Bookcover of Process Validation, Area and Equipment Qualification
Booktitle:

Process Validation, Area and Equipment Qualification

Process validation of metformin HCL ER tablets in new equipment set up with equipment qualification, area qualification

LAP LAMBERT Academic Publishing (2013-06-12 )

Books loader

Omni badge eligible for voucher
ISBN-13:

978-3-659-40508-2

ISBN-10:
3659405086
EAN:
9783659405082
Book language:
English
Blurb/Shorttext:
Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i.e. FBD, RMG, Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments, batch size of Metformin ER tablets is increasing from 0.4 mio to 0.6 mio. As the production in new area and new equipment, qualification of area, equipment, water and air was carried out as per qualification protocol. Now, further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i.e. standardization batch (BATCH I). Before going to start process validation, one standardization batch was taken, where the process optimization of critical parameter like mixing speed, mixing time, lubrication time was carried out; fast, 15 min, 15 min respectively the results for that. Three process validation batches (PV-1, PV-2 and PV-3) of commercial batch size were taken in which Manufacturing Process, critical parameters, Validation status of equipments & Validation criteria’s were considered.
Publishing house:
LAP LAMBERT Academic Publishing
Website:
https://www.lap-publishing.com/
By (author) :
Mitesh Patel, Kanu Patel, Mukesh Patel
Number of pages:
96
Published at:
2013-06-12
Stock:
Available
Category:
Pharmacy
Price:
54.90 €
Keywords:
HVAC, Process Validation, Equipment Qualification, Area Qualification, Air Qualification, Pharmaceutical Water, Process Optimization

Books loader

Newsletter

Adyen::diners Adyen::jcb Adyen::discover Adyen::amex Adyen::mc Adyen::visa Adyen::cup Adyen::alipay Adyen::unionpay Adyen::paypal Paypal CryptoWallet Wire Transfer

  0 products in the shopping cart
Edit cart
Loading frontend
LOADING