X hits on this document

79 views

0 shares

0 downloads

0 comments

31 / 37

Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

31 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Steam Sterilisation & SIP systems!

Air removal from equipment not adequately considered

Steam quality not assessed adequately

Non-condensable gases

Wet steam (Dryness fraction)

Superheat Clean steam quality tests are not performed at distal points of the distribution system. Steam quality test not performed following modifications

Document info
Document views79
Page views79
Page last viewedSat Dec 03 05:06:51 UTC 2016
Pages37
Paragraphs508
Words2308

Comments