A seminar on Validation of Dry Powder Mixers

1. A seminar on Validation of Dry Powder Mixers By WWW.PARASSHAH.WEEBLY.COM M.Pharm. (Sem - III) Department of Quality Assurance Maliba Pharmacy College.

2. Contents • Introduction • variables • Powder mixers validation • Revalidation • Latest advancements in the blend analysis • References

3. Introduction • Validation of Dry Powder Mixers It is defined as documented act which provide the high degree of the assurance that Powder Mixer equipment actually leads to the desired mixing or blending. • Why it is essential The mixing of the API and excipients is the critical step in the solid dosage form preparations that affect the content uniformity at great extent

4. Types of the powder blenders • V cone blenders • Double cone blenders • Drum mixer • Ribbon blenders • Conical screw mixer • Tumble blender

5. Variable and monitoring Variable Monitoring Blend uniformity • RPM • Mixing time • Mixing load

6. Worst case • Evaluation of worst case: Worst case include, maximum and minimum load, maximum and minimum rpm, maximum and minimum time.

7. URS for the powder mixers • Operating criteria must be adequate • Spares should be available • Easy maintenance • Equipment should not disseminate dust • Low cost • Non reactive surface • Capacity • Mixing speed

8. Installation qualification • Details of the Equipment • Equipment name, made by & model No. shall be noted down. • Location for the installation equipment shall be checked. • Utilities required shall be listed down. • Any deviation observed while following above procedure should be informed for corrective action. • Installation Procedure: • After checking all the specifications as mentioned in the selection criteria, service engineer shall commission the equipment. • Authorized validation team shall carry out installation checks.

10. Operational qualification • After completions of successful installation qualification initiate the actual operation of to ensure that machine is operating within specification. • Check the operation qualification parameters against their specifications. • Document the deviation details • The Quality head and the department head shall decide whether deviation is acceptable or not.

12. Performance qualification • Load the materials to be mixed in the mixer • Start the mixer and rotate it for the time as mentioned in the BMR. • After completion of mixing switch OFF the mixer and separate out the drum. • Collect the sample as per sampling procedure. • Send the samples to Quality control dept. for content uniformity, bulk density and sieve analysis.

13. Sampling Drum mixer Double cone blender V cone blender Top Middle Bottom

14. Content uniformity Sieve Analysis

15. Density

16. Revalidation Criteria • Location of the equipment is changed. • There is change of spare/ parts that have a direct effect on the performance of the equipment   • At normal revalidation schedule.

17. Latest advancements in the Blend analysis • NIR spectroscopy • Raman spectroscopy • Microscopic FTIR mapping

18. Online Monitoring with NIR probe

19. Online Monitoring with Raman probe

20. References • http://www.validationonline.net/Mixer.html • www.askaboutvalidation.com • Pharmaceutical Master Validation Plan by Sayed Imtiyaz Haider published by st. Luice press page no 125. • A Report of the Product Quality Research Institute Workshop on Blend Uniformity by Jozef H.Timmermans

21. Thank you