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19AK02.HQ00035, WFI03 OOS #163455 - ID Delftia acidovorans / lacustris /…
19AK02.HQ00035
CLEANING
SD85:
Flush 1 (2025.02.02) - PU23 (T3004) ~80ºC
Flush 2 (Chematic) (2025.02.03) - PU23 (T3004) ~80ºC
Flush 3 (2025.02.04) - PU23 (T3004) RT
Flush 4 (2025.02.05) - PU23 (T3004) RT
Flush 5 (2025.02.07) - PU26 (POU1) ~80ºC
Flush 6 (15 days cleaning) (2025.02.21-26) - PU26 (T1506) -
7 repetitions
~80ºC
Rep 8: PU23 (T3004) RT
Rep 9: PU23 (T3004) RT :warning:
Rep 10: WFI ~40ºC -
MICRO samples
SD85 MICRO samples (15 days):
CIC66 - 0 CFU/mL ; 40 CFU/100mL
Burkholderia cepacia compex
Delftia acidovorans / lacustris / tsuruhatensis
CIC67 - 3 CFU/mL ; 72 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola
/Stenotrophomonas lactitubi /
maltophilia
Burkholderia cepacia complex
Delftia acidovorans / lacustris / tsuruhatensis
T191:
Flush 1 (2025.02.01) - PU26 (POU1) ~80ºC
Flush 2 (2025.02.02) - PU26 (POU1) ~40ºC -
MI
Flush 3 (2025.02.02) - PU26 (POU1) ~40ºC -
MI
15 DAYS:
Flush (2025.02.14) - PU26 (POU1) ~80ºC
Flush (2025.02.18-21) - PU26 (POU1) ~40ºC
RESÍDUE:
Flush 1 (2025.02.22) - PU26 (POU1) ~40ºC
Flush Acetone (2025.02.22) - T3004 :warning: :
Flush acetone removal (2025.02.22) - PU26 (POU1) ~40ºC
Flush remoção rep (2025.02.23-24) - PU26 (POU1) ~80ºC
Flush WFI (2025.02.24) - PU26 (POU1) ~40ºC -
MICRO
samples
T191 MICRO samples:
F2 - 0 CFU/mL ; 0 CFU/100mL
F3 - 0 CFU/mL ; 0 CFU/100mL
15 DAYS: 0 CFU/mL ; 15 CFU/100mL
Delftia acidovorans / lacustris / tsuruhatensis
19AK02.HQ00036
19AK02.HQ00037
19AK02.HQ00038
WFI03 OOS #163455 -
ID
Delftia acidovorans / lacustris / tsuruhatensis
Sampling 2025.04.09
T650 Sanitization date:
2025.02.03
2025.02.11
2025.02.14
2025.02.28
2025.03.13
2025.03.27
2025.04.10
Thermal sanitization on 10 April 22h - 11 April 05h
(performed before SD85 preventive repetition)
Root-causes:
Possible microbiological contamination from sampling materials (WFI hose and/or thermal protection gloves during sample uptake)
Water sample contamination by simultaneous operations inside the cleanroom
Sampling PU23:
2025.04.04 0 CFU/mL
WFI01 (POU1):
2025.04.11 0 CFU/100mL
WFI02 (POU 2):
2025.04.07 0 CFU/100mL
WFI03 (POU3):
2025.04.09
>200 CFU/100mL
Event #162087 - PU23
- 36CFU/mL - ID
Burkholderia cepacia complex (Bcc)
Sampling 2025.03.14
Sampling PU23:
2025.01.31 - 0CFU/mL
2025.02.07 - 0CFU/mL
2025.02.14 - 0CFU/mL
2025.02.21 - 0CFU/mL
2025.02.28 - 0CFU/mL
2025.03.07 - 0CFU/mL
2025.03.14 -
36CFU/mL
Resamplings 2025.03.21, 2025.03.24, 2025.03.25
RC:
Possible presence of biofilm inside the purified hose used to transfer purified water from PU23 to tank T3004 due to the stagnation of purified water
PU23 used to feed PW to T3004 which was used in SD85 and T191
CLEANING
SD85:
Flush 1A (2025.03.07) - PU23 (T3004) ~80ºC
Flush 2A (2025.03.07) - PU23 (T3004) ~80ºC
Flush 1B (2025.03.08) - PU23 (T3004) ~80ºC
Flush 2B (2025.03.08) - PU23 (T3004) ~80ºC
Flush 2B repetititon (2025.03.08) - PU23 (T3004) ~80ºC
Flush 1C (2025.03.08) - PU23 (T3004) ~80ºC
