Quality control test for parentrals

quality control test for parentrals

1. Submitted by Meerab Tanveer Quality Control Test For Parentrals

2. Parentrals Sterile products - that are intended to be administered by injection, infusion, or implantation into the body. (or) Sterile dosage forms intended for administration by injection under or through one or more layers of the skin, and exert their action by directly entering into the systemic circulation.

3. Cont ...... Prepared with a higher degree of care and skills than utilized in preparing conventional oral or topical products.

4. Cont..... Finished product must be sterile, non- pyrogenic & free from extraneous insoluble materials.

5. Cont ...... Heavy responsibility on pharmaceutical industry & pharmacist to practice cGMPs & to practice good aseptic practices (GAPs).

6. Content uniformity Package integrity test Clarity test Pyrogen test Sterility test Quality Control Test

7. 1) Content Uniformity Test Intended for sterile solids used for parenteral preparation. For this purpose 10 sterile units are taken. Content of active ingredient in each sterile unit is calculated by performing assay according to individual monographs.

8. Cont...... Limits; 85 - 115% > for all 10 units. If; 9 unit = 85 – 115% & 1 unit = 75 – 125% Then - test carried out on 20 more units. So for all 30 units – limits are 29 units = 85-115% 1 unit = 75-125%

9. 2) Package Integrity Test Package integrity means its ability to keep product in & to keep potential contamination out.

10. Methods Visual Inspection Package is observed visually for leaks. Visual inspection is the easiest leak test method to perform. But is least sensitive. Used for - evaluation of vials, ampoules & large volume parenterals .

11. Cont..... To increase sensitivity of method visual inspection of may be coupled with application of vacuum - to make leakage more readily observable. ADVANTAGES method is simple and inexpensive. DISADVANTAGES method is insensitive, operator dependent, and qualitative.

12. B) Dye Bath Test Used to detect leaks in ampoules. Presence of capillary pores or tiny cracks can cause microbes or other dangerous contaminants to enter ampoules, or may lead to the leakage of contents to outside. This leads to contamination of sterile contents & also spoilage of appearance of the package.

13. Procedure

14. Cont ..... Use It is used for ampoules and vials . Advantages It is inexpensive . Disadvantages It is qualitative destructive and slow .

15. 3) Clarity Test

16. 4) Pyrogen test

17. Horse shoe crab

18. LaL Reagent

19. Procedure

20. Techniques 1) Gel clot technique ---- gel formation in presence of endotoxin . It require positive and negative control. Positive control : known concentration of endotoxin added Negative control : water added without endotoxin

21. Cont......... 2) Turbimetric Technique --- turbidity form after cleavage of endogenous toxin . 3) chromogenic technique --- formation of color after cleavage of synthetic peptide

22. 5) Sterility Test

23. Cont...... Membrane Filteration Method Take a membrane filter of pore size 0.45 micron and 50mm in diameter . Prepare the media and pour in petri plates. Filter sample with help of membrane filter . cut it into two pieces and put into the media. Incubate it. And check results as given in monograph

24. Cont ..... Direct inoculation method Directly inoculate the samlpe in media prepared . Incubate it And observe the results