Due to the increasing demand for pharmaceutical products, many companies are investing in gadgets and equipment that can help them ensure that the products manufactured are of top quality and have a positive effect on the people who interact with them.
Amongst all this, it is imperative to have sterility testing of pharmaceutical products to ensure no contamination exists.
Why a Sterility test?
Sterility testing of pharmaceutical products is a process where, with sterilization validation and quality control, any false-positive results can be eliminated, which is nothing but human error or even contamination from the laboratory.
These errors or contaminations are easy to mix with the pharma products, and it is essential to make sure they are eliminated before it reaches the consumer market.
- Sterility testing of pharmaceutical products, especially those labeled as “Sterile”, should occur without any compromise, as per the standards set by International pharmacopeia.
- These tests are necessary as they reveal any bacteria, yeast, or fungi present in the products that show the presence of moisture or an environment fit to be a breeding ground for all of them.
Duration of a Sterility test:
- Any product that will reach a consumer or a patient in a hospital should be sterile enough such that it does not affect their lives. Every pharma company has to ensure the safety and health of the patient.
- The duration of the sterility testing of pharmaceutical products lasts about 14 days. Still, the new technology and advanced machinery introduced in the market are speeding up the process, making them last for only seven days or so.
- The tested products can not be released into the market until it meets the QC (Quality Control) standards of sanitation and sterilization. Sterilization methods such as Rapid Microbial Methods (RMM) are helping to speed up the process of testing by a week and adhere to the pharmaceutical industry’s stringent requirements.
- The initial results of specific rapid sterilization tests are so quick that they come within an hour (24 hour testing time).
- The technology today is so advanced that it helps companies save a lot of time to get their goods into the market by saving time from 14 days up to 21 days, which was traditionally taken up for testing.
Standard methods of Sterilization testing:
There are two standard testing methods used to test for sterility:
- Membrane Filtration Method: This method has seen to gain a lot of global recognition to overcome and circumvent the activity of antibiotics. This technique or testing is performed usually by highly skilled people who have in-depth knowledge about the process.
- Direct Inoculation Method: In this method, three mediums are used to test the sterility – a nutrient broth, Sabouraud medium, cooked meat medium, and thioglycollate medium. This test is usually used to test pharma products such as ointments, etc.
How to choose labs that provide this service:
There are a lot of analytical and testing labs today that clients find difficult to choose from them. They all have excellent facilities and new technology to cater to their needs, but an important thing to look into is their values, what they believe in, what they want to deliver to their client. Following are a few values and vision that should certainly be looked into:
- They should have the zeal and drive to care for quality and to cure all people of any illness.
- They should certainly not compromise on the quality of testing or services they provide.
- Their equipment and labs must be certified, and these certifications should be valid and not have passed their expiration dates.
- They should constantly keep upgrading their resources and knowledge and encourage their team to continually upgrade their skills, keeping up with the growing industry standards.
- Not only catering to the clients, but the focus of the lab service should also be to save the environment. They should be sustainable, reasonable with their working processes such that they come up with very little to no pollutants.
- A significant factor in seeking is transparency. The clients must do their thorough research and understand if the lab is known for its transparent operations and interaction with their past clients. It is always advised to go through the reviews.
- To see what their reach is if they are locally catering to clients, or even internationally. It will showcase how outgoing they are.
To conclude, sterilization techniques have made such an advancement in the pharmaceutical field. At a bare minimum, pharma companies incorporate these basic protocols to be followed to ensure their customers’ safety at every step.