Flush 2C (2025.03.08) - PU23 (T3004) ~80ºC
Flush 3 (2025.03.08-09) - PU23 (T3004) ~80ºC
Flush 4 (2025.03.09-10 + 12) - PU23 (T3004) – RT
Flush 5 (2025.03.13) - PU26 (POU3) ~80ºC
T191:
Flush 1 (2025.03.06) - PU26 (POU1) ~40ºC
Flush 2 (2025.03.07) - PU26 (POU1) ~40ºC
- MICRO samples
T191 MICRO samples:
2 CFU/mL ; 81 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
R211/CES:
Flush 1 (2025.03.08) - PU26 (POU2) ~80ºC
Flush 2 (2025.02.09) - PU26 (POU2) ~40ºC
Flush 3 (2025.03.09-10) - PU26 (POU2) ~40ºC
Flush 4 (2025.03.10) - PU26 (POU2) ~40ºC -
MICRO samples
R211/CES:
F5 - R211 - 0 CFU/mL; 0CFU/100mL
F5 - CES:
0 CFU/mL ; 0 CFU/100mL
0 CFU/mL ; 0 CFU/100mL
0 CFU/mL ; 0 CFU/100mL
WP302:
Flush 1 (2025.03.08) - PU26 (POU2) ~80ºC
Flush 2 (2025.02.09) - PU26 (POU2) ~40ºC
Flush 3 (2025.03.10) - PU26 (POU2) ~40ºC -
MICRO samples
WP302:
0 CFU/mL ; 0CFU/100mL
CLEANING
SD85:
Flush 1A – Drying chamber + cyclones (2025.03.21) - PU23 (T3004)
Flush 2A (Chematic) – Drying chamber + cyclones (2025.02.02) - PU23 (T3004)
Flush 1B – FM + HEPAs (2025.03.22) - PU23 (T3004)
Flush 2B (Chematic) – FM + HEPAs (2025.03.22) - PU23 (T3004)
Flush 1C – FM + HEPAs (2025.03.22) - PU23 (T3004)
Flush 2C (Chematic) – FM + HEPAs (2025.03.23) - PU23 (T3004)
Flush 3 (2025.03.23) - PU23 (T3004)
Flush 4 (2025.03.24) - PU23 (T3004) -
MICRO swabbing samples
:warning:
Flush 5 (2025.03.26) - PU26 (POU3) ~40ºC -
MICRO rinse samples
Flush 6 (2025.03.26) - PU26 (POU3) ~40ºC -
MICRO rinse samples
SD85 MICRO samples:
CIC66 (F5): 0 CFU/mL ; 0 CFU/100mL
CIC67 (F5): 1 CFU/mL ; 105 CFU/100mL
Delftia acidovorans / lacustris / tsuruhatensis
CIC66 (F6): 0 CFU/mL ; 64 CFU/100mL
Delftia acidovorans / lacustris / tsuruhatensis
CIC67 (F6): 1 CFU/mL ; 89 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Delftia acidovorans / lacustris / tsuruhatensis
T191:
Flush 1 (2025.03.22) - PU26 (POU1) ~40ºC
Flush 1 Rep (2025.03.23) - PU23 (T3004) ~40ºC :warning:
Flush 2 (2025.03.23) - PU26 (POU1) ~40ºC -
MI
Flush 3 (2025.03.23) - PU26 (POU1) ~40ºC -
MI
T191 MICRO samples:
F2: 0 CFU/mL ; 0 CFU/100mL
F3: 0 CFU/mL ; 35 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Penicillium discolor / solitum
R211/CES0701:
Flush 1 (Chematic) (2025.03.20-21) - PU23 (T3004) ~85ºC
Flush 2 (2025.03.21) - PU23 (T3004) RT :warning:
Flush 3 (2025.03.23-24) - PU26 (POU2) ~40ºC
Flush 4 (2025.03.25) - PU26 (POU2) ~40ºC -
MI
Flush 5 (2025.03.25) - PU26 (POU2) ~40ºC -
MI
R211/CES0701 MICRO samples:
F4 (R211): 0 CFU/mL ; 0 CFU/100mL
F4 (CES):
zone 1: 53 CFU/mL ; 201 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
zone 2: 0 CFU/mL ; 0 CFU/100mL
zone 3: 3 CFU/mL ; 201 CFU/100mL
Pseudomonas (Stenotrophomonas) beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
F5 (R211): 0 CFU/mL ; 10 CFU/100mL
F5 (CES):
zone 1: 37 CFU/mL ; 201 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Delftia acidovorans / lacustris / tsuruhatensis
zone 2: 16 CFU/mL ; 201 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
zone 3: 3 CFU/mL ; 201 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
WP302:
