Sources of Contamination in Medicinal Products and Medical Devices Book

1. Introduction

2. Directives for contamination control

PART I: CHEMICAL CONTAMINATION

3. Raw Materials

3.1 Water

3.2 Inorganic Impurities

3.3 Organic Impurities

3.4 Additives

3.5 Residual solvents

Concluding remarks

References

4. Medicinal gases and volatile anesthetics

4.1 Medicinal gases

4.2 Volatile anesthetics

Concluding remarks

References

1. Introduction

2. Directives for contamination control

PART I: CHEMICAL CONTAMINATION

3. Raw Materials

3.1 Water

3.2 Inorganic Impurities

3.3 Organic Impurities

3.4 Additives

3.5 Residual solvents

Concluding remarks

References

4. Medicinal gases and volatile anesthetics

4.1 Medicinal gases

4.2 Volatile anesthetics

Concluding remarks

References

5. Diagnostic imaging agents

5.1 Radiopharmaceuticals

5.2 Contrast agents

Concluding remarks

References

6. Containers

6.1 Glass containers

6.2 Plastics containers

6.3 Metal containers

Concluding remarks

References

7. Closures

Concluding remarks

References

8. Delivery systems and filters

8.1 Delivery systems made of PVC

8.2 Delivery systems made of other plastic materials

8.3 Filters

Concluding remarks

References

9. Medical devices

9.1 General use devices

9.1.1 Medical gloves

9.1.2 Syringes

9.2 Extracorporeal circuits

9.3 Devices for administration of aerosolized drugs

9.4 Reprocessed medical devices

9.5 Tissue substitutes

Concluding remarks

References

PART II: PHYSICAL CONTAMINATION

10. Particulate matter

Concluding remarks

References

PART III: MICROBIOLOGICAL CONTAMINATION

11. Microbiological and endotoxin contamination

11.1 Water

11.2 Raw materials

11.3 Sterile products

11.4 Medicinal gases

11.5 Medical devices

11.6 Biofilms

11.7 Dialysis circuits

11.8 Nosocomial infections

Concluding remarks

References

PART IV: MISCELLANEOUS

12. Contamination from sterilization procedures

12.1 Residuals from radiation sterilization

12.2 Heat sterilization

12.3 Residuals from chemical disinfection/sterilization agents

Concluding remarks

References

13. Biotechnological products

13.1 DNA and Host cell proteins residuals

13.2 Viruses and mycoplasma

13.3 Endotoxin

13.4 Protein degradation

13.5 Protein aggregation

Concluding remarks

References

Appendix