Sterility Testing of Pharmaceutical Products
Sterility testing is anything but an easy task and that is why it is performed by highly qualified laboratory practitioners. It is the process by which any false-positive results are completely eliminated as a means of achieving sterilization validation and quality control. False positives are usually as a result of laboratory contamination or even human error. It is imperative to design the test environment meticulously so as to meet the United States Pharmacopeia requirements. These requirements spell out the acceptable surface and microbial air counts. Any growth media used in the sterility testing must be carefully prepared to enhance microbial growth.
Sterile processing is both a clinical and technical field requiring much knowledge and responsibility. Sure, pretty much anyone can be taught how to do the job and get by at it. But with sterile processing, it was given emphasis that all technician must have to understand what the theories behind and the rationale on everything they are doing within the department they are assigned to, for example, a technician who truly has a good grasp of the principles of microbiology is going to be better equipped to work adequately in decontamination and provide a better quality product than someone who lacks such understanding.
Sterility testing is a very important facet in pharmaceutical production since it ensures that only sterile products are released into the market. Understanding what this process entails is very beneficial since it helps in the process of validation. The process for creating samples, testing, and subsequent follow-up tests must be clearly outlined in the stability protocols. Even before an actual test is done, it is important to send a sample to the appropriate laboratory to ensure the lab determines all the important testing procedures beforehand. It is a good idea for every pharmaceutical company to develop different procedure specifications for testing its different products. A good procedure ought to be straight to the point and also clearly spell out which syringes or vials need to be tested.
At the bare minimum, testing is incorporated as part and parcel of the stability protocol not only at the initial release point but also as at the final testing point. However, the FDA recommends additionally testing to be carried out regularly, e.g. annually, to ensure the products continue to adhere to the guidelines of sterile product protocols.
Sterility testing is an essential part of every sterilization validation. Since medical paraphernalia comes in various sizes and shapes, it is often not easy to entirely to test large medical devices. The workaround is defining a SIP (sample item portion). A SIP is just a small sample portion given in percentage of fractional terms. One of the greatest challenges of sampling is there is always a probability of not catching the infected containers.
In the last two decades, lots of advances have been made in all manner of sterility testing techniques aimed at making the tests more accurate and reliable. This has led to the introduction of molecular methods like nucleic acid amplification. In as much as broad testing is the preferred way of detecting unknown microorganisms, a couple of viruses can easily be screened by using targeted molecular methods. By and large, different techniques including the traditional direct inoculation and membrane filtration techniques can be used in combination with nucleic acid amplification to ensure best results.
