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The purpose of this project is to review and gain knowledge on the detection of biocontamination in a Pharmaceutical Manufacturing Process. The techniques applied to detect it biological contaminant is crucial to guarantee a high-quality product for intended use required by the international community. This study will focus on rapid microorganism method to detected Escherichia coli, salmonella, Staphylococcus aureus using techniques such as Multiplex PCR, quantitative PCR, Loop-mediated isothermal amplification (LAMP), Nucleic acid sequence-based amplification (NASBA) and others that can be found during the research. The methodology applied will be external secondary research of biocontamination and rapid microorganism detection from Journals and books. As results, I expect to find and to describe some documented rapid microbe’s method of E.Coli, Salmonella and Staphylococcus aureus as the main form of biological contaminant. What I expect to conclude with this project is gaining knowledge of some rapid bacterial techniques to detect biocontamination in Pharmaceutical Manufacturing Process.
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Biocontamination has become one of the biggest concerns and challenges of the Pharmaceutical Industry, especially regarding of the detection of biocontainment. The implications of a biological contamination on a product can cause huge financial impact, loss of licence, product recalls and most importantly, patient’s lives.
According to Hall K and Stewart T (2016) the five most common recall reasons were contamination, mislabelling, adverse reaction, defective product, and incorrect potency. Compounding firms were associated more frequently with contamination than were non-compounding firms.
The nature of contamination can occur in many different ways; however, one of the main forms of biological contamination is through the personnel. The techniques applied to prevent the incident as well as the measures taken to detect it are crucial to guarantee a high quality product required by the international community.
The methodology applied will be external secondary research of bio contamination incidents from Journals and books
What I expect to conclude with this project is gain knowledge of some techniques to detect and prevent the risk of bio-contamination in Pharmaceutical Manufacturing Process.
1.1. Drug Development
The Federal Food Drug and Cosmetic Act (FD&C Act) together with U.S Food and Drug administration (FDA) define the term drug as intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. It is also define as intended to affect the structure or any function of the body of a human being or animal.
Unlike many users think, the manufacture of a drug is not straightforward, but quite the contrary, from the moment of discovery of a substance with properties to become a drug until the finished product to be marketed to the population, requires years study, dedication and clinical trial.
According to Woodcock and Woosley the development of a drug can be concentrated as a process initially led by basic research through the series of developmental steps to a commercial product.
The development of a drug has 5 stages until it becomes accessible to the patients. The first stage is the discovery and development, in this first part of the process many substances possess a great poise to become a medical treatment, and however, after some test only a few are approved for phase two. In the second stage also called preclinical researchers need to find out if substances have a potential cause of damage, the test is also called toxicity and can be performed in vitro or in vivo, normally preclinical studies are not long lasting, but the studies should show information on levels of toxicity and then whether the substance can be tested in humans. The third phase of drug development, Clinical Research, refers to the study and trials that are done on humans, at this point in the development the researchers organize a study plan called protocols and elaborate questions and objectives that they intend to respond for example, how many people have been part of the study or how the drug will be passed on to patients and in which dosage. The complete process can take about ten years, thus following the fourth phase where a review of all the steps of the drug is carried out, finishing in the fifth phase, which is the Post-Market Drug Safety Monitoring where the drug is already accessible to the consumer, but monitoring to be continued. (U.S Food & Drug Administration)
1.2. Clean Rooms
The entire manufacturing process of a drug in a Pharmaceutical company needs to be done in a controlled environment and constantly monitored to avoid the risk of contamination that could endanger the life of the user.
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A clean room is where the concentration of air particles is constructed and used in a way to minimize the introduction, generation and retention of particles within the room and where other important parameters such as temperature, humidity and pressure are controlled if necessary. (ISO 14644-1)
According to Whyte (2001), the design and management of a clean room back to more than 100 years ago to control infections in hospitals. Currently, the use of a clean environment for industrial manufacturing is an international requirement. The need for a clean room is due the fact of people, equipment and the structures of the building generate contamination.
Personnel, as well as equipment, produce thousands of particles that can easily spread. A clean room control this dispersion at all levels of manufacturing performed in a clean environment. The use of a clean room is diverse and can be applied in different industries such as Electronic, Semiconductor, Optics, Biotechnology, Pharmacy, Medical Device, Food and Drink. (Whyte 2001).
