascal |
7 | Exit corridor (L0014 F) | Twice in day | 23± 2°C | NMT 60% | NLT-15 Pascal |
Grade | RECOMMENDED LIMITS FOR MICROBIAL CONTAMINATION | |||
---|---|---|---|---|
Air Sample cfu/m3 | Settle Plate (diam. 90 m), cfu/2 hrs | Contact Plates (dia. 55), cfu/plate | Glove print, 5 fingers, cfu/glove | |
A | <1 | <1 | <1 | <1 |
B | 10 | 5 | 5 | 5 |
C | 100 | 50 | 25 | _ |
D | 200 | 100 | 50 | _ |
Location Name | Method used | Colony count | Pr (in case AAS) | ||
---|---|---|---|---|---|
Bacteria CFU | Fungal CFU | Total CFU | |||
Auto clave area | PAS (≤100) | 8 | 9 | 17 | - |
Incubator area | 22 | 11 | 33 | - | |
Door site area | 29 | 11 | 40 | - | |
Middle area | 7 | 9 | 16 | - | |
Upper Table area | 11 | 10 | 21 | - |
Location Name | Method used | Colony count | Pr (in case AAS) | ||
---|---|---|---|---|---|
Bacteria CFU | Fungal CFU | Total CFU | |||
Auto clave area | AAS (≤200) | 3 | 5 | 8 | 8 |
Incubator area | 21 | 9 | 30 | 31 | |
Door site area | 19 | 6 | 25 | 26 | |
Middle area | 16 | 8 | 24 | 25 | |
Upper Table area | 22 | 11 | 31 | 32 |
Location Name | Method used | Colony count | Pr (in case AAS) | ||
---|---|---|---|---|---|
Bacteria CFU | Fungal CFU | Total CFU | |||
Auto clave area | AAS (≤200) | 35 | 15 | 50 | 53 |
Incubator area | 23 | 19 | 43 | 45 | |
Door site area | PAS (≤100 | 14 | 7 | 21 | - |
Middle area | 18 | 9 | 27 | - | |
Upper Table area | 23 | 13 | 36 | - |
Location Name | Method used | Colony count | Pr (in case AAS) | ||
---|---|---|---|---|---|
Bacteria CFU | Fungal CFU | Total CFU | |||
Auto clave area | AAS (≤200) | 43 | 25 | 68 | 74 |
Incubator area | 55 | 32 | 87 | 98 | |
Door site area | PAS (≤100 | 29 | 8 | 37 | - |
Middle area | 18 | 12 | 30 | - | |
Upper Table area | 25 | 18 | 43 | - |
E/M | Environmental Monitoring |
HVAC | Heating Ventilation Air Conditioning |
FDA | Food And Drugs Administration |
ISO | International Standard Organization |
GMPs | Good Manufacturing Practices |
NA | Nutrient Agar |
SDA | Saboruad Dextrose Agar |
HEPA | High Efficiency Particulate Air |
CFU | Colony Forming Unit |
SCDA | Soyabean Casein Digest Agar |
LAF | Laminar Air Flow |
TSA | Triptic Soya Agar |
SOP | Standard Operating Procedure |
AAS | Acative Air Samples |
PAS | Passive Air Samples |
GPT | Growth Promotion Test |
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[11] |
Alireza Zarei, CEO Zamann Pharma Support and with Special Guest Dr. Martin Müllner, Environmental monitoring within the pharmaceutical sector is the systematic measurement of information regarding environmental-conditions-that-have-the-potential-to-impact-product-quality.zamann-pharma.com.[Cited-20-may-2024]. Available-from:
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A regular process monitoring what is occurring in a project. Title: “Monitoring and Evaluation: Some Tools, Methods, and-Approaches”Source:World-Bank-Monitoring-and-Evaluation-Methods-approaches.URL:
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[17] |
Passive sampling with settle plates is a traditional method for sampling for microorganisms and Active air samples-take-about,5-10,minutes-to-take-active-sampling-compared-to-settle-plate-testing.
