SOP For Environmental Monitoring of Injectable Facility Report

Form No.
: SOP/SL/006/F/01
Microbiological Environmental Monitoring of Injectable Facility Report
Attachment (A)
GUIDELINE OF NUMBER OF SAMPLING POINTS FOR AIR MONITORING CLASS 100

OF INJECTABLE FACILITY
Position
for
Position for Intensive
Activity/Works Routine Monitori Freque Alert Action
Room Area Monitoringa nga ncy Limit Limit
Room Ampoule/vial Each — 1 CFU/4 h
no. filling working
— 1 CFU/m3
shift or
at least 1 3 CFUs/m3
twice a CFU/m
3
week
Room Loading freeze — 1 CFU/4 h
Form No.: SOP/SL/006/F/01
no. dryer/at rest — 1 CFU/m3

1 3 CFUs/m3
CFU/m
3
Room Syringe filling — 1 CFU/4h

no.
— 1 CFU/m3
1 3 CFUs/m3
CFU/m
3
Room Unloading — 1 CFU/4h

no. autoclave
— 1 CFU/m3
1 3 CFUs/m3
CFU/m
3
Room Pass box — 1 CFU/4h

no.
— 1 CFU/m3
LAF Pass box — 1 CFU/4h
path — 1 CFU/m3
Room Gowning 1 3 CFUs/m3
no. CFU/m
3
Room Sterilization and — 1 CFU/m3

no. depyrogenation
tunnel
Washing area 1 3 CFUs/m3
CFU/m
3
Room LAF path — 1 CFU/4 h

no.
Weighing area 1 3 CFUs/m3
CFU/m
3
Samplin LAF 2 — 1 CFU/4 h

g
room LAF 1 1 3 CFUs/m3
CFU/m
3
LAF 2 1 3 CFUs/m3
CFU/m
3
Notes:
a
S = settled plate; R = RCS + air sampler; M = M air T air sampler.
The sampling frequency and number of sampling positions can be decreased or increased according
to the trend performance
Attachment (B)
GUIDELINE OF NUMBER OF SAMPLING POINTS FOR

SURFACE MONITORING CLASS 100 OF INJECTABLE FACILITIES
Routine Freque Alert Action
Activity Room Monitoringa Intensive Monitoringa ncy Limit Limit
Ampoule/ Room no. Vial machine, Vial filling machine (two Each — 1 CFU
vial ampoule positions), ampoule filling working
filling machine, vial machine (two positions), each shift or
inlet, filling vial hopper, each curtain, vial at least
needles inlet, filling needles (nozzles), twice a
(nozzles), filling filling tank, each control panel, week
tank, ampoule each tool, table, storage
inlet, conveyor, containers, conveyor (four
curtain, mobile positions), ampoule inlet,
LAF (wall, two mobile LAF (wall, each shelf)

shelves)
Wall, floor, Wall, wall near machine, 1 CFU 3 CFUs
corner, control doorknob, above the door,
panel, mobile floor beneath the machine,
LAF (door each control panel, floor below
handle and outer the door, chairs, belts of
surface) moving benches or chairs,
waste containers, corners
(especially unused), mobile
LAF (door handle, glass, outer
surface and movable belt)
Loading/ Room no. Inlet and outlet Conveyor (five positions), — 1 CFU
unloading of conveyor, F. tray, moving parts (two
freeze D. door, tray, positions), each curtain, tray
dryer curtain (five positions), F.D. door,
inner floor
Wall, floor, Wall, wall near machine, 1 CFU 3 CFUs
panel, corner doorknob, above the door,
floor beneath the F.D., floor