Flush 1 (Chematic) (2025.03.21) - PU23 (T3004) ~80ºC
Flush 2 (2025.03.21) - PU23 (T3004) RT :warning:
Flush 3 (2025.03.24) - PU26 (POU2) RT
WP302 MICRO samples:
0 CFU/mL ; 0 CFU/100mL
CLEANING
SD85:
Flush 1A (2025.04.05) - PU23 (T3004) ~80ºC
Flush 2A (2025.04.05) - PU23 (T3004 ~80ºC
Flush 1B (2025.04.05) - PU23 (T3004) ~80ºC
Flush 2B (2025.04.05) - PU23 (T3004) ~80ºC
Flush 1C (2025.04.05) - PU23 (T3004) ~80ºC
Flush 2C (2025.04.06) - PU23 (T3004) ~80ºC
Flush 3 (2025.04.06) - PU23 (T3004) - RT :warning:
Flush 4 (2025.04.06-07) - PU23 (T3004) - RT -
MICRO swabbing samples
Flush 5 (2025.04.09) - PU26 (POU3) ~40ºC -
MICRO rinse samples
Flush 6 (2025.04.09) - PU26 (POU3) ~40ºC -
MICRO rinse samples
SD85 MICRO samples:
CIC66 (F5): 0 CFU/mL ; >200 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Achromobacter piechaudii
CIC67 (F5): 1 CFU/mL ; 42CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
CIC66 (F6): 11 CFU/mL ; >200CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Delftia acidovorans / lacustris / tsuruhatensis
Burkholderia cepacia complex
CIC67 (F6): 0 CFU/mL ; 21CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Delftia acidovorans / lacustris / tsuruhatensis
SD85 preventive repetition:
Flush 6 (2025.04.12) - PU26 (POU3) ~80ºC -
MICRO rinse samples
SD85 MICRO samples:
CIC66 (F6): 2 CFU/mL ; 49 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
CIC67 (F6):
120 CFU/mL
:red_cross: ; 168 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Delftia acidovorans / lacustris / tsuruhatensis
SD85 after WFI POU3 OOS:
Flush 6 (2025.04.19) - PU26 (POU2) ~80ºC -
MICRO rinse samples
SD85 MICRO samples:
CIC66 (F6): 0 CFU/mL ; 1 CFU/100mL
Kocuria palustris
CIC67 (F6):
>200 CFU/mL
:red_cross: ; >200 CFU/100mL
Trichoderma atroviride
(fungi)
SD85:
Drying at 121ºC for 10h + Cyclone sanitization with Minncare
Flush 6 (2025.04.26) - PU26 (POU2) ~80ºC -
MICRO rinse samples
SD85 MICRO samples:
CIC66 (F6): 0 CFU/mL ; 0 CFU/100mL
CIC67 (F6): 0 CFU/mL ; 1 CFU/100mL
Penicillium aurantioviolaceum / cartierense / fusisporum / glabrum / roseoviride / valentinum
T191:
Flush 1 (2025.04.06) - PU26 (POU1) ~40ºC
Flush 1 repetition (2025.04.06) - PU26 (T3004) ~40ºC
Flush 2 (2025.04.07) - PU26 (T1506) ~40ºC -
MICRO rinse samples
Flush 3 (2025.04.07) - PU26 (T1506) ~40ºC
Flush 3 repetition (2025.04.07) - PU26 (T1506) ~40ºC -
MICRO rinse samples
Flush 3 (2nd) repetition (2025.04.07) - PU26 (T1506) ~40ºC -
MICRO rinse samples
Flush 3 (3rd) repetition (2025.04.07) - PU26 (T1506) ~40ºC -
MICRO rinse samples
T191 MICRO samples:
F2: 11 CFU/mL ; >200CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Delftia acidovorans / lacustris / tsuruhatensis
F3 (1x): 1 CFU/mL ; >200CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Delftia acidovorans / lacustris / tsuruhatensis
(2x): 1 CFU/mL ; 45CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Delftia acidovorans / lacustris / tsuruhatensis
(3x): 1 CFU/mL ; 59CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Kocuria arsenatis / rhizophila / tytonis
T191:
Flush 3 preventive repetition (2025.04.12) - PU26 (POU1) ~80ºC -
MICRO rinse samples
T191 MICRO samples:
F3: 0 CFU/mL ; 0 CFU/100mL
R211/CES0701:
Flush 1 (2025.04.05) - PU26 (POU2) ~80ºC
Flush 2 (2025.04.06) - PU26 (POU2) ~40ºC
Flush 3 (2025.04.06) - PU26 (POU2) ~40ºC
Flush 4 (2025.04.08-09) - PU26 (POU2) ~40ºC -
MICRO rinse samples
Flush 5 (2025.04.09) - PU26 (POU2) ~40ºC -
MICRO rinse samples
R211/CES0701 MICRO samples:
F4 (R211): 0 CFU/mL ; 0CFU/100mL
F4 (CES): 1 CFU/mL ; 50 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Burkholderia cepacia complex
1 CFU/mL ; >200 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
Delftia acidovorans / lacustris / tsuruhatensis
0 CFU/mL ; 40 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
F5 (R211): 0 CFU/mL ; 0CFU/100mL
F5 (CES): 0 CFU/mL ; 0 CFU/100mL
9 CFU/mL ; >200 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
1 CFU/mL ; >200 CFU/100mL
Stenotrophomonas beteli / geniculata / hibiscicola /Stenotrophomonas lactitubi /
maltophilia
R211/CES:
Flush 5 preventive repetition (2025.04.13) - PU26 (POU2) ~80ºC -
MICRO rinse samples
R211/CES MICRO samples:
F5 (R11): 0 CFU/mL ; 0 CFU/100mL
F5 (CES): 0 CFU/mL ; 0 CFU/100mL
0 CFU/mL ; 0 CFU/100mL
0 CFU/mL ; 0 CFU/100mL
WP302:
Flush 1 (2025.04.05) - PU26 (POU2) ~80ºC
Flush 2 (2025.04.06) - PU26 (POU2) ~40ºC
Flush 3 (2025.04.06) - PU26 (POU2) ~40ºC -
MICRO rinse samples
WP302 MICRO samples:
0 CFU/mL ; 0CFU/100mL
WP302:
Flush 3 preventive repetition (2025.04.13) - PU26 (POU2) ~80ºC -
MICRO rinse samples
WP302 MICRO samples:
0 CFU/mL ; 0CFU/100mL
VQi #162828 :!!:
VQi #162828 :!!:
VQi #162828 :!!:
T3004 used for all equipment!
T3004 used for all equipment!
VQi #163595 :!!:
Sampling PU26:
2025.01.31 - 0CFU/mL
2025.02.07 - 0CFU/mL
2025.02.14 - 0CFU/mL
2025.02.21 - 0CFU/mL
2025.02.28 - 0CFU/mL
2025.03.07 - 0CFU/mL
2025.03.14 -
16CFU/mL
Pure acetone in T3004: Not efective to remove biofilms
T191 cleaning with WFI at 40ºC not effective to remove biofilms from previous cleaning
CES0701 possible contamination (excluded for R211):
R211 and CES0701 connected by a hose
Flush 4 R211 with a MI sample
Flush 4 CES0701 with MI samples
CES0701 sampling through R211 - CES contamination
VQi #162828 :!!:
T3004 used for SD85!
Root-cause:
CIP Setup hose not placed in sanitization station prior to flush
WFI system conform since:
POU1 and POU2 used to feed WFI at 80ºC with 0CFU/mL.
R211 on 2025.04.09 with 0 CFU/mL (POU2).
Root-cause:
Lack of instructions to clean and sanitize the cyclones discharge piping
VQi #163595 :!!:
Sampling PU23
:
2025.01.31 0CFU/mL
2025.02.28 0 CFU/mL
2025.03.07 0 CFU/mL
WFI01 (POU1):
2025.02.27 0 CFU/100mL
WFI02 (POU 2):
2025.02.16 0 CFU/100mL
WFI03 (POU3):
2025.03.04 0 CFU/100mL
WFI01 (POU1):
2025.03.21 0 CFU/100mL
WFI02 (POU 2):
2025.03.17 0 CFU/100mL
WFI03 (POU3):
2025.03.19 0 CFU/100mL
Sampling PU23:
2025.03.21 0 CFU/mL
2025.03.24 0 CFU/mL
2025.03.25 0 CFU/mL
2025.03.28 0 CFU/mL
WFI01 (POU1):
2025.03.28 0 CFU/100mL
WFI02 (POU 2):
2025.03.24 0 CFU/100mL
WFI03 (POU3):
2025.03.26 0 CFU/100mL