The secret of well design clean room is the understanding of what is required to build and run and maintain of it. It is crucial, even at the beginning, that the design of the clean room regard to the contamination control required is directed related to the product that will be manufactured within it, is exactly right (O’Donoghue 2011).
All the rooms in a clean environment it is significant important for effective and correct operation of the facility. It is required a spacious gowning room for personnel to enter and leave, a separate area for transfer material that allows the enter of equipment and goods and also a segregated area that will conducted the transport of the finish product out of the clean room (O’Donoghue 2011).
According with the International Organization for Standardisation (ISO) dedicated to Cleanrooms and associated controlled environments (ISO 14644-1 2015) a clean room can be defined accordingly with the occupancy stage; as-built when the condition of the clear zone is complete with all services connected, but with no equipment, materials or personnel; at-rest when the conditions of the clean room is complete with equipment installed and operating, but with no personnel present and operational; when the clean zone is operating in the specified manner with a specified number of personnel present.
1.3. Monitoring of clean rooms
A routine of extensive monitoring program of the clean room should be in place in all stages of the process and should include the monitoring of airborne viable and nonviable particulates, pressure differentials, microbes contaminants on equipment, product contact surfaces, walls, floors and personnel (O’Donoghue 2011).
According to World Health Organization (WHO) a clean room classification based on airborne particulates. The grades of the clean room can range between A to D and is related with the max permitted particles allowed in wherever is the stage of the clean room.
During the occupancy stage as built the monitoring is performed when the installation is complete and the result proves that the environment was correctly installed and meets the intended design specification. At the occupancy of at rest the monitoring is performed when the equipment is installed and operating in a manner agreed and the results proves that all parts of the installation operate together to achieve the required specifications. Operational occupancy stage the testing and monitoring is performed when the installation is complete and functioning in the specified manner include the personnel and the results proves that the complete installation achieve the required operational performance including the personnel working within the environment (O’Donoghue 2011).
For every type of clean environment, a monitoring routine of analysis of the layout of the room, the materials, equipment, and personnel present should be conduct as well as the activities performed, and the potential risk to the product. From this analysis, a risk-based routine sampling plan detailing sampling sites, volumes, and frequencies can be organized; a schematic drawing of the room showing sampling locations, and a justification of the choice of sampling locations should be clearly documented. Risk assessments should be kept up to date (WHO 2012).
Contamination is described as unwanted impurities of chemical or microbiological nature or a foreign substance, into or onto a raw material, intermediate or API during the manufacturing process, such as packaging, assembly, storage and/or transport (Niazi S K 2009).
The main forms of occurrence of biocontamination are through equipment, material, manufacturing process, air system and personnel. As explained by Jimenez (2004) the air system, the personnel and surfaces are the major sources of microbial contamination, especially the personnel, which has been substantially documented that human can easily spread viable and nonviable particles being the most significant sources on contamination in a clean zone.
Microbial contamination becomes one of the main reasons for product recalls, closure of the production and losses in work and manufacturing. Companies are losing money due to lack of quality control, process control, and proper testing. When a contaminant is found during any stage of the Pharmaceutical production, an investigation should immediately start to determine the contamination source, the numbers, and the types of microorganisms (Jimenez L 2004)
According to the author Jimenez L (2007) an expressive number of recalls by the FDA is regarding to the microorganisms contamination including Salmonella spp, Staphylococcus spp and E.coli, which the last two microorganisms has been frequently found in samples of pharmaceutical product worldwide.
Deficiencies of the mechanism of controls in a Pharmaceutical Industry represent a significant factor of product contamination. The clinical result of the microbial contamination, regardless the route of the contamination can cause risk to the consumer and even kill the patient. Adhering a good manufacturing practice and the use of advance technologies can effectively contribute to detect microorganism and hence prevent the reoccurrence of a microbial contamination.
- Hall K., Stewart T., Chang J., Freeman MK. (2016). Characteristics of FDA drug recalls: A 30-month analysis.
- Woodcock J., Woosley R. (2008) “The FDA Critical Path Initiative and Influence on the New Drug Development” The Annual Review of Medicine 59:1-12
- Human Drugs (2018) available from <https://www.fda.gov/ForIndustry/ImportProgram/ImportBasics/RegulatedProducts/ucm511482.htm > [05 October 2018]
- The Drug Development Process (2018) available from <https://www.fda.gov/forpatients/approvals/drugs/defaut.htm>[05 October 2018]
Whyte W. (2001) “Cleanroom Technology: Fundamentals of Design, Testing and Operation”.
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