below the door, chamber,
control panel, each used tool,
table, chairs, belts of moving
benches or chairs, waste
contain-ers, corner (especially
unused)
Syringe Room no. Machine surface, Machine, storage containers, — 1 CFU
filling filling needles, machine surface, filling
filling tank, needles, filling tank (two
hopper positions), hopper, each
curtain
Wall, floor, Wall, wall near doorknob, 1 CFU 3 CFUs
control panel, above the door, floor beneath
corner, conveyor the machine, floor below the
door, control panel, each tool,
table, chairs, belts of moving
benches or chairs, waste
containers, corners (especially
unused)
Unloading Room no. Wall, floor, Wall, wall near autoclave, 1 CFU 3 CFUs
autoclave autoclave doorknob, above autoclave
surface, control door, floor beneath autoclave,
panel, movable autoclave surface, control
table, corner panel, each tool, table, chairs,
belts of moving benches or
chairs, waste contain-ers,
corners (especially unused)
Syringe Room no. Wall, floor Wall, floor beneath door, each — 1 CFU
pass box tool inside, corners
Doorknob, door control unit 1 CFU 3 CFUs
Routine Freque Alert Action
Activity Room Monitoringa Intensive Monitoring a
ncy Limit Limit
LAF path LAF Path Wall, floor Wall, floor beneath the door, — 1 CFU
each tool inside, corners
Doorknob, door control unit 1 CFU 3 CFUs
Change Room no. Wall, floor Wall, doorknob, floor beneath 1 CFU 3 CFUs
room both doors, door control
units, cupboard, mirror,
corners
Commodity Room no. Sink, curtain, Sink, curtain, wall (two 1 CFU 3 CFUs
washing wall, bench positions), bench (two
positions), glass, each vessel
LAF LAF Wall, floor Wall, floor, each tool inside, — 1 CFU
(room corner
no.) Doorknob, door control unit 1 CFU 3 CFUs
Weighing Weighing Curtain, wall, Curtain, wall (two points), 1 CFU 3 CFUs
Area table, floor table, scalor, balance, floor
(room (two points)
no.)
Sampling LAF1 Wall, floor Wall, curtain, plate, floor 1 CFU 3 CFUs
samplin
g
room
Sampling LAF2 LAF (screen, LAF (screen, wall, left side, — 1 CFU
samplin wall, floor) right side, electrical socket,
g room floor)
LAF surface, LAF surface, curtain, wall 1 CFU 3 CFUs
curtain, wall, (two points), floor (two
floor points), chair
a
The sampling frequency and number of sampling positions can be decreased or increased according to
the trend performance.
Microbiological Environmental Monitoring of Injectable
Facility Report
Attachment (C)
GUIDELINE OF NUMBER OF SAMPLING POINTS FOR AIR

MONITORING OF STERILITY TESTING ROOM
Position for Position for

Room/ Routine Intensive Frequen Alert Action
Activity Monitoring Monitoringa
a
cy Limit Limit
Testing Holten safe Holten safe Each — 1
LAF: LAF: operatin CFU/m
3
g
day or
Near Near 0.1 0.3
at least
entrance, entrance, CFU/m CFU/m
twice/ 3 3
center center,
week
near left
side
Incubatio Near Near 10 20
n entrance, entrance, CFUs/ CFUs/
near center near m3 m3
center,
near
incubators
Change Near Near Twice/ 10 20
entrance entrance week CFUs/ CFUs/
After bench Near m3 m3
lockers
After bench,
near mirror
Notes: S = settled plate; R = RCS + air sampler.

a
The sampling frequency and number of sampling positions can be
decreased or increased according to the trend performance.
Facility Report
Attachment (D)
GUIDELINE OF NUMBER OF SAMPLING POINTS FOR

SURFACE MONITORING OF STERILITY TESTING ROOM
Position
for
Routine Position for
Room/ Monitorin Intensive Frequenc Alert Action
a a
Activity g Monitoring y Limit Limit
Testing Holten Holten safe Each — 1 CFU
safe LAF LAF: operating
(screen, (electrical
wall, socket, screen, day or
floor) wall, floor, left at least
steritest side, right twice/we
surface side) surface ek
of steritest
(two points)
Surface of Surface of 1 CFU 3
LAF, LAF, chair, CFUs
door door handle,
handle, doorknob wall
wall, (two points),
corner, corner, floor
floor (two points)
Incubatio Incubator Incubator (1), Each 0.3 0.5
n (1), incubator (2), operating CFU CFU
incubator table, writing day or
(2), table, table, chair, at least
door door handle, twice/we
handle, door knob, ek
wall, wall (two
corner, points), corner,
floor floor (two 0.5 10
points) CFU CFUs
Changing Wall, Wall (two Twice/ 0.3 0.5
hanger, points), week CFU CFU
bench, hanger, bench,
floor, mirror, door
corner handle, floor
Facility Report
(two points), 0.5 10

