MARCYRL PHARMA-Qualification

Sr. Doc. Name Issue date Project System
01 LAF REQ Protocol & Annex December 20, 2020 Washing Area
02 LAF REQ Protocol & Annex December 20, 2020 Washing Area
03 LAF REQ Protocol & Annex December 20, 2020 Sterile Area
04 LAF REQ Protocol & Annex December 20, 2020 Sterile Area
05 LAF REQ Protocol & Annex December 20, 2020 Sterile Area
06 LAF REQ Protocol & Annex December 20, 2020 Sterile Area
07 Isolator REQ Protocol & Annex December 20, 2020 Preparation Room S04
08 Pass Box (S20) Test Reports (FILTER AIR VELOCITY VERIFICATION TEST & INSTALLED HEPA FILTER LEAK TEST & PRESSURE DIFFERENCE ACROSS HEPA FILTERS TEST & AIR BORNE PARTICLE COUNT TEST & RECOVERY RATE TEST) December 20, 2020 Sterile Area
09 Pass Box(S21) Test Reports (FILTER AIR VELOCITY VERIFICATION TEST & INSTALLED HEPA FILTER LEAK TEST & PRESSURE DIFFERENCE ACROSS HEPA FILTERS TEST & AIR BORNE PARTICLE COUNT TEST & RECOVERY RATE TEST) December 20, 2020 Sterile Area
10 Pass Box (S22)Test Reports (FILTER AIR VELOCITY VERIFICATION TEST & INSTALLED HEPA FILTER LEAK TEST & PRESSURE DIFFERENCE ACROSS HEPA FILTERS TEST & AIR BORNE PARTICLE COUNT TEST & RECOVERY RATE TEST) December 20, 2020 Sterile Area
11 Pass Box (S24)Test Reports (FILTER AIR VELOCITY VERIFICATION TEST & INSTALLED HEPA FILTER LEAK TEST & PRESSURE DIFFERENCE ACROSS HEPA FILTERS TEST & AIR BORNE PARTICLE COUNT TEST & RECOVERY TIME TEST) December 20, 2020 Sterile Area
12 Pass Box (S25) Test Reports (FILTER AIR VELOCITY VERIFICATION TEST & INSTALLED HEPA FILTER LEAK TEST & PRESSURE DIFFERENCE ACROSS HEPA FILTERS TEST & AIR BORNE PARTICLE COUNT TEST & RECOVERY TIME TEST) December 20, 2020 Sterile Area
13 Pass Box (S28) Test Reports (FILTER AIR VELOCITY VERIFICATION TEST & INSTALLED HEPA FILTER LEAK TEST & PRESSURE DIFFERENCE ACROSS HEPA FILTERS TEST & AIR BORNE PARTICLE COUNT TEST & RECOVERY TIME TEST) December 20, 2020 Sterile Area
14 Dispensing LAF REQ  Protocol & Annex December 20, 2020 Ware House (Sampling Room WH14)