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| Year : 2014 | Volume
: 2
| Issue : 1 |
Page : 24-35 |
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Critical review on qualification of sterilization equipment in aseptic processing
Sachin J. Shinde, Pritam S. Jain, Nikita K. Kale
Correspondence Address:Department of Quality Assurance, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule (MS), India. Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule (MS), India.
Source of Support: ,
Conflict of Interest: None
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DOI: 10.4103/2231-4040.197331
Aseptic filling is an aseptic process that requires the close coordination and complex interaction between personnel, sterilized product, the fill/finish equipment system, clean room and support facilities and sterilized filling components. Aseptic manufacturing means drug substance and excipients were sterilized appropriately and all materials, equipment and container closure systems were used only after sterilization. Regulatory GMP for the aseptic manufacture of human and veterinary products mandate that an incidence involving product sterility failure or media fill contamination is fully investigated and also manufacturer establishes an environmental monitoring program that is properly validated to ensure that environmental contaminates are detected. The stability of the aseptic filled drugs will be affected by steam (autoclave), dry heat (depyrogenation tunnel) and rubber stopper. Hence there is a need to utilize an aseptic process to fill certain biological, pharmaceuticals and biotechnology drugs.
Keywords: Qualification, depyrogenation tunnel, autoclave, rubber stopper washer
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