corner CFU CFUs
a
Attachment (E)
GUIDELINE OF NUMBER OF SAMPLING POINTS

FOR AIR MONITORING CLASS 10,000
AND CLASS 100,000 OF INJECTABLE FACILITY
Position Position
for for
Routine Intensive Actio
Monitori Monitorin Frequenc Alert n
Activity Room nga ga y Limit Limit
Production Provide Once/ 25 50
corridor room week CF CF
no. Us Us
Syringe Provide Twice/ 0.5 10
preparatio room week CF CF
n no. U Us
Change Provide Twice/ 20 35
room room week CF CF
no. Us Us
Coding Provide Each 0.5 10
room room oper- CF CF
no. ating day U Us
or at
least
twice/
week
Air lock Provide Twice/ 25 50
washing room week CF CF
no. Us Us
Packaging Provide Once/ 25 50
room week CF CF
Facility Report
no. Us Us
Washing Provide Once/ 25 50
area room week CF CF
no. Us Us
Air lock Provide Twice/ 0.5 10
for room week CF CF
materials no. U Us
Personnel Provide Twice/ 0.5 10
air lock room week CF CF
no. U Us
Position Position
for for
Monitori Monitorin Frequenc Alert n
Activity Room nga ga y Limit Limit
Solution Provide Each 0.5 10
preparatio room oper- CF CF
n no. ating day U Us
or at
least
twice/
week
LAF Provide Each 0.5 10
room oper- CF CF
no. ating day U Us
or at
least
twice/
week
Vial Provide Twice/ 0.5 10
capping room week CF CF
no. U Us
Commodit Provide Each 0.5 10
y room oper- CF CF
washing no. ating day U Us
or at
least
twice/
week
Facility Report
Packaging Provide Once/ 25 50

room week CF CF
no. Us Us
Loading Provide Each 0.5 10
freeze room unloadin CF CF
dryer no. g U Us
Solution Provide Each 0.5 10
room room oper- CF CF
no. ating day U Us
or at
least
twice/
week
Personnel Provide Once/ 25 50
air lock room week CF CF
no. Us Us
Sampling Samplin Twice/ 25 50
room g week CF CF
room Us Us
a
Attachment (F)
GUIDELINE OF NUMBER OF SAMPLING POINTS

FOR SURFACE MONITORING CLASS 10,000
AND CLASS 100,000 OF INJECTABLE FACILITY
Monitorin Monitorin Frequenc Alert n
Activity Room ga ga y Limit Limit
Production Provid Wall (two Wall Once 25 50
corridor e (three /week CF CFU
room positions positions Us
no. ) ), door
handles,
trays
Facility Report
Glass 50 100
Floor (two CF CFU
(two positions Us
positions )
) Floor
(three
positions
)
Syringe Provid Wall Wall, Twice 0.3 0.5
preparatio e Conveyor, floor, /week CF CFU
n room curtain door U s
no. handle, 0.1 0.3
electrical CF CFU
box, U s
panel
Floor conveyor
, curtain
Floor, 0.5 10
corner CF CFU
U s
Change Provid Wall Wall, Twice 15 25
room e sink, /week CF CFU
room gown Us s
no. shelf,
Floor drier
Floor 15 30
(two CF CFU
positions Us s
), corner
Monitorin Monitorin Frequenc Alert n
a a
Activity Room g g y Limit Limit
Coding Provid Wall, Wall, Each 0.3 0.5
room e machine machine, oper- CF CFU
room table, ating day U
no. trolley or at
Floor Floor least 10
(two twice/ 0.5 CFU
positions week CF s
), corner U
Facility Report
Air lock Provid Wall Wall (two Once 25 50

washing e positions /week CF CFU
room ), doors Us s
no. handles
Floor Floor
(two 50 100
positions CF CFU
), corner Us s
Packaging Provid Wall Wall (two Once 25 50
e positions /week CF CFU
room ), Us s
no. machine,
Floor table
Floor 50 100
(two CF CFU
positions Us s
), corner
Washing Provid Wall Wall, Once 25 50
area e gown /week CF CFU
room hanger, Us s
no. Floor table
Floor 50 100
(two CF CFU
positions Us s
), drain,
corner
a
Facility Report
Attachment (F)
Monitorin Monitorin Frequen Alert n
Activity Room ga ga cy Limit Limit
Air lock Provid Wall Wall (two Once 0.3 0.5
for e positions) /week CF CF
material room , door U U
no. handles
Floor Floor (two
positions) 0.5 10
, corner CF CF
U Us
Personnel Provid Wall Wall (two Once 0.3 0.5
air lock e positions) /week CF CF
room , sink, U U
no. Floor shelf
Floor (two 0.5 10
positions) CF CF
, corner U Us
Solution Provid Wall, prep. Wall (two Each 0.3 0.5
preparatio e tank, positions) oper- CF CF
n room mobile , prep. ating U U
no. tank, table tank, day
mob. or at
tank, least
table, twice/
panel, week
Homogeniz balance,
e tools 0.5 10
Floor Homogeniz CF CF
e U Us
Floor (two
positions)
, corner
LAF Provid Wall, Wall (two Each 0.3 0.5
e table, points), oper- CF CF
room cage table, ating U U
no. cage, door day or at
handle least
Floor twice
Facility Report
Floor, (three /week 0.5 10