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[19] |
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[20] |
Identification of microbial contaminants and relate to the effectiveness of the equipment in preventing contamination and ensuring product safety and quality. flairpharma.com. [Cited-2025]. Available-from:
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Kazi. However, such testing provides a robust environmental monitoring program and high levels of microbial protection of medicines using appropriate manufacturing-processes. gmpsop.com.[Cited-14-march-2025].Available-from:
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APA Style
Markam, L., Mishra, S., Malik, N., Mukherjee, A., Verma, N. (2025). Morphological & Identification of Different Microorganisms from Classified Area in an Environmental Monitoring. International Journal of Microbiology and Biotechnology, 10(3), 102-110. https://doi.org/10.11648/j.ijmb.20251003.14
ACS Style
Markam, L.; Mishra, S.; Malik, N.; Mukherjee, A.; Verma, N. Morphological & Identification of Different Microorganisms from Classified Area in an Environmental Monitoring. Int. J. Microbiol. Biotechnol. 2025, 10(3), 102-110. doi: 10.11648/j.ijmb.20251003.14
AMA Style
Markam L, Mishra S, Malik N, Mukherjee A, Verma N. Morphological & Identification of Different Microorganisms from Classified Area in an Environmental Monitoring. Int J Microbiol Biotechnol. 2025;10(3):102-110. doi: 10.11648/j.ijmb.20251003.14
@article{10.11648/j.ijmb.20251003.14, author = {Lakshman Markam and Saarvika Mishra and Neeraj Malik and Anirban Mukherjee and Neeraj Verma}, title = {Morphological & Identification of Different Microorganisms from Classified Area in an Environmental Monitoring }, journal = {International Journal of Microbiology and Biotechnology}, volume = {10}, number = {3}, pages = {102-110}, doi = {10.11648/j.ijmb.20251003.14}, url = {https://doi.org/10.11648/j.ijmb.20251003.14}, eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijmb.20251003.14}, abstract = {The pharmaceutical manufacturing unit is a facility where staff and supplies can be used repeatedly to complete various activities. Results from environmental monitoring reveal details about the room's physical arrangement, the operation of the HVAC system, gowning customs, employee hygiene, equipment, and cleaning procedures. Environmental monitoring is a key part of any pharmaceutical, biotechnology-produced, or medical device-controlled process to demonstrate that the microbial particulate level of all clean-room air and work surfaces is at acceptable levels. It is also regulation-driven. Microorganisms are used to classify particulate particle levels, microbial diversity, and ecosystem health.}, year = {2025} }
TY - JOUR T1 - Morphological & Identification of Different Microorganisms from Classified Area in an Environmental Monitoring AU - Lakshman Markam AU - Saarvika Mishra AU - Neeraj Malik AU - Anirban Mukherjee AU - Neeraj Verma Y1 - 2025/08/26 PY - 2025 N1 - https://doi.org/10.11648/j.ijmb.20251003.14 DO - 10.11648/j.ijmb.20251003.14 T2 - International Journal of Microbiology and Biotechnology JF - International Journal of Microbiology and Biotechnology JO - International Journal of Microbiology and Biotechnology SP - 102 EP - 110 PB - Science Publishing Group SN - 2578-9686 UR - https://doi.org/10.11648/j.ijmb.20251003.14 AB - The pharmaceutical manufacturing unit is a facility where staff and supplies can be used repeatedly to complete various activities. Results from environmental monitoring reveal details about the room's physical arrangement, the operation of the HVAC system, gowning customs, employee hygiene, equipment, and cleaning procedures. Environmental monitoring is a key part of any pharmaceutical, biotechnology-produced, or medical device-controlled process to demonstrate that the microbial particulate level of all clean-room air and work surfaces is at acceptable levels. It is also regulation-driven. Microorganisms are used to classify particulate particle levels, microbial diversity, and ecosystem health. VL - 10 IS - 3 ER -