The applied segment of microbiology is pharmaceutical microbiology. It deals with the study of microbes like methods to minimize the number of bacteria in the environment, eliminating bacteria like bacterial endotoxins from water and other raw materials and also makes sure that the manufactured pharmaceutical product is sterile and free from contamination.
The primary focus of pharmaceutical processing is the drug safety. The microbiological entities like the pathogenic bacteria, fungi, viruses, etc. and the harmful toxins produced by them cause significant damage to the patient’s well being and can cause many health related issues, and that is why it is essential to make sure that the finished formulation does not contain any pathogens and is sterile.
Also, it is essential to determine that how the produced product will react if there is any contamination. Like what will happen if any microbe falls off in the bottle of medicine when the lid is off. For this, the product is challenged with specific amounts of microorganisms and the anti-microbial activity is tested.
The validation of disinfectants also comes under the field of pharmaceutical microbiology. Pharmacopeia which are of various types do the testing of the products. For example, US Pharmacopoeia for the united states, Japanese Pharmacopoeia and many more. They have a testing method that is usually followed to tet the products. It also has particular specifications regarding microbial limit that is allowed in the finished product.
In India, the Indian Pharmacopoeia Commission defines the standards of the medicines produced, sold, managed, and consumed in the country. It derives many of its rules from the British Pharmacopoeia.
The other things covered under pharmacopeia are sterility testing, testing of endotoxins, how to use indicators, the measurement of the amount of microbial contamination, counting their numbers and the examination of solvents including water being used for the pharmaceutical formulations.
Risk assessment and management
Risk assessment involves the understanding of how to assess cleanrooms, and control the levels of contamination, the various strategies to combat corruption.
Their use classifies cleanrooms. The cleanliness of these zones is measured by measuring the particles. The environmental monitoring methods are used to evaluate the cleanrooms.
Viable monitoring involves the detection of the bacterial levels and fungi levels which are present in different locations at different stages of manufacturing and final processing of a product. For the detection of mesophilic microbes present in the aerobic state, viable monitoring is carried out. There are many more methods to detect another type of microbes like anaerobic bacteria if the nitrogen lines have been used during manufacturing.
Surface methods for testing microorganisms are:
- Product Contact Surfaces
- The base of the rooms
- Wall of the industry
- Ceiling of sector
Following techniques are used:
- Contact Plate method
- Touch-Plate method
- Surface Rinsing
Agar settle plates are used for monitoring the air.
Active air- sampling types:
- From slit to the agar
- Filtering the membrane
Tryptone soya agar is used for the monitoring. It is used as a dual incubation temperature of 30oC – 35oC. Sometimes, two different culture media are also used as one is selective for fungi ( Sabourand dextrose agar). The media, temperatures and time of incubations also need the validating. Many times, instead of just one, two culturing media are used, for example, one being specific for fungi and other being specific for bacteria as in the process of sterility testing.
Review Of Literature
In recent years, several types of research have been done regarding the challenges in formulations, Manufacturing process and maintenance of sterility. One such problem is discussed in the following research article: Sterile Products: Advances and Challenges in Formulation, Manufacturing, and Regulatory Aspects—A Regulatory Review Perspective; David Hussong; AAPS PharmSciTech. 2010 Sep; 11(3): 1482–1484.
In this article, aspects of pharmaceutical microbiology to ensure a safe product and better quality are discussed. Current good manufacturing practices (cGMP) guidelines have been issued by the FDA to establish manufacturing standards. Pharmacists must ensure that the sterile preparations that are formulated are free of any microbiological contamination of any kind. A great deal of technology and techniques have been employed for aseptic manufacturing of sterile pharmaceutical formulations, and thus, pharmaceutical microbiology became a significant segment of pharmacy industries. It is often observed that improper handling of the products, not following the instructions, inadequate training of handling practices, or improper packaging, all contribute to a contaminated finished product which is a significant hazard to the health of consumers as well as to workers employed during the manufacturing process.
Some products support rapid microbial growth, but still, it is not advised to add antimicrobial preservatives to single dosage drugs. Thus, the alternative will be to check different diluents to ensure their proper storage or another option is using various diluents.
The best way to avoid microbial contaminants is safe practices but cannot be fool-proof due to human factors. Many cases were seen in which parents had hepatitis due to the contamination present in the containers. Other causes were using devices more than once without sterilizing. The best way to avoid any problems of such kind is educational approaches.