Evaluation of previous product residue on magnetic bar used for manufacturing of Japanese Encephalitis vaccine

Kornkew LimTssnee DmrirmTulyluck Aupichit Krun TunchroenBoonrk Thwornrungroj

aGovernment Pharmaceutical Organization-Merieux Biological Products Co.,Ltd.(GPO-MBP),241 Moo 7, Huasamrong,Plaengyao,Chachoengsao 24190,Thailand

bSanofPasteur Co.,Ltd.,87/2 CRC Tower,23rd Floor All Seasons Place,Wireless Road,Lumpini,Pathumwan, Bangkok 10330,Thailand

Evaluation of previous product residue on magnetic bar used for manufacturing of Japanese Encephalitis vaccine

Ratiya Kukhetpitakwonga,*,Worawit Sangamruma, Kornkaew Laimaa,Tassanee Damrirama,Tulyaluck Aupaichita, Karuna Tuncharoena,Boonrak Thawornrungroajb

aGovernment Pharmaceutical Organization-Merieux Biological Products Co.,Ltd.(GPO-MBP),241 Moo 7, Huasamrong,Plaengyao,Chachoengsao 24190,Thailand

bSanofPasteur Co.,Ltd.,87/2 CRC Tower,23rd Floor All Seasons Place,Wireless Road,Lumpini,Pathumwan, Bangkok 10330,Thailand

A R T I C L E I N F O

Article history:

Available online 23 November 2015

Cleaning validation

Rinse sampling

Total organic carbon

Correlation

Cleaning validation is one of recommendation from Pharmaceutical Inspection Co-operation Scheme(PIC/S)to avoid contamination of pharmaceutical products.The objective of cleaning validation is to confrm reliability of cleaning procedure for removal of contaminants associated with previous products,residues of cleaning agents and potential microbial contaminants[1].Japanese Encephalitis vaccine is a new product that is prequalifed by World Health Organization (WHO)and manufactured at GPO-MBP.Magnetic bar is dedicated for this product and used in stainless steel vessel, which is used for blending and flling processes of the fnal bulk product.

To validate the cleaning procedure for the magnetic bar,rinse sampling was applied.Total organic carbon(TOC)was used todetect product residue in rinsing solution.Correlation between TOC and diluted vaccine(vaccine and water for injection(WFI) ratio=9:1(v/v))can be expressed with a linear equation; y=40.589×–0.322.Coeffcient of determination(r2)is 0.9993. Recovery of the sampling technique is 92.7±9.45%.Acceptance criteria for the product residue was defned based on no more than 0.1%of the normal therapeutic dose of the product that will appear in the maximum daily dose of the product. Maximum residue of the previous product should not more than 3.7 μl/ml of rinsing solution.TOC values of rinsing solution from cleaning validation of magnetic bar were less than those of the positive control,and conformed to the acceptance criteria.In conclusion,cleaning procedure according to standard operating procedure of GPO-MBP is validated.

Fig.1–(A)Magnetic bar;(B)Correlation between TOC and product content.

Acknowledgement

The authors acknowledge the technical support received from Global Manufacturing Technology,SanofPasteur,France.

R E F E R E N C E

[1]Pharmaceutical Inspection Co-operation Scheme Secretariat. Recommendations on validation master plan,installation and operational qualifcation,non-sterile process validation, cleaning validation.Documents for inspectors.PI 006-3;25 September 2007:17–22.

*E-mail address:ratiya.kukhetpitakwong@gpo-mbp.com.

Peer review under responsibility of Shenyang Pharmaceutical University.

http://dx.doi.org/10.1016/j.ajps.2015.10.024

1818-0876/©2016 The Authors.Production and hosting by Elsevier B.V.on behalf of Shenyang Pharmaceutical University.This is an open access article under the CC BY-NC-ND license(http://creativecommons.org/licenses/by-nc-nd/4.0/).