3. The Reasons Why Microbiological Control is Necessary
As I wrote in one of my earlier articles, microorganisms exist everywhere. They should exist in drug products and medical devices, of course, if microbiological control isn't in place. And you cannot actually see them with the naked eye. They keep reproducing in any environment where the conditions such as water, the temperature, nutrition, pH, and osmotic pressure, are good for them. They reproduce very fast. Some microorganisms may be pathogenic or cause decomposition or degeneration. Therefore, appropriate microbiological control is required in manufacturing control for drug products and medical devices. In order to do so, we need to prevent contamination caused by microorganisms from happening as much as realistically possible.
Sterility is required and/or microbial count limits (the maximum number of viable microorganisms or the number of species acceptable per unit) are established often for many drug products and medical devices. The same applies not only to finished product units of them but also to raw and other materials, in-process products, manufacturing facilities, manufacturing environment, personnel, and others. In order to fulfill the requirements, various requirements in terms of microbiological control are provided in the manufacturing process of drug products and medical devices, and we need to meet the specifications of microbiological items at the time of product release.
Now, let me describe the reasons why such microbiological requirements, often strict ones, are established for drug products and medical devices.
1. Infection Control
Direct contact with patients' blood or other types of body fluids may be required for some drug products and medical devices. Even otherwise, people in a poor physical conditions due to a disease or injury are the patient/user in many cases. Which means that a harmful microorganism may work as a pathogen and cause infection if they exist in a drug product/medical device.
The extent of microbiological requirements differs among products. Sterility is strictly required for injectables or catheters for blood vessels especially. Meanwhile, sterility will not be required in general for oral drugs and medical devices for digestive organs.
2. Prevention of Deterioration
Microorganisms may deteriorate a product when they reproduce in/on it. This applies to infection, too. Possible deterioration includes accumulation of hazardous materials, as well as changes in color, pH level, odor, appearance, and so on. In order to prevent such deterioration from occurring, preservatives are often used in cosmetics and personal care products.
3. Compliance with Regulation
For instance, injection needles generally used for treatment or testing procedures are "sterilized injection needles", which are sterilized as the name indicates. In other words, those needles are required to be sterile. Such needles contact directly with human blood. Therefore, such requirement is established as regulation to prevent infection from occurring.
4. To Prove that the Product was Not the Cause of Infection
We cannot ensure that sterile drug products and sterilized medical devices are always used in a sterile environment. Even in clean rooms a number of microorganisms exist on patients' skin and mucosa. That means we cannot deny the possibility of infectious cases happening even when the product used was sterile.
This is the reason why you must have a sterilization process because you will need the process as the basis when you claim that your product was sterilized properly thus wasn't the cause.
5. Due to the Need for Marketing Purposes
Especially for products for the general public, you may use the label such as "Sterilized" or "Disinfected" for the purpose of giving an impression that the product is reliable. There is no criteria to achieve "disinfection" in terms of the approach. However, you will need to guarantee that the product is sterile when you use the label, "Sterilized".
If the contaminant is as big as an insect like a bee, then the user will immediately notice it and contact the marketing authorization holder to report a complaint. Contamination is one of the extremely critical issues in drug products and medical devices thus it leads to a recall in many cases once it happens. When the contaminant is a microorganism, you cannot see it with the naked eye but it can cause a serious infection.
Manufacturers of drug products and medical devices have to always be aware of this point in your manufacturing/quality control activities.
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