corner points), CF CF
corner U Us
Monitorin Monitorin Frequen Alert n
a a
Activity Room g g cy Limit Limit
Vial Provid Wall, Wall (two Twice 0.3 0.5
capping e hopper, positions) /week CF CF
room machine , hopper, U U
no. surface, machine
conveyor, surface,
panel conveyor,
panel,
glass,
hopper
Floor Floor (two
positions) 05 10
, corner CF CF
U Us
Commodit Provid Wall, Wall (two Each 0.3 0.5
y e washing positions) oper- CF CF
washing room machine, , washing ating U U
no. table, machine, day or at
electric electric least
panel panel twice
sink, /week
autoclave
door,
Floor table,
trolley 0.5 10
Floor (two CF CF
positions) U Us
, corner
Packaging Provid Wall, Wall (two Once 25 50
e machine positions) /week CF CF
room surface , panel, Us Us
no. machine
surface,
machine
tray,
Floor Floor (two
Facility Report
positions) 50 100
, corner CF CF
Us Us
a
Facility Report
Attachment (F)
Routine Actio
Monitori Intensive Alert n
Activity Room nga Monitoringa Frequency Limit Limit
Loading Provide Wall, Wall, During 0.3 0.5
freeze room no. corner, conveyor, unloading CFU CFU
dryer conveyor moving process
belts, door
knob, glass
Floor Floor, corner 0.5 10
CFU CFU
s
Solution Provide Wall, Wall (two Each oper- 0.3 0.5
room room no. table, positions), ating day CFU CFU
mobile table, filter or at least
tank (top cover, LAF twice
dish, control unit, /week
surface) mobile tank
(top dish,
surface,
nitrogen
hose,
silicon
Floor hose) 0.5 10
Floor (two CFU CFU
positions), s
corner
Sampling Sampling Wall Wall, drier, Once 25 50
room sink, /week CFU CFU
room refrigerator, s s
scalor
Floor Floor (two
points), 50 100
corner CFU CFU
s s
Personnel Provide Wall Wall (two Once 25 50
air lock room no. points), /week CFU CFU
shelves s s
Floor Floor (two
Facility Report
points), 50 100
corner CFU CFU
s s
Facility Report
Attachment (G)
THE POSSIBLE SAMPLING POINT OF THE GOWNING
SUITES
Facility Report
Attachment (H)
Facility Report
Attachment (I)
ENVIRONMENTAL EXCURSION INVESTIGATION

REPORT: MICROBIAL AIR MONITORING OF
INJECTABLE PLANT
Microbial Air Monitoring of Injectable Plant
Date: ____________ Time: _____________ Room No.:_________

Product: _____________________________ Batch No.: _________
Cleaner Name: ________________________ ID No.: __________
ALERT ACTION RESULTS
LIMIT LIMIT
Trend: Isolated Excursion Frequent Excursion 

Microbial Identification:
Microbiological Section Head

QA Investigation
Performed by: Reviewed by:
Area environmental monitoring trend:

Materials handled inside the room:
HEPA filter status:
Unusual events during processing:
Method of sampling:
Other environmental monitoring data in the area:
Sanitization records:
RH/temperature of the area:
Facility Report
Pressure differential of the area:

Source of particulate count:
Personnel hygiene:
Visual inspections:
Comments:
Corrective actions (performed by production):
Conclusion:
___________________________
_____________________________
QC Manager QA Manager
cc: QA File/Area Manager/QC Microbiology

Facility Report
Attachment (J)

REPORT: SURFACE MONITORING OF INJECTABLE
FACILITY
Surface Monitoring of Injectable Facility
Date: ____________ Time: _____________ Room No.:_________

Product: _____________________________ Batch No.: _________
Cleaner Name: ________________________ ID No.: ___________
LIMIT LIMIT
Trend: Isolated Excursion  Frequent Excursion 


QA Investigation
Area environmental monitoring trend:

Cleaner training record:
Cleaner glove and gowning monitor:
Method of sampling:
Other environmental monitoring data in the area:
Microbiological status of used disinfectant:
Facility Report
Microbiological status of preparation water:

Holding time of the disinfectant:
Status of cleaning tools:
Visual inspections:
Comments:
Conclusion:
___________________________
______________________________

Facility Report
Attachment (K)

