CERTIFICATE

IMPACT FACTOR 2021

Subject Area

  • Life Sciences / Biology
  • Architecture / Building Management
  • Asian Studies
  • Business & Management
  • Chemistry
  • Computer Science
  • Economics & Finance
  • Engineering / Acoustics
  • Environmental Science
  • Agricultural Sciences
  • Pharmaceutical Sciences
  • General Sciences
  • Materials Science
  • Mathematics
  • Medicine
  • Nanotechnology & Nanoscience
  • Nonlinear Science
  • Chaos & Dynamical Systems
  • Physics
  • Social Sciences & Humanities

Why Us? >>

  • Open Access
  • Peer Reviewed
  • Rapid Publication
  • Life time hosting
  • Free promotion service
  • Free indexing service
  • More citations
  • Search engine friendly

Cleaning validation of recombinant human granulocyte colony stimulating factor (rhu-gcsf) in multi product manufacturing facility: a case study

Author: 
Krishna Kattavarapu, Leelanath Tanneeru, Krishnanand Tiwari and Maheshwari K. Mishra
Subject Area: 
Health Sciences
Abstract: 

Cleaning validation is an integral part of current good manufacturing practices in any Biopharmaceutical industry. Drug products usually get contaminate with residue of other drug products or cleaning agents manufactured in the same equipments, if the cleaning procedure is not proper. We studied the cleaning validation of GCSF Injection on three consecutive batches in multi product manufacturing facility. Various acceptance limits for product carryover was calculated based on 0.1 % of therapeutic dose, 10 ppm and 1/1000 Therapeutic daily dose of the drug. The stringent limit of maximum allowable carryover (MACO) of GCSF in other products was found to be 18 µg. The 0.5 M NaOH solution was used as a cleaning agent to clean the equipments and accessories used for bulk manufacturing of GCSF. Rinse and swab samples were collected from the cleaned equipments and accessories and tested for product carryover by sandwitch ELISA. The product carryover of GCSF in subsequent product was determined to be less than 0.1 µg and the level of cleaning agent was less than 10 ppm, thus indicating establishment of effective cleaning procedure for GCSF manufacturing.

PDF file: 

CALL FOR PAPERS

 

ONLINE PAYPAL PAYMENT

IJMCE RECOMMENDATION

Advantages of IJCR

  • Rapid Publishing
  • Professional publishing practices
  • Indexing in leading database
  • High level of citation
  • High Qualitiy reader base
  • High level author suport

Plagiarism Detection

IJCR is following an instant policy on rejection those received papers with plagiarism rate of more than 20%. So, All of authors and contributors must check their papers before submission to making assurance of following our anti-plagiarism policies.

 

EDITORIAL BOARD

CHUDE NKIRU PATRICIA
Nigeria
Dr. Swamy KRM
India
Dr. Abdul Hannan A.M.S
Saudi Arabia.
Luai Farhan Zghair
Iraq
Hasan Ali Abed Al-Zu’bi
Jordanian
Fredrick OJIJA
Tanzanian
Firuza M. Tursunkhodjaeva
Uzbekistan
Faraz Ahmed Farooqi
Saudi Arabia
Eric Randy Reyes Politud
Philippines
Elsadig Gasoom FadelAlla Elbashir
Sudan
Eapen, Asha Sarah
United State
Dr.Arun Kumar A
India
Dr. Zafar Iqbal
Pakistan
Dr. SHAHERA S.PATEL
India
Dr. Ruchika Khanna
India
Dr. Recep TAS
Turkey
Dr. Rasha Ali Eldeeb
Egypt
Dr. Pralhad Kanhaiyalal Rahangdale
India
DR. PATRICK D. CERNA
Philippines
Dr. Nicolas Padilla- Raygoza
Mexico
Dr. Mustafa Y. G. Younis
Libiya
Dr. Muhammad shoaib Ahmedani
Saudi Arabia
DR. MUHAMMAD ISMAIL MOHMAND
United State
DR. MAHESH SHIVAJI CHAVAN
India
DR. M. ARUNA
India
Dr. Lim Gee Nee
Malaysia
Dr. Jatinder Pal Singh Chawla
India
DR. IRAM BOKHARI
Pakistan
Dr. FARHAT NAZ RAHMAN
Pakistan
Dr. Devendra kumar Gupta
India
Dr. ASHWANI KUMAR DUBEY
India
Dr. Ali Seidi
Iran
Dr. Achmad Choerudin
Indonesia
Dr Ashok Kumar Verma
India
Thi Mong Diep NGUYEN
France
Dr. Muhammad Akram
Pakistan
Dr. Imran Azad
Oman
Dr. Meenakshi Malik
India
Aseel Hadi Hamzah
Iraq
Anam Bhatti
Malaysia
Md. Amir Hossain
Bangladesh
Ahmet İPEKÇİ
Turkey
Mirzadi Gohari
Iran