“GLP” For Aseptic Techniques in A Microbiological Laboratory

Roberto Ligugnana^1*

¹SIMA Italian Society for Applied Microbiology, Villa Cella, Milan, Italy
*Correspondence author: Roberto Ligugnana, SIMA Italian Society for Applied Microbiology, Villa Cella, Milan, Italy; Email: [email protected]

Published Date: 04-10-2023

Copyright^© 2023 by Ligugnana R. All rights reserved. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

The activity of the microbiological laboratory for the correct application of the aseptic techniques should be monitored with new personnel and in any case, at regular intervals to control the effective application.

The reported check list provides a concise list of questions about the aseptic procedures to give a guide to achieve a solid aseptic technique.

The presented subjects are: Working area, personal hygiene, personal dressing, workflow manipulation within aseptic workstation, cleanroom handling and working activity, culture media, microbial air monitoring.

Keywords: Air Sampler; Aseptic Techniques; Bacteria; Contact Plate; Contamination; Disinfection; Hygiene; Isopropyl Alcohol; Non-Viable; Sterilization; Viable

Abbreviations

GLP: Good Laboratory Practice; GMP: Good Microbiological Practices; USFDA: USA Food and Drug Administration

Introduction

Aseptic techniques are a set of specific practices and procedures performed under carefully controlled conditions with the goal of minimizing microorganisms’ contamination. The more frequent microbial contamination in an aseptic process involves the personnel. The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with the conditions under which laboratory and environmental quality control procedures and studies are planned, performed, monitored, recorded, reported and archived. The Good Microbiological Practices (GMP) defines a set of rules and criteria to reduce the risk of microbial contamination during the microbiologist activity. Viable samples are living microorganisms; the reverse is true of nonviable samples: they are non-living particles. These include dust, clothing particles, skin cells and more. They do not reproduce or spread, but they can still be problematic in a risk environment like cleanroom, operating theater, etc. Good Manufacturing Practices (GMP or ‘cGMP’ ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification [1-12].

Examples of infractions in aseptic processing reported by the US Food and Drug Administration (FDA) are the more effective way to introduce the involved subject [4-6,11]:

• The cleanroom operator was observed re-using coveralls that were hanging on a hook in the anteroom
• Your cleanroom is maintained in a manner that could lead to product contamination. We observed that contaminated items (waste, used gloves, etc.) were not correctly disposed according the specified protocol
• The personnel operating in the vertical laminar flow bench was not using the mask in a correct way
• The certificate of analysis showing sterility of the sterile containers were not correct

The basics of aseptic technique:

1. Perform appropriate hand hygiene
2. Use standard precautions
3. Maintain a sterile field and equipment
4. Apply and safely remove sterile gloves and personal protective equipment
5. Dispose of contaminated wastes appropriately

The activity of the microbiological laboratory for the correct application of the aseptic techniques should be monitored with new personnel and at regular intervals, to control the effective application. The reported Check list provides a concise list of questions about the aseptic procedures to give a guide to achieve a solid aseptic technique.

Check List

Working Area (Table 1)

Table 1: Working surfaces.

Personal Hygiene (Table 2)

Table 2: Personal hygiene: hands and forearms.

Personal Dressing (Table 3)

Table 3: Personal dressing.

Workflow Manipulation Within Aseptic Workstation (Table 4)

Table 4: Workflow manipulation within aseptic workstation.

Cleanroom Handling and Working Activity (Table 5)

Table 5: Cleanroom handling and working activity.

Culture Media (Petri dishes, Contact plates, test tubes and bottles with liquid media) (Table 6)

Table 6: Culture media details.

Microbial Air Monitoring (Table 7)

Table 7: Microbial air monitoring.

Conclusion

The personnel should be actively involved in the filling of this document to reduce the risk of microbial contamination.

Conflict of Interest

The author has no conflict of interest to declare.

References

1. Public health agency of Canada. Canadian biosafety standards and guidelines. 2013.
2. Laboratory biosafety guidelines. Public health agency of Canada. 3^rd Edition. 2004.
3. Association canadienne de normalisation, Dodd M. Evaluation of single-use medical sharps containers for biohazardous and cytotoxic waste. Canadian Standards Assoc. 2002.
4. Principles of good microbiological practice fact sheet. OSHA and American biological safety association alliance. 2011.
5. Bowyer. Good microbiological practice and containment. University of Manchester. 2012.
6. Good microbiological laboratory practice. University of Lethbridge. Biosafety Committee. 2013.
7. Thompson rivers university. GMLP Safety and Emergency Management. 2017.
8. Weill Cornell University NY, New York. GMLP Environmental Health and Safety. 2020.
9. Principle of good microbiological practices fact sheets. OSHA alliance program: American Biological Safety Association.
10. Microbiological best laboratory practices. PDA Assoc. 2013;32:616.
11. WHO Annex 2-WHO good practices for pharmaceutical microbiology laboratory. WHO Technical Report. 2011:961.
12. Dougherty L, Lister S. The Royal Marsden manual of clinical nursing procedures. John Wiley and Sons. 2015.

Article Type

Review Article

Publication History

Received Date: 12-09-2023 
Accepted Date: 26-09-2023 
Published Date: 04-10-2023

Copyright© 2023 by Ligugnana R. All rights reserved. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Citation: Ligugnana R. “GLP” For Aseptic Techniques in A Microbiological Laboratory.  J Clin Immunol Microbiol. 2023;4(3):1-4.

Table 1: Working surfaces.

Table 2: Personal hygiene: hands and forearms.

Table 3: Personal dressing.

Table 4: Workflow manipulation within aseptic workstation.

Table 5: Cleanroom handling and working activity.

Table 6: Culture media details.

Table 7: Microbial air monitoring.