REPORT: PERSONNEL HYGIENE MONITORING
OF STERILE PRODUCT PREPARATION
Personnel Hygiene Monitoring of Sterile Product Preparation
Date: ____________ Time: _____________ Room No.:_________

Product: _____________________________ Batch No.: _________
Cleaner Name: ________________________ ID No.: ___________
LIMIT LIMIT
Trend: Isolated Excursion  Frequent Excursion 


QA Investigation
Operator training record:

Operator glove and gowning trend:
Gowning sterilization cycle:
Operator aseptic technique:

Facility Report
Comments:
Conclusion:
___________________________
______________________________

Facility Report
SOP No.: 1700.80

Issued On: mm/dd/yyyy
Revision No. New
Attachment (L)
QUALITY CONTROL DEPARTMENT

Microbological Laboratories
VISUAL INSPECTION REPORT
Written by: Date:

Plant: Activity:
Descriptio
Operat n
Roo or of Recommenda
Observation/Deviation Result m ID No. Deviation Nature of Citation tion
Personnel Hygiene Mino Majo Critic
r r al
Sick operator (flu or cold) Ye N

s o
Improper gowning Ye N
s o
Dirty gowning Ye N
s o
Long nail Ye N
s o
Wearing jewelry Ye N
s o
Personnel Behavior
Shouting Ye N
s o
Running/fast movement Ye N
s o
Crowding Ye N
s o
Touching/sitting on floor Ye N
s o
Cleaning
Dust/Dirt on the area Ye N
s o
Unclean equipments Ye N
s o
Dirty cages/pallets Ye N
s o
Absence of hand Ye N
disinfectant s o
Absence of alcohol Ye N
s o
Others
Ye N
______________________ s o
__
Ye N
s o
______________________
__ Ye N
s o
______________________
Ye N
__
s o
______________________
__
______________________
__
______________________
__
______________________
__
______________________
__
Prepared by: Checked by:

QC Manager:

SOP For Environmental Monitoring of Injectable Facility Report

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

SOP For Environmental Monitoring of Injectable Facility Report

Uploaded by

Copyright:

Available Formats

Form No.

GUIDELINE OF NUMBER OF SAMPLING POINTS FOR AIR MONITORING CLASS 100

no. dryer/at rest — 1 CFU/m3

Room Syringe filling — 1 CFU/4h

Room Unloading — 1 CFU/4h

Room Pass box — 1 CFU/4h

Room Sterilization and — 1 CFU/m3

Room LAF path — 1 CFU/4 h

Samplin LAF 2 — 1 CFU/4 h

GUIDELINE OF NUMBER OF SAMPLING POINTS FOR

LAF (wall, two mobile LAF (wall, each shelf)

floor beneath the F.D., floor

GUIDELINE OF NUMBER OF SAMPLING POINTS FOR AIR

Position for Position for

Notes: S = settled plate; R = RCS + air sampler.

GUIDELINE OF NUMBER OF SAMPLING POINTS FOR

(two points), 0.5 10

GUIDELINE OF NUMBER OF SAMPLING POINTS

Packaging Provide Once/ 25 50

GUIDELINE OF NUMBER OF SAMPLING POINTS

Air lock Provid Wall Wall (two Once 25 50

Floor, (three /week 0.5 10

ENVIRONMENTAL EXCURSION INVESTIGATION

Date: ____________ Time: _____________ Room No.:_________

Trend: Isolated Excursion Frequent Excursion 

Microbiological Section Head

Area environmental monitoring trend:

Pressure differential of the area:

Corrective actions (performed by production):

cc: QA File/Area Manager/QC Microbiology

ENVIRONMENTAL EXCURSION INVESTIGATION

Date: ____________ Time: _____________ Room No.:_________

Trend: Isolated Excursion  Frequent Excursion 

Microbiological Section Head

Area environmental monitoring trend:

Microbiological status of preparation water:

Corrective actions (performed by production):

cc: QA File/Area Manager/QC Microbiology

ENVIRONMENTAL EXCURSION INVESTIGATION

Date: ____________ Time: _____________ Room No.:_________

Trend: Isolated Excursion  Frequent Excursion 

Microbiological Section Head

Operator training record:

Gowning sterilization cycle:

Operator aseptic technique:

Corrective actions (performed by production):

cc: QA File/Area Manager/QC Microbiology

SOP No.: 1700.80

QUALITY CONTROL DEPARTMENT

Written by: Date:

Sick operator (flu or cold) Ye N

Prepared by: Checked by:

You might also like

Date: ______ Time: _ Room No.:___

Date: ______ Time: _ Room No.:___

Date: ______ Time: _ Room No.:___