Quality-control_Tests_for_Containers_Pharma.pptx

It is a ppt about quality control test has to perform on different types of container to check it's quality and prevent the substance from unfortunate contamination

1. Quality Control Tests for Containers in Pharmaceutical Industry Presented by: RajKundan College Project

2. Introduction to Containers • Containers protect and preserve medicines • Maintain stability, safety, and efficacy • Improper containers → loss of drug effectiveness

3. Importance of QC • Ensures patient safety • Regulatory compliance • Prevents contamination • Maintains product stability and shelf life

4. Regulatory Guidelines • USP (United States Pharmacopeia) • IP (Indian Pharmacopeia) • WHO guidelines • ICH Q10 (Pharma Quality System)

5. Types of Containers • Glass (ampoules, vials, bottles) • Plastic (HDPE, PET bottles) • Metal (aluminium tubes, foils) • Rubber closures

6. QC Test 1: Physical Tests • Visual inspection • Dimension check • Closure integrity test • Drop test

7. QC Test 2: Chemical Tests • pH check • Extractables test • Leachables test • Heavy metals & residue analysis

8. QC Test 3: Biological Tests • Sterility testing • Pyrogen/endotoxin test • Microbial contamination test

9. Light Transmission Test • Ensures protection from light • UV & visible light absorption measured • Prevents degradation of light-sensitive drugs

10. Moisture Permeation Test • Determines container resistance to moisture • Conducted on plastic bottles • Critical for hygroscopic drugs

11. Compatibility & Safety Evaluation • Container-drug interaction study • Adsorption, absorption, leaching • Ensures no toxic substances migrate

12. Case Example: Glass Vial QC Flowchart: 1. Visual inspection 2. Dimension check 3. Hydrolytic resistance test 4. Sterility & endotoxin test

13. Challenges in QC • High cost of testing • Advanced instruments required • Variability in container materials • Time-consuming processes

14. Conclusion & Future Trends • QC ensures safety and efficacy of drugs • Smart packaging and AI-based testing emerging • Future: real-time container monitoring

15. References & Thank You • USP, IP, WHO guidelines • Pharma QC textbooks • Research articles Thank You!