Lecture 12 & 13 Sterile diagnostics.pptx

diagnostics

1. Sterile diagnostics

2. Content Introduction D iagnostic products Definition A septic manufacturing consideration Factory design, process equipment and instrumentation Environmental control system Sterilization process Human serum production

3. Introduction Sterile diagnostics refer to the practices and tests performed to ensure that certain products, particularly those intended for patient use, are free from viable microorganisms. This is crucial in fields such as pharmaceuticals and medical devices, where sterility must be confirmed before product release. Sterility testing is a GMP requirement and includes methods to confirm that no microbial contamination is present.

4. D iagnostic products Definition Diagnostic products refer to any device, product, process, substance, composition, or service that is designed to predict, detect, identify, or monitor diseases. This can include in vitro diagnostics (IVD) like tests performed on samples from the body (such as blood or tissue) and other methods used to ascertain health issues.

5. In vitro diagnostics (IVD) In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person’s DNA to detect genomic variations. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.

6. Historical development diagram of in vitro diagnostic industry.