Short Communication - Journal of Evolutionary Medicine ( 2022) Volume 10, Issue 6

Microbial Contamination of Pharmaceutical Product in Industries and Preventive Methods

Junfeng Dou*
Department of Animal Breeding, University of Veterinary Sciences Brno, Indonesia
*Corresponding Author:
Junfeng Dou, Department of Animal Breeding, University of Veterinary Sciences Brno, Indonesia, Email:

Received: 01-Jun-2022, Manuscript No. jem-22- 69284 ;;Accepted Date: Jun 22, 2022; Editor assigned: 03-Jun-2022, Pre QC No. jem-22- 69284 (PQ); Reviewed: 17-Jun-2022, QC No. jem-22- 69284; Revised: 22-Jun-2022, Manuscript No. jem-22- 69284 (R); Published: 29-Jun-2022, DOI: 10.4303/jem/236069


Contamination of pharmaceutical products has the potential to have catastrophic consequences in the pharmaceutical industry, ranging from patient safety and access to drug shortages and business viability and sustainability. Contamination prevention is a critical component in the manufacturing of sterile pharmaceutical products for complying with state and federal regulations as well as protecting public safety. Following the 2012 meningitis outbreak, the FDA and other regulatory agencies tightened their approach and expectations regarding product contamination monitoring. Although bio-burden levels can be reduced with appropriate cleaning methods, preventing contamination is the best approach when assessing the risk of contamination for a facility and/or drug product. Cleanroom suites are essential in the production of sterile pharmaceutical drug products. Although many methods of decontamination and sterilisation have proven effective, contamination prevention is critical to maintaining optimal microbial levels in an aseptic environment.


This presentation will go over the top potential sources of contamination and how to effectively prevent them from contaminating product, cleanroom suites, and the organisation as a whole. Furthermore, this talk will evaluate the top potential sources of contamination in detail based on risk and the specific role they play in the contamination pathway. Topics of discussion include facility design, cleanroom behaviour, gowning and cleaning requirements, and so on. Contamination of pharmaceuticals with microorganisms, whether harmful or non-pathogenic, can cause changes in the physicochemical properties of the medicines. Although sterility is not required in official compendia for non-sterile pharmaceuticals, bio-burdens must be kept to acceptable levels. As a result, this study investigated the microbial contamination of ten non-sterile pharmaceuticals commonly delivered to outpatients by identifying and quantifying microbial contaminants as well as conducting susceptibility pattern testing on the microbes isolated. Contamination in the pharmaceutical industry can have disastrous consequences. It can jeopardise the safety of patients, staff, and the environment, as well as have an impact on the business. While maintaining high hygiene standards is important, simply controlling bio-burden levels through effective cleaning is insufficient: it is also critical to identify and prevent potential contaminants. We discuss the different types of pharmaceutical contamination and the most common sources of contamination, as well as the most effective measures you can take to prevent contamination throughout the entire value chain.

The following are the most common contaminants found in pharmaceutical products:

Chips, particles, and fibre materials are examples of physical contaminants that can enter the manufacturing or packaging process and contaminate the entire batch.

Pyrogenic Substances are Microorganisms capable of causing fever.

Moisture, gases, vapour, or molecules may also contaminate sterile pharmaceutical products.

Biological components are viruses, bacteria, or fungi that can cause disease and should not be present in pharmaceutical products.

Contamination is always a possibility in the pharmaceutical industry. Adequate preventative measures and adequate training can assist in maintaining high quality standards and complying with legislation. It is critical to have definitive preventive measures in place once you have identified the sources that could potentially contaminate pharmaceutical processes and products. Here’s how you can avoid pharmaceutical contamination: Contamination of Personnel ensure that all personnel involved in the production and handling processes are highly qualified and have received professional hygiene and cleanliness training. Make sure that sanitary clothing is always available, and emphasise the importance of wearing protective workwear at all times.

Disinfect: The foundation of preventing pharmaceutical contamination is regular cleaning and sanitization. Cleanliness and hygiene of workwear are equally important as thorough cleaning and disinfection of the facility.

The facility design should adhere to regulatory standards, ensuring proper humidity, temperature, and air filtration. In manufacturing or packing areas, using UV airlocks, restricted access barrier systems, or laminar flow will help eliminate particles and other contaminants.

To avoid water-borne contamination, only distilled water should be used in the manufacture of pharmaceutical products. Because of poor handling during dispensing, repackaging, and/or noncompliance with good manufacturing practise, the non-sterile pharmaceuticals were presumably microbiologically contaminated. As a result, training and educating dispensers as well as patients on proper medicine handling and use cannot be overstated, as these are critical aspects in preventing medicine cross-contamination [1-4].


These microorganisms have vastly different properties, sources, virulence factors, and environmental fates, and the current indicators used to classify harvest waters are severely limited. A lot of progress is being made right now in detecting pathogenic microorganisms and understanding their fate in the environment. The challenges associated with managing microbial contamination and shellfish safety continue to evolve as human development in coastal areas increases, new diseases emerge, habitat is destroyed, and global climate changes.



Conflict of Interest



Copyright: © 2022 Junfeng D. 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 work is properly cited