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Validation of aseptic processes for pharmaceuticals
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  • Validation of aseptic processes for pharmaceuticals
  • Validation of aseptic processes for pharmaceuticals
저자명
Joseph. Lincy,George. Mathew,Jain. Saurabh Kumar
간행물명
Oriental pharmacy and experimental medicine : OPEM
권/호정보
2010년|10권 4호|pp.231-238 (8 pages)
발행정보
경희한의학연구센터
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정기간행물|ENG|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Sterile Products may be broadly classified into two main categories, according to the manner in which they are produced: those which are sterilized after the product has been filled and sealed in the final container(s) ("terminally sterilized" products) and those where the sterilization stage (or stages) takes place is it before or after the bulk product filled in to final container. In this latter instance, all subsequent processing (typically, the filling and sealing operations) must be conducted aseptically in order to prevent recontamination of the sterilized product. The two most common pharmaceutical applications of aseptic processing methods are (a) the filling of liquid products following sterilization by filtration and (b) the filling of previously sterilized bulk powder products. An aseptic processing operation should be tested using a microbiological growth medium (media fill) during lyophilized injection formulation, filling, loading, lyophilisation, stoppering, and unloading activities.